[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Rules and Regulations]
[Pages 8833-8834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-N-0585]


Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, 
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; 
Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a guidance for industry entitled ``Food 
Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, 
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids--
Small Entity Compliance Guide.'' The small entity compliance guide 
(SECG) is intended to help small entities comply with the final rule 
titled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, 
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids.''

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0585 for ``Food Labeling: Nutrient Content Claims; Alpha-
Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 
Fatty Acids; Small Entity Compliance Guide.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the SECG to the Office 
of Nutrition and Food Labeling, Center for Food Safety and Applied 
Nutrition (HFS-830), 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

[[Page 8834]]

INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1774.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 28, 2014 (79 FR 23262), (see also 
Docket Nos. FDA-2007-0601, FDA-2004-N-0382, FDA-2005-P-0371, and FDA-
2006-P-0224 (formerly Docket Nos. 2004N-0217, 2005P-0189, and 2006P-
0137)), we issued a final rule prohibiting certain nutrient content 
claims for foods, including conventional foods and dietary supplements, 
that contain omega-3 fatty acids based on our determination that such 
nutrient content claims do not meet the requirements of the Federal 
Food, Drug, and Cosmetics Act. The final rule became effective January 
1, 2016.
    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 may 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, as amended by Pub. L. 110-28), we are making available the SECG to 
explain the actions that a small entity must take to comply with the 
rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG represents the current 
thinking of the FDA on this topic. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the SECG 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: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03697 Filed 2-22-16; 8:45 am]
 BILLING CODE 4164-01-P