[Federal Register Volume 62, Number 47 (Tuesday, March 11, 1997)]
[Proposed Rules]
[Pages 11129-11130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 94P-0390 and 95P-0241]


Food Labeling: Health Claims; Availability of FDA Report of 
Effects of Food Label Health Claim Statements; 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 April 
24, 1997, the comment period for a proposal to amend its regulations on 
nutrient content claims and health claims to provide additional 
flexibility in the use of these claims on food products, which 
published in the Federal Register of December 21, 1995 (66206). In the 
Federal Register of January 24, 1997 (3635), the comment period for 
this proposal was reopened to provide interested persons an opportunity 
to review three studies that are relevant to issues under consideration 
in this rulemaking. The agency is taking this action in response to 
requests for an extension to allow interested persons additional time 
to review these studies and to submit comments.

DATES: Written comments by April 24, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Alan S. Levy, Center for Food Safety 
and Applied Nutrition (HFS-727), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-9448.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1997, 
FDA announced the availability of a report entitled ``Consumer Impacts 
of Health Claims: An Experimental Study'' (the FDA Study). FDA advised 
that the FDA Study bore directly on the issues involving health claims 
that were raised in a rulemaking that FDA had instituted on December 
21, 1995, with a proposal entitled ``Food Labeling: Nutrient Content 
Claims, General Principles; Health Claims, General Requirements and 
Other Specific Requirements for Individual Health Claims'' (the 
nutrient content/health claim proceeding) (60 FR 66206). FDA also 
announced the availability of two other studies that it

[[Page 11130]]

had received in a comment to a separate rulemaking. Because it might 
consider the results of these three studies in developing a final rule 
in the nutrient content/health claim proceeding, FDA also announced 
that it was reopening the comment period for that rulemaking to provide 
an opportunity for interested persons to comment on the studies.
    FDA has received two requests for an extension of the comment 
period. The requests were from a trade association, for an extension of 
30 days, and from a consumer group, for an extension of 45 days. The 
request from the consumer group indicated a need to seek outside 
experts to review and analyze the studies and, if necessary, to conduct 
survey research. The other, from the trade association whose petition 
led to the nutrient content/health claim proceeding, noted that the 
author of the FDA Study had remarked in the study's Executive Summary 
about the complexity of the study findings and said that it was 
``equally complex for interested parties to analyze the research and to 
comment on the applicability of the findings to the proposed rule.''
    After careful consideration, FDA has decided that some additional 
time is necessary for interested persons to review the results of the 
FDA Study and other studies and to submit meaningful comments on them. 
Therefore, FDA is extending the comment period for the proposal for an 
additional 45 days, until April 24, 1997.
    Interested persons may, on or before April 24, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
the studies that were added to this docket on January 24, 1997. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6145 Filed 3-7-97; 9:39 am]
BILLING CODE 4160-01-F