Sec. 2143. Meetings between CDC and vaccine developers
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Section 310 of the Public Health Service Act ( 42 U.S.C. 242o ) is amended by adding at the end the following: In this subsection, the term vaccine developer means a nongovernmental entity engaged in— the development of a vaccine with the intent to pursue licensing of the vaccine by the Food and Drug Administration; or the production of a vaccine licensed by the Food and Drug Administration; and vaccine research. Upon the submission of a written request for a meeting by a vaccine developer, that includes a justification for the meeting, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall convene a meeting of representatives of the vaccine developer and experts from the Centers for Disease Control and Prevention in immunization programs, epidemiology, and other relevant areas at which the Director (or the Director’s designee), for the purpose of informing the vaccine developer’s understanding of public health needs and priorities, shall provide the perspectives of the Centers for Disease Control and Prevention and other relevant Federal agencies regarding— public health needs, epidemiology, and implementation considerations with regard to a vaccine developer’s potential vaccine profile; and potential implications of such perspectives for the vaccine developer’s vaccine research and development planning.
In addition to the representatives specified in subparagraph (A), the Secretary may, with the agreement of the vaccine developer requesting a meeting under such subparagraph, include in such meeting representatives of— the Food and Drug Administration; and the National Vaccine Program. The Secretary shall convene a meeting requested under subparagraph
(A)not later than 120 days after receipt of the request for the meeting. Upon the submission of a written request by a vaccine developer, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that— are specified in the request; have been published; have been performed by or are in the possession of the Centers; are not a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; and do not contain individually identifiable information. The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph
(A)not later than 120calendar days after receipt of the request for the analyses. The Secretary shall promptly notify a vaccine developer if— the Secretary becomes aware of any change to information that was— shared by the Secretary with the vaccine developer during a meeting under paragraph (2); or provided by the Secretary to the vaccine developer in one or more analyses under paragraph (3); and the change may have implications for the vaccine developer’s vaccine research and development. .
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Sec. 2143
Meetings between CDC and vaccine developers
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