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2019-04-02
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
Rules and Regulations
D09002ee1bdb867da
D09002ee1bdb86865
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations.
83 FR 48940
https://www.govinfo.gov/app/details/FR-2018-09-28/2018-21146
2018-21146
fr28se18-12
4164-01-P
Docket No. FDA-2018-N-0002
https://www.govinfo.gov/app/details/FR-2018-09-28/2018-21146
https://www.govinfo.gov/content/pkg/FR-2018-09-28/html/2018-21146.htm
https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/2018-21146.pdf
Administrative Practice and Procedure
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
Foods
Animal Feeds
11 p.
48940
48950
83 FR 48940
Code of Federal Regulations
Title 21 Part 510
21 CFR Part 510
Code of Federal Regulations
Title 21 Part 520
21 CFR Part 520
Code of Federal Regulations
Title 21 Part 522
21 CFR Part 522
Code of Federal Regulations
Title 21 Part 524
21 CFR Part 524
Code of Federal Regulations
Title 21 Part 529
21 CFR Part 529
Code of Federal Regulations
Title 21 Part 556
21 CFR Part 556
Code of Federal Regulations
Title 21 Part 558
21 CFR Part 558
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name; Federal Register Vol. 83, Issue
RULE
2018-21146
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-09-28
Docket No. FDA-2018-N-0002
4164-01-P
2018-21146
Final rule; technical amendments.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations.
This rule is effective September 28, 2018, except for amendatory instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.
Administrative Practice and Procedure
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
Foods
Animal Feeds
New Animal Drugs:
Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
,
george.haibel@fda.hhs.gov
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm
Federal Register
Vol. 83, no. 189
Office of the Federal Register, National Archives and Records Administration
2018-09-28
continuing
daily
deposited
born digital
370 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-09-28
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0042-1219
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https://www.govinfo.gov/app/details/FR-2018-09-28
https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/FR-2018-09-28.pdf
https://www.govinfo.gov/content/pkg/FR-2018-09-28/xml/FR-2018-09-28.xml
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FR-2018-09-28
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