# Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
> **Food and Drug Administration** · Final rule; correction. · Published 2016-12-13 · Effective 2016-12-13 · 81 FR 89848
## Document
- **Document number:** 2016-29774
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 89848
- **CFR reference:** 21 CFR 20
- **Publication date:** 2016-12-13
- **Effective date:** 2016-12-13
- **HHS docket:** Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)
## Abstract

The Food and Drug Administration (FDA) is correcting a final rule entitled "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs" that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/12/13/2016-29774/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs)
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