42 USC 71 - Biomedical Advanced Research and Development Authority

View all text of Part B [§ 243 - § 247d-12]

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.

(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.

(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

(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

(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

(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;

(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.)