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Regulatory Information
1999_register
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2010-09-24
article
Supplements and Other Changes to Approved New Animal Drug Applications
Proposed Rules
D09002ee1bdfbc812
D09002ee1bdfbc8be
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) is proposing to amend its regulations on supplements and other changes to an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This proposed rule would require manufacturers to validate the effect of any manufacturing change on the identity, strength, quality, purity, and potency of a new animal drug as those factors relate to the safety or effectiveness of the product. The proposal identifies changes requiring submission and approval of a supplement prior to the distribution of the new animal drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the new animal drug, changes requiring the submission of a supplement at the time of distribution, and changes to be described in an annual report.
64 FR 53281
https://www.govinfo.gov/app/details/FR-1999-10-01/99-25493
99-25493
fr01oc99-32
RIN 0910-AB49
4160-01-F
Docket No. 99N-1415
https://www.govinfo.gov/app/details/FR-1999-10-01/99-25493
https://www.govinfo.gov/content/pkg/FR-1999-10-01/html/99-25493.htm
https://www.govinfo.gov/content/pkg/FR-1999-10-01/pdf/99-25493.pdf
14 p.
53281
53294
64 FR 53281
Code of Federal Regulations
Title 21 Part 25
21 CFR Part 25
Code of Federal Regulations
Title 21 Part 5
21 CFR Part 5
Code of Federal Regulations
Title 21 Part 500
21 CFR Part 500
Code of Federal Regulations
Title 21 Part 510
21 CFR Part 510
Code of Federal Regulations
Title 21 Part 514
21 CFR Part 514
Code of Federal Regulations
Title 21 Part 558
21 CFR Part 558
Regulation Identification Number 0910-AB49
RIN 0910-AB49
Supplements and Other Changes to Approved New Animal Drug Applications; Federal Register Vol. 64, Issue
PRORULE
99-25493
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1999-12-15
Docket No. 99N-1415
4160-01-F
99-25493
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its regulations on supplements and other changes to an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This proposed rule would require manufacturers to validate the effect of any manufacturing change on the identity, strength, quality, purity, and potency of a new animal drug as those factors relate to the safety or effectiveness of the product. The proposal identifies changes requiring submission and approval of a supplement prior to the distribution of the new animal drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the new animal drug, changes requiring the submission of a supplement at the time of distribution, and changes to be described in an annual report.
Written comments by December 15, 1999.
Dennis M. Bensley, Jr., Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956.
Federal Register
Vol. 64, no. 190
Office of the Federal Register, National Archives and Records Administration
1999-10-01
continuing
daily
deposited
born digital
410 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1999-10-01
P0b002ee180a4afcd
0097-6326
0042-1219
0364-1406
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000582072
f:fr01oc99
https://www.govinfo.gov/app/details/FR-1999-10-01
https://www.govinfo.gov/content/pkg/FR-1999-10-01/pdf/FR-1999-10-01.pdf
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53579
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2010-09-24
2023-05-05
FR-1999-10-01
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FR
FR-1999-10-01
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