[Federal Register Volume 69, Number 17 (Tuesday, January 27, 2004)]
[Proposed Rules]
[Page 3868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2003N-0496]
RIN 0910-AF09


Food Labeling: Health Claims; Dietary Guidance; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
February 25, 2004, the comment period for the advance notice of 
proposed rulemaking (ANPRM) that appeared in the Federal Register of 
November 25, 2003 (68 FR 66040). In the ANPRM, FDA requested comments 
on alternatives for regulating qualified health claims in the labeling 
of conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional foods and dietary supplement labels. The agency is taking 
this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: Submit written and electronic comments by February 25, 2004.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nancy T. Crane, Center for Food Safety 
and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1456, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 25, 2003 (68 FR 66040), FDA 
published an ANPRM with a 60-day comment period to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional foods and dietary supplement labels. Comments on the 
regulatory alternatives and the additional topics will inform FDA's 
rulemaking to establish regulations for qualified health claims, as 
well as any policy initiative(s) that FDA may undertake to provide 
information to consumers to help them make wise food choices.
    The agency has received multiple requests for either a 30-day or 
60-day extension of the comment period for the ANPRM. Each request 
conveyed concern that the current 60-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
ANPRM. In addition, two requests noted that the current comment period 
occurred during a period of time that included the Thanksgiving and 
year-end holidays. All of the requests explained that an extension is 
necessary due to the complexity, implications, and/or importance of the 
rulemaking on health claims and dietary guidance in food and dietary 
supplement labeling.
    FDA has considered the requests and is extending the comment period 
for the ANPRM for 30 days, until February 25, 2004. The agency believes 
that a 30-day extension allows adequate time for interested persons to 
submit comments without significantly delaying rulemaking on these 
important issues.

II. Request for Comments

    Interested persons may, on or before February 25, 2004, submit to 
the Division of Dockets Management (see ADDRESSES) written or 
electronic comments on this ANPRM. Submit two copies of any comments, 
except that individuals may submit one copy. Identify comments with the 
docket number found in brackets in the heading of this document. 
Interested persons may review received comments in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1772 Filed 1-23-04; 10:57 am]
BILLING CODE 4160-01-S