1. U.S. Code
  2. title 42
  3. chapter 6A
  4. subchapter II
  5. part B
  6. § 247b-9a

Collapse to view only § 247b-9a. Better diabetes care

§ 243. General grant of authority for cooperation
(a) Enforcement of quarantine regulations; prevention of communicable diseases
(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees
(c) Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States
(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (including epidemics and health emergencies).
(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received.
(July 1, 1944, ch. 373, title III, § 311, 58 Stat. 693; Pub. L. 89–749, § 5, Nov. 3, 1966, 80 Stat. 1190; Pub. L. 90–174, § 4, Dec. 5, 1967, 81 Stat. 536; Pub. L. 91–515, title II, § 282, Oct. 30, 1970, 84 Stat. 1308; Pub. L. 94–317, title II, § 202(b), (c), June 23, 1976, 90 Stat. 703; Pub. L. 97–35, title IX, § 902(c), Aug. 13, 1981, 95 Stat. 559; Pub. L. 97–414, § 8(d), Jan. 4, 1983, 96 Stat. 2060; Pub. L. 99–117, § 11(a), Oct. 7, 1985, 99 Stat. 494.)

CITE AS: 42 USC 243

§ 244. Public access defibrillation programs
(a) In general
The Secretary shall award grants to States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs—
(1) by training and equipping local emergency medical services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary resuscitation and automated external defibrillation, to cardiac arrest victims;
(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims;
(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;
(4) by providing training to members of the public in cardiopulmonary resuscitation and automated external defibrillation;
(5) by integrating the emergency medical services system with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators in their community; and
(6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide training for their employees to administer cardiopulmonary resuscitation and external automated defibrillation to cardiac arrest victims in their community.
(b) Preference
In awarding grants under subsection (a), the Secretary shall give a preference to a State, political subdivision of a State, Indian tribe, or tribal organization that—
(1) has a particularly low local survival rate for cardiac arrests, or a particularly low local response rate for cardiac arrest victims; or
(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access defibrillation program.
(c) Use of funds
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to—
(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;
(2) provide automated external defibrillation and basic life support training in automated external defibrillator usage through nationally recognized courses;
(3) provide information to community members about the public access defibrillation program to be funded with the grant;
(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in public places;
(5) produce materials to encourage private companies, including small businesses, to purchase automated external defibrillators;
(6) establish an information clearinghouse, that shall be administered by an organization that has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden death, that provides information to increase public access to defibrillation in schools; and
(7) further develop strategies to improve access to automated external defibrillators in public places.
(d) Application
(1) In general
(2) Contents
An application submitted under paragraph (1) shall—
(A) describe the comprehensive public access defibrillation program to be funded with the grant and demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community;
(B) contain procedures for implementing appropriate nationally recognized training courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators;
(C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with the local emergency medical services system in the oversight of training and notification of incidents of the use of the automated external defibrillators;
(D) contain procedures for proper maintenance and testing of the automated external defibrillators, according to the labeling of the manufacturer;
(E) contain procedures for ensuring notification of local emergency medical services system personnel, including dispatchers, of the location and type of devices used in the public access defibrillation program; and
(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.
(e) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 312, as added Pub. L. 107–188, title I, § 159(c), June 12, 2002, 116 Stat. 634; amended Pub. L. 108–41, § 2, July 1, 2003, 117 Stat. 839; Pub. L. 111–148, title X, § 10412, Mar. 23, 2010, 124 Stat. 990.)

CITE AS: 42 USC 244

§ 244–1. Repealed. Pub. L. 94–484, title V, § 503(b), Oct. 12, 1976, 90 Stat. 2300

CITE AS: 42 USC 244-1

§ 244a. Repealed. Pub. L. 93–353, title I, § 102(a), July 23, 1974, 88 Stat. 362

CITE AS: 42 USC 244a

§ 245. Public awareness campaign on the importance of vaccinations
(a) In general
(b) Consultation
(c) RequirementsThe campaign under this section shall—
(1) be a nationwide, evidence-based media and public engagement initiative;
(2) include the development of resources for communities with low rates of vaccination, including culturally and linguistically appropriate resources, as applicable;
(3) include the dissemination of vaccine information and communication resources to public health departments, health care providers, and health care facilities, including such providers and facilities that provide prenatal and pediatric care;
(4) be complementary to, and coordinated with, any other Federal, State, local, or Tribal efforts, as appropriate; and
(5) assess the effectiveness of communication strategies to increase rates of vaccination.
(d) Additional activitiesThe campaign under this section may—
(1) include the use of television, radio, the internet, and other media and telecommunications technologies;
(2) include the use of in-person activities;
(3) be focused to address specific needs of communities and populations with low rates of vaccination; and
(4) include the dissemination of scientific and evidence-based vaccine-related information, such as—
(A) advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development;
(B) information on vaccinations for individuals and communities, including individuals for whom vaccines are not recommended by the Advisory Committee for Immunization Practices, and the effects of low vaccination rates within a community on such individuals;
(C) information on diseases that may be prevented by vaccines; and
(D) information on vaccine safety and the systems in place to monitor vaccine safety.
(e) EvaluationThe Secretary shall—
(1) establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section;
(2) conduct qualitative assessments regarding the awareness campaign under this section; and
(3) prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives an evaluation of the awareness campaign under this section.
(f) Supplement not supplant
(g) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 313, as added Pub. L. 116–260, div. BB, title III, § 311(a), Dec. 27, 2020, 134 Stat. 2923.)

CITE AS: 42 USC 245

§ 245a. Repealed. Pub. L. 94–484, title V, § 503(b), Oct. 12, 1976, 90 Stat. 2300

CITE AS: 42 USC 245a

§ 246. Grants and services to States
(a) Comprehensive health planning and services
(1) In order to assist the States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the administration of the State’s health planning functions under the plan;
(B) provide for the establishment of a State health planning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in whole or in part within the State), and of consumers of health services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services;
(C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the people of the State and including environmental considerations as they relate to public health;
(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds;
(F) provide such methods of administration (including methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from time to time, but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and recommend appropriate modification thereof;
(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this subsection; and
(K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection.
(3)
(A) From the sums appropriated for such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State’s plan approved thereunder, until the close of the succeeding fiscal year.
(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.
(4) From each State’s allotment for a fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The “Federal share” for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per centum of such cost.
(b) Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents
(1)
(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a), project grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local government where the recipient of the grant is not a local government or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the foreseeable future, any agency or organization which is qualified for such a grant will file application therefor.
(2)
(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services.
(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner.
(c) Project grants for training, studies, and demonstrations; authorization of appropriations
(July 1, 1944, ch. 373, title III, § 314, 58 Stat. 693; July 3, 1946, ch. 538, § 9, 60 Stat. 424; June 16, 1948, ch. 481, § 5, 62 Stat. 468; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 1, 1956, ch. 852, § 18, 70 Stat. 910; Pub. L. 85–544, § 1, July 22, 1958, 72 Stat. 400; Pub. L. 87–395, § 2(a)–(d), Oct. 5, 1961, 75 Stat. 824; Pub. L. 87–688, § 4(a)(1), Sept. 25, 1962, 76 Stat. 587; Pub. L. 89–109, § 4, Aug. 5, 1965, 79 Stat. 436; Pub. L. 89–749, § 3, Nov. 3, 1966, 80 Stat. 1181; Pub. L. 90–174, §§ 2(a)–(f), 3(b)(2), 8(a), (b), 12(d), Dec. 5, 1967, 81 Stat. 533–535, 540, 541; Pub. L. 91–296, title I, § 111(b), title IV, § 401(b)(1)(C), (D), June 30, 1970, 84 Stat. 340, 352; Pub. L. 91–513, title I, § 3(b), Oct. 27, 1970, 84 Stat. 1241; Pub. L. 91–515, title II, §§ 220, 230, 240, 250, 260(a)–(c)(1), 282, Oct. 30, 1970, 84 Stat. 1304–1306, 1308; Pub. L. 91–616, title III, § 331, Dec. 31, 1970, 84 Stat. 1853; Pub. L. 91–648, title IV, § 403, Jan. 5, 1971, 84 Stat. 1925, as amended Pub. L. 95–454, title VI, § 602(c), Oct. 13, 1978, 92 Stat. 1189; Pub. L. 92–255, title IV, § 403(a), Mar. 21, 1972, 86 Stat. 77; Pub. L. 93–45, title I, § 106, June 18, 1973, 87 Stat. 92; Pub. L. 93–151, § 8, Nov. 9, 1973, 87 Stat. 568; Pub. L. 94–63, title I, § 102, title V, § 501(b), title VII, § 701(a), (b), July 29, 1975, 89 Stat. 304, 346, 352; Pub. L. 94–484, title IX, § 905(b)(1), Oct. 12, 1976, 90 Stat. 2325; Pub. L. 95–83, title III, § 302, Aug. 1, 1977, 91 Stat. 387; Pub. L. 95–454, title VI, § 602(c), Oct. 13, 1978, 92 Stat. 1189; Pub. L. 95–622, title I, § 109, Nov. 9, 1978, 92 Stat. 3417; Pub. L. 95–626, title II, § 201(a), (b)(2), Nov. 10, 1978, 92 Stat. 3570; Pub. L. 96–32, § 6(e), (f), July 10, 1979, 93 Stat. 83; Pub. L. 96–79, title I, § 115(k)(2), Oct. 4, 1979, 93 Stat. 610; Pub. L. 96–398, title I, § 107(d), Oct. 7, 1980, 94 Stat. 1571; Pub. L. 97–35, title IX, § 902(b), Aug. 13, 1981, 95 Stat. 559; Pub. L. 99–117, § 12(a), Oct. 7, 1985, 99 Stat. 495; Pub. L. 102–54, § 13(q)(1)(D), June 13, 1991, 105 Stat. 279.)

CITE AS: 42 USC 246

§ 246a. Bureau of State Services management fund; establishment; advancements; availability

For the purpose of facilitating the economical and efficient conduct of operations in the Bureau of State Services which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by the Secretary: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.

(Pub. L. 86–703, title II, § 201, Sept. 2, 1960, 74 Stat. 765; Pub. L. 91–515, title II, § 282, Oct. 30, 1970, 84 Stat. 1308.)

CITE AS: 42 USC 246a

§ 247. Assisting veterans with military emergency medical training to meet requirements for becoming civilian health care professionals
(a) Program
(1) In general
(2) Consultation and collaboration
(b) Use of fundsAmounts received as a demonstration grant under this section shall be used to—
(1) prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—
(A) determining the extent to which the requirements for the education, training, and skill level of civilian health care professions (such as emergency medical technicians, paramedics, licensed practical nurses, registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to requirements for the education, training, and skill level of veterans who served in medical related fields while a member of the Armed Forces of the United States; and
(B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed Forces of the United States to forgo or meet any such equivalent State requirements; and
(2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to meet certification, licensure or other requirements applicable to becoming a civilian health care professional (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State, develop or expand career pathways at institutions of higher education to support veterans in meeting such requirements.
(c) Report
(d) Funding
(e) Sunset
(July 1, 1944, ch. 373, title III, § 315, as added Pub. L. 114–198, title I, § 105, July 22, 2016, 130 Stat. 701.)

CITE AS: 42 USC 247

§ 247a. Family support groups for Alzheimer’s disease patients
(a) Establishment; priorities
Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
(1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such disease; and
(2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
(b) National network to coordinate groups
(July 1, 1944, ch. 373, title III, § 316, as added Pub. L. 99–319, title IV, § 401, May 23, 1986, 100 Stat. 489; amended Pub. L. 103–43, title XX, § 2008(a), June 10, 1993, 107 Stat. 210.)

CITE AS: 42 USC 247a

§ 247b. Project grants for preventive health services
(a) Grant authority
(b) ApplicationNo grant may be made under section (a) 1
1 So in original. Probably should be “subsection (a)”.
unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—
(1) a complete description of the type and extent of the program for which the applicant is seeking a grant under subsection (a);
(2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under subsection (a) will be provided in a manner consistent with the State health plan in effect under section 300m–3(c) 2
2 See References in Text note below.
of this title and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under section 247 2 of this title;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a);
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) for a grant for a program for which a grant was previously made under subsection (a) unless the Secretary determines—
(A) the program for which the application was submitted is operating effectively to achieve its stated purpose,
(B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) to determine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.
(d) Amount of grant; payment
(e) ReductionThe Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee,
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment pro­hibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection (a).
(2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program.
(h) Reports
(i) Technical assistance
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(1) for such fiscal year.
(2) For grants under subsection (a) for preventive health service programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be appropriated such sums as may be necessary.
(k) Additional grants to States, political subdivisions, and other public and nonprofit private entities
(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases that may be prevented through vaccination;
(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of such diseases;
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel);
(E) planning, implementation, and evaluation of activities to address vaccine-preventable diseases, including activities to—
(i) identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through improved data collection and analysis;
(ii) pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination;
(iii) reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;
(iv) partner with community organizations and health care providers to develop and deliver evidence-based interventions, including culturally and linguistically appropriate interventions, to increase vaccination rates;
(v) improve delivery of evidence-based vaccine-related information to parents and others; and
(vi) improve the ability of State, local, Tribal, and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases, including, as appropriate, with local educational agencies, as defined in section 7801 of title 20; and
(F) research related to strategies for improving awareness of scientific and evidence-based vaccine-related information, including for communities with low rates of vaccination, in order to understand barriers to vaccination, improve vaccination rates, and assess the public health outcomes of such strategies.
(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and conditions;
(C) public information and education programs for the prevention and control of such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a) of this section.
(l) Authority to purchase recommended vaccines for adults
(1) In general
(2) State purchase
(m) Demonstration program to improve immunization coverage
(1) In general
(2) State plan
(3) Use of fundsFunds received under a grant under this subsection shall be used to implement interventions that are recommended by the Task Force on Community Preventive Services (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) or other evidence-based interventions, including—
(A) providing immunization reminders or recalls for target populations of clients, patients, and consumers;
(B) educating targeted populations and health care providers concerning immunizations in combination with one or more other interventions;
(C) reducing out-of-pocket costs for families for vaccines and their administration;
(D) carrying out immunization-promoting strategies for participants or clients of public programs, including assessments of immunization status, referrals to health care providers, education, provision of on-site immunizations, or incentives for immunization;
(E) providing for home visits that promote immunization through education, assessments of need, referrals, provision of immunizations, or other services;
(F) providing reminders or recalls for immunization providers;
(G) conducting assessments of, and providing feedback to, immunization providers;
(H) any combination of one or more interventions described in this paragraph; or
(I) immunization information systems to allow all States to have electronic databases for immunization records.
(4) Consideration
(5) Evaluation
(6) Report to Congress
(7) Authorization of appropriations
(n) Vaccination data
(July 1, 1944, ch. 373, title III, § 317, as added Pub. L. 87–868, § 2, Oct. 23, 1962, 76 Stat. 1155; amended Pub. L. 89–109, § 2, Aug. 5, 1965, 79 Stat. 435; Pub. L. 91–464, § 2, Oct. 16, 1970, 84 Stat. 988; Pub. L. 92–449, title I, § 101, Sept. 30, 1972, 86 Stat. 748; Pub. L. 93–354, § 4, July 23, 1974, 88 Stat. 376; Pub. L. 94–63, title VI, § 601, July 29, 1975, 89 Stat. 346; Pub. L. 94–317, title II, § 202(a), June 23, 1976, 90 Stat. 700; Pub. L. 94–380, § 2, Aug. 12, 1976, 90 Stat. 1113; Pub. L. 95–626, title II, §§ 202, 204(b)(2), Nov. 10, 1978, 92 Stat. 3574, 3583; Pub. L. 96–32, § 6(i), July 10, 1979, 93 Stat. 83; Pub. L. 97–35, title IX, § 928, Aug. 13, 1981, 95 Stat. 569; Pub. L. 98–555, § 2, Oct. 30, 1984, 98 Stat. 2854; Pub. L. 99–117, § 11(c), Oct. 7, 1985, 99 Stat. 495; Pub. L. 100–177, title I, §§ 110(a), 111, Dec. 1, 1987, 101 Stat. 990, 991; Pub. L. 101–368, § 2, Aug. 15, 1990, 104 Stat. 446; Pub. L. 101–502, § 2(a), Nov. 3, 1990, 104 Stat. 1285; Pub. L. 103–183, title III, § 301(b), Dec. 14, 1993, 107 Stat. 2235; Pub. L. 105–392, title III, § 303, Nov. 13, 1998, 112 Stat. 3586; Pub. L. 106–310, div. A, title XVII, § 1711, Oct. 17, 2000, 114 Stat. 1152; Pub. L. 111–148, title IV, § 4204(a)–(c), Mar. 23, 2010, 124 Stat. 571, 572; Pub. L. 116–260, div. BB, title III, § 311(b), Dec. 27, 2020, 134 Stat. 2924.)

CITE AS: 42 USC 247b

§ 247b–1. Screenings, referrals, and education regarding lead poisoning
(a) Authority for grants
(1) In generalSubject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels; and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood lead poisoning.
(2) Authority regarding certain entities
(3) Provision of all services and activities through each grantee
(b) Status as medicaid provider
(1) In generalSubject to paragraph (2), the Secretary may not make a grant under subsection (a) unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the State involved—
(A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan.
(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary donations regarding the provision of services to the public.
(c) Priority in making grants
(d) Grant applicationNo grant may be made under subsection (a), unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following:
(1) A complete description of the program which is to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include educational programs designed to—
(A) communicate to parents, educators, and local health officials the significance and prevalence of lead poisoning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and
(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other interventions available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) with related activities and services carried out in the State by grantees under title V or XIX of the Social Security Act [42 U.S.C. 701 et seq., 1396 et seq.].
(6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non-Federal funds.
(7) Assurances satisfactory to the Secretary that the applicant will ensure complete and consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in accordance with guidelines of the Centers for Disease Control and Prevention for standardized reporting as described in subsection (m).
(8) Such other information as the Secretary may prescribe.
(e) Relationship to services and activities under other programs
(1) In generalA recipient of a grant under subsection (a) may not make payments from the grant for any service or activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service or activity—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
(f) Method and amount of payment
(g) Supplies, equipment, and employee detailThe Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(1) the fair market value of any supplies or equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(h) Records
(i) Audit and examination of records
(j) Annual report
(1) In general
(2) Certain requirementsEach report under paragraph (1) shall include, in addition to any other information that the Secretary may require, the following information:
(A) The number of infants and children screened.
(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the blood lead levels of the infants and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and local health departments.
(G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved.
(k) Indian tribes
(l) Funding
(1) Authorization of appropriations
(2) Allocation for other programs
(m) Guidelines for standardized reporting
(July 1, 1944, ch. 373, title III, § 317A, as added Pub. L. 100–572, § 3, Oct. 31, 1988, 102 Stat. 2887; amended Pub. L. 102–531, title III, § 303(a), Oct. 27, 1992, 106 Stat. 3484; Pub. L. 103–183, title VII, § 705(a), Dec. 14, 1993, 107 Stat. 2241; Pub. L. 105–392, title IV, § 404, Nov. 13, 1998, 112 Stat. 3588; Pub. L. 106–310, div. A, title XXV, §§ 2501(a), (b), 2504, Oct. 17, 2000, 114 Stat. 1161, 1164; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023.)

CITE AS: 42 USC 247b-1

§ 247b–2. Repealed. Pub. L. 97–35, title IX, § 902(a), Aug. 13, 1981, 95 Stat. 559

CITE AS: 42 USC 247b-2

§ 247b–3. Education, technology assessment, and epidemiology regarding lead poisoning
(a) Prevention
(1) Public education
(2) Interagency Task Force
(A) Not later than 6 months after October 27, 1992, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the “Task Force”). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the chair of the Task Force;
(ii) the Secretary of Housing and Urban Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials respectively.
(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as members of the Task Force, including—(I) the plan of the Secretary of Health and Human Services entitled “Strategic Plan for the Elimination of Lead Poisoning”, dated February 21, 1991;(II) the plan of the Secretary of Housing and Urban Development entitled “Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing”, dated December 7, 1990; and(III) the strategy of the Administrator of the Environmental Protection Agency entitled “Strategy for Reducing Lead Exposures”, dated February 21, 1991;
(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of research and education concerning lead poisoning;
(v) identify the practical and technological constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a result of such review and that contains the recommendations of the Task Force on the programs and policies with respect to which the Task Force is established, including related budgetary recommendations; and
(vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Government.
(b) Technology assessment and epidemiologyThe Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—
(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for each State;
(3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in infants and children.
(July 1, 1944, ch. 373, title III, § 317B, as added Pub. L. 102–531, title III, § 303(b), Oct. 27, 1992, 106 Stat. 3488; amended Pub. L. 103–43, title XX, § 2008(i)(1)(B)(i), June 10, 1993, 107 Stat. 212.)

CITE AS: 42 USC 247b-3

§ 247b–3a. Training and reports by the Health Resources and Services Administration
(a) Training
(b) Report
(c) Authorization of appropriations
(Pub. L. 106–310, div. A, title XXV, § 2503, Oct. 17, 2000, 114 Stat. 1163; Pub. L. 108–173, title IX, § 900(e)(6)(E), Dec. 8, 2003, 117 Stat. 2374.)

CITE AS: 42 USC 247b-3a

§ 247b–4. National Center on Birth Defects and Developmental Disabilities
(a) In general
(1) National Center
(2) General duties
The Secretary shall carry out programs—
(A) to collect, analyze, and make available data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the causes of such defects and disabilities and on the incidence and prevalence of such defects and disabilities;
(B) to operate regional centers for the conduct of applied epidemiological research on the prevention of such defects and disabilities;
(C) to provide information and education to the public on the prevention of such defects and disabilities;
(D) to conduct research on and to promote the prevention of such defects and disabilities, and secondary health conditions among individuals with disabilities; and
(E) to support a National Spina Bifida Program to prevent and reduce suffering from the Nation’s most common permanently disabling birth defect.
(3) Folic acid
(4) Certain programs
(A) Transfers
(B) Relevant programs
The programs and functions described in this subparagraph are all programs and functions that—
(i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases, disorders, or conditions as determined 1
1 So in original. Probably should be followed by the word “by”.
the Secretary; and
(ii) were carried out through the National Center for Environmental Health as of the day before October 17, 2000.
(C) Related transfers
(b) Grants and contracts
(1) In general
(2) Supplies and services in lieu of award funds
(A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(3) Application for award
(c) Biennial report
Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
(1) contains information regarding the incidence and prevalence of birth defects, developmental disabilities, and the health status of individuals with disabilities and the extent to which these conditions have contributed to the incidence and prevalence of infant mortality and affected quality of life;
(2) contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
(3) contains an assessment of the extent to which various approaches of preventing birth defects, developmental disabilities, and secondary health conditions among individuals with disabilities have been effective;
(4) describes the activities carried out under this section;
(5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or developmental disabilities, information on the health status of individuals with disabilities, information on any health disparities experienced by such individuals, and recommendations for improving the health and wellness and quality of life of such individuals;
(6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Disease Control and Prevention, including conferences related to spina bifida; and
(7) contains any recommendations of the Secretary regarding this section.
(d) Applicability of privacy laws
(e) Advisory committee
(f) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317C, as added Pub. L. 102–531, title III, § 306(a), Oct. 27, 1992, 106 Stat. 3494; amended Pub. L. 103–43, title XX, § 2008(i)(1)(B)(iii), June 10, 1993, 107 Stat. 213; Pub. L. 105–168, § 2, Apr. 21, 1998, 112 Stat. 43; Pub. L. 106–310, div. A, title VI, § 611, Oct. 17, 2000, 114 Stat. 1119; Pub. L. 108–154, § 2, Dec. 3, 2003, 117 Stat. 1933; Pub. L. 111–256, § 2(f)(1), Oct. 5, 2010, 124 Stat. 2644.)

CITE AS: 42 USC 247b-4

§ 247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss
(a) Definitions
For the purposes of this section only, the following terms in this section are defined as follows:
(1) Hearing screening
(2) Audiologic evaluation
(3) Medical evaluation
(4) Medical intervention
(5) Audiologic rehabilitation
(6) Early intervention
(b) Purposes
The purposes of this section are to clarify the authority within the Public Health Service Act [42 U.S.C. 201 et seq.] to authorize statewide newborn and infant hearing screening, evaluation and intervention programs and systems, technical assistance, a national applied research program, and interagency and private sector collaboration for policy development, in order to assist the States in making progress toward the following goals:
(1) All babies born in hospitals in the United States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or adoption should have a hearing screening as early as possible.
(2) All babies who are not born in hospitals in the United States and its territories should have a hearing screening within the first 3 months of life.
(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to allow appropriate referral and provisions for audiologic rehabilitation, medical and early intervention before the age of 6 months.
(4) All newborn and infant hearing screening programs and systems should include a component for audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing statewide systems of intervention and rehabilitative services for newborns and infants with hearing loss.
(5) Public policy in regard to newborn and infant hearing screening and intervention should be based on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or hard-of-hearing have unique language, learning, and communication needs, and should be the result of consultation with pertinent public and private sectors.
(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
Under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], the Secretary of Health and Human Services (in this section referred to as the “Secretary”), acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing screening, evaluation and intervention programs and systems for the following purposes:
(1) To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act [20 U.S.C. 1431 et seq.], which offer programs specifically designed to meet the unique language and communication needs of deaf and hard-of-hearing newborns, infants, toddlers, and children.
(2) To collect data on statewide newborn and infant hearing screening, evaluation and intervention programs and systems that can be used for applied research, program evaluation and policy development.
(d) Technical assistance, data management, and applied research
(1) Centers for Disease Control and Prevention
Under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramural program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention programs and systems. The program shall develop standardized procedures for data management and program effectiveness and costs, such as—
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;
(B) to provide technical assistance on data collection and management;
(C) to study the costs and effectiveness of newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in order to answer issues of importance to State and national policymakers;
(D) to identify the causes and risk factors for congenital hearing loss;
(E) to study the effectiveness of newborn and infant hearing screening, audiologic and medical evaluations and intervention programs and systems by assessing the health, intellectual and social developmental, cognitive, and language status of these children at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.
(2) National Institutes of Health
(e) Coordination and collaboration
(1) In general
(2) Policy development
(3) State early detection, diagnosis, and intervention programs and systems; data collection
(f) Rule of construction
(g) Authorization of appropriations
(1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
(2) Technical assistance, data management, and applied research; Centers for Disease Control and Prevention
(3) Technical assistance, data management, and applied research; National Institute on Deafness and Other Communication Disorders
(Pub. L. 106–113, div. B, § 1000(a)(4) [title VI, § 601], Nov. 29, 1999, 113 Stat. 1535, 1501A–276.)

CITE AS: 42 USC 247b-4a

§§ 247b–4b to 247b–4d. Repealed. Pub. L. 109–416, § 3(b)(1)–(3), Dec. 19, 2006, 120 Stat. 2829

CITE AS: 42 USC 247b-4b to 247b-4d

§ 247b–4e. Repealed. Pub. L. 109–416, § 3(b)(4), Dec. 19, 2006, 120 Stat. 2829; Pub. L. 109–482, title I, § 104(b)(3)(D), Jan. 15, 2007, 120 Stat. 3694

CITE AS: 42 USC 247b-4e

§ 247b–4f. Research relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants
(a) Omitted
(b) Studies and activities on preterm birth
(1) In general
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—
(A) conduct epidemiological studies on the factors relating to prematurity, such as clinical, biological, social, environmental, genetic, and behavioral factors, and other determinants that contribute to health disparities and are related to prematurity, as appropriate;
(B) conduct activities to improve national data to facilitate tracking the burden of preterm birth; and
(C) continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.
(2) Report
(c) Pregnancy risk assessment monitoring survey
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall—
(1) continue systems for the collection of maternal-infant clinical and biomedical information, including electronic health records, electronic databases, and biobanks, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) and other epidemiological studies of prematurity in order to track, to the extent practicable, all pregnancy outcomes and prevent preterm birth; and
(2) provide technical assistance, as appropriate, to support States in improving the collection of information pursuant to this subsection.
(d) Evaluation of existing tools and measures
(e)
(Pub. L. 109–450, § 3, Dec. 22, 2006, 120 Stat. 3341; Pub. L. 113–55, title I, § 102, Nov. 27, 2013, 127 Stat. 641; Pub. L. 115–328, § 2, Dec. 18, 2018, 132 Stat. 4471.)

CITE AS: 42 USC 247b-4f

§ 247b–4g. Repealed. Pub. L. 113–55, title I, § 104(a), Nov. 27, 2013, 127 Stat. 643

CITE AS: 42 USC 247b-4g

§ 247b–5. Preventive health measures with respect to prostate cancer
(a) In generalThe Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs that may include the following:
(1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer.
(2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer.
(3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate 1
1 So in original. Probably should be “prostate”.
cancer screening and followup.
(4) To develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Preventive Services Task Force and shall seek input, where appropriate, from professional societies and other private and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
(A) to screen men for prostate cancer as a preventive health measure;
(B) to provide appropriate referrals for the medical treatment of men who have been screened under subparagraph (A) and to ensure, to the extent practicable, the provision of appropriate followup services and support services such as case management;
(C) to establish mechanisms through which State and local health departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
(D) to improve, in consultation with the Health Resources and Services Administration, the education, training, and skills of health practitioners (including appropriate allied health professionals) in the detection and control of prostate cancer.
(8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or program monitoring activities.
(b) Requirement of matching funds
(1) In general
(2) Determination of amount of non-Federal contribution
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection.
(C) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] by the applicant involved toward the purpose described in paragraphs (1) and (2) of subsection (a).
(c) Education on significance of early detection
(d) Requirement of provision of all services by date certainThe Secretary may not make a grant under subsection (a) unless the applicant involved agrees—
(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection;
(2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activities described in such subsection is provided; and
(3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in paragraphs (3) through (6) of such section.2
2 So in original. Probably should be “subsection.”
(e) Additional required agreements
(1) Priority for low-income men
(2) Limitation on imposition of fees for servicesThe Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will be adjusted to reflect the income of the man involved; and
(C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title.
(3) Relationship to items and services under other programsThe Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) Coordination with other prostate cancer programs
(5) Limitation on administrative expenses
(6) Restrictions on use of grant
(7) Records and auditsThe Secretary may not make a grant under subsection (a) unless the applicant involved agrees that—
(A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 3
3 So in original. Probably should be “subsection;”.
and
(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.
(f) Reports to Secretary
(g) Description of intended uses of grantThe Secretary may not make a grant under subsection (a) unless—
(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the applicant 4
4 So in original. Probably should be “application”.
with a need for the services or activities described in subsection (a);
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or nonprivate entities; and
(4) the description provides assurances that the grant funds will be used in the most cost-effective manner.
(h) Requirement of submission of application
(i) Method and amount of payment
(j) Technical assistance and provision of supplies and services in lieu of grant funds
(1) Technical assistance
(2) Provision of supplies and services in lieu of grant funds
(A) Upon the request of an applicant receiving a grant under subsection (a), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) to the applicant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(k) “Units of local government” defined
(l) Authorization of appropriations
(1) In general
(2) Allocation for technical assistance
(July 1, 1944, ch. 373, title III, § 317D, as added Pub. L. 102–531, title III, § 308, Oct. 27, 1992, 106 Stat. 3495; amended Pub. L. 103–43, title XX, § 2010(i)(1)(B)(iv), June 10, 1993, 107 Stat. 213; Pub. L. 103–183, title VII, § 705(b), Dec. 14, 1993, 107 Stat. 2241; Pub. L. 105–392, title IV, § 401(a)(3), Nov. 13, 1998, 112 Stat. 3587; Pub. L. 106–505, title VI, § 602(a), Nov. 13, 2000, 114 Stat. 2345.)

CITE AS: 42 USC 247b-5

§ 247b–6. National strategy for combating and eliminating tuberculosis
(a) In general
(b) Research and development; demonstration projects; education and trainingWith respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:
(1) Research, with priority given to research and development concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and research concerning cases of tuberculosis that affect certain populations at risk for tuberculosis.
(2) Research and development and related activities to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice.
(3) Demonstration projects for—
(A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug resistant and extensively drug resistant strains of tuberculosis;
(B) the intensification of efforts to reduce health disparities in the incidence of tuberculosis;
(C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among United States-Mexico binational populations, including through expansion of the scope and number of programs that—
(i) detect and treat binational cases of tuberculosis; and
(ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
(D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States;
(E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings documented as having a high risk for tuberculosis; and
(F) tuberculosis detection, control, and prevention.
(4) Public information and education activities.
(5) Education, training, clinical skills improvement activities, and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees.
(6) Support of Centers to carry out activities under paragraphs (1) through (4).
(7) Collaboration with international organizations and foreign countries in carrying out such activities.
(8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance and database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary.
(c) Cooperation with providers of primary health services
(d) Application for grant
(1) In general
(2) Plan for prevention, control, and elimination
(3) Determination of amount of nonfederal contributions
(A) Priority
(B) Federal amounts not to be included as contributions
(e) Supplies and services in lieu of grant funds
(1) In general
(2) Corresponding reduction in payments
(f) Advisory Council
(1) In general
(2) DutiesThe Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—
(A) coordinating the activities of the Department of Health and Human Services and other Federal agencies that relate to the disease, including activities under subsection (b);
(B) responding rapidly and effectively to emerging issues in tuberculosis; and
(C) efficiently utilizing the Federal resources involved.
(3) Comprehensive plan
(A) In general
(B) ConsultationIn carrying out subparagraph (A), the Council may consult with appropriate public and private entities, which may, subject to the direction or discretion of the Secretary, include—
(i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not officers or employees of the Federal Government and who represent the disciplines relevant to tuberculosis elimination;
(ii) members of public-private partnerships or private entities established to address the elimination of tuberculosis;
(iii) members of national and international nongovernmental organizations whose purpose is to eliminate tuberculosis;
(iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis; and
(v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
(C) Certain components of planIn carrying out subparagraph (A), the Council shall, subject to the direction or discretion of the Secretary—
(i) consider recommendations for the involvement of the United States in continuing global and cross-border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States; and
(ii) review the extent to which progress has been made toward eliminating tuberculosis.
(4) Biennial report
(A) In generalThe Council shall submit a biennial report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section. Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, including with respect to—
(i) activities under subsection (b); and
(ii) the national plan referred to in paragraph (3).
(B) Public
(5) CompositionThe Council shall be composed of—
(A) ex officio representatives from the Centers for Disease Control and Prevention, the National Institutes of Health, the United States Agency for International Development, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other Federal departments and agencies that carry out significant activities related to tuberculosis;
(B) State and local tuberculosis control and public health officials;
(C) individuals who are scientists, physicians, laboratorians, and other health professionals who represent disciplines relevant to tuberculosis elimination; and
(D) members of national and international nongovernmental organizations established to address the elimination of tuberculosis.
(6) Staff, information, and other assistance
(g) Federal Tuberculosis Task Force
(1) Duties
(2) Comprehensive plan for new tools development
(3) ConsultationIn developing the comprehensive plan under paragraph (1),2
2 So in original. Probably should be “paragraph (2),”.
the Task Force shall consult with external parties including representatives from groups such as—
(A) scientists, physicians, laboratorians, and other health professionals who represent the specialties and disciplines relevant to the research under consideration;
(B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities relevant to research under consideration;
(C) members of national and international nongovernmental organizations established to address tuberculosis elimination;
(D) members from the general public who are knowledgeable with respect to tuberculosis including individuals who have or have had tuberculosis; and
(E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
(h) Authorization of appropriations
(1) General program
(A) In general
(B) Reservation for emergency grants
(C) Priority
(D) Allocation of funds
(i) Requirement of formula
(ii) Relevant factors
(iii) No change to formula required
(2) Limitation
(July 1, 1944, ch. 373, title III, § 317E, as added Pub. L. 103–183, title III, § 301(a), Dec. 14, 1993, 107 Stat. 2233; amended Pub. L. 105–392, title IV, §§ 401(b)(1), 405, Nov. 13, 1998, 112 Stat. 3587, 3588; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023; Pub. L. 110–392, title I, §§ 101, 111(a), (c), 131, Oct. 13, 2008, 122 Stat. 4196, 4197, 4199, 4200.)

CITE AS: 42 USC 247b-6

§ 247b–7. Loan repayment program
(a) In general
(1) Authority
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 2 years.
(b) Applicability of certain provisions
(c) Authorization of appropriations
(1) In general
(2) Epidemic Intelligence Service program
(d) Availability of appropriations
(July 1, 1944, ch. 373, title III, § 317F, as added Pub. L. 103–183, title VII, § 703, Dec. 14, 1993, 107 Stat. 2240; amended Pub. L. 105–392, title IV, § 406, Nov. 13, 1998, 112 Stat. 3588; Pub. L. 116–22, title III, § 301(c), June 24, 2019, 133 Stat. 932.)

CITE AS: 42 USC 247b-7

§ 247b–8. Fellowship and training programs

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment procedures.

(July 1, 1944, ch. 373, title III, § 317G, as added Pub. L. 105–115, title IV, § 408(b)(1), Nov. 21, 1997, 111 Stat. 2371.)

CITE AS: 42 USC 247b-8

§ 247b–9. Diabetes in children and youth
(a) Surveillance on juvenile diabetes
(b) Type 2 diabetes in youth
The Secretary shall implement a national public health effort to address type 2 diabetes in youth, including—
(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2 diabetes in youth and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and
(2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia and improving existing glucometers that measure blood glucose.
(c) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317H, as added Pub. L. 106–310, div. A, title IV, § 401, Oct. 17, 2000, 114 Stat. 1112.)

CITE AS: 42 USC 247b-9

§ 247b–9a. Better diabetes care
(a) Short title
(b) National diabetes report card
(1) In general
(2) Contents
(A) In general
Each Report Card shall include aggregate health outcomes related to individuals diagnosed with diabetes and prediabetes including—
(i) preventative care practices and quality of care;
(ii) risk factors; and
(iii) outcomes.
(B) Updated reports
Each Report Card that is prepared after the initial Report Card shall include trend analysis for the Nation and, to the extent possible, for each State, for the purpose of—
(i) tracking progress in meeting established national goals and objectives for improving diabetes care, costs, and prevalence (including Healthy People 2010); and
(ii) informing policy and program development.
(3) Availability
(c) Improvement of vital statistics collection
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with appropriate agencies and States, shall—
(A) promote the education and training of physicians on the importance of birth and death certificate data and how to properly complete these documents, including the collection of such data for diabetes and other chronic diseases;
(B) encourage State adoption of the latest standard revisions of birth and death certificates; and
(C) work with States to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data.
(2) Death certificate additional language
(d) Study on appropriate level of diabetes medical education
(1) In general
(2) Report
(e) Authorization of appropriations
(Pub. L. 111–148, title X, § 10407, Mar. 23, 2010, 124 Stat. 976.)

CITE AS: 42 USC 247b-9a

§ 247b–10. Compilation of data on asthma
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma management;
(2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
(3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma nationally.
(b) Surveillance activities
(c) Collaborative efforts
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317I, as added Pub. L. 106–310, div. A, title V, § 531, Oct. 17, 2000, 114 Stat. 1117.)

CITE AS: 42 USC 247b-10

§ 247b–11. Effects of folic acid in prevention of birth defects
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes:
(1) To provide education and training for health professionals and the general public for purposes of explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a dietary supplement that provides an appropriate level of folic acid.
(2) To conduct research with respect to such education and training, including identifying effective strategies for increasing the rate of consumption of folic acid by women of reproductive capacity.
(3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding with respect to cleft lip, cleft palate, and heart defects.
(4) To provide for appropriate epidemiological activities regarding folic acid and birth defects, including epidemiological activities regarding neural tube defects.
(b) Consultations with States and private entities
(c) Technical assistance
(d) Evaluations
(e) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317J, as added Pub. L. 106–310, div. A, title VI, § 601, Oct. 17, 2000, 114 Stat. 1118.)

CITE AS: 42 USC 247b-11

§ 247b–12. Safe motherhood
(a) Surveillance
(1) Purpose
(2) ActivitiesFor the purpose described in paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out the following activities:
(A) The Secretary may continue and improve activities related to a national maternal mortality data collection and surveillance program to identify and support the review of pregnancy-associated deaths and pregnancy-related deaths that occur during, or within 1 year following, pregnancy, including improving disaggregation of data (in a manner consistent with applicable State and Federal privacy laws).
(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System to provide surveillance and collect data in each State.
(C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical support, financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health programs in each State.
(D) The Secretary may, in cooperation with States, Indian tribes, and tribal organizations, develop a program to support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality review committees, in accordance with subsection (d).
(b) Prevention research
(1) Purpose
(2) ResearchThe Secretary may carry out activities to expand research relating to—
(A) prepregnancy counseling, especially for at risk populations such as women with diabetes and women with substance use disorder;
(B) the identification of critical components of prenatal delivery and postpartum care;
(C) the identification of outreach and support services, such as folic acid education, that are available for pregnant women;
(D) the identification of women who are at high risk for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean sections;
(H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes, including an examination of the higher rates of maternal mortality among African American women and other groups of women with disproportionately high rates of maternal mortality;
(I) activities to reduce disparities in maternity services and outcomes;
(J) an examination of the relationship between interpersonal violence and maternal complications and mortality;
(K) preventing and reducing adverse health consequences that may result from smoking and substance abuse and misuse before, during and after pregnancy;
(L) preventing infections that cause maternal and infant complications;
(M) an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care; and
(N) other areas determined appropriate by the Secretary.
(c) Prevention programsThe Secretary may carry out activities to promote safe motherhood, including—
(1) public education campaigns on healthy pregnancies;
(2) education programs for physicians, nurses and other health care providers;
(3) activities to promote community support services for pregnant women; and
(4) activities to promote physical, mental, and behavioral health during, and up to 1 year following, pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use disorder.
(d) Maternal mortality review committees
(1) In generalIn order to participate in the program under subsection (a)(2)(D), the applicable maternal mortality review committee of the State, Indian tribe, or tribal organization shall—
(A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State, tribal, or local public health officials, epidemiologists, statisticians, community organizations, geographic regions within the area covered by such committee, and individuals or organizations that represent the populations in the area covered by such committee that are most affected by pregnancy-related deaths or pregnancy-associated deaths and lack of access to maternal health care services; and
(B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review committee’s methods and processes for data collection and review, as required under paragraph (3), use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths, regardless of the outcome of the pregnancy.
(2) Process for confidential reportingStates, Indian tribes, and tribal organizations that participate in the program described in this subsection shall, through the State maternal mortality review committee, develop a process that—
(A) provides for confidential case reporting of pregnancy-associated and pregnancy-related deaths to the appropriate State or tribal health agency, including such reporting by—
(i) health care professionals;
(ii) health care facilities;
(iii) any individual responsible for completing death records, including medical examiners and medical coroners; and
(iv) other appropriate individuals or entities; and
(B) provides for voluntary and confidential case reporting of pregnancy-associated deaths and pregnancy-related deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate individuals, for purposes of review by the applicable maternal mortality review committee; and
(C) shall include—
(i) making publicly available contact information of the committee for use in such reporting; and
(ii) conducting outreach to local professional organizations, community organizations, and social services agencies regarding the availability of the review committee.
(3) Data collection and review
(A) annually identify pregnancy-associated deaths and pregnancy-related deaths—
(i) through the appropriate vital statistics unit by—(I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as applicable;(II) to the extent practicable, identifying an underlying or contributing cause of each pregnancy-associated death and each pregnancy-related death in the State or tribal area in the applicable year; and(III) collecting data from medical examiner and coroner reports, as appropriate;
(ii) using other appropriate methods or information to identify pregnancy-associated deaths and pregnancy-related deaths, including deaths from pregnancy outcomes not identified through clause (i)(I);
(B) through the maternal mortality review committee, review data and information to identify adverse outcomes that may contribute to pregnancy-associated death and pregnancy-related death, and to identify trends, patterns, and disparities in such adverse outcomes to allow the State, Indian tribe, or tribal organization to make recommendations to individuals and entities described in paragraph (2)(A), as appropriate, to improve maternal care and reduce pregnancy-associated death and pregnancy-related death;
(C) identify training available to the individuals and entities described in paragraph (2)(A) for accurate identification and reporting of pregnancy-associated and pregnancy-related deaths;
(D) ensure that, to the extent practicable, the data collected and reported under this paragraph is in a format that allows for analysis by the Centers for Disease Control and Prevention; and
(E) publicly identify the methods used to identify pregnancy-associated deaths and pregnancy-related deaths in accordance with this section.
(4) ConfidentialityStates, Indian tribes, and tribal organizations participating in the program described in this subsection shall establish confidentiality protections to ensure, at a minimum, that—
(A) there is no disclosure by the maternal mortality review committee, including any individual members of the committee, to any person, including any government official, of any identifying information about any specific maternal mortality case; and
(B) no information from committee proceedings, including deliberation or records, is made public unless specifically authorized under State and Federal law.
(5) Reports to CDCFor fiscal year 2019, and each subsequent fiscal year, each maternal mortality review committee participating in the program described in this subsection shall submit to the Director of the Centers for Disease Control and Prevention a report that includes—
(A) data, findings, and any recommendations of such committee; and
(B) as applicable, information on the implementation during such year of any recommendations submitted by the committee in a previous year.
(6) State partnerships
(7) Appropriate mechanisms for Indian tribes and tribal organizations
(8) Research availability
(e) DefinitionsIn this section—
(1) the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25;
(2) the term “pregnancy-associated death” means a death of a woman, by any cause, that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
(3) the term “pregnancy-related death” means a death of a woman that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
(A) from any cause related to, or aggravated by, the pregnancy or its management; and
(B) not from accidental or incidental causes.
(f) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317K, as added Pub. L. 106–310, div. A, title IX, § 901, Oct. 17, 2000, 114 Stat. 1125; amended Pub. L. 115–344, § 2, Dec. 21, 2018, 132 Stat. 5047; Pub. L. 117–103, div. P, title I, § 141(c), Mar. 15, 2022, 136 Stat. 798.)

CITE AS: 42 USC 247b-12

§ 247b–13. Prenatal and postnatal health
(a) In generalThe Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs—
(1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including—
(A) data on—
(i) the incidence, prevalence, and implications of such activities; and
(ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and
(B) additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis;
(2) to conduct applied epidemiological research on the prevention and long-term outcomes associated with prenatal and postnatal smoking, alcohol and other substance abuse and misuse;
(3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
(4) to provide information and education to the public on the prevention and implications of prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
(5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
(A) long-term outcomes of children affected by neonatal abstinence syndrome;
(B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
(C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
(b) Grants
(c) Coordinating activitiesTo carry out this section, the Secretary may—
(1) provide technical and consultative assistance to entities receiving grants under subsection (b);
(2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention;
(3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and
(4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology.
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317L, as added Pub. L. 106–310, div. A, title IX, § 911, Oct. 17, 2000, 114 Stat. 1127; amended Pub. L. 115–271, title VII, § 7064, Oct. 24, 2018, 132 Stat. 4021.)

CITE AS: 42 USC 247b-13

§ 247b–13a. Screening and treatment for maternal mental health and substance use disorders
(a) Grants
(b) ApplicationTo seek a grant under this section, an entity listed in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. At a minimum, any such application shall include explanations of—
(1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for maternal mental health and substance use disorders in 1 or more communities; and
(2) how a program, or programs, if expanded, would increase access to screening and treatment services for maternal mental health and substance use disorders.
(c) PriorityIn awarding grants under this section, the Secretary shall, as appropriate, give priority to entities listed in subsection (a) that—
(1) are proposing to create, improve, or enhance screening, prevention, and treatment services for maternal mental health and substance use disorders in primary care settings;
(2) are currently partnered with, or will partner with, one or more community-based organizations to address maternal mental health and substance use disorders;
(3) are located in, or provide services under this section in, an area with disproportionately high rates of maternal mental health or substance use disorders or other related disparities; and
(4) operate in a health professional shortage area designated under
(d) Use of fundsThe activities eligible for funding through a grant under subsection (a)—
(1) shall include—
(A) providing appropriate training on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers), and referrals for treatment to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals;
(B) providing information on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers) and referrals for treatment, follow-up support services, and linkages to community-based resources to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals; and
(C) to the extent practicable and appropriate, enabling health care providers (such as obstetrician-gynecologists, nurse practitioners, nurse midwives, pediatricians, psychiatrists, mental and other behavioral health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in-person or remotely), including through the use of technology-enabled collaborative learning and capacity building models (as defined in section 254c–20 of this title), to aid in the treatment of pregnant and postpartum women; and
(2) may include—
(A) establishing linkages with and among community-based resources, including mental health resources, primary care resources, and support groups;
(B) utilizing telehealth services, including for rural areas and medically underserved areas (as defined in section 254c–14(a) of this title);
(C) providing assistance to pregnant and postpartum women to receive maternal mental health and substance use disorder treatment, including patient consultation, care coordination, and navigation for such treatment;
(D) coordinating, as appropriate, with maternal and child health programs of State, local, and Tribal governments, including child psychiatric access programs;
(E) conducting public outreach and awareness regarding grants under subsection (a);
(F) creating multistate consortia to carry out the activities required or authorized under this subsection; and
(G) training health care providers in the primary care setting and relevant health paraprofessionals on trauma-informed care, culturally and linguistically appropriate services, and best practices related to training to improve the provision of maternal mental health and substance use disorder care for racial and ethnic minority populations and reduce related disparities in the delivery of such care.
(e) Technical assistance
(f) Dissemination of best practices
(g) Matching requirement
(h) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317L–1, as added Pub. L. 114–255, div. B, title X, § 10005, Dec. 13, 2016, 130 Stat. 1266; amended Pub. L. 117–328, div. FF, title I, § 1111, Dec. 29, 2022, 136 Stat. 5640.)

CITE AS: 42 USC 247b-13a

§ 247b–14. Oral health promotion and disease prevention
(a) Grants to increase resources for community water fluoridation
(1) In general
(2) Use of fundsA State shall use amounts provided under a grant under paragraph (1)—
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on the benefits of fluoridation; or
(D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
(b) Community water fluoridation
(1) In general
(2) Requirements
(A) Collaboration
(B) General use of funds
(C) Fluoridation specialists
(i) In general
(ii) Liaison
(iii) CDC
(D) Implementation
(3) EvaluationIn conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall ensure that such evaluation includes—
(A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under this section;
(B) the identification of the administrative, technical and operational challenges that are unique to the fluoridation of small water systems;
(C) the development of a practical model that may be easily utilized by other tribal, State, county or local governments in improving the quality of water fluoridation with emphasis on small water systems; and
(D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the benefits of optimally fluoridated water.
(c) School-based dental sealant program
(1) In general
(2) Use of funds
(3) EligibilityTo be eligible to receive funds under paragraph (1), an entity shall—
(A) prepare and submit to the State an application at such time, in such manner and containing such information as the State may require; and
(B) be a public elementary or secondary school—
(i) that is located in an urban area in which and 1
1 So in original. The word “and” probably should not appear.
more than 50 percent of the student population is participating in Federal or State free or reduced meal programs; or
(ii) that is located in a rural area and, with respect to the school district in which the school is located, the district involved has a median income that is at or below 235 percent of the poverty line, as defined in section 9902(2) of this title.
(d) Oral health infrastructure
(1) Cooperative agreements
(2) Authorization of appropriations
(e) Definitions
(f) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317M, as added Pub. L. 106–310, div. A, title XVI, § 1602, Oct. 17, 2000, 114 Stat. 1148; amended Pub. L. 111–148, title IV, § 4102(b), (c), Mar. 23, 2010, 124 Stat. 551, 552.)

CITE AS: 42 USC 247b-14

§ 247b–14a. Identification of interventions that reduce the burden and transmission of oral, dental, and craniofacial diseases in high risk populations; development of approaches for pediatric oral and craniofacial assessment
(a) In general
The Secretary of Health and Human Services, through the Maternal and Child Health Bureau, the Indian Health Service, and in consultation with the National Institutes of Health and the Centers for Disease Control and Prevention, shall—
(1) support community-based research that is designed to improve understanding of the etiology, pathogenesis, diagnosis, prevention, and treatment of pediatric oral, dental, craniofacial diseases and conditions and their sequelae in high risk populations;
(2) support demonstrations of preventive interventions in high risk populations including nutrition, parenting, and feeding techniques; and
(3) develop clinical approaches to assess individual patients for the risk of pediatric dental disease.
(b) Compliance with State practice laws
(c) Authorization of appropriations
(Pub. L. 106–310, div. A, title XVI, § 1601, Oct. 17, 2000, 114 Stat. 1148.)

CITE AS: 42 USC 247b-14a

§ 247b–15. Surveillance and education regarding infections associated with illicit drug use and other risk factors
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following:
(1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections.
(2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
(3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
(4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary.
(5) To improve the education, training, and skills of health professionals in the detection and control of infections described in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians.
(b) Laboratory procedures
(c) Definition
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317N, as added Pub. L. 106–310, div. A, title XVIII, § 1801, Oct. 17, 2000, 114 Stat. 1152; amended Pub. L. 115–271, title VII, § 7141, Oct. 24, 2018, 132 Stat. 4056.)

CITE AS: 42 USC 247b-15

§ 247b–16. Grants for lead poisoning related activities
(a) Authority to make grants
(1) In generalThe Secretary shall make grants to States to support public health activities in States and localities where data suggests that at least 5 percent of preschool-age children have an elevated blood lead level through—
(A) effective, ongoing outreach and community education targeted to families most likely to be at risk for lead poisoning;
(B) individual family education activities that are designed to reduce ongoing exposures to lead for children with elevated blood lead levels, including through home visits and coordination with other programs designed to identify and treat children at risk for lead poisoning; and
(C) the development, coordination and implementation of community-based approaches for comprehensive lead poisoning prevention from surveillance to lead hazard control.
(2) State match
(3) Application
(b) Coordination with other children’s programsA State shall identify in the application for a grant under this section how the State will coordinate operations and activities under the grant with—
(1) other programs operated in the State that serve children with elevated blood lead levels, including any such programs operated under title V, XIX, or XXI of the Social Security Act [42 U.S.C. 701 et seq., 1396 et seq., 1397aa et seq.]; and
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such Act [42 U.S.C. 620 et seq., 670 et seq.];
(B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under section 1786 of this title;
(D) local public and private elementary or secondary schools; or
(E) public housing agencies, as defined in section 1437a of this title.
(c) Performance measures
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317O, as added Pub. L. 106–310, div. A, title XXV, § 2502(a), Oct. 17, 2000, 114 Stat. 1162.)

CITE AS: 42 USC 247b-16

§ 247b–17. Human papillomavirus (Johanna’s Law)
(a) Surveillance
(1) In generalThe Secretary, acting through the Centers for Disease Control and Prevention, shall—
(A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human papillomavirus (referred to in this section as “HPV”) in different sites in various regions of the United States, through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and
(B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
(2) Report
(b) Prevention activities; education program
(1) In generalThe Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV, including—
(A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
(B) formative research to assist with the development of educational messages and information for the public, for patients, and for their partners about HPV;
(C) surveys of physician and public knowledge, attitudes, and practices about genital HPV infection; and
(D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and disseminate educational materials for the public and health care providers regarding HPV and its impact and prevention.
(2) Report; final proposal
(c) HPV education and prevention
(1) In generalThe Secretary shall prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address—
(A) modes of transmission;
(B) consequences of infection, including the link between HPV and cervical cancer;
(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.
(2) Medically accurate information
(d) Johanna’s Law
(1) National public awareness campaign
(A) In general
(B) Written materialsActivities under the national campaign under subparagraph (A) shall include—
(i) maintaining a supply of written materials that provide information to the public on gynecologic cancers; and
(ii) distributing the materials to members of the public upon request.
(C) Public service announcements
(2) Report and strategy
(A) ReportNot later than 6 months after January 12, 2007, the Secretary shall submit to the Congress a report including the following:
(i) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of the public with respect to different types of cancer, including gynecologic cancers.
(ii) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of health care providers with respect to different types of cancer, including gynecologic cancers.
(iii) For each activity described pursuant to clause (i) or (ii), a description of the following:(I) The funding for such activity for fiscal year 2006 and the cumulative funding for such activity for previous fiscal years.(II) The background and history of such activity, including—(aa) the goals of such activity;(bb) the communications objectives of such activity;(cc) the identity of each agency within the Department of Health and Human Services responsible for any aspect of the activity; and(dd) how such activity is or was expected to result in change.(III) How long the activity lasted or is expected to last.(IV) The outcomes observed and the evaluation methods, if any, that have been, are being, or will be used with respect to such activity.(V) For each such outcome or evaluation method, a description of the associated results, analyses, and conclusions.
(B) Strategy
(i) Development; submission to Congress
(ii) Consultation
(3) Full compliance
(A)In general.—Not later than March 1, 2008, the Secretary shall ensure that all provisions of this section, including activities directed to be carried out by the Centers for Disease Control and Prevention and the Food and Drug Administration, are fully implemented and being complied with. Not later than April 30, 2008, the Secretary shall submit to Congress a report that certifies compliance with the preceding sentence and that contains a description of all activities undertaken to achieve such compliance.
(B) If the Secretary fails to submit the certification as provided for under subparagraph (A), the Secretary shall, not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the month for which the report is being submitted to bring the Secretary into compliance with such sentence, and the anticipated date the Secretary expects to be in full compliance with such sentence.
(4) Consultation with nonprofit gynecologic cancer organizations
(6)1
1 So in original. No par. (5) has been enacted.
Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317P, as added Pub. L. 106–554, § 1(a)(1) [title V, § 516(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–72; amended Pub. L. 109–475, § 2, Jan. 12, 2007, 120 Stat. 3565; Pub. L. 111–324, § 1, Dec. 22, 2010, 124 Stat. 3536.)

CITE AS: 42 USC 247b-17

§ 247b–18. Surveillance and research regarding muscular dystrophy
(a) In general
(b) National muscular dystrophy epidemiology program
(c) Coordination with centers of excellence
(d) Data
(e) Reports and study
(1) Annual report
Not later than 18 months after October 8, 2008, and annually thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress a report—
(A) concerning the activities carried out by MD STARnet site 1
1 So in original. Probably should be plural.
funded under this section during the year for which the report is prepared;
(B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as funded under a grant under this section during fiscal years 2008 through 2012); and
(C) that every 2 years outlines prospective data collection objectives and strategies.
(2) Tracking health outcomes
(f) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317Q, as added Pub. L. 107–84, § 4, Dec. 18, 2001, 115 Stat. 828; amended Pub. L. 110–361, § 3, Oct. 8, 2008, 122 Stat. 4010; Pub. L. 113–166, § 3, Sept. 26, 2014, 128 Stat. 1880.)

CITE AS: 42 USC 247b-18

§ 247b–19. Information and education
(a) In general
(b) Stipends
(c) Requirements
In carrying out this section, the Secretary may—
(1) partner with leaders in the muscular dystrophy patient community;
(2) cooperate with professional organizations and the patient community in the development and issuance of care considerations for pediatric and adult patients, including acute care considerations, for Duchenne-Becker muscular dystrophy, and various other forms of muscular dystrophy, and in periodic review and updates, as appropriate;
(3) in developing and updating care considerations under paragraph (2), incorporate strategies specifically responding to the findings of the national transitions survey of minority, young adult, and adult communities of muscular dystrophy patients; and
(4) widely disseminate the Duchenne-Becker muscular dystrophy and various other forms of muscular dystrophy care considerations as broadly as possible, including through partnership opportunities with the muscular dystrophy patient community.
(d) Authorization of appropriations
(Pub. L. 107–84, § 5, Dec. 18, 2001, 115 Stat. 828; Pub. L. 110–361, § 4, Oct. 8, 2008, 122 Stat. 4011; Pub. L. 113–166, § 4, Sept. 26, 2014, 128 Stat. 1880.)

CITE AS: 42 USC 247b-19

§ 247b–20. Food safety grants
(a) In general
(b) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317R, as added Pub. L. 107–188, title III, § 312, June 12, 2002, 116 Stat. 674; amended Pub. L. 108–75, § 2(1), Aug. 15, 2003, 117 Stat. 898; Pub. L. 111–353, title II, § 205(d), Jan. 4, 2011, 124 Stat. 3939.)

CITE AS: 42 USC 247b-20

§ 247b–21. Mosquito-borne diseases; coordination grants to States; assessment and control grants to political subdivisions
(a) Coordination grants to States; assessment grants to political subdivisions
(1) In generalWith respect to mosquito control programs to prevent and control mosquito-borne diseases (referred to in this section as “control programs”), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States for the purpose of—
(A) coordinating control programs in the State involved; and
(B) assisting such State in making grants to political subdivisions of the State to conduct assessments to determine the immediate needs in such subdivisions for control programs, including programs to address emerging infectious mosquito-borne diseases, and to develop, on the basis of such assessments, plans for carrying out control programs in the subdivisions or improving existing control programs.
(2) Preference in making grants
(3) Certain requirementsA grant may be made under paragraph (1) only if—
(A) the State involved has developed, or agrees to develop, a plan for coordinating control programs in the State, and the plan takes into account any assessments or plans described in subsection (b)(3) that have been conducted or developed, respectively, by political subdivisions in the State;
(B) in developing such plan, the State consulted or will consult (as the case may be under subparagraph (A)) with political subdivisions in the State that are carrying out or planning to carry out control programs;
(C) the State agrees to monitor control programs in the State in order to ensure that the programs are carried out in accordance with such plan, with priority given to coordination of control programs in political subdivisions described in paragraph (2) that are contiguous;
(D) the State agrees that the State will make grants to political subdivisions as described in paragraph (1)(B), and that such a grant will not exceed $10,000; and
(E) the State agrees that the grant will be used to supplement, and not supplant, State and local funds available for the purpose described in paragraph (1).
(4) Reports to SecretaryA grant may be made under paragraph (1) only if the State involved agrees that, promptly after the end of the fiscal year for which the grant is made, the State will submit to the Secretary a report that—
(A) describes the activities of the State under the grant; and
(B) contains an evaluation of whether the control programs of political subdivisions in the State were effectively coordinated with each other, which evaluation takes into account any reports that the State received under subsection (b)(5) from such subdivisions.
(5) Number of grants
(b) Prevention and control grants to political subdivisions
(1) In general
(2) Preference in making grantsIn making grants under paragraph (1), the Secretary shall give preference to a political subdivision or consortium of political subdivisions that—
(A) has—
(i) a history of elevated incidence or prevalence of mosquito-borne disease;
(ii) a population of infected mosquitoes;
(iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-borne disease that presents a serious public health threat; or
(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;
(B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions will, if appropriate to the mosquito circumstances involved, effectively coordinate the activities of the control programs with contiguous political subdivisions;
(C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political subdivision or consortium of political subdivisions is located has identified or will identify geographic areas in such State that have a significant need for control programs and will effectively coordinate such programs in such areas; and
(D)
(i) is located in a State that has received a grant under subsection (a); or
(ii) that 1
1 So in original.
demonstrates to the Secretary that the control program is consistent with existing State mosquito control plans or policies, or other applicable State preparedness plans.
(3) Requirement of assessment and planA grant may be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved—
(A) has conducted an assessment to determine the immediate needs in such subdivision or consortium for a control program, including an entomological survey of potential mosquito breeding areas; and
(B) has, on the basis of such assessment, developed a plan for carrying out such a program.
(4) Requirement of matching funds
(A) In general
(B) Determination of amount contributed
(C) WaiverThe Secretary may waive the requirement established in subparagraph (A) if the Secretary determines that—
(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or
(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—(I) the size or density of the potentially impacted human population;(II) the size or density of a mosquito population that requires heightened control; or(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.
(5) Reports to Secretary
(6) Number of grants
(c) Applications for grants
(d) Technical assistance
(e) Definition of political subdivision
(f) Authorization of appropriations
(1) In general
(2) Public health emergencies
(3) Fiscal year 2019 appropriations
(July 1, 1944, ch. 373, title III, § 317S, as added Pub. L. 108–75, § 2(2), Aug. 15, 2003, 117 Stat. 898; amended Pub. L. 116–22, title VI, § 607(a), June 24, 2019, 133 Stat. 959.)

CITE AS: 42 USC 247b-21

§ 247b–22. Microbicide research
(a) In general
(b) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317T, as added Pub. L. 110–293, title II, § 203(d), July 30, 2008, 122 Stat. 2941.)

CITE AS: 42 USC 247b-22

§ 247b–23. National strategy and regional centers of excellence in vector-borne diseases
(a) In generalThe Secretary shall—
(1)
(A) ensure the development and implementation of a national strategy to address vector-borne diseases, including tick-borne diseases, that—
(i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
(ii) identifies strategic goals to address such diseases and appropriate benchmarks to measure progress toward achieving such goals; and
(B) update such strategy, as appropriate; and
(2) coordinate programs and activities, including related to data collection, research, and the development of diagnostics, treatments, vaccines, and other related activities, to address vector-borne diseases, including tick-borne diseases, across the Department of Health and Human Services and with other Federal agencies or departments, as appropriate.
(b) ConsultationIn carrying out subsection (a)(1), the Secretary shall consult with the Tick-Borne Disease Working Group established under section 284s of this title and other individuals, as appropriate, such as—
(1) epidemiologists with experience in vector-borne diseases;
(2) representatives of patient advocacy and research organizations that focus on vector-borne diseases, including such organizations that have demonstrated experience in related research, public health, data collection, or patient access to care;
(3) health information technology experts or other information management specialists;
(4) clinicians, entomologists, vector management professionals, public health professionals, and others with expertise in vector-borne diseases; and
(5) researchers, including researchers with experience conducting translational research.
(c) Centers of excellenceThe Secretary, in coordination with the Director of the Centers for Disease Control and Prevention, shall award grants, contracts, or cooperative agreements to institutions of higher education for the establishment or continued support of regional centers of excellence in vector-borne diseases to address vector-borne diseases, including tick-borne diseases, by—
(1) facilitating collaboration between academia and public health organizations for public health surveillance, prevention, and response activities related to vector-borne diseases, including tick-borne diseases;
(2) providing training for public health entomologists and other health care professionals, as appropriate, to address vector-borne diseases, including tick-borne diseases;
(3) conducting research to develop and validate prevention and control tools and methods, including evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease outbreaks; or
(4) preparing for and responding to outbreaks of vector-borne diseases, including tick-borne diseases.
(d) Eligibility
(e) Reports
(1) Program summary
(2) Progress report
(f) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317U, as added Pub. L. 116–94, div. N, title I, § 404(b), Dec. 20, 2019, 133 Stat. 3116.)

CITE AS: 42 USC 247b-23

§ 247b–24. Addressing factors related to improving health outcomes
(a) In general
(b) Eligible entitiesTo be eligible to receive an award under this section, an entity shall—
(1)
(A) be a State, local, or Tribal health department, community-based organization, Indian Tribe or Tribal organization (as such terms are defined in section 5304 of title 25), urban Indian organization (as defined in section 1603 of title 25), or other public or private entity, as the Secretary determines appropriate; or
(B) be a consortia of entities described in subparagraph (A) or a public-private partnership, including a community partnership;
(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary shall require;
(3) in the case of an entity other than a community-based organization, demonstrate a history of successfully working with an established community-based organization to address health outcomes; and
(4) submit a plan to conduct activities described in subsection (a) based on a community needs assessment that takes into account community input.
(c) Use of fundsAn entity described in subsection (b) shall use funds received under subsection (a), in consultation with State, local, and Tribal health departments, community-based organizations, entities serving medically underserved communities, and other entities, as applicable, for one or more of the following purposes:
(1) Supporting the implementation, evaluation, and dissemination of strategies, through evidence-informed or evidence-based programs and through the support and use of public health and health care professionals to address factors related to health outcomes.
(2) Establishing, maintaining, or improving, in consultation with State, local, or Tribal health departments, technology platforms or networks to support, in a manner that is consistent with applicable Federal and State privacy law—
(A) coordination among appropriate entities, and, as applicable and appropriate, activities to improve such coordination;
(B) information sharing on health and related social services; and
(C) technical assistance and related support for entities participating in the platforms or networks.
(3) Implementing best practices for improving health outcomes and reducing disease among underserved populations.
(4) Supporting consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, research, and other relevant activities.
(d) Best practices and technical assistanceThe Secretary, in consultation with the Director of the Office of Minority Health, the National Coordinator for Health Information Technology, and the Administrator of the Administration for Community Living, may award grants, contracts, and cooperative agreements to public or nonprofit private entities, including minority serving institutions (defined, for purposes of this subsection, as institutions and programs described in section 1063b(e)(1) of title 20 and institutions described in section 1067q(a) of title 20), to—
(1) identify or facilitate the development of best practices to support improved health outcomes for underserved populations;
(2) provide technical assistance, training, and evaluation assistance to award recipients under subsection (a);
(3) disseminate best practices, including to award recipients under subsection (a); and
(4) leverage, establish, or operate regional centers to develop, evaluate, and disseminate effective strategies on factors related to health outcomes, including supporting research and training related to such strategies.
(e) Award periods
(f) ReportNot later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes information on activities funded under this section. Such report shall include a description of—
(1) changes in the capacity of public health entities to address factors related to health outcomes in communities, including any applicable platforms or networks developed or utilized to coordinate health and related social services and any changes in workforce capacity or capabilities;
(2) improvements in health outcomes and in reducing health disparities in medically underserved communities;
(3) activities conducted to support consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, and other relevant activities;
(4) communities and populations served by recipients of awards under subsection (a);
(5) activities supported under subsection (e); and
(6) other relevant activities and outcomes, as determined by the Secretary.
(g) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 317V, as added Pub. L. 117–328, div. FF, title II, § 2201(a)(1), Dec. 29, 2022, 136 Stat. 5727.)

CITE AS: 42 USC 247b-24

§ 247c. Sexually transmitted diseases; prevention and control projects and programs
(a) Technical assistance to public and nonprofit private entities and scientific institutions
(b) Research, demonstration, and public information and education projectsThe Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—
(1) research into the prevention and control of sexually transmitted diseases;
(2) demonstration projects for the prevention and control of sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such diseases; and
(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(c) Project grants to StatesThe Secretary is also authorized to make proj­ect grants to States and, in consultation with the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.
(d) Grants for innovative, interdisciplinary approaches
(e) Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure
(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual’s consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a state or political subdivision of a State. Information derived from any such program may be disclosed—
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed.
(f) Consent of individuals

CITE AS: 42 USC 247c

§ 247c–1. Infertility and sexually transmitted diseases
(a) In general
(b) Authority regarding individual diseases
(c) Authorized activities
With respect to any sexually transmitted disease described in subsection (a), the activities referred to in such subsection are—
(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f);
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner of the woman the services described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6);
(8) providing to the public information and education on the prevention and control of the disease, including disseminating such information; and
(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).
(d) Requirement of availability of all services through each grantee
(e) Required providers regarding certain services
(f) Quality assurance regarding screening for diseases
(g) Confidentiality
(h) Limitation on imposition of fees for services
The Secretary may make a grant under subsection (a) only if the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(1) will be made according to a schedule of charges that is made available to the public;
(2) will be adjusted to reflect the income of the individual involved; and
(3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title.
(i) Limitations on certain expenditures
(j) Reports to Secretary
(1) Collection of data
The Secretary may make a grant under subsection (a) only if the applicant involved agrees, with respect to any disease selected under subsection (b) for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing—
(A) the incidence of the disease among the population of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5);
(D) an assessment of the extent to which the activities carried pursuant to subsection (a) have reduced the incidence of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the project carried out with the grant.
(2) Utility and comparability of data
(k) Maintenance of effort
(l) Requirement of application
(1) In general
(2) Submission of plan for program of grantee
(A) In general
(B) Participation of certain entities
The Secretary may make a grant under subsection (a) only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been prepared in consultation with an appropriate number and variety of—
(i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and education regarding such diseases; and
(ii) representatives of entities in such area that provide family planning services.
(m) Duration of grant
(n) Technical assistance, and supplies and services in lieu of grant funds
(1) Technical assistance
(2) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(A) the fair market value of any supplies or equipment furnished the grant recipient; and
(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(o) Evaluations and reports by Secretary
(1) Evaluations
(2) Report to Congress
Not later than 1 year after the date on which amounts are first appropriated pursuant to subsection (q), and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—
(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1), including information on the incidence of sexually transmitted diseases described in subsection (a); and
(B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.
(p) Coordination of Federal programs
(q) Authorization of appropriations
(r) Separate grants for research on delivery of services
(1) In general
(2) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 318A, as added Pub. L. 102–531, title III, § 304, Oct. 27, 1992, 106 Stat. 3490; amended Pub. L. 103–43, title XX, § 2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub. L. 103–183, title IV, § 402, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023.)

CITE AS: 42 USC 247c-1

§ 247c–2. Data collection regarding programs under subchapter XXIV

For the purpose of collecting and providing data for program planning and evaluation activities under subchapter XXIV, there are authorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available for such purpose.

(July 1, 1944, ch. 373, title III, § 318B, as added Pub. L. 106–345, title IV, § 412, Oct. 20, 2000, 114 Stat. 1350.)

CITE AS: 42 USC 247c-2

§ 247d. Public health emergencies
(a) EmergenciesIf the Secretary determines, after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
(b) Public Health Emergency Fund
(1) In general
(2) Uses
(A) facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);
(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 247d–3a, 247d–3b, or 247d–3c of this title;
(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1);
(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 247d–4 of this title;
(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title;
(F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and
(G) carry out other activities, as the Secretary determines applicable and appropriate.
(3) ReportNot later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
(A) the expenditures made from the Public Health Emergency Fund in such fiscal year, including—
(i) the amount obligated;
(ii) the recipient or recipients of such obligated funds;
(iii) the specific response activities such obligated funds will support; and
(iv) the declared or potential public health emergency for which such funds were obligated; and
(B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.
(4) Review
(5) GAO reportNot later than 4 years after June 24, 2019, the Comptroller General of the United States shall—
(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and
(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.
(c) Supplement not supplant
(d) Data submittal and reporting deadlines
(e) Temporary reassignment of State and local personnel during a public health emergency
(1) Emergency reassignment of federally funded personnel
(2) Activation of emergency reassignment
(A) Public health emergency
(B) Contents of requestTo seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:
(i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.
(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).
(iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 247d–3a of this title.
(iv) An identification of—(I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and(II) the number of personnel who would be so reassigned from each such program.
(v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.
(C) Consideration
(D) Termination and extension
(i) TerminationA State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:(I) The Secretary’s determination that the public health emergency no longer exists.(II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility.
(ii) Extension of reassignment flexibilityThe Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—(I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and(II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).
(3) Voluntary nature of temporary reassignment of State and local personnel
(A) In generalUnless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—
(i) shall have the opportunity to volunteer for temporary reassignment; and
(ii) shall not be required to agree to a temporary reassignment.
(B) Prohibition on conditioning Federal awards
(4) Notice to CongressThe Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—
(A) any initial request for temporary reassignment of personnel; and
(B) any request for an extension of such temporary reassignment.
(5) GuidanceThe Secretary shall—
(A) not later than 6 months after March 13, 2013, issue proposed guidance on the temporary reassignment of personnel under this subsection; and
(B) after providing notice and a 60-day period for public comment, finalize such guidance.
(6) Report to CongressNot later than 4 years after March 13, 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—
(A) a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;
(B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;
(C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;
(D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and
(E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.
(7) DefinitionsIn this subsection—
(A) the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25; and
(B) the term “State” includes, in addition to the entities listed in the definition of such term in section 201 of this title, the Freely Associated States.
(8) Sunset
(f) Determination with respect to Paperwork Reduction Act waiver during a public health emergency
(1) DeterminationIf the Secretary determines, after consultation with such public health officials as may be necessary, that—
(A)
(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or
(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and
(B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paperwork Reduction Act),
then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.
(2) Transparency
(3) Effectiveness of waiver
(4) Termination of waiver
(5) Limitations
(A) Period of waiver
(B) Subsequent compliance
(g) Certain appointments to support public health emergency responses
(1) In generalIn order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to—
(A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or
(B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section.
(2) Number of appointmentsEach fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—
(A) 400 individuals under paragraph (1)(A); and
(B) 100 individuals under paragraph (1)(B).
(3) Compensation
(4) ReportingThe Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—
(A) the number of positions filled through such authority;
(B) the types of appointments of such positions;
(C) the titles, occupational series, and grades of such positions;
(D) the number of positions publicly noticed to be filled under such authority;
(E) the number of qualified applicants who apply for such positions;
(F) the qualification criteria for such positions; and
(G) the demographic information of individuals appointed to such positions.
(5) Notification to CongressIn the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include—
(A) information on each such appointment within such fiscal year;
(B) a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and
(C) the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.
(6) Reports to Congress
(7) Sunset
(h) Stockpile depletion reportingThe Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 247d–6b(a) of this title to respond to a public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.], and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on—
(1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests;
(2) the amount of such products that remain within the stockpile following such deployment; and
(3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.
(July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2315; amended Pub. L. 107–188, title I, §§ 141, 144(a), 158, June 12, 2002, 116 Stat. 626, 630, 633; Pub. L. 113–5, title II, § 201, Mar. 13, 2013, 127 Stat. 170; Pub. L. 114–255, div. A, title III, § 3087, Dec. 13, 2016, 130 Stat. 1147; Pub. L. 116–22, title II, § 206, title VII, § 701(c), June 24, 2019, 133 Stat. 925, 961; Pub. L. 117–328, div. FF, title II, §§ 2103(a), 2223(a), 2407, Dec. 29, 2022, 136 Stat. 5711, 5747, 5788; Pub. L. 118–15, div. B, title III, § 2332, Sept. 30, 2023, 137 Stat. 96; Pub. L. 118–22, div. B, title II, § 203(a), Nov. 17, 2023, 137 Stat. 120; Pub. L. 118–35, div. B, title I, § 103(a), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, § 103(a), Mar. 9, 2024, 138 Stat. 398.)

CITE AS: 42 USC 247d

§ 247d–1. Vaccine tracking and distribution
(a) Tracking
(b) Distribution
(c) Confidentiality
(d) Guidelines
(e) Authorization of appropriations
(f) Report to Congress
(July 1, 1944, ch. 373, title III, § 319A, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2316; amended Pub. L. 107–188, title I, § 111(1), June 12, 2002, 116 Stat. 611; Pub. L. 109–417, title II, § 204(a), Dec. 19, 2006, 120 Stat. 2850; Pub. L. 113–5, title II, § 202(b), Mar. 13, 2013, 127 Stat. 175; Pub. L. 116–22, title VII, § 701(b), June 24, 2019, 133 Stat. 961; Pub. L. 117–328, div. FF, title II, § 2232, Dec. 29, 2022, 136 Stat. 5754.)

CITE AS: 42 USC 247d-1

§ 247d–2. Earlier development of diagnostic tests

The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under section 247d of this title, or that has significant potential to cause such a public health emergency.

(July 1, 1944, ch. 373, title III, § 319B, as added Pub. L. 117–328, div. FF, title II, § 2303(b), Dec. 29, 2022, 136 Stat. 5758.)

CITE AS: 42 USC 247d-2

§ 247d–3. Repealed. Pub. L. 109–417, title II, § 204(b)(1), Dec. 19, 2006, 120 Stat. 2851

CITE AS: 42 USC 247d-3

§ 247d–3a. Improving State and local public health security
(a) In general
(b) Eligible entitiesTo be eligible to receive an award under subsection (a), an entity shall—
(1)
(A) be a State;
(B) be a political subdivision determined by the Secretary to be eligible for an award under this section (based on criteria described in subsection (h)(4)); or
(C) be a consortium of States; and
(2) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—
(A) an All-Hazards Public Health Emergency Preparedness and Response Plan which shall include—
(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under section 300hh–1 of this title, including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or deliberate;
(ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);
(iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency;
(iv)(I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);(II) providing for optional registration to participate in volunteer services during processes related to State medical licensing, registration, or certification or renewal of such licensing, registration, or certification; or(III) other mechanisms as the State determines appropriate;
(v) a description of how the entity will include the State Unit on Aging in public health emergency preparedness;
(vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies, in public health emergency preparedness and response;
(vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs during and following a public health emergency;
(viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State education agencies 1
1 So in original. Section 7801 of title 20 defines “State educational agencies”.
(as defined in section 7801 of title 20), State child care lead agencies (designated under section 9858b of this title), and other relevant State agencies 2
2 So in original. Probably should be followed by a semicolon.
(ix) in the case of entities that operate on the United States-Mexico border or the United States-Canada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section;
(x) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;
(xi) a description of how the entity will partner with health care facilities, including hospitals and nursing homes and other long-term care facilities, to promote and improve public health preparedness and response;
(xii) a description of how the entity will provide technical assistance to improve public health preparedness and response, as appropriate, to agencies or other entities that operate facilities within the entity’s jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public health emergency declared under section 247d of this title, such as residential care facilities, group homes, and other similar settings; and
(xiii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency;
(B) an assurance that the entity will report to the Secretary on an annual basis (or more frequently as determined by the Secretary) on the evidence-based benchmarks and objective standards established by the Secretary to evaluate the preparedness and response capabilities of such entity under subsection (g);
(C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the Secretary to test the preparedness and response capabilities of such entity, including addressing the needs of at-risk individuals, and that the entity will report back to the Secretary within the application of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective actions taken to address material weaknesses;
(D) an assurance that the entity will require relevant staff to complete relevant preparedness and response trainings, including trainings related to efficient and effective operation during an incident or event within an Incident Command System;
(E) an assurance that the entity will provide to the Secretary the data described under section 247d–4(c)(3) of this title as determined feasible by the Secretary;
(F) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of such entity on the role of such hospitals in the plan required under subparagraph (A);
(G) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement an accountability system to ensure that such entity makes satisfactory annual improvement and describes such system in the plan under subparagraph (A);
(H) a description of the means by which to obtain public comment and input on the plan described in subparagraph (A) and on the implementation of such plan, that shall include an advisory committee or other similar mechanism for obtaining comment from the public and from other State, local, and tribal stakeholders; and
(I) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this section.
(c) Limitation
(d) Use of funds
(1) In general
(2) Effect of section
(e) Coordination with local response capabilities
(f) Consultation with Homeland SecurityIn making awards under subsection (a), the Secretary shall consult with the Secretary of Homeland Security to—
(1) ensure maximum coordination of public health and medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;
(2) minimize duplicative funding of programs and activities; and
(3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and guidance on best practices for such activities.
(g) Achievement of measurable evidence-based benchmarks and objective standards
(1) In generalNot later than 180 days after December 19, 2006, the Secretary shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in section 247d–3b of this title. In developing such benchmarks and standards, the Secretary shall consult with and seek comments from State, local, and tribal officials and private entities, as appropriate. Where appropriate, the Secretary shall incorporate existing objective standards. Such benchmarks and standards shall—
(A) include outcome goals representing operational achievements of the National Preparedness Goals developed under section 300hh–1(b) of this title with respect to all-hazards, including chemical, biological, radiological, or nuclear threats; and
(B) at a minimum, require entities to—
(i) measure progress toward achieving the outcome goals; and
(ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency preparedness and response capabilities of the entity, and report to the Secretary on such measured and tested capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by the Secretary.
(2) Criteria for pandemic influenza plans
(A) In general
(B) Rule of construction
(3) Technical assistance
(4) Notification of failures
(5) Withholding of amounts from entities that fail to achieve benchmarks or submit influenza planBeginning with fiscal year 2019, and in each succeeding fiscal year, the Secretary shall—
(A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures described in paragraph (1) for either of the 2 immediately preceding fiscal years (beginning with fiscal year 2018), pursuant to the process developed under paragraph (4), the amount described in paragraph (6); and
(B) withhold from each entity that has failed to submit to the Secretary a plan for responding to pandemic influenza that meets the criteria developed under paragraph (2), the amount described in paragraph (6).
(6) Amounts described
(A) In generalThe amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section 247d–3b of this title:
(i) For no more than one of each of the first 2 fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5), an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.
(ii) For no more than one of the first 2 fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.
(B) Separate accounting
(7) Reallocation of amounts withheld
(A) In general
(B) Preference in reallocation
(8) Waive or reduce withholding
(h) Funding
(1) Authorization of appropriations
(A) In general
(B) Requirement for State matching fundsBeginning in fiscal year 2009, in the case of any State or consortium of two or more States, the Secretary may not award a cooperative agreement under this section unless the State or consortium of States agree that, with respect to the amount of the cooperative agreement awarded by the Secretary, the State or consortium of States will make available (directly or through donations from public or private entities) non-Federal contributions in an amount equal to—
(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of such costs ($1 for each $20 of Federal funds provided in the cooperative agreement); and
(ii) for any second fiscal year of the cooperative agreement, and for any subsequent fiscal year of such cooperative agreement, not less than 10 percent of such costs ($1 for each $10 of Federal funds provided in the cooperative agreement).
(C) Determination of amount of non-Federal contributions
(2) Maintaining State funding
(A) In general
(B) Rule of construction
(3) Determination of amount
(A) In general
(B) Base amount
(C) Increase on basis of populationAfter determining the base amount for a State under subparagraph (B), the Secretary shall increase the base amount by an amount equal to the product of—
(i) the amount appropriated under paragraph (1)(A) for the fiscal year, less an amount equal to the sum of all base amounts determined for the States under subparagraph (B), and less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); and
(ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the population of the State over an amount equal to the total population of the States (as indicated by the most recent data collected by the Bureau of the Census).
(D) Minimum amountSubject to the amount appropriated under paragraph (1)(A), an award pursuant to subparagraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or the minimum amount under this subparagraph. The minimum amount under this subparagraph is—
(i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of—(I) $5,000,000; or(II) if the amount appropriated under paragraph (1)(A) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); or
(ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not exceed the amount determined under clause (i).
(4) Certain political subdivisions
(A) In general
(B) Coordination with Statewide plans
(C) Relationship to formula grants
(D) Continuity of funding
(5) Significant unmet needs; degree of risk
(A) In generalFor fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to eligible entities that—
(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3); and
(ii) face a particularly high degree of risk of such a threat.
(B) Recipients of grants
(C) Finding with respect to District of Columbia
(6) Funding of local entities
(7) Availability of cooperative agreement funds
(A) In general
(B) Funds contingent on achieving benchmarks
(i) Administrative and fiscal responsibility
(1) Annual reporting requirementsEach entity shall prepare and submit to the Secretary annual reports on its activities under this section and section 247d–3b of this title. Each such report shall be prepared by, or in consultation with, the health department. In order to properly evaluate and compare the performance of different entities assisted under this section and section 247d–3b of this title and to assure the proper expenditure of funds under this section and section 247d–3b of this title, such reports shall be in such standardized form and contain such information as the Secretary determines and describes within 180 days of December 19, 2006 (after consultation with the States) to be necessary to—
(A) secure an accurate description of those activities;
(B) secure a complete record of the purposes for which funds were spent, and of the recipients of such funds;
(C) describe the extent to which the entity has met the goals and objectives it set forth under this section or section 247d–3b of this title;
(D) determine the extent to which funds were expended consistent with the entity’s application transmitted under this section or section 247d–3b of this title; and
(E) publish such information on a Federal Internet website consistent with subsection (j).
(2) Audits; implementation
(A) In general
(B) Repayment
(C) Withholding of payment
(j) Compilation and availability of data
(k) Evaluation
(1) In general
(2) ContentThe evaluation under this paragraph shall include—
(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;
(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 300hh–1 of this title;
(C) a description of amounts received by eligible entities described in subsection (b) and section 247d–3b(b) of this title, and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and
(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 300hh–1 of this title.
(July 1, 1944, ch. 373, title III, § 319C–1, as added Pub. L. 107–188, title I, § 131(a), June 12, 2002, 116 Stat. 617; amended Pub. L. 109–417, title II, § 201, Dec. 19, 2006, 120 Stat. 2837; Pub. L. 113–5, title II, §§ 202(a), (c)(1), 204(b), Mar. 13, 2013, 127 Stat. 173, 175, 179; Pub. L. 114–95, title IX, § 9215(kkk)(1), Dec. 10, 2015, 129 Stat. 2187; Pub. L. 116–22, title II, §§ 201(a), 202(a), (b)(1), (d), 203(e)(1), 207(b), title VII, § 705(b), June 24, 2019, 133 Stat. 907–910, 914, 927, 964; Pub. L. 117–328, div. FF, title II, § 2111(a), Dec. 29, 2022, 136 Stat. 5720.)

CITE AS: 42 USC 247d-3a

§ 247d–3b. Partnerships for State and regional hospital preparedness to improve surge capacity
(a) In general
(b) EligibilityTo be eligible for an award under subsection (a), an entity shall—
(1)
(A) be a coalition that includes—
(i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with section 300d–13(c) of this title;
(ii) one or more other local health care facilities, including clinics, health centers, community health centers, primary care facilities, mental health centers, mobile medical assets, or nursing homes;
(iii)(I) one or more political subdivisions;(II) one or more States; or(III) one or more States and one or more political subdivisions; and
(iv) one or more emergency medical service organizations or emergency management organizations; and
(B) prepare, in consultation with the Chief Executive Officer and the lead health officials of the State, District, or territory in which the hospital and health care facilities described in subparagraph (A) are located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require; or
(2)
(A) be an entity described in section 247d–3a(b)(1) of this title; and
(B) submit an application at such time, in such manner, and containing such information as the Secretary may require, including the information or assurances required under section 247d–3a(b)(2) of this title and an assurance that the State will adhere to any applicable guidelines established by the Secretary.
(c) Use of funds
(d) Preferences
(1) Regional coordinationIn making awards under subsection (a), the Secretary shall give preference to eligible entities that submit applications that, in the determination of the Secretary—
(A) will enhance coordination—
(i) among the entities described in subsection (b)(1)(A)(i);
(ii) among one or more facilities in a regional health care emergency system under section 247d–3c of this title; and
(iii) between such entities and the entities described in subsection (b)(1)(A)(ii); and
(B) include, in the coalition described in subsection (b)(1)(A), a significant percentage of the hospitals and health care facilities within the geographic area served by such coalition.
(2) Other preferencesIn making awards under subsection (a), the Secretary shall give preference to eligible entities that, in the determination of the Secretary—
(A) include one or more hospitals that are participants in the National Disaster Medical System;
(B) are located in a geographic area that faces a high degree of risk, as determined by the Secretary in consultation with the Secretary of Homeland Security; or
(C) have a significant need for funds to achieve the preparedness and response goals described in section 300hh–1(b)(3) of this title.
(e) Consistency of planned activities
(f) Limitation on awards
(g) Coordination
(1) Local response capabilities
(2) National collaboration
(h) Maintenance of funding
(1) In general
(2) Rule of construction
(i) Performance and accountability
(1) In general
(2) Meeting goals of National Health Security Strategy
(j) Authorization of appropriations
(1) In general
(A) Authorization of appropriations
(B) Reservation of amounts for regional systems
(i) In general
(ii) Reservation contingent on continued appropriations for this section
(iii) Sunset
(2) Reservation of amounts for partnerships
(3) Awards to States and political subdivisions
(A) In general
(B) Amount
(4) Availability of cooperative agreement funds
(A) In general
(B) Funds contingent on achieving benchmarks
(July 1, 1944, ch. 373, title III, § 319C–2, as added Pub. L. 107–188, title I, § 131(a), June 12, 2002, 116 Stat. 624; amended Pub. L. 109–417, title III, § 305, Dec. 19, 2006, 120 Stat. 2861; Pub. L. 110–85, title XI, § 1104(1), Sept. 27, 2007, 121 Stat. 975; Pub. L. 113–5, title II, §§ 202(c)(2), 203(c), Mar. 13, 2013, 127 Stat. 175, 176; Pub. L. 116–22, title II, §§ 201(b), 202(c), (e), 203(c), (e)(2), June 24, 2019, 133 Stat. 908–910, 914.)

CITE AS: 42 USC 247d-3b

§ 247d–3c. Guidelines for regional health care emergency preparedness and response systems
(a) Purpose
(b) GuidelinesThe Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as the Secretary determines to be appropriate, and State, local, Tribal, and territorial public health officials, shall, not later than 2 years after June 24, 2019—
(1) identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—
(A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including—
(i) the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under section 247d–3b(b) of this title; and
(ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;
(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;
(C) protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;
(D) in a manner that allows for disease containment (within the meaning of section 300hh–1(b)(2)(B) of this title), coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as applicable and appropriate, between systems in different States or regions; and
(E) the needs of children and other at-risk individuals;
(2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security; and
(3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and information resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such Act), to address new and emerging public health threats.
(c) ConsiderationsIn identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—
(1) include input from hospitals and health care facilities (including health care coalitions under section 247d–3b of this title), State, local, Tribal, and territorial public health departments, and health care or subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or nuclear threats, including emerging infectious diseases), as the Assistant Secretary determines appropriate, to meet the goals under section 300hh–1(b)(3) of this title;
(2) consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts that the Assistant Secretary determines appropriate, to meet the goals under section 300hh–1(b)(3) of this title;
(3) consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and
(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.
(d) Technical assistance
(e) Demonstration project for regional health care preparedness and response systems
(1) In general
(2) Sunset
(July 1, 1944, ch. 373, title III, § 319C–3, as added Pub. L. 116–22, title II, § 203(a), June 24, 2019, 133 Stat. 911.)

CITE AS: 42 USC 247d-3c

§ 247d–4. Facilities and capacities of the Centers for Disease Control and Prevention
(a) In general
(1) Findings
(2) Facilities
(A) In general
(B) Multiyear contracting authority
(3) Improving the capacities of the Centers for Disease Control and PreventionThe Secretary shall expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies, by—
(A) expanding or enhancing the training of personnel;
(B) improving communications facilities and networks, including delivery of necessary information to rural areas;
(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b); and
(D) improving laboratory facilities related to bioterrorism, infectious disease outbreaks, and other public health emergencies, including increasing the security of such facilities.
(4) Study of resources for facilities and capacities
(b) Establishment of systems of public health communications and surveillance networks
(1) In generalThe Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among—
(A) Federal, State, local, and Tribal public health officials; and
(B) public and private health-related laboratories, hospitals, poison control centers, immunization information systems, and other health care facilities; 1
1 So in original.
(2) Requirements
(3) Standards
(A) In general
(B) Deference to standards development organizations
(c)
(1) In general
(2) Coordination and consultationIn establishing and improving the network under paragraph (1), the Secretary shall—
(A) facilitate coordination among agencies within the Department of Health and Human Services that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and
(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.
(3) Elements
(A) In generalThe network described in paragraph (1) shall include data and information transmitted in a standardized format from—
(i) State, local, and Tribal public health entities, including public health laboratories;
(ii) Federal health agencies;
(iii) zoonotic disease monitoring systems; and
(iv) public and private sector health care entities, hospitals, pharmacies, poison control centers or professional organizations in the field of poison control, immunization information systems, community health centers, health centers, clinical laboratories, and public environmental health agencies, to the extent practicable and provided that such data are voluntarily provided simultaneously to the Secretary and appropriate State, local, and Tribal public health agencies.
(B) Review
(4) Rule of construction
(5) Required activities
(A) In generalIn establishing, operating, and updating, as appropriate, the network described in paragraph (1), the Secretary shall—
(i) utilize applicable interoperability standards as adopted by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology, through a joint public and private sector process;
(ii) define minimal data elements for such network;
(iii) in collaboration with State, local, and Tribal public health officials, integrate and build upon existing State, local, and Tribal capabilities, ensuring simultaneous sharing of data, information, and analyses that is deidentified, as applicable, from the network described in paragraph (1) with State, local, and Tribal public health agencies in accordance with applicable Federal and State privacy and security law;
(iv) in collaboration with State, local, and Tribal public health officials, develop procedures and standards for the collection, analysis, and interpretation of data that States, regions, or other entities collect and report to the network described in paragraph (1);
(v) pilot test standards and implementation specifications, consistent with the process described in section 300jj–12(b)(3)(C) of this title, which State, local, Tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network; and
(vi) in collaboration with State, local, and Tribal public health officials, integrate and update applicable existing public health data systems and networks of the Department of Health and Human Services to reflect technological advancements, consistent with section 300hh–33 of this title, as applicable.
(B) Public meeting
(i) In general
(ii) Experts
(iii) TopicsSuch public meeting shall include a discussion of—(I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;(II) standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;(III) strategies to encourage the access, exchange, and use of information;(IV) considerations for State, local, Tribal, and territorial capabilities and infrastructure related to data exchange and interoperability, including existing public health data systems;(V) privacy and security protections provided at the Federal, State, local, Tribal, and territorial levels, and by nongovernmental stakeholders;(VI) opportunities for the incorporation of innovative technologies to improve the network;(VII) strategies to integrate laboratory and public health data systems and capabilities to support rapid and accurate reporting of laboratory test results and associated relevant data;(VIII) strategies to improve the collection, reporting, and dissemination of relevant, aggregated, deidentified demographic data to inform responses to public health emergencies, including identification of at-risk populations and to address potential health disparities; and(IX) strategies to improve the electronic exchange of health information, as appropriate, between State and local health departments and health care providers and facilities to improve the detection of, and responses to, potentially catastrophic infectious disease outbreaks.
(6) Strategy and implementation plan
(A) In generalNot later than 18 months after June 24, 2019, and every 5 years thereafter, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—
(i) is informed by the public meeting under paragraph (5)(B);
(ii) includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);
(iii) identifies and demonstrates the measurable steps the Secretary will carry out to—(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);(II) modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies;(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;(V) improve coordination and collaboration, as appropriate, with other Federal departments to improve the capabilities of the network and reduce administrative burden on State, local, and Tribal entities; and(VI) implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities;
(iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii);
(v) establishes dates by which each measurable step under clause (iii) will be implemented, including a description of how such steps will further the goals of the network, consistent with paragraph (1); and
(vi) identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of laboratory test results, deidentified as appropriate, during a public health emergency, and improve coordination and collaboration with State, local, and Tribal public health officials, clinical laboratories, and other entities with expertise in public health surveillance.
(B) Annual budget planNot later than 2 years after June 24, 2019, and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—
(i) a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);
(ii) estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);
(iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and
(iv) a strategy to minimize and address such gaps and improve inefficiencies.
(7) Consultation with the National Biodefense Science BoardIn carrying out this section and consistent with section 247d–7g of this title, the National Biodefense Science Board shall provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall—
(A) identify the steps necessary to achieve a national biosurveillance system for human health (taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health), with international connectivity, where appropriate, that is predicated on State, regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers;
(B) identify any duplicative surveillance programs and gaps in surveillance programs under the authority of the Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic;
(C) coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees consisting of representatives from State, local, and Tribal public health authorities and appropriate public and private sector health care entities, animal health organizations related to zoonotic disease, and academic institutions, in order to provide guidance on public health surveillance activities; and
(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section 300hh–1 of this title.
(8) Situational awareness and biosurveillance as a national security priority
(9) Rules of construction
(A) Nothing in this subsection shall be construed to supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to public health surveillance.
(B) Nothing in this subsection shall be construed to alter the authority of the Secretary with respect to the types of data the Secretary may receive through systems supported or established under this section.
(d) State and regional systems to enhance situational awareness in public health emergencies
(1) In general
(2) EligibilityTo be eligible to receive a grant under paragraph (1), the State or consortium of States shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the State or consortium of States will submit to the Secretary—
(A) reports of such deidentified data, information, and metrics as the Secretary may require, in consultation with such State or consortium of States;
(B) a report on the effectiveness of the systems funded under the grant;
(C) a description of the manner in which grant funds will be used to enhance the timelines and comprehensiveness of efforts to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public health emergencies, including any public-private partnerships or other partnerships entered into to improve such capacity; and
(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).
(3) Use of fundsA State or consortium of States that receives an award under this subsection—
(A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies;
(B) may award grants or contracts to entities described in paragraph (1) within or serving such State to assist such entities in improving the operation of information technology systems, facilitating the secure exchange of data and information, and training personnel to enhance the operation of the system described in subparagraph (A); and
(C) may conduct a pilot program for the development of multi-State telehealth network test beds that build on, enhance, and securely link existing State and local telehealth programs to prepare for, monitor, respond to, and manage the events of public health emergencies, facilitate coordination and communication among medical, public health, and emergency response agencies, and provide medical services through telehealth initiatives within the States that are involved in such a multi-State telehealth network test bed.
(4) LimitationInformation technology systems acquired or implemented using grants awarded under this section must be compliant with—
(A) interoperability and other technological standards, as determined by the Secretary; and
(B) data collection and reporting requirements for the network described in subsection (c).
(5) Technical assistance
(6) Non-duplication of effort
(e) Personnel authorities
(1) Specially qualified personnelIn addition to any other personnel authorities, to carry out subsections (b) and (c), the Secretary may—
(A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and
(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903 2
2 So in original. Probably should be preceded by “section”.
of title 5 are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.
(2) Limitations
(f) Timeline
(g) Independent evaluation
(h) Authorization of appropriationsThere are authorized to be appropriated—
(1) to carry out subsection (a), $25,000,000 for each of fiscal years 2022 and 2023; and
(2) to carry out subsections (b), (c), and (d), $136,800,000 for each of fiscal years 2022 and 2023.
(i) Definition
(July 1, 1944, ch. 373, title III, § 319D, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2318; amended Pub. L. 107–188, title I, § 103, June 12, 2002, 116 Stat. 603; Pub. L. 109–417, title II, §§ 202, 204(b)(2), Dec. 19, 2006, 120 Stat. 2845, 2851; Pub. L. 113–5, title II, § 204(a), Mar. 13, 2013, 127 Stat. 177; Pub. L. 116–22, title II, § 205(a), (b), June 24, 2019, 133 Stat. 918, 924; Pub. L. 117–328, div. FF, title II, § 2211, Dec. 29, 2022, 136 Stat. 5729.)

CITE AS: 42 USC 247d-4

§ 247d–4a. Infectious Diseases Rapid Response Reserve Fund

There is established in the Treasury a reserve fund to be known as the “Infectious Diseases Rapid Response Reserve Fund” (the “Reserve Fund”): Provided, That of the funds provided under the span “CDC-Wide Activities and Program Support” [132 Stat. 3073], $50,000,000, to remain available until expended, shall be available to the Director of the CDC for deposit in the Reserve Fund: Provided further, That amounts in the Reserve Fund shall be for carrying out titles II, III, and XVII of the PHS Act [42 U.S.C. 201 et seq., 241 et seq., 300u et seq.] to prevent, prepare for, or respond to an infectious disease emergency, including, in connection with such activities, to purchase or lease and provide for the insurance of passenger motor vehicles for official use in foreign countries: Provided further, That amounts in the Reserve Fund may only be provided for an infectious disease emergency if the infectious disease emergency (1) is declared by the Secretary of Health and Human Services under section 319 of the PHS Act [42 U.S.C. 247d] to be a public health emergency; or (2) as determined by the Secretary, has significant potential to imminently occur and potential, on occurrence, to affect national security or the health and security of United States citizens, domestically or internationally: Provided further, That amounts in the Reserve Fund may be transferred by the Director of the CDC to other accounts of the CDC, to accounts of the NIH, or to the Public Health and Social Services Emergency Fund, to be merged with such accounts or Fund for the purposes provided in this section: Provided further, That the Director shall provide to the Committees on Appropriations of the House of Representatives and the Senate, at least 7 days in advance of any transfer or obligation of funds made under the authority provided in this section, both a notification on the anticipated uses of funds by program, project, or activity; and a detailed spend plan of anticipated uses of funds, including estimated personnel and administrative costs, disaggregated by program, project, or activity: Provided further, That such spend plans shall be updated to include all applicable obligations to date and unobligated amounts and submitted quarterly to such Committees on Appropriations until such funds are fully expended: Provided further, That amounts in the Reserve Fund shall be in addition to amounts otherwise available to the Department of Health and Human Services for the purposes provided in this section: Provided further, That the transfer authorities in this section are in addition to any transfer authority otherwise available to the Department of Health and Human Services: Provided further, That products purchased using amounts in the Reserve Fund may, at the discretion of the Secretary of Health and Human Services, be deposited in the Strategic National Stockpile under section 319F–2 of the PHS Act [42 U.S.C. 247d–6b]: Provided further, That this section shall be in effect as of September 28, 2018, through each fiscal year hereafter.

(Pub. L. 115–245, div. B, title II, § 231, Sept. 28, 2018, 132 Stat. 3095; Pub. L. 118–47, div. D, title II, § 236, Mar. 23, 2024, 138 Stat. 680.)

CITE AS: 42 USC 247d-4a

§ 247d–4b. Children’s Preparedness Unit
(a) Enhancing emergency preparedness for children
(b) Expertise
(c) Duties
The team described in subsection (a) may—
(1) assist State, local, Tribal, and territorial emergency planning and response activities related to children, which may include developing, identifying, and sharing best practices;
(2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections 247d–3a and 247d–3b of this title;
(3) improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency, including public awareness of such methods;
(4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections 247d–3b and 247d–3c of this title, to address gaps and inefficiencies in emergency preparedness and response efforts for children;
(5) provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for, and responding to, public health emergencies, including pursuant to section 247d–3c of this title; and
(6) carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.
(July 1, 1944, ch. 373, title III, § 319D–1, as added Pub. L. 116–22, title III, § 304, June 24, 2019, 133 Stat. 936.)

CITE AS: 42 USC 247d-4b

§ 247d–5. Combating antimicrobial resistance
(a) Task force
(1) In general
(2) Members of task force
(3) Agenda
(A) In generalThe task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to increasing antimicrobial resistance;
(ii) public health needs to detect and monitor antimicrobial resistance;
(iii) detection, prevention, and control strategies for resistant pathogens;
(iv) the need for improved information and data collection;
(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance.
(B) Detection and controlThe Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.
(4) Meetings
(b) Research and development of new antimicrobial drugs and diagnosticsThe Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
(3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
(4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and
(5) other relevant research areas.
(c) Education of medical and public health personnelThe Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and
(3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens.
(d) Grants
(1) In general
(2) Eligible entities
(3) Use of fundsAn eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that—
(A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;
(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and
(C) develop and implement policies to control the spread of antimicrobial resistance.
(e) Grants for demonstration programs
(1) In general
(2) Eligible entities
(3) Technical assistance
(f) Monitoring at Federal health care facilities
(g) Report on antimicrobial resistance in humans and use of antimicrobial drugsNot later than 1 year after December 13, 2016, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning—
(1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 356(h) of title 21;
(2) antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and
(3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of—
(A) any applicable resistance under paragraph (1); and
(B) drugs approved under section 356(h) of title 21.
(h) Information related to antimicrobial stewardship programs
(i) Supporting State-based activities to combat antimicrobial resistanceThe Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may include activities to related to—
(1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;
(2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and
(3) promoting antimicrobial stewardship.
(j) Antimicrobial resistance and stewardship activities
(1) In generalFor the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 356(h) of title 21, the Secretary shall—
(A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and
(B) evaluate—
(i) antimicrobial resistance data using a standardized approach; and
(ii) trends in the utilization of drugs approved under such section 356(h) of title 21 with respect to patient populations.
(2) Use of systems
(k) Network of antibiotic resistance regional laboratories
(1) In generalThe Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate, maintain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capabilities, within existing laboratory capacity maintained or supported by the Centers for Disease Control and Prevention, to—
(A) identify and monitor the emergence and changes in the patterns of antimicrobial-resistant pathogens;
(B) detect, identify, confirm, and isolate such resistant pathogens, including, as appropriate, performing such activities upon the request of another laboratory and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and
(C) perform activities to support the diagnosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.
(2) Geographic distribution
(3) Partnerships and nonduplication of current domestic capacity
(l) International collaboration
(1) In generalThe Secretary, in coordination with heads of other relevant Federal departments and agencies, shall support activities related to addressing antimicrobial resistance internationally, including by—
(A) supporting basic, translational, epidemiological, and clinical research related to antimicrobial-resistant pathogens, including such pathogens that have not yet been detected in the United States, and improving related public health surveillance systems, and laboratory and other response capacity; and
(B) providing technical assistance related to antimicrobial resistant infection and control activities.
(2) Awards
(m) Antimicrobial
(n) Supplement not supplant
(o) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 319E, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2318; amended Pub. L. 107–188, title I, § 109, June 12, 2002, 116 Stat. 610; Pub. L. 114–255, div. A, title III, § 3041(a), Dec. 13, 2016, 130 Stat. 1111; Pub. L. 117–328, div. FF, title II, § 2234, Dec. 29, 2022, 136 Stat. 5754.)

CITE AS: 42 USC 247d-5

§ 247d–5a. Repealed. Pub. L. 114–255, div. A, title III, § 3044(b)(1), Dec. 13, 2016, 130 Stat. 1121

CITE AS: 42 USC 247d-5a

§ 247d–6. Public health countermeasures to a bioterrorist attack
(a) All-hazards public health and medical response curricula and training
(1) In general
(2) CurriculumThe public health and medical response training program may include course work related to—
(A) medical management of casualties, taking into account the needs of at-risk individuals;
(B) public health aspects of public health emergencies;
(C) mental health aspects of public health emergencies;
(D) national incident management, including coordination among Federal, State, local, tribal, international agencies, and other entities; and
(E) protecting health care workers and health care first responders from workplace exposures during a public health emergency.
(3) Peer review
(4) CreditThe Secretary and the Secretary of Defense shall—
(A) take into account continuing professional education requirements of public health and healthcare professions; and
(B) cooperate with State, local, and tribal accrediting agencies and with professional associations in arranging for students enrolled in the program to obtain continuing professional education credit for program courses.
(5) Dissemination and training
(A) In general
(B) Certain entities
(C) Grants and contracts
(b) Advice to the Federal Government
(1) Required advisory committees
(2) National Advisory Committee on At-Risk Individuals and Public Health Emergencies
(A) In general
(B) DutiesThe Advisory Committee shall provide recommendations regarding—
(i) the preparedness of the health care (including mental health care) system to respond to public health emergencies as they relate to at-risk individuals;
(ii) needed changes to the health care and emergency medical service systems and emergency medical services protocols to meet the special needs of at-risk individuals; and
(iii) changes, if necessary, to the national stockpile under section 300hh–12 of this title to meet the emergency health security of at-risk individuals.
(C) Composition
(D) Termination
(3) Emergency Public Information and Communications Advisory Committee
(A) In general
(B) Duties
(C) Composition
(D) Dissemination
(E) Termination
(c) Expansion of Epidemic Intelligence Service Program
(d) Centers for Public Health Preparedness and Response
(1) In general
(2) EligibilityTo be eligible to receive an award under this subsection, an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will—
(A) coordinate relevant activities with applicable State, local, and Tribal health departments and officials, health care facilities, and health care coalitions to improve public health preparedness and response, as informed by the public health preparedness and response needs of the community, or communities, involved;
(B) prioritize efforts to implement evidence-informed or evidence-based practices to improve public health preparedness and response, including by helping to reduce the transmission of emerging infectious diseases; and
(C) use funds awarded under this subsection, including by carrying out any activities described in paragraph (3).
(3) Use of fundsThe Centers established or maintained under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include—
(A) identifying, translating, and disseminating promising research findings or strategies into evidence-informed or evidence-based practices to inform preparedness for, and responses to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and other public health emergencies, which may include conducting research related to public health preparedness and response systems;
(B) improving awareness of such evidence-informed or evidence-based practices and other relevant scientific or public health information among health care professionals, public health professionals, other stakeholders, and the public, including through the development, evaluation, and dissemination of trainings and training materials, consistent with section 300hh–1(b)(2) of this title, as applicable and appropriate, and with consideration given to existing training materials, to support preparedness for, and responses to, such threats;
(C) utilizing and expanding relevant technological and analytical capabilities to inform public health and medical preparedness and response efforts;
(D) expanding activities, including through public-private partnerships, related to public health preparedness and response, including participation in drills and exercises and training public health experts, as appropriate; and
(E) providing technical assistance and expertise that relies on evidence-based practices, as applicable, related to responses to public health emergencies, as appropriate, to State, local, and Tribal health departments and other entities pursuant to paragraph (2)(A).
(4) Distribution of awards
(e) Accelerated research and development on priority pathogens and countermeasures
(1) In generalWith respect to pathogens of potential use in a bioterrorist attack, and other agents that may cause a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to—
(A) the epidemiology and pathogenesis of such pathogens;
(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the working group established in subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy;
(C) the development of priority countermeasures; and
(D) other relevant areas of research;
with consideration given to the needs of children and other vulnerable populations.
(2) Priority
(3) Role of Department of Veterans Affairs
(4) Priority countermeasuresFor purposes of this section, the term “priority countermeasure” means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be—
(A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to section 262a(a)(1) of this title, or harm from any other agent that may cause a public health emergency; or
(B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A).
(f) Authorization of appropriations
(1) Fiscal year 2007There are authorized to be appropriated to carry out this section for fiscal year 2007—
(A) to carry out subsection (a)—
(i) $5,000,000 to carry out paragraphs (1) through (4); and
(ii) $7,000,000 to carry out paragraph (5);
(B) to carry out subsection (c), $3,000,000; and
(C) to carry out subsection (d), $31,000,000.
(2) Subsequent fiscal years
(July 1, 1944, ch. 373, title III, § 319F, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2321; amended Pub. L. 107–188, title I, §§ 104(a) 105, 108, 111(3), 125, June 12, 2002, 116 Stat. 605, 606, 609, 611, 614; Pub. L. 108–276, § 2(d), July 21, 2004, 118 Stat. 842; Pub. L. 109–417, title III, §§ 301(d), (e), 304, Dec. 19, 2006, 120 Stat. 2854, 2855, 2859; Pub. L. 113–5, title II, § 203(a), Mar. 13, 2013, 127 Stat. 175; Pub. L. 117–328, div. FF, title II, § 2231(a), Dec. 29, 2022, 136 Stat. 5752.)

CITE AS: 42 USC 247d-6

§ 247d–6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities
(a) In general
(1) Authority
(2) Definitions
In this section:
(A) Qualified countermeasure
The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—
(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;
(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or
(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
(B) Infectious disease
(3) Interagency cooperation
(A) In general
(B) Limitation
(4) Availability of facilities to the Secretary
(5) Transfers of qualified countermeasures
(b) Expedited procurement authority
(1) Increased simplified acquisition threshold for qualified countermeasure procurements
(A) In general
For any procurement by the Secretary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development needs under this section, the amount specified in section 134 of title 41, as applicable pursuant to section 3101(b)(1)(A) of title 41, shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of—
(i)section 3305(a)(1) of title 41 and its implementing regulations; and
(ii)section 3101(b)(1)(B) of title 41 and its implementing regulations.
(B) Application of certain provisions
Notwithstanding subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of subparagraph (A):
(i) Chapter 37 of title 40 (relating to contract work hours and safety standards).
(ii)Section 8703(a) of title 41.
(iii)Section 4706 of title 41 (relating to the examination of contractor records).
(iv)Section 3131 of title 40 (relating to bonds of contractors of public buildings or works).
(v)Section 3901 of title 41 (relating to contingent fees to middlemen).
(vi)Section 6962 of this title.
(vii)Section 1354 of title 31 (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements).
(C) Internal controls to be instituted
(D) Authority to limit competition
(2) Procedures other than full and open competition
(A) In general
(B) Relation to other authorities
(C) Applicable government-wide regulations
(3) Increased micropurchase threshold
(A) In general
(B) Internal controls to be instituted
(C) Exception to preference for purchase card mechanism
(4) Review
(A) Review allowed
Notwithstanding subsection (f), section 1491 of title 28, and section 3556 of title 31, review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest—
(i) with a contracting agency; or
(ii) with the Comptroller General under subchapter V of chapter 35 of title 31.
(B) Override of stay of contract award or performance committed to agency discretion
Notwithstanding section 1491 of title 28 and section 3553 of title 31, the following authorizations by the head of a procuring activity are committed to agency discretion:
(i) An authorization under section 3553(c)(2) of title 31 to award a contract for a procurement described in paragraph (1) of this subsection.
(ii) An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.
(c) Authority to expedite peer review
(1) In general
The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under sections 241(a)(3), 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c of this title, as applicable to a grant, contract, or cooperative agreement—
(A) that is for performing, administering, or supporting qualified countermeasure research and development activities; and
(B) the amount of which is not greater than $1,500,000.
(2) Subsequent phases of research
(d) Authority for personal services contracts
(1) In general
(2) Federal Tort Claims Act coverage
(A) In general
(B) Exclusivity of remedy
(C) Recourse in case of gross misconduct or contract violation
(i) In general
(ii) Venue
(3) Internal controls to be instituted
(A) In general
(B) Determination of employee status to be final
(4) Number of personal services contracts limited
(e) Streamlined personnel authority
(1) In general
(2) Limitations
The authority provided for under paragraph (1) shall be exercised in a manner that—
(A) recruits and appoints individuals based solely on their abilities, knowledge, and skills;
(B) does not discriminate for or against any applicant for employment on any basis described in section 2302(b)(1) of title 5;
(C) does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official;
(D) does not discriminate for or against an individual because of the exercise of any activity described in paragraph (9) or (10) of section 2302(b) of such title; and
(E) accords a preference, among equally qualified persons, to persons who are preference eligibles (as defined in section 2108(3) of such title).
(3) Internal controls to be instituted
(f) Actions committed to agency discretion
(July 1, 1944, ch. 373, title III, § 319F–1, as added Pub. L. 108–276, § 2(a), July 21, 2004, 118 Stat. 835; amended Pub. L. 109–417, title IV, § 403(a), Dec. 19, 2006, 120 Stat. 2874; Pub. L. 113–5, title IV, § 402(g)(1), Mar. 13, 2013, 127 Stat. 195; Pub. L. 116–22, title VII, § 705(a)(1), June 24, 2019, 133 Stat. 964.)

CITE AS: 42 USC 247d-6a

§ 247d–6b. Strategic National Stockpile and security countermeasure procurements
(a) Strategic National Stockpile
(1) In general
(2) Threat-based review
(A) In general
(B) Additions, modifications, and replenishmentsEach annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—
(i) information regarding—(I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including—(aa) consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies on the health care system; and(bb) an assessment of the current supply chain for such products, including information on supply chain redundancies, any known domestic manufacturing capacity for such products, and any related vulnerabilities;(III) the presence or lack of a commercial market for the countermeasure at the time of procurement;(IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;(V) an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;(VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 300hh–10(b)(7) of this title, including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and(VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and
(ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.
(3) ProceduresThe Secretary, in managing the stockpile under paragraph (1), shall—
(A) consult with the working group under section 247d–6(a) of this title and the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title;
(B) ensure that adequate procedures are followed, regularly reviewed, and updated with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile;
(C) in consultation with Federal, State, local, and Tribal officials, take into consideration the timing and location of special events, and the availability, deployment, dispensing, and administration of countermeasures;
(D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that—
(i) emerging threats, advanced technologies, and new countermeasures are adequately considered;
(ii) the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment; and
(iii) such contents are in working condition or usable, as applicable, and are ready for deployment, which may include conducting maintenance services on such contents of the stockpile and disposing of such contents that are no longer in working condition, or usable, as applicable;
(E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;
(F) deploy the stockpile at the discretion of the Secretary, in consultation with, or at the request of, the Secretary of Homeland Security, to respond to an actual or potential emergency;
(G) deploy the stockpile at the discretion of the Secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety;
(H) ensure the adequate physical security of the stockpile;
(I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 247d–7e of this title, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States;
(J) provide assistance, including technical assistance, to maintain and improve State 1
1 So in original. Probably should be followed by a comma.
local, and Tribal public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate; and
(K) convene meetings, not less than once per year, with representatives from State, local, and Tribal health departments or officials, relevant industries, other Federal agencies, and other appropriate stakeholders, in a manner that does not compromise national security, to coordinate and share information related to maintenance and use of the stockpile, including a description of future countermeasure needs and additions, modifications, and replenishments of the contents of the stockpile, and considerations related to the manufacturing and procurement of products consistent with the requirements of the with the requirements of 2
2 So in original.
chapter 83 of title 41 (commonly referred to as the “Buy American Act”), as appropriate.
(4) Utilization guidelines
(5) Vendor-managed inventory and warm-base surge capacity
(A) In generalFor the purposes of maintaining the stockpile under paragraph (1) and carrying out procedures under paragraph (3), the Secretary may enter into contracts or cooperative agreements with vendors, which may include manufacturers or distributors of medical products, with respect to medical products intended to be delivered to the ownership of the Federal Government. Each such contract or cooperative agreement shall be subject to such terms and conditions as the Secretary may specify, including terms and conditions with respect to—
(i) procurement, maintenance, storage, and delivery of products, in alignment with inventory management and other applicable best practices, under such contract or cooperative agreement, which may consider, as appropriate, costs of transporting and handling such products; or
(ii) maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities are available, and that such capacity and capabilities are able to support the rapid manufacture, purchase, storage, and delivery of such products, as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency.
(B) ReportNot later than 2 years after December 29, 2022, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on any contracts or cooperative agreements entered into under subparagraph (A) for purposes of establishing and maintaining vendor-managed inventory or reserve manufacturing capacity and capabilities for products intended for the stockpile, including a description of—
(i) the amount of each award;
(ii) the recipient of each award;
(iii) the product or products covered through each award; and
(iv) how the Secretary works with each recipient to ensure situational awareness related to the manufacturing capacity for, or inventory of, such products and coordinates the distribution and deployment of such products, as appropriate and applicable.
(6) GAO report
(A) In generalNot later than 3 years after June 24, 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include—
(i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;
(ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;
(iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;
(iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;
(v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);
(vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;
(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;
(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities;
(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 247d–7e of this title, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States; and
(x) with respect to reports issued in 2027 or any subsequent year, an assessment of selected contracts or cooperative agreements entered into pursuant to paragraph (5).
(B) Submission
(7) Reimbursement for certain supplies
(A) In generalThe Secretary may, at appropriate intervals, make available for purchase excess contents procured for, and maintained within, the stockpile under paragraph (1) to any Federal agency or State, local, or Tribal government. The Secretary shall make such contents available for purchase only if—
(i) such contents are in excess of what is required for appropriate maintenance of such stockpile;
(ii) the Secretary determines that the costs for maintaining such excess contents are not appropriate to expend to meet the needs of the stockpile; and
(iii) the Secretary determines that such action does not compromise national security and is in the national interest.
(B) Reimbursement and collection
(C) Rule of construction
(D) Report
(E) Sunset
(b) Smallpox vaccine development
(1) In general
(2) Rule of construction
(c) Additional authority regarding procurement of certain countermeasures; availability of special reserve fund
(1) In general
(A) Use of fund
(B) Security countermeasureFor purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that—
(i)(I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and(III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or
(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].
(2) Determination of material threats
(A) Material threatThe Homeland Security Secretary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis—
(i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security.
(B) Public health impact; necessary countermeasuresThe Secretary shall on an ongoing basis—
(i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and
(ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health.
(C) Notice to Congress
(D) Assuring access to threat information
(3) Assessment of availability and appropriateness of countermeasures
(A) In general
(B) InformationThe Secretary shall institute a process for making publicly available the results of assessments under subparagraph (A) while withholding such information as—
(i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
(ii) would otherwise be exempt from disclosure under section 552 of title 5.
(4) Call for development of countermeasures; commitment for recommendation for procurement
(A) Proposal to the PresidentIf, pursuant to an assessment under paragraph (3), the Homeland Security Secretary and the Secretary make a determination that a countermeasure would be appropriate but is either currently not developed or unavailable for procurement as a security countermeasure or is approved, licensed, or cleared only for alternative uses, such Secretaries may jointly submit to the President a proposal to—
(i) issue a call for the development of such countermeasure; and
(ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under paragraph (5), the Secretaries will, based in part on information obtained pursuant to such call, and subject to the availability of appropriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable.
(B) Countermeasure specificationsThe Homeland Security Secretary and the Secretary shall, to the extent practicable, include in the proposal under subparagraph (A)—
(i) estimated quantity of purchase (in the form of number of doses or number of effective courses of treatments regardless of dosage form);
(ii) necessary measures of minimum safety and effectiveness;
(iii) estimated price for each dose or effective course of treatment regardless of dosage form; and
(iv) other information that may be necessary to encourage and facilitate research, development, and manufacture of the countermeasure or to provide specifications for the countermeasure.
(C) Presidential approvalIf the President approves a proposal under subparagraph (A), the Homeland Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure involved—
(i) the call for the countermeasure;
(ii) specifications for the countermeasure under subparagraph (B); and
(iii) the commitment described in subparagraph (A)(ii).
(5) Secretary’s determination of countermeasures appropriate for funding from special reserve fund
(A) In general
(B) RequirementsIn making a determination under subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and consider the following:
(i) The quantities of the product that will be needed to meet the stockpile needs.
(ii) The feasibility of production and delivery within 10 years of sufficient quantities of the product.
(iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.
(6) Recommendations for procurement
(A) Notice to appropriate congressional committees
(B) Subsequent specific countermeasures
(7) Procurement
(A) Payments from special reserve fund
(B) Procurement
(i) In generalThe Secretary shall be responsible for—(I) arranging for procurement of a security countermeasure, including negotiating terms (including quantity, production schedule, and price) of, and entering into, contracts and cooperative agreements, and for carrying out such other activities as may reasonably be required, including advanced research and development, in accordance with the provisions of this subparagraph; and(II) promulgating such regulations as the Secretary determines necessary to implement the provisions of this subsection.
(ii) Contract termsA contract for procurements under this subsection shall (or, as specified below, may) include the following terms:(I) Payment conditioned on delivery(II) Discounted payment(III) Contract duration(IV) Storage by vendor(V) Product approval(VI) Non-stockpile transfers of security countermeasures(VII) Sales exclusivity(VIII) Warm based surge capacity(IX) Contract termsThe Secretary, in any contract for procurement under this section—(aa) may specify—(AA) the dosing and administration requirements for the countermeasure to be developed and procured;(BB) the amount of funding that will be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; and(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and(bb) shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined in paragraph (1)(B).
(iii) Availability of simplified acquisition procedures(I) In generalIf the Secretary determines that there is a pressing need for a procurement of a specific countermeasure, the amount of the procurement under this subsection shall be deemed to be below the threshold amount specified in section 134 of title 41, for purposes of application to such procurement, pursuant to section 3101(b)(1)(A) of title 41, of—(aa)section 3305(a)(1) of title 41 and its implementing regulations; and(bb)section 3101(b)(1)(B) of title 41 and its implementing regulations.(II) Application of certain provisionsNotwithstanding subclause (I) and the provision of law and regulations referred to in such clause, each of the following provisions shall apply to procurements described in this clause to the same extent that such provisions would apply to such procurements in the absence of subclause (I):(aa) Chapter 37 of title 40 (relating to contract work hours and safety standards).(bb)Section 8703(a) of title 41.(cc)Section 4706 of title 41 (relating to the examination of contractor records).(dd)Section 3131 of title 40 (relating to bonds of contractors of public buildings or works).(ee)Section 3901 of title 41 (relating to contingent fees to middlemen).(ff)Section 6962 of this title.(gg)Section 1354 of title 31 (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements).(III) Internal controls to be established(IV) Authority to limit competition
(iv) Procedures other than full and open competition(I) In general(II) Relation to other authorities(III) Applicable government-wide regulations
(v) Premium provision in multiple award contracts(I) In generalIf, under this subsection, the Secretary enters into contracts with more than one vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in each of such contracts a provision that—(aa) identifies an increment of the total quantity of security countermeasure required, whether by percentage or by numbers of units; and(bb) promises to pay one or more specified premiums based on the priority of such vendors’ production and delivery of the increment identified under item (aa), in accordance with the terms and conditions of the contract.(II) Determination of Government’s requirement not reviewable
(vi) Extension of closing date for receipt of proposals not reviewable
(vii) Limiting competition to sources responding to request for information
(viii) Flexibility
(8) Interagency cooperation
(A) In general
(B) Limitation
(d) Disclosures
(e) DefinitionFor purposes of subsection (a), the term “stockpile” includes—
(1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to such Secretary supplies described in subsection (a).
(f) Authorization of appropriations
(1) Strategic National Stockpile
(2) Smallpox vaccine development
(g) Special reserve fund
(1) Authorization of appropriations
(2) Use of special reserve fund for advanced research and development
(3) Restrictions on use of funds
(4) Report on security countermeasure procurementNot later than March 1 of each year in which the Secretary determines that the amount of funds available for procurement of security countermeasures is less than $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have—
(A) in meeting the security countermeasure needs identified under this section; and
(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 300hh–10(d) of this title).
(5) Clarification on contracting authority
(h) DefinitionsIn this section:
(1) The term “advanced research and development” has the meaning given such term in section 247d–7e(a) of this title.
(2) The term “special reserve fund” means the “Biodefense Countermeasures” appropriations account, any appropriation made available pursuant to section 321j(a) of title 6, and any appropriation made available pursuant to subsection (g)(1).
(i) Pilot program to support State medical stockpiles
(1) In general
(2) Requirements
(A) ApplicationTo be eligible to receive an award under paragraph (1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such State or States, and submit to the Secretary an application that contains such information as the Secretary may require, including—
(i) a plan for such stockpile, consistent with paragraph (4), including—(I) a description of the activities such entity will carry out under the agreement;(II) an assurance that such entity will use funds under such award in alignment with the requirements of chapter 83 of title 41 (commonly referred to as the “Buy American Act”); and(III) an outline of proposed expenses; and
(ii) a description of how such entity will coordinate with relevant entities in receipt of an award under section 247d–3a or 247d–3b of this title pursuant to paragraph (4), including through promoting alignment between the stockpile plan established pursuant to clause (i) and applicable plans that are established by such entity pursuant to section 247d–3a or 247d–3b of this title.
(B) Matching funds
(i) Subject to clause (ii), the Secretary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to—(I) for each of fiscal years 2023 and 2024, not less than $1 for each $20 of Federal funds provided in the award; and(II) for fiscal year 2025 and each fiscal year thereafter, not less than $1 for each $10 of Federal funds provided in the award.
(ii)Waiver.—The Secretary may, upon the request of a State, waive the requirement under clause (i), in whole or in part, if the Secretary determines that extraordinary economic conditions in the State in the fiscal year involved or in the previous fiscal year justify the waiver. A waiver provided by the Secretary under this subparagraph shall apply only to the fiscal year involved.
(C) Administrative expenses
(3) Lead entity
(4) Use of fundsAn entity in receipt of an award under paragraph (1) shall use such funds to—
(A) purchase, store, and maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies to be used during a public health emergency, major disaster, or emergency described in paragraph (1), in such numbers, types, and amounts as the entity determines necessary, consistent with such entity’s stockpile plan established pursuant to paragraph (2)(A)(i);
(B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency, major disaster, or other emergency described in paragraph (1);
(C) replenish and make necessary additions or modifications to the contents of such stockpile, including to address potential depletion;
(D) in consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile;
(E) ensure that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as appropriate;
(F) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that, to the extent practicable, new technologies and medical products are considered;
(G) carry out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies, major disasters, or other emergencies described in paragraph (1) of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other training for recipients of awards under section 247d–3a or 247d–3b of this title, as applicable; and
(H) carry out other activities related to the State strategic stockpile as the entity determines appropriate, to support State efforts to prepare for, and respond to, public health threats.
(5) Supplement not supplant
(6) Guidance for StatesNot later than 180 days after December 29, 2022, the Secretary, in consultation with States, health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such guidance as appropriate, for States related to maintaining and replenishing a stockpile of medical products, which may include strategies and best practices related to—
(A) types of medical products and medical supplies that are critical to respond to public health emergencies, and may be appropriate for inclusion in a stockpile by States, with consideration of threats that require the large-scale and simultaneous deployment of stockpiles, including the stockpile maintained by the Secretary pursuant to subsection (a), and long-term public health and medical response needs;
(B) appropriate management of the contents of a stockpile, including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the State and appropriate disposition of excess products, as applicable; and
(C) the procurement of medical products and medical supplies consistent with the requirements of chapter 83 of title 41 (commonly referred to as the “Buy American Act”).
(7) Technical assistance
(8) Reporting
(A) State reports
(B) Reports to CongressNot later than 1 year after the initial issuance of awards pursuant to paragraph (1), and annually thereafter for the duration of the program established under this subsection, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on such program, including—
(i) Federal and State expenditures to support stockpiles under such program;
(ii) activities conducted pursuant to paragraph (4); and
(iii) any additional information from the States that the Secretary determines relevant.
(9) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 319F–2, formerly Pub. L. 107–188, title I, § 121, June 12, 2002, 116 Stat. 611; Pub. L. 107–296, title XVII, § 1705(a), Nov. 25, 2002, 116 Stat. 2316; renumbered § 319F–2 of act July 1, 1944, and amended Pub. L. 108–276, § 3(a), July 21, 2004, 118 Stat. 842; Pub. L. 109–417, title I, § 102(c), title IV, §§ 403(b), 406, Dec. 19, 2006, 120 Stat. 2834, 2874, 2879; Pub. L. 113–5, title IV, §§ 401, 403, Mar. 13, 2013, 127 Stat. 192, 196; Pub. L. 114–255, div. A, title III, §§ 3081, 3082(a), 3085, Dec. 13, 2016, 130 Stat. 1140, 1144; Pub. L. 116–22, title IV, § 403(a), (c), title V, §§ 502, 504(a), title VII, § 702, June 24, 2019, 133 Stat. 943, 947, 950, 951, 962; Pub. L. 116–136, div. A, title III, § 3102, Mar. 27, 2020, 134 Stat. 361; Pub. L. 117–58, div. G, title IX, § 70953(f)(3), Nov. 15, 2021, 135 Stat. 1316; Pub. L. 117–328, div. FF, title II, §§ 2402, 2403, 2404(b)–2406, 2408(a), 2409(a), Dec. 29, 2022, 136 Stat. 5785–5787, 5789.)

CITE AS: 42 USC 247d-6b

§ 247d–6c. Repealed. Pub. L. 113–5, title II, § 205, Mar. 13, 2013, 127 Stat. 179

CITE AS: 42 USC 247d-6c

§ 247d–6d. Targeted liability protections for pandemic and epidemic products and security countermeasures
(a) Liability protections
(1) In general
(2) Scope of claims for loss
(A) LossFor purposes of this section, the term “loss” means any type of loss, including—
(i) death;
(ii) physical, mental, or emotional injury, illness, disability, or condition;
(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.
Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.
(B) Scope
(3) Certain conditionsSubject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—
(A) the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;
(B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and
(C) in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—
(i) was in a population specified by the declaration; and
(ii) was at the time of administration physically present in a geographic area specified by the declaration or had a connection to such area specified in the declaration.
(4) Applicability of certain conditionsWith respect to immunity under paragraph (1) and subject to the other provisions of this section:
(A) In the case of a covered person who is a manufacturer or distributor of the covered countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in paragraph (3)(C).
(B) In the case of a covered person who is a program planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in paragraph (3)(C).
(5) Effect of distribution method
(6) Rebuttable presumption
(b) Declaration by Secretary
(1) Authority to issue declaration
(2) ContentsIn issuing a declaration under paragraph (1), the Secretary shall identify, for each covered countermeasure specified in the declaration—
(A) the category or categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure;
(B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in paragraph (6);
(C) the population or populations of individuals for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
(D) the geographic area or areas for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under subparagraph (C), a specification, as determined appropriate by the Secretary, of whether the declaration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and
(E) whether subsection (a) is effective only to a particular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
(3) Effective period of declaration
(A) Flexibility of period
(B) Additional time to be specifiedIn each declaration under paragraph (1), the Secretary, after consulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered countermeasure, shall also specify a date that is after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
(i) a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return of such product to the manufacturer; and
(ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit administration or use of the covered countermeasure.
(C) Additional period for certain strategic national stockpile countermeasures
(4) Amendments to declaration
(5) Certain disclosures
(6) Factors to be considered
(7) Judicial review
(8) Preemption of State lawDuring the effective period of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
(A) is different from, or is in conflict with, any requirement applicable under this section; and
(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(9) Report to Congress
(c) Definition of willful misconduct
(1) Definition
(A) In generalExcept as the meaning of such term is further restricted pursuant to paragraph (2), the term “willful misconduct” shall, for purposes of subsection (d), denote an act or omission that is taken—
(i) intentionally to achieve a wrongful purpose;
(ii) knowingly without legal or factual justification; and
(iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
(B) Rule of construction
(2) Authority to promulgate regulatory definition
(A) In general
(B) Factors to be considered
(C) Temporal scope of regulations
(D) Initial rulemaking
(3) Proof of willful misconduct
(4) Defense for acts or omissions taken pursuant to Secretary’s declaration
(5) Exclusion for regulated activity of manufacturer or distributor
(A) In generalIf an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—
(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.
Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action.
(B) DefinitionsFor purposes of this paragraph, the following terms have the following meanings:
(i) Enforcement action
(ii) Covered remedyThe term “covered remedy” means an outcome—(I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal of an approval or clearance under chapter 5 1
1 So in original. Probably should be chapter “V”.
of such Act or of a licensure under section 262 of this title; and(II) that results from a final determination by a court or from a final agency action.
(iii) FinalThe terms “final” and “finally”—(I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and(II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.
(C) Rules of construction
(i) In generalNothing in this paragraph shall be construed—(I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], of this chapter, or of any other applicable statute or regulation; or(II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], under title 18, or under any other applicable statute or regulation.
(ii) Mandatory recalls
(d) Exception to immunity of covered persons
(1) In general
(2) Persons who can sue
(e) Procedures for suit
(1) Exclusive Federal jurisdiction
(2) Governing law
(3) Pleading with particularityIn an action under subsection (d), the complaint shall plead with particularity each element of the plaintiff’s claim, including—
(A) each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed;
(B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and
(C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or serious physical injury.
(4) Verification, certification, and medical records
(A) In general
(B) Verification requirement
(i) In general
(ii) Identification of matters alleged upon information and belief
(C) Materials requiredIn an action under subsection (d), the plaintiff shall file with the complaint—
(i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physician’s belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered countermeasure; and
(ii) certified medical records documenting such injury or death and such proximate causal connection.
(5) Three-judge court
(6) Civil discovery
(A) TimingIn an action under subsection (d), no discovery shall be allowed—
(i) before each covered person sued has had a reasonable opportunity to file a motion to dismiss;
(ii) in the event such a motion is filed, before the court has ruled on such motion; and
(iii) in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
(B) Standard
(7) Reduction in award of damages for collateral source benefits
(A) In general
(B) Provider of collateral source benefits not to have lien or subrogation
(C) Collateral source benefit definedFor purposes of this paragraph, the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
(i) any State or Federal health, sickness, income-disability, accident, or workers’ compensation law;
(ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;
(iii) any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; or
(iv) any other publicly or privately funded program.
(8) Noneconomic damages
(9) Rule 11 sanctions
(10) Interlocutory appeal
(f) Actions by and against the United States
(g) Severability
(h) Rule of construction concerning National Vaccine Injury Compensation Program
(i) DefinitionsIn this section:
(1) Covered countermeasureThe term “covered countermeasure” means—
(A) a qualified pandemic or epidemic product (as defined in paragraph (7));
(B) a security countermeasure (as defined in section 247d–6b(c)(1)(B) of this title);
(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b]; or
(D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under section 247d of this title.
(2) Covered personThe term “covered person”, when used with respect to the administration or use of a covered countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
(3) Distributor
(4) ManufacturerThe term “manufacturer” includes—
(A) a contractor or subcontractor of a manufacturer;
(B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and
(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
(5) Person
(6) Program planner
(7) Qualified pandemic or epidemic productThe term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),2
2 So in original. A third closing parenthesis probably should appear.
biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) 2 that is—
(A)
(i) a product manufactured, used, designed, developed, modified, licensed, or procured—(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or(II) to limit the harm such pandemic or epidemic might otherwise cause;
(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or
(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and
(B)
(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;
(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or
(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
(8) Qualified personThe term “qualified person”, when used with respect to the administration or use of a covered countermeasure, means—
(A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or
(B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
(9) Security countermeasure
(10) Serious physical injuryThe term “serious physical injury” means an injury that—
(A) is life threatening;
(B) results in permanent impairment of a body function or permanent damage to a body structure; or
(C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
(July 1, 1944, ch. 373, title III, § 319F–3, as added Pub. L. 109–148, div. C, § 2, Dec. 30, 2005, 119 Stat. 2818; amended Pub. L. 113–5, title IV, § 402(g)(2), (3), Mar. 13, 2013, 127 Stat. 196; Pub. L. 116–127, div. F, § 6005, Mar. 18, 2020, 134 Stat. 207; Pub. L. 116–136, div. A, title III, § 3103, Mar. 27, 2020, 134 Stat. 361.)

CITE AS: 42 USC 247d-6d

§ 247d–6e. Covered countermeasure process
(a) Establishment of Fund
(b) Payment of compensation
(1) In general
(2) Elements of compensation
(3) Rule of construction
(4) Determination of eligibility and compensation
(5) Covered countermeasure injury table
(A) In general
(B) Amendments
(C) Judicial review
(6) Meanings of terms
(A) the terms “vaccine” and “smallpox vaccine” shall be deemed to mean a covered countermeasure;
(B) the terms “smallpox vaccine injury table” and “table established under section 239b of this title” shall be deemed to refer to the table established under paragraph (4); and
(C) other terms used in those sections shall have the meanings given to such terms by this section.
(c) Voluntary program
(d) Exhaustion; exclusivity; election
(1) Exhaustion
(2) Tolling of statute of limitations
(3) Rule of construction
(4) Exclusivity
(5) Election
(e) Definitions
For purposes of this section, the following terms shall have the following meanings:
(1) Covered countermeasure
(2) Covered individual
The term “covered individual”, with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual—
(A) who is in a population specified in such declaration, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifications of such declaration; or
(B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by subparagraph (A).
(3) Covered injury
(4) Declaration
(5) Eligible individual
(July 1, 1944, ch. 373, title III, § 319F–4, as added Pub. L. 109–148, div. C, § 3, Dec. 30, 2005, 119 Stat. 2829.)

CITE AS: 42 USC 247d-6e

§ 247d–6f. Provision of medical countermeasures to Indian programs and facilities

In the event that the Secretary deploys the contents of the Strategic National Stockpile under section 247d–6b(a) of this title, or otherwise distributes medical countermeasures to States to respond to a public health emergency declared by the Secretary under section 247d of this title, the Secretary shall, in consultation with the applicable States, make such contents or countermeasures directly available to Indian Tribes and Tribal organizations (as such terms are defined in section 5304 of title 25), which may include through health programs or facilities operated by the Indian Health Service, that are affected by such public health emergency.

(July 1, 1944, ch. 373, title III, § 319F–5, as added Pub. L. 117–328, div. FF, title II, § 2408(b), Dec. 29, 2022, 136 Stat. 5789.)

CITE AS: 42 USC 247d-6f

§ 247d–7. Repealed. Pub. L. 117–328, div. FF, title II, § 2231(b), Dec. 29, 2022, 136 Stat. 5753

CITE AS: 42 USC 247d-7

§ 247d–7a. Grants regarding training and education of certain health professionals
(a) In general
(b) Authority regarding non-Federal contributions
(c) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 319H, as added Pub. L. 107–188, title I, § 106, June 12, 2002, 116 Stat. 607.)

CITE AS: 42 USC 247d-7a

§ 247d–7b. Emergency system for advance registration of volunteer health professional
(a) In general
(b) RequirementsThe interoperable network of systems established under subsection (a) (referred to in this section as the “verification network”) shall include—
(1) with respect to each volunteer health professional included in the verification network—
(A) information necessary for the rapid identification of, and communication with, such professionals; and
(B) the credentials, certifications, licenses, and relevant training of such individuals; and
(2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any other relevant federally-sponsored or administered programs determined necessary by the Secretary.
(c) Other assistance
(d) Accessibility
(e) Confidentiality
(f) Coordination
(g) Updating of information
(h) Clarification
(i) Health care provider licenses
(j) Rule of construction
(k) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 319I, as added Pub. L. 107–188, title I, § 107, June 12, 2002, 116 Stat. 608; amended Pub. L. 109–417, title III, § 303(b), Dec. 19, 2006, 120 Stat. 2857; Pub. L. 113–5, title II, § 203(b)(1), Mar. 13, 2013, 127 Stat. 175; Pub. L. 116–22, title II, § 207(a), June 24, 2019, 133 Stat. 926.)

CITE AS: 42 USC 247d-7b

§ 247d–7c. Supplies and services in lieu of award funds
(a) In general
(b) Corresponding reduction in payments
(July 1, 1944, ch. 373, title III, § 319J, as added Pub. L. 107–188, title I, § 110, June 12, 2002, 116 Stat. 611.)

CITE AS: 42 USC 247d-7c

§ 247d–7d. Security for countermeasure development and production
(a) In general
(b) Guidelines
(July 1, 1944, ch. 373, title III, § 319K, as added Pub. L. 107–188, title I, § 124, June 12, 2002, 116 Stat. 614; amended Pub. L. 116–22, title VII, § 705(a)(2), June 24, 2019, 133 Stat. 964.)

CITE AS: 42 USC 247d-7d

Biomedical Advanced Research and Development Authority
(a) DefinitionsIn this section:
(1) BARDA
(2) Fund
(3) Other transactions
(4) Qualified countermeasure
(5) Qualified pandemic or epidemic product
(6) Advanced research and development
(A) In generalThe term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
(i) are conducted after basic research and preclinical development of the product; and
(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title.
(B) Activities includedThe term under subparagraph (A) includes—
(i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;
(ii) design and development of tests or models, including animal models, for such testing;
(iii) activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;
(iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products;
(v) activities to improve the shelf-life of the product or technologies for administering the product; and
(vi) such other activities as are part of the advanced stages of testing, refinement, improvement, manufacturing, or preparation of the product for such use and as are specified by the Secretary.
(7) Security countermeasure
(8) Research tool
(9) Program manager
(10) Person
(b) Strategic plan for countermeasure research, development, and procurement
(1) In general
(2) ContentThe strategic plan under paragraph (1) shall guide—
(A) research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases;
(B) innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products (such research and development referred to in this section as “countermeasure and product advanced research and development”);
(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; and
(D) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department.
(c) Biomedical Advanced Research and Development Authority
(1) Establishment
(2) In generalBased upon the strategic plan described in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
(A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
(B) promoting countermeasure and product advanced research and development, including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities, consistent with subsection (a)(6)(B)(iv);
(C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section 262 of this title; and
(D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and development.
(3) Director
(4) Duties
(A) CollaborationTo carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i) facilitate and increase the expeditious and direct communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by—(I) facilitating such communication regarding the processes for procuring such advanced research and development with respect to qualified countermeasures and qualified pandemic or epidemic products of interest;(II) soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies;(III) facilitating such communication, as appropriate, regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and(IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–4a];
(ii) at least annually—(I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons;(II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and(III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are necessary to carry out this section;
(iii) communicate regularly with entities in receipt of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and
(iv) carry out the activities described in section 247d–7f of this title.
(B) Support advanced research and developmentTo carry out the purpose described in paragraph (2)(B), the Secretary shall—
(i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
(ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services;
(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or section 262 of this title) and innovation in such areas as the Secretary may identify as priority unmet need areas;
(iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development; and
(v) award contracts, grants, and cooperative agreements and enter into other transactions to support, maintain, and improve domestic manufacturing surge capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency.
(C) Facilitating adviceTo carry out the purpose described in paragraph (2)(C) the Secretary shall—
(i) connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section 262 of this title related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products;
(ii) with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure; and
(iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–4(b)(2)], to ensure that facilities performing manufacturing, pursuant to an award under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this chapter, as appropriate, including current good manufacturing practice pursuant to section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act [21 U.S.C. 351(a)(2)(B)]; and
(D) Supporting innovationTo carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize payments, to promote—
(i) innovation in technologies that may assist countermeasure and product advanced research and development, including to improve manufacturing capacities and capabilities for medical countermeasures;
(ii) research on and development of research tools and other devices and technologies; and
(iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures.
(E) Medical countermeasures innovation partner
(i) In generalTo support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—(I) foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;(II) promote the development of new and promising technologies that address urgent medical countermeasure needs, as identified by the Secretary;(III) address unmet public health needs that are directly related to medical countermeasure requirements, such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and(IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, radiological, and nuclear countermeasure products.
(ii) Eligibility(I) In generalTo be eligible to enter into an agreement under clause (i) an entity shall—(aa) be an independent, nonprofit entity;(bb) have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the Federal Government;(cc) have experience in promoting novel technology innovation;(dd) be problem-driven and solution-focused based on the needs, requirements, and problems identified by the Secretary under clause (iv);(ee) demonstrate the ability, or the potential ability, to promote the development of medical countermeasure products;(ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and(gg) not be within the Department of Health and Human Services.(II) Partnering experience
(iii) Not agency
(iv) DirectionPursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—(I) communicate the medical countermeasure needs, requirements, and problems to be addressed by the entity under the agreement;(II) develop a description of work to be performed by the entity under the agreement;(III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph;(IV) ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provisions of this section; and(V) ensure, as a condition of the agreement that the entity—(aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability;(bb) protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest, ethics, disclosure, and reporting requirements;(cc) provides monthly accounting on the use of funds provided under such agreement; and(dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agreement.
(v) Supplement not supplant
(vi) No establishment of entity
(vii) Transparency and oversight
(viii) Independent evaluation
(ix) Sunset
(F) Strategic initiativesThe Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including—
(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;
(ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and
(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.
(G) Annual reports by award recipients
(5) Transaction authorities
(A) Other transactions
(i) In general
(ii) Limitations on authority(I) In general(II) Written determinations required
(iii) Authority during a public health emergency(I) In general(II) Report
(iv) Guidelines
(B) Expedited authorities
(i) In general
(ii) Application of provisions
(iii) Authority to limit competition
(iv) Availability of data
(C) Advance payments; advertising
(D) Milestone-based payments allowed
(E) Foreign nationals eligible
(F) Establishment of research centers
(G) Government purpose
(H) Supporting warm-base and surge capacity and capabilities
(6) At-risk individuals
(7) Personnel authorities
(A) Specially qualified scientific and professional personnel
(i) In generalIn addition to any other personnel authorities, the Secretary may—(I) without regard to those provisions of title 5 governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and(II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed under section 9903 of such title are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.
(ii) Manner of exercise of authority
(iii) Term of appointment
(B) Special consultants
(C) Limitation
(i) In general
(ii) Report
(d) Fund
(1) Establishment
(2) Funding
(e) Inapplicability of certain provisions
(1) Disclosure
(A) Nondisclosure of information
(i) In general
(ii) Information described(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);(II) information pertaining to the location security, personnel, and research materials and methods of high-containment laboratories conducting research with select agents, toxins, or other agents with a material threat determination under section 247d–6b(c)(2) of this title; or(III) security and vulnerability assessments.
(B) Review
(C) Reporting
(D) Sunset
(2) Review
(f) Independent evaluation
(1) In general
(2) ReportNot later than 1 year after December 29, 2022, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—
(A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;
(B) the activities supported by flexible manufacturing initiatives;
(C) the ability of flexible manufacturing activities carried out under this section to—
(i) secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and
(ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents; and
(D) plans for the near-, mid-, and long-term sustainment of manufacturing activities carried out under this section, including such activities pursuant to subsection (c)(5)(H), specific actions to regularly assess the ability of recipients of an award under subsection (c)(4)(B)(v) to rapidly manufacture countermeasures as required by the Secretary, and recommendations to address challenges, if any, related to such activities.
(July 1, 1944, ch. 373, title III, § 319L, as added Pub. L. 109–417, title IV, § 401, Dec. 19, 2006, 120 Stat. 2865; amended Pub. L. 113–5, title IV, § 402(a)–(d), (f), Mar. 13, 2013, 127 Stat. 194, 195; Pub. L. 114–255, div. A, title III, §§ 3082(b), 3084, Dec. 13, 2016, 130 Stat. 1141; Pub. L. 116–22, title III, § 303(b), title IV, § 404(a), title V, § 504(b), title VI, §§ 601, 602, title VII, § 701(d), (e)(2)(B), (f), June 24, 2019, 133 Stat. 935, 948, 951–953, 961; Pub. L. 116–136, div. A, title III, § 3301, Mar. 27, 2020, 134 Stat. 383; Pub. L. 117–286, § 4(a)(228), Dec. 27, 2022, 136 Stat. 4331; Pub. L. 117–328, div. FF, title II, § 2401(a), Dec. 29, 2022, 136 Stat. 5782; Pub. L. 118–22, div. B, title II, § 203(b), Nov. 17, 2023, 137 Stat. 120; Pub. L. 118–35, div. B, title I, § 103(b), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, § 103(b), Mar. 9, 2024, 138 Stat. 398.)

CITE AS: 42 USC null

§ 247d–7f. Collaboration and coordination
(a) Limited antitrust exemption
(1) Meetings and consultations to discuss security countermeasures, qualified countermeasures, or qualified pandemic or epidemic product development
(A) Authority to conduct meetings and consultations
(B) Meeting and consultation conditionsA meeting or consultation conducted under subparagraph (A) shall—
(i) be chaired or, in the case of a consultation, facilitated by the Secretary;
(ii) be open to persons involved in the development, manufacture, distribution, purchase, or storage of a countermeasure or product, as determined by the Secretary;
(iii) be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;
(iv) be limited to discussions involving covered activities; and
(v) be conducted in such manner as to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting or consultation.
(C) Limitation
(D) Transcript
(E) Exemption
(i) In general
(ii) Limitation
(2) Submission of written agreementsThe Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself, any submission shall include—
(A) an explanation of the intended purpose of the agreement;
(B) a specific statement of the substance of the agreement;
(C) a description of the methods that will be utilized to achieve the objectives of the agreement;
(D) an explanation of the necessity for a cooperative effort among the particular participating persons to achieve the objectives of the agreement; and
(E) any other relevant information determined necessary by the Attorney General, in consultation with the Chairman and the Secretary.
(3) Exemption for conduct under approved agreement
(4) Action on written agreements
(A) In general
(B) Extension
(C) Determination
(5) Limitation on and renewal of exemptions
(6) Authority to obtain information
(7) Limitation on parties
(8) Report
(b) Sunset
(c) DefinitionsIn this section:
(1) Antitrust lawsThe term “antitrust laws”—
(A) has the meaning given such term in subsection (a) of section 12 of title 15, except that such term includes section 45 of title 15 to the extent such section 45 of title 15 applies to unfair methods of competition; and
(B) includes any State law similar to the laws referred to in subparagraph (A).
(2) Countermeasure or product
(3) Covered activities
(A) In general
(B) ExceptionThe term “covered activities” shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons:
(i) Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry out covered activities—(I) with respect to a countermeasure or product regarding which such meeting or consultation is being conducted; or(II) that are described in the agreement as exempted.
(ii) Entering into any agreement or engaging in any other conduct—(I) to restrict or require the sale, licensing, or sharing of inventions, developments, products, processes, or services not developed through, produced by, or distributed or sold through such covered activities; or(II) to restrict or require participation, by any person participating in such covered activities, in other research and development activities, except as reasonably necessary to prevent the misappropriation of proprietary information contributed by any person participating in such covered activities or of the results of such covered activities.
(iii) Entering into any agreement or engaging in any other conduct allocating a market with a competitor that is not expressly exempted from the antitrust laws under subsection (a)(4).
(iv) Exchanging information among competitors relating to production (other than production by such covered activities) of a product, process, or service if such information is not reasonably necessary to carry out such covered activities.
(v) Entering into any agreement or engaging in any other conduct restricting, requiring, or otherwise involving the production of a product, process, or service that is not expressly exempted from the antitrust laws under subsection (a)(4).
(vi) Except as otherwise provided in this subsection, entering into any agreement or engaging in any other conduct to restrict or require participation by any person participating in such covered activities, in any unilateral or joint activity that is not reasonably necessary to carry out such covered activities.
(vii) Entering into any agreement or engaging in any other conduct restricting or setting the price at which a countermeasure or product is offered for sale, whether by bid or otherwise.
(July 1, 1944, ch. 373, title III, § 319L–1, formerly

CITE AS: 42 USC 247d-7f

§ 247d–7g. National Biodefense Science Board and working groups
(a) In general
(1) Establishment and function
(2) MembershipThe membership of the Board shall be comprised of individuals who represent the Nation’s preeminent scientific, public health, and medical experts, as follows—
(A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;
(B) four individuals representing the pharmaceutical, biotechnology, and device industries;
(C) four individuals representing academia; and
(D) five other members as determined appropriate by the Secretary, of whom—
(i) one such member shall be a practicing healthcare professional;
(ii) one such member shall be an individual from an organization representing healthcare consumers;
(iii) one such member shall be an individual with pediatric subject matter expertise; and
(iv) one such member shall be a State, tribal, territorial, or local public health official.
Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements described in subparagraph (D).
(3) Term of appointment
(4) Consecutive appointments; maximum terms
(5) DutiesThe Board shall—
(A) advise the Secretary on current and future trends, challenges, and opportunities presented by advances in biological and life sciences, biotechnology, and genetic engineering with respect to threats posed by naturally occurring infectious diseases and chemical, biological, radiological, and nuclear agents;
(B) at the request of the Secretary, review and consider any information and findings received from the working groups established under subsection (b);
(C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and coordinated biodefense research and development activities; and
(D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.
(6) Meetings
(A) Initial meeting
(B) Subsequent meetings
(7) Vacancies
(8) Chairperson
(9) Powers
(A) Hearings
(B) Postal services
(10) Personnel
(A) Employees of the Federal Government
(B) Other members
(C) Travel expenses
(D) Detail of Government employees
(b) Other working groupsThe Secretary may establish a working group of experts, or may use an existing working group or advisory committee, to—
(1) identify innovative research with the potential to be developed as a qualified countermeasure or a qualified pandemic or epidemic product;
(2) identify accepted animal models for particular diseases and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research tool development and validation; and
(3) obtain advice regarding supporting and facilitating advanced research and development related to qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect such populations.
(c) Definitions
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 319M, as added Pub. L. 109–417, title IV, § 402, Dec. 19, 2006, 120 Stat. 2872; amended Pub. L. 113–5, title IV, § 404, Mar. 13, 2013, 127 Stat. 197.)

CITE AS: 42 USC 247d-7g

§ 247d–8. Coordinated program to improve pediatric oral health
(a) In general
(b) Grants
(c) Distribution
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 320A, as added Pub. L. 106–310, div. A, title XVI, § 1603, Oct. 17, 2000, 114 Stat. 1151.)

CITE AS: 42 USC 247d-8

§ 247d–9. Dental education for parents of newborns

The Secretary shall develop and implement, through entities that fund or provide perinatal care services to targeted low-income children under a State child health plan under title XXI of the Social Security Act [42 U.S.C. 1397aa et seq.], a program to deliver oral health educational materials that inform new parents about risks for, and prevention of, early childhood caries and the need for a dental visit within their newborn’s first year of life.

(Pub. L. 111–3, title V, § 501(c), Feb. 4, 2009, 123 Stat. 87.)

CITE AS: 42 USC 247d-9

§ 247d–10. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids
(a) Grants
(b) Detection activitiesThe Secretary, in consultation with the Director of the National Institute of Standards and Technology, the Director of the Centers for Disease Control and Prevention, the Attorney General of the United States, and the Administrator of the Drug Enforcement Administration, shall, for purposes of this section, develop or identify—
(1) best practices for safely handling and testing synthetic opioids, including fentanyl and its analogues, including with respect to reference materials, instrument calibration, and quality control protocols;
(2) reference materials and quality control standards related to synthetic opioids, including fentanyl and its analogues, to enhance—
(A) clinical diagnostics;
(B) postmortem data collection; and
(C) portable testing equipment utilized by law enforcement and public health officials; and
(3) procedures for the identification of new and emerging synthetic opioid formulations and procedures for reporting those findings to appropriate law enforcement agencies and Federal, State, and local public health laboratories and health departments, as appropriate.
(c) LaboratoriesThe Secretary shall require recipients of grants or cooperative agreements under subsection (a) to—
(1) follow the best practices established under subsection (b) and have the appropriate capabilities to provide laboratory testing of controlled substances, such as synthetic fentanyl, and biospecimens for the purposes of aggregating and reporting public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate;
(2) work with law enforcement agencies and public health authorities, as practicable;
(3) provide early warning information to Federal, State, and local law enforcement agencies and public health authorities regarding trends or other data related to the supply of synthetic opioids, including fentanyl and its analogues;
(4) provide biosurveillance capabilities with respect to identifying trends in adverse health outcomes associated with non-fatal exposures; and
(5) provide diagnostic testing, as appropriate and practicable, for non-fatal exposures of emergency personnel, first responders, and other individuals.
(d) Authorization of appropriations
(Pub. L. 115–271, title VII, § 7011, Oct. 24, 2018, 132 Stat. 4008.)

CITE AS: 42 USC 247d-10

§ 247d–11. State All Payer Claims Databases
(a) In general
(b) UsesA State may use a grant received under subsection (a) for one of the following purposes:
(1) To establish a State All Payer Claims Database.
(2) To improve an 1
1 So in original.
existing State All Payer Claims Databases.1
(c) Eligibility
(d) Grant period and amount
(e) Authorized users
(1) ApplicationAn entity desiring authorization for access to a State All Payer Claims Database that has received a grant under this section shall submit to the State All Payer Claims Database an application for such access, which shall include—
(A) in the case of an entity requesting access for research purposes—
(i) a description of the uses and methodologies for evaluating health system performance using such data; and
(ii) documentation of approval of the research by an institutional review board, if applicable for a particular plan of research; or
(B) in the case of an entity such as an employer, health insurance issuer, third-party administrator, or health care provider, requesting access for the purpose of quality improvement or cost-containment, a description of the intended uses for such data.
(2) Requirements
(A) Access for research purposes
(B) Customized reports
(C) Non-customized reports
(3) Waivers
(f) Expanded access
(1) Multi-State applications
(2) Expansion of data sets
(g) DefinitionsIn this section—
(1) the term “individually identifiable health information” has the meaning given such term in section 1320d(6) of this title;
(2) the term “proprietary financial information” means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan, managed care entity (as defined in section 1396u–2(a)(1)(B) of this title) or other managed care organization, or health insurance issuer offering group or individual health insurance coverage; and
(3) the term “State All Payer Claims Database” means, with respect to a State, a database that may include medical claims, pharmacy claims, dental claims, and eligibility and provider files, which are collected from private and public payers.
(h) Authorization of appropriations
(July 1, 1944, ch. 373, title III, § 320B, as added Pub. L. 116–260, div. BB, title I, § 115(a), Dec. 27, 2020, 134 Stat. 2875.)

CITE AS: 42 USC 247d-11

§ 247d–12. Coordination and collaboration regarding blood supplyThe Secretary of Health and Human Services, or the Secretary’s designee, shall—
(1) ensure coordination and collaboration between relevant Federal departments and agencies related to the safety and availability of the blood supply, including—
(A) the Department of Health and Human Services, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration;
(B) the Department of Defense; and
(C) the Department of Veterans Affairs; and
(2) consult and communicate with private stakeholders, including blood collection establishments, health care providers, accreditation organizations, researchers, and patients, regarding issues related to the safety and availability of the blood supply.
(Pub. L. 117–328, div. FF, title II, § 2233, Dec. 29, 2022, 136 Stat. 5754.)

CITE AS: 42 USC 247d-12