Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide; Availability, 8833-8834 [2016-03697]

Download as PDF Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Rules and Regulations List of Subjects in 20 CFR Part 900 Organization and functions (Government agencies). Adoption of Amendments to the Regulations Accordingly, 20 CFR part 900 is amended as follows: PART 900—STATEMENT OF ORGANIZATION Paragraph 1. The authority citation for part 900 continues to read as follows: ■ Authority: Sec. 3041–2, Pub. L. 93–406, 88 Stat. 829, 1002 (29 U.S.C. 1241–2). Par. 2. Section 900.3 is revised to read as follows: ■ § 900.3 Composition. Pursuant to the Bylaws, the Joint Board consists of three members appointed by the Secretary of the Treasury and two members appointed by the Secretary of Labor. The Board elects a Chairman and a Secretary from among the Department of the Treasury and the Department of Labor members. The Pension Benefit Guaranty Corporation may designate a non-voting representative to sit with, and participate in, the discussions of the Board. All decisions of the Board are made by simple majority vote. Approved: February 12, 2016. Carolyn E. Zimmerman, Chairman, Joint Board for the Enrollment of Actuaries. [FR Doc. 2016–03655 Filed 2–22–16; 8:45 am] BILLING CODE 4830–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [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 asabaliauskas on DSK5VPTVN1PROD with RULES Food and Drug Administration, HHS. ACTION: Notification of availability. 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 SUMMARY: VerDate Sep<11>2014 16:15 Feb 22, 2016 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 21 CFR Part 101 AGENCY: 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; AlphaLinolenic 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: Jkt 238001 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- PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 8833 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 https://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 https://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: https://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 https:// 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 E:\FR\FM\23FER1.SGM 23FER1 8834 Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Rules and Regulations INFORMATION section for electronic access to the SECG. DEPARTMENT OF STATE 22 CFR Part 171 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. [Public Notice: 9448] SUPPLEMENTARY INFORMATION: AGENCY: I. Background ACTION: 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. SUMMARY: asabaliauskas on DSK5VPTVN1PROD with RULES II. Electronic Access Persons with access to the Internet may obtain the SECG at either https:// www.fda.gov/FoodGuidances or https:// 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 VerDate Sep<11>2014 16:15 Feb 22, 2016 Jkt 238001 RIN 1400–AD78 Privacy Act; STATE–75, Family Advocacy Case Records Department of State. Final rule. The Department of State (the Department) finalizes its rule exempting portions of the Family Advocacy Case Records, State–75, from one or more provisions of the Privacy Act of 1974. DATES: This rule is effective on February 23, 2016. FOR FURTHER INFORMATION CONTACT: John Hackett, Director; Office of Information Programs and Services, A/GIS/IPS; Department of State, SA–2; 515 22nd Street NW., Washington, DC 20522– 8001, or at Privacy@state.gov. SUPPLEMENTARY INFORMATION: The Department maintains the Family Advocacy Case Records system of records. The primary purpose of this system of records is to be utilized at post by members of the Family Advocacy Team and in the Department of State by the Family Advocacy Committee. The information may be shared within the Department on a need to know basis and in medical clearance determinations for overseas assignment of covered employees and family members, as well as for making determinations involving curtailment, medical evacuation, suitability, and security clearance. The Department published a notice of proposed rulemaking (NPRM) on September 9, 2015, (80 FR 54256) proposing to amend 22 CFR part 171 to exempt portions of this system of records from the following subsections of the Privacy Act pursuant to subsections (k)(1) and (k)(2): • 5 U.S.C. 552a(c)(3) (requiring that an accounting of certain disclosures be made available to an individual upon request); • 5 U.S.C. 552a(d) (establishing requirements related to an individual’s right to access and request amendment to certain records); • 5 U.S.C. 552a(e)(1) (providing that an agency that maintains a system of records shall ‘‘maintain in its records only such information about an individual as is relevant and necessary to accomplish a purpose of the agency required to be accomplished by statute or by executive order of the President’’); • 5 U.S.C. 552a(e)(4)(G) (requiring that an agency that maintains a system PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 of records publish in the Federal Register ‘‘the agency procedures whereby an individual can be notified at his request if the system of records contains a record pertaining to him’’); • 5 U.S.C. 552a(e)(4)(H) (requiring that an agency that maintains a system of records publish in the Federal Register ‘‘the agency procedures whereby an individual can be notified at his request how he can gain access to any record pertaining to him contained in the system of records, and how he can contest its content’’); • 5 U.S.C. 552a(e)(4)(I) (requiring that an agency that maintains a system of records publish in the Federal Register ‘‘the categories of sources of records in the system’’); and • 5 U.S.C. 552a(f) (requiring that an agency that maintains a system of records promulgate certain regulations). STATE–75 is exempted under subsection (k)(1) to the extent that records within that system are subject to the provisions of 5 U.S.C. 552(b)(1), which covers materials that: (i) Are specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense and foreign policy, and (ii) are in fact properly classified pursuant to such Executive order. STATE–75 is exempted under subsection (k)(2) to the extent that records within that system are comprised of investigatory material compiled for law enforcement purposes, subject to the limitations set forth in subsection (k)(2). The subsection (k)(2) exemption is intended to prevent individuals who are the subject of investigation from frustrating the investigatory process, facilitate the proper functioning and integrity of law enforcement activities, prevent disclosure of investigative techniques, maintain the confidence of foreign governments in the integrity of the procedures under which privileged or confidential information may be provided, fulfill commitments made to sources to protect their identities and the confidentiality of information, and avoid endangering sources and law enforcement personnel. For additional background, see the NPRM published on September 9, 2015. (80 FR 54256) and the system of records notice published on January 5, 2009 (74 FR 330). The Department received no public comments on these documents. List of Subjects in 22 CFR Part 171 Privacy. For the reasons stated in the preamble, 22 CFR part 171 is amended as follows: E:\FR\FM\23FER1.SGM 23FER1

Agencies

[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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 
https://www.fda.gov/FoodGuidances or https://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

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