Source: https://www.law.cornell.edu/cfr/text/21/part-514/subpart-B
Timestamp: 2017-03-23 08:28:51
Document Index: 54489258

Matched Legal Cases: ['§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', '§ 514', 'art 514', 'art 514', 'art 514']

§ 514.80 Records and reports concerning experience with approved new animal drugs.
§ 514.87 Annual reports for antimicrobial animal drug sales and distribution.
§ 514.100 Evaluation and comment on applications.
§ 514.105 Approval of applications.
§ 514.106 Approval of supplemental applications.
§ 514.110 Reasons for refusing to file applications.
§ 514.111 Refusal to approve an application.
§ 514.115 Withdrawal of approval of applications.
§ 514.116 Notice of withdrawal of approval of application.
§ 514.117 Adequate and well-controlled studies.
§ 514.120 Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
§ 514.121 Service of notices and orders.
Title 21 published on 2015-12-03The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 514 after this date.2016-12-13; vol. 81 # 239 - Tuesday, December 13, 201681 FR 89848 - 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
2016-08-11; vol. 81 # 155 - Thursday, August 11, 201681 FR 52995 - New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
typeregulations.gov FR Doc.2016-18809 RIN Docket No.FDA-2016-N-1943 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correcting amendments. This rule is effective August 11, 2016. 21 CFR Part 514 SummaryThe Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.
2016-05-11; vol. 81 # 91 - Wednesday, May 11, 201681 FR 29129 - Antimicrobial Animal Drug Sales and Distribution Reporting
typeregulations.gov FR Doc.2016-11082 RIN0910-AG45 Docket No.FDA-2012-N-0447 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 11, 2016. For the applicable compliance dates, please see section V, “Effective and Compliance Dates” in SUPPLEMENTARY INFORMATION . 21 CFR Part 514 SummaryThe Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our understanding of antimicrobial new animal drug sales intended for use in specific food-producing animal species and the relationship between such sales and antimicrobial resistance.