§379j–42. Authority to assess and use human generic drug fees — Inbound Citations
21 U.S.C. § 379j–42
Cited by 5 provisions in release 119-102.
Citations to 21 U.S.C. § 379j–42 as a whole
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(4) Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 379h, 379j, 379j–42, or 379j–52 of this title.
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(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–42 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;
Citations to §379j–42(a)(4)
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(aa) If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 379j–42(a)(4) of this title or for which identifying information required by section 379j–42(f) of this title has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.
Citations to §379j–42(f)
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(aa) If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 379j–42(a)(4) of this title or for which identifying information required by section 379j–42(f) of this title has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.