80 FR 63477 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 202 (October 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 202 (October 20, 2015)
| Page Range | 63477-63478 | |
| FR Document | 2015-26636 |
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)] [Proposed Rules] [Pages 63477-63478] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26636] ======================================================================= ----------------------------------------------------------------------- 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; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; reopening of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the reopening of the comment period for certain documents associated with 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. We also are reopening the comment period for a supplemental proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are taking this action due to technical difficulties at the Federal eRulemaking Portal. DATES: Submit either electronic or written comments on the supplemental proposed rule and related documents by October 23, 2015. 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-2012-N-1210 for this rulemaking. 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 [[Page 63478]] 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. FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: Philip.Chao@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 labeling regulations for conventional foods and dietary supplements to provide updated nutrition information. 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. We also proposed to establish a Daily Reference Value of 10 percent of total energy intake from added sugars and to require the declaration of the percent Daily Value for added sugars on the label. The supplemental proposed rule also provided additional rationale for the declaration of the amount 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. More recently, in the Federal Register of September 10, 2015 (80 FR 54446), we issued a notice clarifying: (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 also stated that, in response to requests for the raw data for each of these consumer studies that are relevant to the summary memoranda for the studies, we were making the raw data available for comment. We extended the comment period for the two consumer studies pertaining to the proposed changes to the Nutrition Facts label formats (originally scheduled to close on September 25, 2015) to October 13, 2015, to coincide with the end of the comment period for the supplemental proposed rule. However, on October 13 and 14, 2015, the Federal eRulemaking Portal, http://www.regulations.gov, experienced technical difficulties which sometimes prevented the electronic submission of comments. Therefore, we are reopening the comment period for the consumer studies and the supplemental proposal; the reopened comment period will close on October 23, 2015. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26636 Filed 10-19-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Proposed Rules 63477
necessary for the safety of the spacecraft Subpart 1214.17—[Removed and solely responsible for ensuring that your
and personnel on board, subject any of Reserved] comment does not include any
the personnel on board to such restraint confidential information that you or a
as the circumstances require until such ■ 13. Remove and reserve subpart third party may not wish to be posted,
1214.17, consisting of §§ 1214.1700 such as medical information, your or
time as delivery of such individual or
through 1214.1707. anyone else’s Social Security number, or
individuals to the proper authorities is
possible. Nanette Jennings, confidential business information, such
Federal Register Liaison Officer. as a manufacturing process. Please note
■ 10. Amend paragraphs (a), (c) and (d)
that if you include your name, contact
in § 1214.703 to read as follows: [FR Doc. 2015–26475 Filed 10–19–15; 8:45 am]
information, or other information that
BILLING CODE 7510–13–P
§ 1214.703 Chain of command. identifies you in the body of your
comments, that information will be
(a) The NASA Commander is a posted on http://www.regulations.gov.
trained NASA astronaut who has been DEPARTMENT OF HEALTH AND • If you want to submit a comment
designated to serve as commander on a HUMAN SERVICES with confidential information that you
NASA mission and who shall have the do not wish to be made available to the
Food and Drug Administration public, submit the comment as a
authority described in § 1214.702 of this
part. Under normal flight conditions written/paper submission and in the
21 CFR Part 101 manner detailed (see ‘‘Written/Paper
(other than emergencies or when
otherwise designated) the NASA [Docket No. FDA–2012–N–1210] Submissions’’ and ‘‘Instructions’’).
Commander is responsible to the RIN 0910–AF22 Written/Paper Submissions
Mission Flight Director. Submit written/paper submissions as
* * * * * Food Labeling: Revision of the follows:
(c) Before each flight, the other flight Nutrition and Supplement Facts • Mail/Hand delivery/Courier (for
crewmembers will be designated in the Labels; Reopening of the Comment written/paper submissions): Division of
Period Dockets Management (HFA–305), Food
order in which they will assume the
authority of the NASA Commander and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration,
Lane, Rm. 1061, Rockville, MD 20852.
under this subpart in the event that the HHS. • For written/paper comments
NASA Commander is not able to carry Proposed rule; reopening of
ACTION: submitted to the Division of Dockets
out his/her duties. comment period. Management, FDA will post your
(d) The determinations, if any, that a comment, as well as any attachments,
SUMMARY: The Food and Drug
crewmember in the chain of command except for information submitted,
Administration (FDA or we) is
is not able to carry out his or her marked and identified, as confidential,
announcing the reopening of the
command duties and is, therefore, to be if submitted as detailed in
comment period for certain documents
relieved of command, and that another ‘‘Instructions.’’
associated with the proposed rule to Instructions: All submissions received
crewmember in the chain of command amend FDA’s labeling regulations for
is to succeed to the authority of the must include the Docket No. FDA–
conventional foods and dietary 2012–N–1210 for this rulemaking.
NASA Commander, will be made by the supplements to provide updated
NASA Administrator or his/her Received comments will be placed in
nutrition information on the Nutrition the docket and, except for those
designee. Facts and Supplement Facts labels to submitted as ‘‘Confidential
■ 11. Revise § 1214.704 to read as assist consumers in maintaining healthy Submissions,’’ publicly viewable at
follows: dietary practices. We also are reopening http://www.regulations.gov or at the
the comment period for a supplemental Division of Dockets Management
§ 1214.704 Violations. proposed rule to revise the Nutrition between 9 a.m. and 4 p.m., Monday
(a) All personnel on board the NASA Facts and Supplement Facts labels. We through Friday.
mission are subject to the authority of are taking this action due to technical • Confidential Submissions—To
the NASA Commander and shall difficulties at the Federal eRulemaking submit a comment with confidential
Portal. information that you do not wish to be
conform to his/her orders and direction
as authorized by this subpart. DATES: Submit either electronic or made publicly available, submit your
written comments on the supplemental comments only as a written/paper
(b) This regulation is a regulation proposed rule and related documents by submission. You should submit two
within the meaning of 18 U.S.C. 799, October 23, 2015. copies total. One copy will include the
and whoever willfully violates, attempts information you claim to be confidential
ADDRESSES: You may submit comments
to violate, or conspires to violate any with a heading or cover note that states
as follows:
provision of this subpart or any order or ‘‘THIS DOCUMENT CONTAINS
direction issued under this subpart shall Electronic Submissions CONFIDENTIAL INFORMATION’’. The
be subject to fines and imprisonment, as Submit electronic comments in the Agency will review this copy, including
specified by law. following way: the claimed confidential information, in
mstockstill on DSK4VPTVN1PROD with PROPOSALS
• Federal eRulemaking Portal: http:// its consideration of comments. The
Subpart 1214.8—[Removed and www.regulations.gov. Follow the second copy, which will have the
Reserved] instructions for submitting comments. claimed confidential information
Comments submitted electronically, redacted/blacked out, will be available
■ 12. Remove and reserve subpart including attachments, to http:// for public viewing and posted on http://
1214.8, consisting §§ 1214.800 through www.regulations.gov will be posted to www.regulations.gov. Submit both
1214.813. the docket unchanged. Because your copies to the Division of Dockets
comment will be made public, you are Management. If you do not wish your
VerDate Sep<11>2014 16:59 Oct 19, 2015 Jkt 238001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\20OCP1.SGM 20OCP1](https://thefederalregister.org/doc/80_FR_63679/page/1.svg)
![63478 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Proposed Rules
name and contact information to be percent Daily Value for added sugars on committee to prepare proposed
made publicly available, you can the label. The supplemental proposed regulations for the Federal Student Aid
provide this information on the cover rule also provided additional rationale programs authorized under title IV of
sheet and not in the body of your for the declaration of the amount of the Higher Education Act of 1965, as
comments and you must identify this added sugars on the label. We explained amended (HEA). The committee will
information as ‘‘confidential.’’ Any that we were taking these actions based, include representatives of organizations
information marked as ‘‘confidential’’ in part, on the science underlying a new or groups with interests that are
will not be disclosed except in report released by the 2015 Dietary significantly affected by the topics
accordance with 21 CFR 10.20 and other Guidelines Advisory Committee. proposed for negotiations. We request
applicable disclosure law. For more More recently, in the Federal Register nominations for individual negotiators
information about FDA’s posting of of September 10, 2015 (80 FR 54446), who represent key stakeholder
comments to public dockets, see 80 FR we issued a notice clarifying: (1) The constituencies for the issues to be
56469, September 18, 2015, or access consumer studies on the added sugars negotiated to serve on the committee,
the information at: http://www.fda.gov/ declaration and the alternative footnote and we set a schedule for committee
regulatoryinformation/dockets/ statements in the supplemental proposal meetings.
default.htm. relate to topics on which we sought DATES: We must receive your
Docket: For access to the docket to comment and (2) the consumer studies nominations for negotiators to serve on
read background documents or the on the format published in a separate the committee on or before November
electronic and written/paper comments notice in July 2015 were included for 19, 2015. The dates, times, and locations
received, go to http:// comment, and were placed in the docket of the committee meetings are set out in
www.regulations.gov and insert the at that time. We also stated that, in the Schedule for Negotiations section in
docket number, found in brackets in the response to requests for the raw data for the SUPPLEMENTARY INFORMATION section.
heading of this document, into the each of these consumer studies that are
‘‘Search’’ box and follow the prompts relevant to the summary memoranda for ADDRESSES: Please send your
and/or go to the Division of Dockets the studies, we were making the raw nominations for negotiators to Wendy
Management, 5630 Fishers Lane, Rm. data available for comment. We Macias, U.S. Department of Education,
1061, Rockville, MD 20852. extended the comment period for the 1990 K Street NW., Room 8013,
FOR FURTHER INFORMATION CONTACT: two consumer studies pertaining to the Washington, DC 20006. Telephone:
Philip L. Chao, Center for Food Safety proposed changes to the Nutrition Facts (202) 502–7526 or by email:
and Applied Nutrition (HFS–24), Food label formats (originally scheduled to Wendy.Macias@ed.gov.
and Drug Administration, 5100 Paint close on September 25, 2015) to October FOR FURTHER INFORMATION CONTACT: For
Branch Pkwy., College Park, MD 20740, 13, 2015, to coincide with the end of the information about the content of this
240–402–2112, email: Philip.Chao@ comment period for the supplemental notice, including information about the
fda.hhs.gov. proposed rule. negotiated rulemaking process or the
However, on October 13 and 14, 2015, nomination submission process,
SUPPLEMENTARY INFORMATION:
the Federal eRulemaking Portal, http:// contact: Wendy Macias, U.S.
I. Background www.regulations.gov, experienced Department of Education, 1990 K Street
In the Federal Register of March 3, technical difficulties which sometimes NW., Room 8013, Washington, DC
2014 (79 FR 11879), we published a prevented the electronic submission of 20006. Telephone: (202) 502–7526 or by
proposed rule that would amend our comments. Therefore, we are reopening email: Wendy.Macias@ed.gov.
labeling regulations for conventional the comment period for the consumer For information about negotiated
foods and dietary supplements to studies and the supplemental proposal; rulemaking in general, see The
provide updated nutrition information. the reopened comment period will close Negotiated Rulemaking Process for Title
In the Federal Register of July 27, 2015 on October 23, 2015. IV Regulations, Frequently Asked
(80 FR 44302), we reopened the Dated: October 15, 2015.
Questions at www2.ed.gov/policy/
comment period through September 25, highered/reg/hearulemaking/hea08/neg-
Leslie Kux,
2015, for the proposed rule for the sole reg-faq.html.
Associate Commissioner for Policy. If you use a telecommunications
purpose of inviting public comments on [FR Doc. 2015–26636 Filed 10–19–15; 8:45 am]
two consumer studies being added to device for the deaf (TDD) or text
the administrative record. The
BILLING CODE 4164–01–P telephone (TTY), call the Federal Relay
consumer studies pertained to proposed Service (FRS) toll free at 1–800–877–
changes to the Nutrition Facts label 8339.
DEPARTMENT OF EDUCATION
formats. We also issued a supplemental SUPPLEMENTARY INFORMATION: On August
proposed rule (80 FR 44303) with a 34 CFR Chapter VI 20, 2015, we published a notice in the
comment period through October 13, Federal Register (80 FR 50588)
2015. The supplemental proposal [Docket ID ED–2015–OPE–0103] announcing our intent to establish a
included two additional consumer negotiated rulemaking committee under
studies pertaining to the declaration of Negotiated Rulemaking Committee; section 492 of the HEA to develop
added sugars and alternative footnote Negotiator Nominations and Schedule proposed regulations for determining
statements. We proposed text for the of Committee Meetings—Borrower which acts or omissions of an
mstockstill on DSK4VPTVN1PROD with PROPOSALS
footnotes to be used on the Nutrition Defenses institution of higher education
Facts label, after completing our AGENCY: Office of Postsecondary (‘‘institution’’) a borrower may assert as
consumer research in which we tested Education, Department of Education. a defense to repayment of a loan made
various footnote text options for the ACTION: Intent to establish negotiated under the William D. Ford Federal
label. We also proposed to establish a rulemaking committee. Direct Loan (Federal Direct Loan)
Daily Reference Value of 10 percent of Program (‘‘borrower defenses’’) and the
total energy intake from added sugars SUMMARY: We announce our intention to consequences of such borrower defenses
and to require the declaration of the establish a negotiated rulemaking for borrowers, institutions, and the
VerDate Sep<11>2014 16:59 Oct 19, 2015 Jkt 238001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\20OCP1.SGM 20OCP1](https://thefederalregister.org/doc/80_FR_63679/page/2.svg)
Document Created: 2015-12-14 15:24:55
Document Modified: 2015-12-14 15:24:55
| 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 | Proposed Rules | |
| Action | Proposed rule; reopening of comment period. | |
| Dates | Submit either electronic or written comments on the supplemental proposed rule and related documents by October 23, 2015. | |
| Contact | Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: [email protected] | |
| FR Citation | 80 FR 63477 | |
| RIN Number | 0910-AF22 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR