[Federal Register Volume 68, Number 161 (Wednesday, August 20, 2003)]
[Notices]
[Pages 50155-50156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0347]


Small Entity Compliance Guide on Labeling Trans Fatty Acids; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide (SECG) for a final rule 
published in the Federal Register of July 11, 2003, entitled ``Food 
Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content 
Claims, and Health Claims.'' This SECG, also entitled ``Food Labeling: 
Trans Fatty Acids in Nutrition

[[Page 50156]]

Labeling, Nutrient Content Claims, and Health Claims,'' is intended to 
help small businesses understand that final rule and to set forth in 
plain language the requirements of the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments concerning this SECG 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. Submit written requests for 
single copies of the SECG to the Industry Activities Staff, Center for 
Food Safety and Applied Nutrition (HFS-565), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. 
Send one self-adhesive address label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety 
and Applied Nutrition (HFS-800), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2373, FAX 301-
436-2636.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 11, 2003 (68 FR 41434), FDA issued 
a final rule requiring that trans fatty acids be declared in the 
nutrition label of conventional foods and dietary supplements on a 
separate line immediately under the line for the declaration of 
saturated fatty acids. This final rule becomes effective on January 1, 
2006.
    We examined the economic implications of that final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and 
determined that the final rule would have a significant economic impact 
on a substantial number of small entities.
    In compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121), we are making available 
this SECG stating in plain language the requirements of the final rule.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This SECG 
represents the agency's current thinking on the subject. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. You may use an alternative approach if such 
approach satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach, contact 
the FDA staff responsible for implementing this guidance (see FOR 
FURTHER INFORMATION CONTACT).

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the SECG entitled 
``Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient 
Content Claims, and Health Claims.'' 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 number found in brackets in the heading of this 
document. A copy of the SECG and 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 document at 
http://www.cfsan.fda.gov/dms/guidance.html.

    Dated: August 12, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-21228 Filed 8-19-03; 8:45 am]
BILLING CODE 4160-01-S