21 USC 360 - Countermeasure development, review, and technical assistance

View all text of Part E [§ 360bbb - § 360bbb-8d]

§ 360bbb–4. Countermeasure development, review, and technical assistance

(a) DefinitionsIn this section—

(1) the term “countermeasure” means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;

(2) the term “qualified countermeasure” has the meaning given such term in section 247d–6a of title 42;

(3) the term “security countermeasure” has the meaning given such term in section 247d–6b of title 42; and

(4) the term “qualified pandemic or epidemic product” means a product that meets the definition given such term in section 247d–6d of title 42 and—

(A) that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or

(B) is included under this paragraph pursuant to a determination by the Secretary.

(b) General dutiesIn order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—

(1) ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 247d–6, 247d–6a, 247d–6b, 247d–6d, 247d–7e, and 300hh–10 of title 42;

(2) ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 247d–7e of title 42, including with respect to meeting regulatory requirements set forth in this chapter;

(3) promote countermeasure expertise within the Food and Drug Administration by—

(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 247d–6b of title 42 for the agent or agents for which the countermeasure under review is intended;

(B) training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;

(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;

(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—

(A) consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and

(B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—

(i) in order to inform the process for countermeasure approval, clearance, and licensure; and

(ii) with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and

(5) establish within the Food and Drug Administration a team of experts on manufacturing and regulatory activities (including compliance with current Good Manufacturing Practice) to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 247d–6a of title 42), security countermeasures (as defined in section 247d–6b of title 42), or vaccines, at the request of such a manufacturer and at the discretion of the Secretary, if the Secretary determines that a shortage or potential shortage may occur in the United States in the supply of such vaccines or countermeasures and that the provision of such assistance would be beneficial in helping alleviate or avert such shortage.

(1) In general

(2) Authority to extend deadline

(d) Development and animal modeling procedures

(1) Availability of animal model meetingsTo facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after March 13, 2013, establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive—

(A) a meeting to discuss proposed animal model development activities; and

(B) a meeting prior to initiating pivotal animal studies.

(2) Pediatric models

(e) Review and approval of countermeasures

(1) Material threat

(2) Review expertise

(f) Regulatory management plan

(1) DefinitionIn this subsection, the term “eligible countermeasure” means—

(A) a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 247d–6b(c) of title 42; or

(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 247d–7e of title 42 for advanced research and development.

(2) Regulatory management plan process

(3) PublicationThe Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—

(A) the process by which an applicant may submit a request for a regulatory management plan;

(B) the timeframe by which the Secretary is required to respond to such request;

(D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and

(E) contact information for beginning the regulatory management plan process.

(4) Submission of request and proposed plan by sponsor or applicant

(A) In general

(B) Timing of submission

(5) PlanThe span of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include—

(A) an agreement between the Secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the Secretary as described in subparagraph (B);

(B) performance targets and goals for timely and appropriate responses by the Secretary to the triggers described under subparagraph (A), including meetings between the Secretary and the sponsor or applicant, written feedback, decisions by the Secretary, and other activities carried out as part of the development and review process; and

(6) Milestones and performance targetsThe developmental milestones described in paragraph (5)(A) and the performance targets and goals described in paragraph (5)(B) shall include—

(A) feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;

(B) feedback from the Secretary regarding the data necessary to inform any authorization under section 360bbb–3 of this title;

(C) feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;

(D) feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 355(b)(5)(B) of this title;

(E) feedback from the Secretary regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;

(F) identification of the population for which the countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and

(G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 360bbb–3 of this title, approval, licensure, or clearance for adults.

(7) Prioritization

(A) Plans for security countermeasures

(B) Plans for other eligible countermeasures

(g) Annual reportNot later than 180 days after March 13, 2013, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including—

(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—

(A) the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; and

(B) the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;

(2) with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure—

(A) whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;

(B) whether the Secretary adhered to the timely and appropriate response times set forth in such plan; and

(3) the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A);

(4) an estimate of resources obligated to countermeasure development and regulatory assessment, including—

(A) Center-specific objectives and accomplishments; and

(B) the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures;

(5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 360bbb–3 of this title;

(6) the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and

(7) the number, type, and frequency of meetings between the Food and Drug Administration and—

(A) sponsors of a countermeasure as defined in subsection (a); or

(B) another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.

(h) Accelerating countermeasure development and review during an emergency

(1) Acceleration of countermeasure development and review

(2) ActionsThe actions to expedite the development and review of a countermeasure under paragraph (1) may include the following:

(A) Expedited review of submissions made by sponsors of countermeasures to the Food and Drug Administration, including rolling submissions of countermeasure applications and other submissions.

(B) Expedited and increased engagement with sponsors regarding countermeasure development and manufacturing, including—

(i) holding meetings with the sponsor and the review team and providing timely advice to, and interactive communication with, the sponsor regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or authorization is as efficient as practicable;

(ii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(iii) assigning a cross-disciplinary project lead for the review team to facilitate;

(iv) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; and

(v) streamlining the review of approved, licensed, cleared, or authorized countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures.

(C) Expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing.

(D) Other steps to expedite the development and review of a countermeasure application submitted for approval, licensure, clearance, or authorization, as the Secretary determines appropriate.

(3) Limitation of effect

(i) Third party evaluation of tests used during an emergency

(1) In general

(2) Requirements regarding evaluations and recommendations

(A) In general

(B) Written recommendations

(3) Rule of construction

(June 25, 1938, ch. 675, § 565, as added Pub. L. 109–417, title IV, § 404, Dec. 19, 2006, 120 Stat. 2875; amended Pub. L. 113–5, title III, §§ 303–306, Mar. 13, 2013, 127 Stat. 185–190; Pub. L. 116–22, title V, § 503, June 24, 2019, 133 Stat. 951; Pub. L. 117–328, div. FF, title II, §§ 2501, 2502(a), Dec. 29, 2022, 136 Stat. 5796, 5797.)