Sec. 307. Pediatric medical countermeasures
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Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) is amended— in subsection (d), by adding at the end the following: With respect to a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of the Public Health Service Act), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section. ; and in subsection (n)(1), by adding at the end the following:
For a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of such Act), in addition to any action with respect to such drug under subparagraph
(A)or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs. . Section 409I of the Public Health Service Act ( 42 U.S.C. 284m ) is amended— by striking subsection (a)(2) and inserting the following: In developing and prioritizing the list under paragraph (1), the Secretary— shall consider— therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and may consider the availability of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified pandemic or epidemic products (as defined in section 319F–3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section. ; and in subsection (b), by striking subsection
(a)and inserting paragraphs
(1)and (2)(A) of subsection
(a). Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended— in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: the development of countermeasures (as defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for pediatric populations. .
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