80_FR_54621 80 FR 54446 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Administrative Docket Update; Availability

80 FR 54446 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Administrative Docket Update; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range54446-54447
FR Document2015-22757

The Food and Drug Administration (FDA or we) is announcing the availability of certain documents to update the administrative docket of the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015) 
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Proposed Rules]
[Pages 54446-54447]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels; Administrative Docket Update; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notification.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of certain documents to update the administrative docket 
of the proposed rule to amend FDA's labeling regulations for 
conventional foods and dietary supplements to provide updated nutrition 
information on the Nutrition Facts and Supplement Facts labels to 
assist consumers in maintaining healthy dietary practices.

DATES: We are extending the comment period that was scheduled to close 
on September 25, 2015, until October 13, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2012-N-1210) for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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.

FOR FURTHER INFORMATION CONTACT: Serena Lo, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-2488, email: 
ConsumerStudiesBranch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11879), we 
published a proposed rule that would amend our

[[Page 54447]]

labeling regulations for conventional foods and dietary supplements to 
provide updated nutrition information. More recently, in the Federal 
Register of July 27, 2015 (80 FR 44302), we reopened the comment period 
through September 25, 2015, for the proposed rule for the sole purpose 
of inviting public comments on two consumer studies being added to the 
administrative record. The consumer studies pertained to proposed 
changes to the Nutrition Facts label formats. We also issued a 
supplemental proposed rule (80 FR 44303) with a comment period through 
October 13, 2015. The supplemental proposal included two additional 
consumer studies pertaining to the declaration of added sugars and 
alternative footnote statements. We proposed text for the footnotes to 
be used on the Nutrition Facts label, after completing our consumer 
research in which we tested various footnote text options for the 
label, and to establish a Daily Reference Value of 10 percent of total 
energy intake from added sugars. The supplemental proposal also would 
require the declaration of the percent Daily Value for added sugars on 
the label and provide an additional rationale for the declaration of 
added sugars on the label. We explained that we were taking these 
actions based, in part, on the science underlying a new report released 
by the 2015 Dietary Guidelines Advisory Committee.
    We have received some comments suggesting we are not eliciting 
comment on the consumer studies in the supplemental proposal published 
in July 2015. We clarify in this notice that: (1) The consumer studies 
on the added sugars declaration and the alternative footnote statements 
in the supplemental proposal relate to topics on which we sought 
comment and (2) the consumer studies on the format published in a 
separate notice in July 2015 were included for comment, and were placed 
in the docket at that time. We are now responding to additional 
requests for the raw data for each of these consumer studies that are 
relevant to the summary memoranda for the studies, also now available 
for comment.

II. Updated Information

    We are updating the docket for the rulemaking with two additional 
documents: A request from the Grocery Manufacturers Association for the 
raw data associated with the four consumer studies described in this 
document, and our response to that request indicating that we will 
provide the raw data underlying the four consumer studies to anyone who 
submits a request to ConsumerStudiesBranch@fda.hhs.gov.
    These documents may be seen by interested persons at the Division 
of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday, and are available electronically at http://www.regulations.gov.
    In addition, we are extending to October 13, 2015, the comment 
period on the two consumer studies pertaining to proposed changes to 
the Nutrition Facts label formats, which had been scheduled to close on 
September 25, 2015, to align the comment periods for all consumer 
studies.
    We will continue to take comment on the supplemental proposed rule, 
including taking comment on the consumer studies on added sugars and 
the footnote, until October 13, 2015.

    Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22757 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P

54446 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules Therefore, this proposed regulation: (1) Designated altitudes. Surface to 3,500 feet SUMMARY: The Food and Drug Is not a ‘‘significant regulatory action’’ MSL. Administration (FDA or we) is under Executive Order 12866; (2) is not Time of designation. By NOTAM. announcing the availability of certain Controlling agency. U.S. Navy, Patuxent a ‘‘significant rule’’ under Department of River Radar Approach Control. documents to update the administrative Transportation (DOT) Regulatory Using agency. Chief, Wallops Station, docket of the proposed rule to amend Policies and Procedures (44 FR 11034; National Aeronautics and Space FDA’s labeling regulations for February 26, 1979); and (3) does not Administration, Wallops Island, VA. conventional foods and dietary warrant preparation of a regulatory supplements to provide updated R–6604D Chincoteague Inlet, VA [New] evaluation as the anticipated impact is nutrition information on the Nutrition so minimal. Boundaries. Beginning at lat. 38°01′42″ N., Facts and Supplement Facts labels to long. 75°29′28″ W.; to lat. 38°07′12″ N., long. Since this is a routine matter that will assist consumers in maintaining healthy 75°14′48″ W.; to lat. 38°04′36″ N., long. only affect air traffic procedures and air 75°08′07″ W.; thence 3 NM from and parallel dietary practices. navigation, it is certified that this to the shoreline to lat. 37°51′31″ N., long. DATES: We are extending the comment proposed rule, when promulgated, will 75°17′16″ W.; to lat. 37°56′45″ N., long. period that was scheduled to close on not have a significant economic impact 75°27′29″ W.; to lat. 37°53′55″ N., long. September 25, 2015, until October 13, on a substantial number of small entities 75°29′11″ W.; to lat. 37°55′40″ N., long. 2015. under the criteria of the Regulatory 75°33′27″ W.; to the point of beginning; excluding R–6604C. ADDRESSES: You may submit comments Flexibility Act. Designated altitudes. 100 feet AGL to 3,500 by any of the following methods: Environmental Review feet MSL. Time of designation. By NOTAM. Electronic Submissions This proposal will be subjected to an Controlling agency. U.S. Navy, Patuxent Submit electronic comments in the environmental analysis in accordance River Radar Approach Control. following way: with FAA Order 1050.1E, Using agency. Chief, Wallops Station, • Federal eRulemaking Portal: http:// ‘‘Environmental Impacts: Policies and National Aeronautics and Space www.regulations.gov. Follow the Procedures,’’ prior to any FAA final Administration, Wallops Island, VA. instructions for submitting comments. regulatory action. R–6604E Chincoteague Inlet, VA [New] Written Submissions List of Subjects in 14 CFR Part 73 Boundaries. Beginning at lat. 37°55′40″ N., long. 75°33′27″ W.; to lat. 37°53′55″ N., long. Submit written submissions in the Airspace, Prohibited areas, Restricted 75°29′11″ W.; to lat. 37°50′24″ N., long. following ways: areas. 75°31′19″ W.; to lat. 37°39′20″ N., long. • Mail/Hand delivery/Courier (for 75°31′19″ W.; to lat. 37°38′57″ N., long. paper submissions): Division of Dockets The Proposed Amendment 75°31′31″ W.; to lat. 37°46′55″ N., long. Management (HFA–305), Food and Drug In consideration of the foregoing, the 75°39′13″ W.; to the point of beginning. Administration, 5630 Fishers Lane, Rm. Federal Aviation Administration Designated altitudes. 700 feet AGL to 3,500 feet MSL. 1061, Rockville, MD 20852. proposes to amend 14 CFR part 73 as Instructions: All submissions received Time of designation. By NOTAM. follows: must include the Docket No. (FDA– Controlling agency. U.S. Navy, Patuxent River Radar Approach Control. 2012–N–1210) for this rulemaking. All PART 73—SPECIAL USE AIRSPACE Using agency. Chief, Wallops Station, comments received may be posted National Aeronautics and Space without change to http:// ■ 1. The authority citation for part 73 Administration, Wallops Island, VA. continues to read as follows: www.regulations.gov, including any * * * * * personal information provided. For Authority: 49 U.S.C. 106(f), 106(g); 40103, additional information on submitting 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Issued in Washington, DC on September 1, 2015. comments, see the ‘‘Comments’’ heading 1959–1963 Comp., p. 389. Gary A. Norek, of the SUPPLEMENTARY INFORMATION § 73.66 [Amended] Manager, Airspace Policy and Regulations section of this document. ■ 2. Section 73.66 is amended as Group. Docket: For access to the docket to follows: [FR Doc. 2015–22827 Filed 9–9–15; 8:45 am] read background documents or comments received, go to http:// * * * * * BILLING CODE 4910–13–P www.regulations.gov and insert the R–6604A Chincoteague Inlet, VA docket number(s), found in brackets in [Amended] the heading of this document, into the DEPARTMENT OF HEALTH AND ‘‘Search’’ box and follow the prompts By removing the current boundaries and inserting the following in its place: HUMAN SERVICES and/or go to the Division of Dockets Boundaries. Beginning at lat. 37°55′25″ N., Management, 5630 Fishers Lane, Rm. long. 75°24′54″ W.; to lat. 37°51′31″ N., long. Food and Drug Administration 1061, Rockville, MD 20852. 75°17′16″ W.; then along a line 3 NM from 21 CFR Part 101 FOR FURTHER INFORMATION CONTACT: and parallel to the shoreline to lat. 37°39′20″ N., long. 75°31′19″ W.; to lat. 37°47′00″ N., Serena Lo, Center for Food Safety and [Docket No. FDA–2012–N–1210] Applied Nutrition (HFS–830), Food and long. 75°31′18″ W.; to lat. 37°51′00″ N., long. 75°29′36″ W.; to the point of beginning. RIN 0910–AF22 Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– R–6604C Chincoteague Inlet, VA [New] rmajette on DSK2VPTVN1PROD with PROPOSALS Food Labeling: Revision of the 402–2488, email: Boundaries. Beginning at lat. 37°56′57″ N., Nutrition and Supplement Facts ConsumerStudiesBranch@fda.hhs.gov. long. 75°28′37″ W.; to lat. 37°56′54″ N., long. Labels; Administrative Docket Update; 75°26′56″ W.; to lat. 37°56′ 23″ N., long. SUPPLEMENTARY INFORMATION: Availability 75°26′ 46″ W.; to lat. 37°56′ 45″ N., long. I. Background 75°27′29″ W.; to lat. 37°55′15″ N., long. AGENCY: Food and Drug Administration, 75°28′23″ W.; to lat. 37°55′15″ N., long. HHS. In the Federal Register of March 3, 75°28′39″ W.; to lat. 37°56′32″ N., long. 2014 (79 FR 11879), we published a ACTION: Proposed rule; notification. 75°29′18″ W.; to the point of beginning. proposed rule that would amend our VerDate Sep<11>2014 17:08 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\10SEP1.SGM 10SEP1

Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules 54447 labeling regulations for conventional These documents may be seen by a.m., must be received by December 9, foods and dietary supplements to interested persons at the Division of 2015. provide updated nutrition information. Dockets Management, Food and Drug ADDRESSES: Send submissions to More recently, in the Federal Register of Administration, 5630 Fishers Lane, Rm. CC:PA:LPD:PR (REG–112997–10), Room July 27, 2015 (80 FR 44302), we 1061, Rockville, MD 20852, between 9 5205, Internal Revenue Service, PO Box reopened the comment period through a.m. and 4 p.m., Monday through 7604, Ben Franklin Station, Washington, September 25, 2015, for the proposed Friday, and are available electronically DC 20044. Submissions may be hand- rule for the sole purpose of inviting at http://www.regulations.gov. delivered Monday through Friday public comments on two consumer In addition, we are extending to between the hours of 8 a.m. and 4 p.m. studies being added to the October 13, 2015, the comment period to CC:PA:LPD:PR (REG–112997–10), administrative record. The consumer on the two consumer studies pertaining Courier’s Desk, Internal Revenue studies pertained to proposed changes to proposed changes to the Nutrition Service, 1111 Constitution Avenue NW., to the Nutrition Facts label formats. We Facts label formats, which had been Washington, DC; or sent electronically also issued a supplemental proposed scheduled to close on September 25, via the Federal eRulemaking Portal at rule (80 FR 44303) with a comment 2015, to align the comment periods for http://www.regulations.gov (IRS–REG– period through October 13, 2015. The all consumer studies. 112997–10). The public hearing will be supplemental proposal included two We will continue to take comment on held in the IRS Auditorium, Internal additional consumer studies pertaining the supplemental proposed rule, Revenue Building, 1111 Constitution to the declaration of added sugars and including taking comment on the Avenue NW., Washington, DC. alternative footnote statements. We consumer studies on added sugars and proposed text for the footnotes to be FOR FURTHER INFORMATION CONTACT: the footnote, until October 13, 2015. used on the Nutrition Facts label, after Concerning the proposed regulations, Dated: September 3, 2015. Karlene Lesho or Leslie Finlow at (202) completing our consumer research in which we tested various footnote text Leslie Kux, 317–6859; concerning the submission of options for the label, and to establish a Associate Commissioner for Policy. comments, the public hearing, or to be Daily Reference Value of 10 percent of [FR Doc. 2015–22757 Filed 9–9–15; 8:45 am] placed on the building access list to total energy intake from added sugars. BILLING CODE 4164–01–P attend the hearing, Oluwafunmilayo The supplemental proposal also would Taylor at (202) 317–6901 (not toll-free require the declaration of the percent numbers) or email at Daily Value for added sugars on the DEPARTMENT OF THE TREASURY Oluwafunmilayo.P.Taylor@ label and provide an additional irscounsel.treas.gov. rationale for the declaration of added Internal Revenue Service SUPPLEMENTARY INFORMATION: sugars on the label. We explained that we were taking these actions based, in 26 CFR Part 28 Paperwork Reduction Act part, on the science underlying a new [REG–112997–10] The collections of information report released by the 2015 Dietary contained in this notice of proposed Guidelines Advisory Committee. RIN 1545–BJ43 rulemaking have been submitted to the We have received some comments Office of Management and Budget for suggesting we are not eliciting comment Guidance Under Section 2801 Regarding the Imposition of Tax on review in accordance with the on the consumer studies in the Paperwork Reduction Act of 1995 (44 supplemental proposal published in Certain Gifts and Bequests From Covered Expatriates U.S.C. 3507(d)). Comments on the July 2015. We clarify in this notice that: collection of information should be sent (1) The consumer studies on the added AGENCY: Internal Revenue Service (IRS), to the Office of Management and sugars declaration and the alternative Treasury. Budget, Attn: Desk Officer for the footnote statements in the supplemental ACTION: Notice of proposed rulemaking Department of the Treasury, Office of proposal relate to topics on which we and notice of public hearing. Information and Regulatory Affairs, sought comment and (2) the consumer Washington, DC 20503, and to studies on the format published in a SUMMARY: This document contains Clearance Officer, SE:CAR:MP:T:T:SP, separate notice in July 2015 were proposed regulations relating to a tax on Washington, DC 20224. Comments on included for comment, and were placed United States citizens and residents the collection of information should be in the docket at that time. We are now who receive gifts or bequests from received by November 9, 2015. responding to additional requests for the certain individuals who relinquished Comments are specifically requested raw data for each of these consumer United States citizenship or ceased to be studies that are relevant to the summary concerning: lawful permanent residents of the Whether the proposed collections of memoranda for the studies, also now United States on or after June 17, 2008. available for comment. information are necessary for the proper These proposed regulations affect performance of IRS functions, including II. Updated Information taxpayers who receive covered gifts or whether the information will have We are updating the docket for the covered bequests on or after the date practical utility; rulemaking with two additional these regulations are published as final The accuracy of the estimated burden documents: A request from the Grocery regulations in the Federal Register. This associated with the proposed collections rmajette on DSK2VPTVN1PROD with PROPOSALS Manufacturers Association for the raw document also provides notice of a of information; data associated with the four consumer public hearing on these proposed How the quality, utility, and clarity of studies described in this document, and regulations. the information to be collected may be our response to that request indicating DATES: Written or electronic comments enhanced; that we will provide the raw data must be received by December 9, 2015. How the burden of complying with underlying the four consumer studies to Requests to speak and outlines of topics the proposed collections of information anyone who submits a request to to be discussed at the public hearing may be minimized, including through ConsumerStudiesBranch@fda.hhs.gov. scheduled for January 6, 2016, at 10 the application of automated collection VerDate Sep<11>2014 14:39 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\10SEP1.SGM 10SEP1


Document Created: 2015-12-15 10:04:28
Document Modified: 2015-12-15 10:04:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule; notification.
DatesWe are extending the comment period that was scheduled to close on September 25, 2015, until October 13, 2015.
ContactSerena Lo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2488, email: [email protected]
FR Citation80 FR 54446 
RIN Number0910-AF22
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