# Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal
> **Food and Drug Administration** · Direct final rule; withdrawal. · Published 2009-02-10 · 74 FR 6541
## Document
- **Document number:** E9-2746
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 6541
- **CFR reference:** 21 CFR 314
- **Publication date:** 2009-02-10
- **HHS docket:** Docket No. FDA-2008-N-0341
## Abstract

The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/02/10/E9-2746/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-postmarketing-reports)
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