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Regulatory Information
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2013-11-13
article
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Proposed Rules
D09002ee1bdc8fbb0
D09002ee1bdc8fc84
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 or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the ``Highlights of Prescribing Information'' for drug products with labeling in the ``Physician Labeling Rule'' (PLR) format.
78 FR 67985
https://www.govinfo.gov/app/details/FR-2013-11-13/2013-26799
2013-26799
fr13no13-15
RIN 0910-AG94
4160-01-P
Docket No. FDA-2013-N-0500
https://www.govinfo.gov/app/details/FR-2013-11-13/2013-26799
https://www.govinfo.gov/content/pkg/FR-2013-11-13/html/2013-26799.htm
https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/2013-26799.pdf
Administrative Practice and Procedure
Confidential Business Information
Drugs
Reporting and Recordkeeping Requirements
Biologics
15 p.
67985
67999
78 FR 67985
Code of Federal Regulations
Title 21 Part 314
21 CFR Part 314
Code of Federal Regulations
Title 21 Part 601
21 CFR Part 601
Regulation Identification Number 0910-AG94
RIN 0910-AG94
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Federal Register Vol. 78, Issue
PRORULE
2013-26799
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-01-13
Docket No. FDA-2013-N-0500
4160-01-P
2013-26799
Proposed rule.
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the ``Highlights of Prescribing Information'' for drug products with labeling in the ``Physician Labeling Rule'' (PLR) format.
Submit either electronic or written comments on the proposed rule by January 13, 2014. See section VII for the proposed effective date of a final rule based on this proposed rule. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by December 13, 2013, (see the ``Paperwork Reduction Act of 1995'' section of this document).
Janice L. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD 20993-0002, 301- 796-3601.
Administrative Practice and Procedure
Confidential Business Information
Drugs
Reporting and Recordkeeping Requirements
Biologics
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
,
oira_submission@omb.eop.gov
http://labels.fda.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.imshealth.com/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.pdf
http://www.regulations.gov
Federal Register
Vol. 78, no. 219
Office of the Federal Register, National Archives and Records Administration
2013-11-13
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daily
deposited
born digital
408 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2013-11-13
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https://www.govinfo.gov/app/details/FR-2013-11-13
https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/FR-2013-11-13.pdf
https://www.govinfo.gov/content/pkg/FR-2013-11-13/xml/FR-2013-11-13.xml
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2013-11-13
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FR-2013-11-13
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