2016-29774: 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

Summary

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.

The agency’s own summary, as published.

What this changes

Amends 9 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 20 Public Information
• 21 CFR 201 Labeling
• 21 CFR 207 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, and the National Drug Code
• 21 CFR 314 Applications for FDA Approval to Market a New Drug
• 21 CFR 514 New Animal Drug Applications
• 21 CFR 515 Medicated Feed Mill License
• 21 CFR 601 Licensing
• 21 CFR 607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
• 21 CFR 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products