United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2018_register
executive
2018-11-01
article
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 and Address
Rules and Regulations
D09002ee1bdb9268a
D09002ee1bdb92710
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 July, August, and September 2017. 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 address, and to make technical amendments to improve the accuracy of the regulations.
83 FR 13632
https://www.govinfo.gov/app/details/FR-2018-03-30/2018-06358
2018-06358
fr30mr18-3
4164-01-P
Docket No. FDA-2017-N-0002
https://www.govinfo.gov/app/details/FR-2018-03-30/2018-06358
https://www.govinfo.gov/content/pkg/FR-2018-03-30/html/2018-06358.htm
https://www.govinfo.gov/content/pkg/FR-2018-03-30/pdf/2018-06358.pdf
Administrative Practice and Procedure
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
Food
Animal Feeds
6 p.
13632
13637
83 FR 13632
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 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 and Address; Federal Register Vol. 83, Issue
RULE
2018-06358
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-03-30
Docket No. FDA-2017-N-0002
4164-01-P
2018-06358
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 2017. 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 address, and to make technical amendments to improve the accuracy of the regulations.
This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 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
Food
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 and Address
,
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. 62
Office of the Federal Register, National Archives and Records Administration
2018-03-30
continuing
daily
deposited
born digital
202 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-03-30
P0b002ee19d9476f1
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr30mr18
https://www.govinfo.gov/app/details/FR-2018-03-30
https://www.govinfo.gov/content/pkg/FR-2018-03-30/pdf/FR-2018-03-30.pdf
https://www.govinfo.gov/content/pkg/FR-2018-03-30/xml/FR-2018-03-30.xml
fdlp
13625
13815
DGPO
2018-11-01
2023-04-28
FR-2018-03-30
machine generated
eng
FR
FR-2018-03-30
83
62