21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS | Title 21 - Food and Drugs | Code of Federal Regulations

Authority:

21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e, 381.

Source:

40 FR 13825, Mar. 27, 1975, unless otherwise noted.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

USC : Title 21 - FOOD AND DRUGS

§ 356a - Manufacturing changes

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 514 after this date.

2012-09-26; vol. 77 # 187 - Wednesday, September 26, 2012

77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-23740
RIN
Docket No.	FDA-2012-N-0447

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Advance notice of proposed rulemaking; extension of comment period.

The comment period for the advance notice of proposed rulemaking that published July 27, 2012 (77 FR 44177) is extended. Submit written or electronic comments by November 26, 2012.

21 CFR Part 514

Summary

The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of July 27, 2012. In the advance notice of proposed rulemaking, FDA requested comments regarding potential changes to its regulations relating to records and reports for approved antimicrobial new animal drugs. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

2012-07-27; vol. 77 # 145 - Friday, July 27, 2012

77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-18366
RIN
Docket No.	FDA-2012-N-0447

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Advance notice of proposed rulemaking.

Submit electronic or written comments by September 25, 2012.

21 CFR Part 514

Summary

The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS

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