Document ID: FDA-2011-D-0376-0079
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period
Posted Date: 2011-09-09T04:00Z

[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23098]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Draft Guidance for Industry; Dietary Supplements: New Dietary 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.

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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``Draft Guidance for Industry; Dietary Supplements: New Dietary 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 the Federal Register of 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document, FDA announced the availability of a draft guidance for 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 to http://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 the Federal Register of 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the draft guidance for industry entitled ``Draft Guidance for Industry; 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 Comments on the draft guidance will assist FDA in the 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 
(see ADDRESSES) 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 either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or http://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.
[FR Doc. 2011-23098 Filed 9-8-11; 8:45 am]
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