Sec. 304. Enhancing medical countermeasure activities

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Section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ), as amended by section 303, is further amended— in the section heading, by striking and inserting Technical Assistance ; Countermeasure Development, Review, and Technical Assistance in subsection (b), by striking the subsection enumerator and all that follows through shall establish and inserting the following: In 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— ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 of the Public Health Service Act; ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 319L of the Public Health Service Act, including with respect to meeting regulatory requirements set forth in this Act; promote countermeasure expertise within the Food and Drug Administration by— 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 319F–2 of the Public Health Service Act for the agent or agents for which the countermeasure under review is intended; training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance; holding public meetings at least twice annually to encourage the exchange of scientific ideas; and establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures; 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— 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 improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures— in order to inform the process for countermeasure approval, clearance, and licensure; and 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 establish ; and by adding at the end the following:

Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 , the Secretary shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in subsection

(a)when human efficacy studies are not ethical or feasible. The Secretary may extend the deadline for providing final guidance under paragraph

(1)by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. To 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 the enactment of this subsection, 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 meeting to discuss proposed animal model development activities; and a meeting prior to initiating pivotal animal studies. To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph

(1)shall include discussion of animal models for pediatric populations, as appropriate. When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under section 319F–2 of the Public Health Service Act for which the countermeasure under review is intended. When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph

(1)shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D). .

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21 USC 360bbb–4

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Sec. 304

Enhancing medical countermeasure activities

Cite21 USC 360bbb–4

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