Sec. 402. Miscellaneous FDA amendments
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Section 507(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 357 ) is amended— by redesignating paragraph
(3)as paragraph (4); and by inserting after paragraph
(2)the following: In making information publicly available pursuant to paragraph (1), the Secretary— shall not disclose information that would compromise national security; and may make available summaries in lieu of data and evidence contained in qualification submissions. . Subparagraph
(A)of section 564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is amended by striking subsection (a)(1)(C)(i) and inserting subsection (a)(1)(C) . Section 564B(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3b ) is amended— in subparagraph (B), by inserting a comma after 505 ; and in subparagraph (C), by inserting or section 564A before the period at the end.
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- 21 USC 360bbb–3a(e)(2)
- 21 USC 360bbb–3b
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