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2016-02-12
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Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
Rules and Regulations
D09002ee1bdc20eb1
D09002ee1bdc20f9d
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
81 FR 7445
https://www.govinfo.gov/app/details/FR-2016-02-12/2016-02884
2016-02884
fr12fe16-1
4164-01-P
Docket No. FDA-2015-N-2103
https://www.govinfo.gov/app/details/FR-2016-02-12/2016-02884
https://www.govinfo.gov/content/pkg/FR-2016-02-12/html/2016-02884.htm
https://www.govinfo.gov/content/pkg/FR-2016-02-12/pdf/2016-02884.pdf
Administrative Practice and Procedure
Biologics
Confidential Business Information
2 p.
7445
7446
81 FR 7445
Code of Federal Regulations
Title 21 Part 601
21 CFR Part 601
Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Federal Register Vol. 81, Issue
RULE
2016-02884
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-03-14
Docket No. FDA-2015-N-2103
4164-01-P
2016-02884
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
This rule is effective March 14, 2016.
Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Administrative Practice and Procedure
Biologics
Confidential Business Information
Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
,
http://www.regulations.gov
Federal Register
Vol. 81, no. 29
Office of the Federal Register, National Archives and Records Administration
2016-02-12
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261 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-02-12
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0042-1219
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https://www.govinfo.gov/app/details/FR-2016-02-12
https://www.govinfo.gov/content/pkg/FR-2016-02-12/pdf/FR-2016-02-12.pdf
https://www.govinfo.gov/content/pkg/FR-2016-02-12/xml/FR-2016-02-12.xml
fdlp
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DGPO
2016-02-12
2023-04-29
FR-2016-02-12
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FR
FR-2016-02-12
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