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Food and Drug Administration

[Docket No. FDA-2011-D-0376]

Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA) is extending the comment period by 60 days to December 2, 2011, for the notice entitled "Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability," that appeared in theFederal Registerof July 5, 2011 (76 FR 39111). In that document, FDA announced the availability of a draft guidance for industry and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
DATES: Submit either electronic or written comments by December 2, 2011.
ADDRESSES: Submit electronic comments tohttp://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Corey Hilmas, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2375.
SUPPLEMENTARY INFORMATION: I. Background

In theFederal Registerof July 5, 2011 (76 FR 39111), FDA published a notice with a 90-day comment period to request comments on the draft guidance for industry entitled “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” Comments on the draft guidance will assist FDA in the development of final guidance for industry on new dietary ingredient notifications and related issues.

The Agency has received a request for a 45-day extension of the comment period for this notice. FDA has considered the request and is extending the comment period for the notice entitled “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,” until December 2, 2011. The Agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying action by the Agency.

II. Comments

Interested persons may submit to the Division of Dockets Management (seeADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the draft guidance at eitherhttp://www.fda.gov/RegulatoryInformation/Guidances/default.htmorhttp://www.regulations.gov. Always access an FDA guidance document by using FDA's Web site listed previously to find the most current version of the guidance.

Dated: September 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy.