Sec. 4. Transparency to support infant formula innovation
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Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ), as amended by section 3(a) of this Act, is further amended by adding at the end the following: Not later than March 30 of each year, the Secretary shall submit a report to the Congress containing, with respect to the preceding calendar year, the following information: The number of submissions received by the Secretary under subsection (d). For each such submission— the amount of time taken by the Secretary to respond; the number of times the Secretary requested additional information from the person making such submission; and whether such submission included any new ingredients that were not included in any infant formula already on the market.
The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with subsection (b)(2). The time between any inspection referred to in paragraph
(3)and any necessary reinspection to evaluate compliance with subsection (b)(2). . Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ), as amended by subsection (a), is further amended by adding at the end the following: Subject to paragraph (2), the Secretary shall respond to a submission under subsection
(d)for infant formula not later than 90 days after receiving such notification. The Secretary shall respond to a submission under subsection
(d)for infant formula not later than 75 days after receiving such notification if it— is submitted by a manufacturer that is not already marketing infant formula in the United States; or is for infant formula containing one or more ingredients that are not contained in infant formula that is already being marketed in the United States. Whenever the Secretary fails to respond to a submission under subsection
(d)by the deadline applicable under paragraph
(1)or (2), the Secretary shall give notice of such failure to the Congress, including an explanation of the reasons for failing to meet the deadline. . Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(c)(1)(B) ) is amended by striking subsection (c)(1) and inserting subsection (d)(1) .
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Sec. 4
Transparency to support infant formula innovation
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