[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36322-36323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0404]


Small Entity Compliance Guide: Gluten-Free Labeling of Foods; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Gluten-Free Labeling 
of Foods--Small Entity Compliance Guide.'' The small entity compliance 
guide (SECG) is being issued for a final rule published in the Federal 
Register of August 5, 2013, and is intended to set forth in plain 
language the requirements of the regulation and to help small 
businesses understand the regulation.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the SECG to the 
Food Labeling and Standards Staff, Center for Food Safety and Applied 
Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the SECG.
    Submit electronic comments on the SECG to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration,

[[Page 36323]]

5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 5, 2013 (78 FR 47154), we issued 
a final rule that established a regulatory definition of the term 
``gluten-free'' for voluntary use in the labeling of foods. The final 
rule, which is codified at 21 CFR 101.91, became effective on September 
4, 2013, but has a compliance date of August 5, 2014.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rule could 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 (Pub. L. 104-
121), we are making available this SECG to explain the actions that a 
small entity must take to comply with the rule.
    We are issuing this SECG consistent with our good guidance 
practices regulation (21 CFR 10.115(c)(2)). This SECG represents our 
current thinking on establishing a regulatory definition of the term 
``gluten-free'' for voluntary use in the labeling of foods. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14929 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P