Sec. 805. Suitability petitions
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/bill/115/hr/2430/eh/section-805·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2)(C) ) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of submission. The Secretary of Health and Human Services shall include in the annual reports under section 807— the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2)(C) ); and the number of such petitions pending a substantive response for more than 180 days from the date of receipt.
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Sec. 805
Suitability petitions
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