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U.S. Department of Health and Human Services

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FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers (“Changes Being Effected” Supplements proposed rule)

[12/18/2013]  FDA has decided to extend the comment period by 60 days for the proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (“Changes Being Effected” Supplements proposed rule). The comment period on the proposed rule will be extended to March 13, 2014, and the comment period on information collection issues under the Paperwork Reduction Act of 1995 will be extended to February 11, 2014. This extension is being provided in response to requests to provide interested persons with additional time to submit comments. FDA is expediting publication of a notice in the Federal Register to extend the comment period.

In the Federal Register of November 13, 2013, FDA published a proposed rule with a 60-day comment period to request comments on the proposal 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. Comments on the proposal to permit holders of abbreviated new drug applications to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug upon submission of a “changes being effected” supplement will inform FDA's rulemaking.

Submit comments electronically to the FDA docket on http://www.regulations.gov, use docket number FDA-2013-N-0500. 

To submit comments by mail, send to FDA at:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All submissions must include the agency name and docket number.