# Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-Discontinuance
> **Food and Drug Administration** · Interim final rule; request for comments. · Published 2011-12-19 · Effective 2012-01-18 · 76 FR 78530
## Document
- **Document number:** 2011-32354
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 78530
- **CFR reference:** 21 CFR 314
- **Publication date:** 2011-12-19
- **Effective date:** 2012-01-18
- **HHS docket:** Docket No. FDA-2011-N-0898
## Abstract

The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term "discontinuance" and clarifies the term "sole manufacturer" with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/12/19/2011-32354/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-revision-of)
---
*AI Analytics · CC0 1.0*