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Regulatory Information
2011_register
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2011-04-13
article
Revision of the Requirements for Constituent Materials
Rules and Regulations
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D09002ee1bdd0ae97
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
76 FR 20513
https://www.govinfo.gov/app/details/FR-2011-04-13/2011-8885
2011-8885
fr13ap11-11
4160-01-P
Docket No. FDA-2010-N-0099
https://www.govinfo.gov/app/details/FR-2011-04-13/2011-8885
https://www.govinfo.gov/content/pkg/FR-2011-04-13/html/2011-8885.htm
https://www.govinfo.gov/content/pkg/FR-2011-04-13/pdf/2011-8885.pdf
Biologics
Labeling
Reporting and Recordkeeping Requirements
6 p.
20513
20518
76 FR 20513
Code of Federal Regulations
Title 21 Part 610
21 CFR Part 610
Revision of the Requirements for Constituent Materials; Federal Register Vol. 76, Issue
RULE
2011-8885
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-05-13
Docket No. FDA-2010-N-0099
4160-01-P
2011-8885
Final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
This rule is effective May 13, 2011.
Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, 301-827-6210.
Biologics
Labeling
Reporting and Recordkeeping Requirements
Revision of the Requirements for Constituent Materials
,
http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm049563.htm
Federal Register
Vol. 76, no. 71
Office of the Federal Register, National Archives and Records Administration
2011-04-13
continuing
daily
deposited
born digital
357 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2011-04-13
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0042-1219
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https://www.govinfo.gov/app/details/FR-2011-04-13
https://www.govinfo.gov/content/pkg/FR-2011-04-13/pdf/FR-2011-04-13.pdf
https://www.govinfo.gov/content/pkg/FR-2011-04-13/xml/FR-2011-04-13.xml
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DGPO
2011-04-13
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FR-2011-04-13
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FR-2011-04-13
76
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