81 FR 8833 - Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 35 (February 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 35 (February 23, 2016)
| Page Range | 8833-8834 | |
| FR Document | 2016-03697 |
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)] [Rules and Regulations] [Pages 8833-8834] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03697] ======================================================================= ----------------------------------------------------------------------- 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: 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
![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Rules and Regulations 8833
List of Subjects in 20 CFR Part 900 Acid, and Docosahexaenoic Acid Linolenic Acid, Eicosapentaenoic Acid,
Organization and functions Omega-3 Fatty Acids—Small Entity and Docosahexaenoic Acid Omega-3
(Government agencies). Compliance Guide.’’ The small entity Fatty Acids; Small Entity Compliance
compliance guide (SECG) is intended to Guide.’’ Received comments will be
Adoption of Amendments to the help small entities comply with the placed in the docket and, except for
Regulations final rule titled ‘‘Food Labeling: those submitted as ‘‘Confidential
Accordingly, 20 CFR part 900 is Nutrient Content Claims; Alpha- Submissions,’’ publicly viewable at
amended as follows: Linolenic Acid, Eicosapentaenoic Acid, http://www.regulations.gov or at the
and Docosahexaenoic Acid Omega-3 Division of Dockets Management
PART 900—STATEMENT OF Fatty Acids.’’ between 9 a.m. and 4 p.m., Monday
ORGANIZATION DATES: Submit either electronic or through Friday.
written comments on FDA guidances at • Confidential Submissions—To
■ Paragraph 1. The authority citation any time. submit a comment with confidential
for part 900 continues to read as information that you do not wish to be
follows: ADDRESSES: You may submit comments
made publicly available, submit your
as follows: comments only as a written/paper
Authority: Sec. 3041–2, Pub. L. 93–406, 88
Stat. 829, 1002 (29 U.S.C. 1241–2). Electronic Submissions submission. You should submit two
copies total. One copy will include the
■ Par. 2. Section 900.3 is revised to read Submit electronic comments in the information you claim to be confidential
as follows: following way: with a heading or cover note that states
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
§ 900.3 Composition.
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Pursuant to the Bylaws, the Joint instructions for submitting comments.
Board consists of three members Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
appointed by the Secretary of the including attachments, to http://
Treasury and two members appointed its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
by the Secretary of Labor. The Board the docket unchanged. Because your
elects a Chairman and a Secretary from claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
among the Department of the Treasury solely responsible for ensuring that your
and the Department of Labor members. for public viewing and posted on
comment does not include any http://www.regulations.gov. Submit
The Pension Benefit Guaranty confidential information that you or a
Corporation may designate a non-voting both copies to the Division of Dockets
third party may not wish to be posted, Management. If you do not wish your
representative to sit with, and such as medical information, your or name and contact information to be
participate in, the discussions of the anyone else’s Social Security number, or made publicly available, you can
Board. All decisions of the Board are confidential business information, such provide this information on the cover
made by simple majority vote. as a manufacturing process. Please note sheet and not in the body of your
Approved: February 12, 2016. that if you include your name, contact comments and you must identify this
Carolyn E. Zimmerman, information, or other information that information as ‘‘confidential.’’ Any
Chairman, Joint Board for the Enrollment of identifies you in the body of your information marked as ‘‘confidential’’
Actuaries. comments, that information will be will not be disclosed except in
[FR Doc. 2016–03655 Filed 2–22–16; 8:45 am] posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
BILLING CODE 4830–01–P
• If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND
written/paper submission and in the the information at: http://www.fda.gov/
HUMAN SERVICES
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
21 CFR Part 101 read background documents or the
Submit written/paper submissions as electronic and written/paper comments
[Docket No. FDA–2016–N–0585] follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Food Labeling: Nutrient Content written/paper submissions): Division of docket number, found in brackets in the
Claims; Alpha-Linolenic Acid, Dockets Management (HFA–305), Food heading of this document, into the
Eicosapentaenoic Acid, and and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Docosahexaenoic Acid Omega-3 Fatty Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Acids; Small Entity Compliance Guide; • For written/paper comments Management, 5630 Fishers Lane, Rm.
Availability submitted to the Division of Dockets 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Management, FDA will post your Submit written requests for single
HHS. comment, as well as any attachments, copies of the SECG to the Office of
asabaliauskas on DSK5VPTVN1PROD with RULES
ACTION: Notification of availability. except for information submitted, Nutrition and Food Labeling, Center for
marked and identified, as confidential, Food Safety and Applied Nutrition
SUMMARY: The Food and Drug if submitted as detailed in (HFS–830), Food and Drug
Administration (FDA, the Agency, or ‘‘Instructions.’’ Administration, 5100 Paint Branch
we) is announcing the availability of a Instructions: All submissions received Pkwy., College Park, MD 20740. Send
guidance for industry entitled ‘‘Food must include the Docket No. FDA– two self-addressed adhesive labels to
Labeling: Nutrient Content Claims; 2016–N–0585 for ‘‘Food Labeling: assist that office in processing your
Alpha-Linolenic Acid, Eicosapentaenoic Nutrient Content Claims; Alpha- request. See the SUPPLEMENTARY
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![8834 Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Rules and Regulations
INFORMATION section for electronic DEPARTMENT OF STATE of records publish in the Federal
access to the SECG. Register ‘‘the agency procedures
22 CFR Part 171 whereby an individual can be notified at
FOR FURTHER INFORMATION CONTACT:
[Public Notice: 9448] his request if the system of records
Vincent de Jesus, Center for Food Safety
contains a record pertaining to him’’);
and Applied Nutrition (HFS–830), Food RIN 1400–AD78
and Drug Administration, 5100 Paint • 5 U.S.C. 552a(e)(4)(H) (requiring
Branch Pkwy., College Park, MD 20740, Privacy Act; STATE–75, Family that an agency that maintains a system
240–402–1774. Advocacy Case Records of records publish in the Federal
Register ‘‘the agency procedures
SUPPLEMENTARY INFORMATION: AGENCY: Department of State. whereby an individual can be notified at
ACTION: Final rule. his request how he can gain access to
I. Background
any record pertaining to him contained
In the Federal Register of April 28, SUMMARY: The Department of State (the in the system of records, and how he
2014 (79 FR 23262), (see also Docket Department) finalizes its rule exempting can contest its content’’);
Nos. FDA–2007–0601, FDA–2004–N– portions of the Family Advocacy Case • 5 U.S.C. 552a(e)(4)(I) (requiring that
0382, FDA–2005–P–0371, and FDA– Records, State–75, from one or more an agency that maintains a system of
2006–P–0224 (formerly Docket Nos. provisions of the Privacy Act of 1974. records publish in the Federal Register
2004N–0217, 2005P–0189, and 2006P– DATES: This rule is effective on February ‘‘the categories of sources of records in
0137)), we issued a final rule 23, 2016. the system’’); and
prohibiting certain nutrient content FOR FURTHER INFORMATION CONTACT: John • 5 U.S.C. 552a(f) (requiring that an
claims for foods, including conventional Hackett, Director; Office of Information agency that maintains a system of
foods and dietary supplements, that Programs and Services, A/GIS/IPS; records promulgate certain regulations).
contain omega-3 fatty acids based on Department of State, SA–2; 515 22nd STATE–75 is exempted under
our determination that such nutrient Street NW., Washington, DC 20522– subsection (k)(1) to the extent that
content claims do not meet the 8001, or at Privacy@state.gov. records within that system are subject to
requirements of the Federal Food, Drug, SUPPLEMENTARY INFORMATION: The the provisions of 5 U.S.C. 552(b)(1),
and Cosmetics Act. The final rule Department maintains the Family which covers materials that: (i) Are
became effective January 1, 2016. Advocacy Case Records system of specifically authorized under criteria
We examined the economic records. The primary purpose of this established by an Executive order to be
implications of the final rule as required system of records is to be utilized at kept secret in the interest of national
by the Regulatory Flexibility Act (5 post by members of the Family defense and foreign policy, and (ii) are
U.S.C. 601–612) and determined that Advocacy Team and in the Department in fact properly classified pursuant to
the final rule may have a significant of State by the Family Advocacy such Executive order. STATE–75 is
economic impact on a substantial Committee. The information may be exempted under subsection (k)(2) to the
number of small entities. In compliance shared within the Department on a need extent that records within that system
with section 212 of the Small Business to know basis and in medical clearance are comprised of investigatory material
Regulatory Enforcement Fairness Act determinations for overseas assignment compiled for law enforcement purposes,
(Pub. L. 104–121, as amended by Pub. of covered employees and family subject to the limitations set forth in
L. 110–28), we are making available the members, as well as for making subsection (k)(2). The subsection (k)(2)
SECG to explain the actions that a small determinations involving curtailment, exemption is intended to prevent
entity must take to comply with the medical evacuation, suitability, and individuals who are the subject of
rule. security clearance. investigation from frustrating the
The Department published a notice of investigatory process, facilitate the
We are issuing the SECG consistent proposed rulemaking (NPRM) on
with our good guidance practices proper functioning and integrity of law
September 9, 2015, (80 FR 54256) enforcement activities, prevent
regulation (21 CFR 10.115(c)(2)). The proposing to amend 22 CFR part 171 to
SECG represents the current thinking of disclosure of investigative techniques,
exempt portions of this system of maintain the confidence of foreign
the FDA on this topic. It does not records from the following subsections
establish any rights for any person and governments in the integrity of the
of the Privacy Act pursuant to procedures under which privileged or
is not binding on FDA or the public. subsections (k)(1) and (k)(2):
You can use an alternative approach if confidential information may be
• 5 U.S.C. 552a(c)(3) (requiring that provided, fulfill commitments made to
it satisfies the requirements of the an accounting of certain disclosures be
applicable statutes and regulations. sources to protect their identities and
made available to an individual upon the confidentiality of information, and
II. Electronic Access request); avoid endangering sources and law
• 5 U.S.C. 552a(d) (establishing enforcement personnel.
Persons with access to the Internet requirements related to an individual’s
For additional background, see the
may obtain the SECG at either http:// right to access and request amendment
NPRM published on September 9, 2015.
www.fda.gov/FoodGuidances or http:// to certain records);
• 5 U.S.C. 552a(e)(1) (providing that (80 FR 54256) and the system of records
www.regulations.gov. Use the FDA Web
an agency that maintains a system of notice published on January 5, 2009 (74
site listed in the previous sentence to
FR 330). The Department received no
asabaliauskas on DSK5VPTVN1PROD with RULES
find the most current version of the records shall ‘‘maintain in its records
only such information about an public comments on these documents.
guidance.
Dated: February 18, 2016. individual as is relevant and necessary List of Subjects in 22 CFR Part 171
to accomplish a purpose of the agency
Leslie Kux,
required to be accomplished by statute Privacy.
Associate Commissioner for Policy. or by executive order of the President’’); For the reasons stated in the
[FR Doc. 2016–03697 Filed 2–22–16; 8:45 am] • 5 U.S.C. 552a(e)(4)(G) (requiring preamble, 22 CFR part 171 is amended
BILLING CODE 4164–01–P that an agency that maintains a system as follows:
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Document Created: 2018-02-02 14:33:24
Document Modified: 2018-02-02 14:33:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 8833 |
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