[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Proposed Rules]
[Pages 23930-23931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 91N-384H and 96P-0500]
RIN 0910-AC49


Food Labeling; Nutrient Content Claims, Definition of Sodium 
Levels for the Term ``Healthy''; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 5, 
2003, the comment period for a proposed rule published in the Federal 
Register of February 20, 2003. The proposed rule would amend the 
regulation for sodium levels for foods that use the nutrient content 
claim

[[Page 23931]]

``healthy.'' This action is being taken in response to a request for 
more time to submit comments to FDA.

DATES: Submit written or electronic comments on the proposed rule by 
July 5, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(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: Constance B. Henry, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 02740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 20, 2003 (68 FR 8163), FDA 
published a proposed rule that, if finalized, would amend the 
regulation for sodium levels for foods that use the nutrient content 
claim ``healthy.'' The agency proposed that a previously established, 
but not yet implemented, more restrictive second-tier sodium level 
would be permitted to take effect as a criterion that individual foods 
must meet to qualify to bear the term ``healthy.'' The agency proposed 
to retain the current first-tier sodium levels for meal and main dish 
products because implementing the more restrictive second-tier sodium 
level could result in the substantial elimination from the marketplace 
of meal and main dish products bearing the claim ``healthy.''
    In the February 20, 2003, proposed rule, FDA announced that the 
time period for public comment would be 75 days from the date of the 
publication in the Federal Register. On April 9, 2003, FDA received a 
request to allow an additional 60 days for interested persons to 
comment. In the requester's view, the time period of 75 days was 
insufficient to respond fully to FDA's multiple requests for comments 
and analyses and to enable all potential respondents adequate time to 
conduct the research necessary to provide complete scientific responses 
to questions posed in the proposed rule.
    FDA believes that an extension of the comment period is 
appropriate, given the variety of issues raised by the proposed rule. 
Therefore, FDA is extending the comment period for an additional 60 
days, until July 5, 2003. This extension will provide the public with a 
total of 135 days to submit comments.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding the proposal. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket numbers found in brackets 
in the heading of this document. Received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: May 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11272 Filed 5-2-03; 11:12 am]
BILLING CODE 4160-01-S