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2019-03-13
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
Rules and Regulations
D09002ee1bdb79d74
D09002ee1bdb79dfe
United States
Department of Health and Human Services
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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 July, August, and September 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 make technical amendments to improve the readability of the regulations.
84 FR 8967
https://www.govinfo.gov/app/details/FR-2019-03-13/2019-04226
2019-04226
fr13mr19-7
4164-01-P
Docket No. FDA-2018-N-0002
https://www.govinfo.gov/app/details/FR-2019-03-13/2019-04226
https://www.govinfo.gov/content/pkg/FR-2019-03-13/html/2019-04226.htm
https://www.govinfo.gov/content/pkg/FR-2019-03-13/pdf/2019-04226.pdf
Administrative Practice and Procedure
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
Foods
Animal Feeds
16 p.
8967
8982
84 FR 8967
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 526
21 CFR Part 526
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; Federal Register Vol. 84, Issue
RULE
2019-04226
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-03-13
Docket No. FDA-2018-N-0002
4164-01-P
2019-04226
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 July, August, and September 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 make technical amendments to improve the readability of the regulations.
This rule is effective March 13, 2019, except for amendatory instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019.
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
,
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. 84, no. 49
Office of the Federal Register, National Archives and Records Administration
2019-03-13
continuing
daily
deposited
born digital
277 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-03-13
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https://www.govinfo.gov/content/pkg/FR-2019-03-13/xml/FR-2019-03-13.xml
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2019-03-13
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FR-2019-03-13
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FR-2019-03-13
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