FDA Extends GMP Interim Final Rule Comment Period for 30 Days

September 14, 2007

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All comments must be submitted to the agency by Wednesday, October 24, 2007.

The Food and Drug Administration (FDA) is extending the comment period for the interim final rule (IFR) that appeared in the Federal Register on June 25, 2007 (72 FR 34959). The new comment period ends Wednesday, October 24, 2007. In the IFR, the FDA requested comments on a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. The agency is allowing interested persons additional time to submit comments on this procedure.

You may submit comments, identified by Docket Number 2007N-0186 or by Regulation Identifier Number (RIN) 0910-AB88, using any of these channels:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

To ensure timelier processing of comments, the FDA is no longer accepting comments submitted by e-mail. Use one of the above portals for electronic submissions, or send your comments by fax or mail.

Written and electronic comments must be submitted by October 24. For complete instructions on submitting comments, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0186-nec0001.pdf. You may also contact Daniel Fabricant -- [email protected], or (202) 223-0101 ext. 102 -- at the Natural Products Association with questions about the rule or the comments process.

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