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Food and Drug Administration, HHS.
Notice.
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.
Submit either electronic or written comments on FDA guidances at any time.
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, ( printed page 36323) 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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.
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.
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.
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