Document ID: FDA-2005-N-0464-0238
Agency: fda
Document Type: Rule
Title: 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
Posted Date: 2016-12-13T05:00Z

[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Rules and Regulations]
[Pages 89848-89849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29774]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271

[Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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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

[[Page 89849]]

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.

DATES: Effective December 13, 2016.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-2242.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 31, 2016 
(81 FR 60169), FDA published the final rule ``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.'' The final rule published with an 
incorrect statement in the preamble about the rule's effect on 
establishments at which investigational drugs are manufactured. Under 
the amended regulations, manufacturers, repackers, relabelers, or 
salvagers who manufacture, repack, relabel, or salvage drugs solely for 
use in research, teaching, or chemical analysis and not for sale are 
exempt from the establishment registration requirement under 21 CFR 
207.13(e) if they do not engage in other activities that require them 
to register.
    In the Federal Register of August 31, 2016, in FR Doc. 2016-20471, 
the following correction is made: On page 60185, in the first column, 
in the third paragraph under ``2. When must initial registration 
information be provided? (Sec.  207.21),'' the following sentence is 
removed: ``Accordingly, an establishment at which an investigational 
drug is manufactured is subject to the establishment registration 
requirement.''

    Dated: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29774 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P