Sec. 305. Regulatory management plans

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Section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ), as amended by section 304, is further amended by adding at the end the following: In this subsection, the term eligible countermeasure means— a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 319F–2(c) of the Public Health Service Act; or a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 319L of the Public Health Service Act for advanced research and development.

The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection. A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph

(2)upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan. A sponsor or applicant may submit a written request under subparagraph

(A)after the eligible countermeasure has an investigational new drug or investigational device exemption in effect. The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached. The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include— 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); 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 an agreement on how the plan shall be modified, if needed. The developmental milestones described in paragraph (4)(A) and the performance targets and goals described in paragraph (4)(B) shall include— feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved; feedback from the Secretary regarding the data necessary to inform any authorization under section 564; feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile; feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 505(b)(5)(B); 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; 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 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 564, approval, licensure, or clearance for adults. The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (3)(A). The Secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may receive regulatory management plans. .

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21 USC 360bbb–4

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Sec. 305

Regulatory management plans

Cite21 USC 360bbb–4

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