81_FR_96655 81 FR 96404 - Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period

81 FR 96404 - Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 251 (December 30, 2016)

Page Range96404-96405
FR Document2016-31734

The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term ``healthy'' in the labeling of human food products. We established the docket through a notice that appeared in the Federal Register of September 28, 2016. In the notice, we requested comments on the term ``healthy'', generally, and as a nutrient content claim in the context of food labeling; we also requested comments on specific questions contained in the notice. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 81 Issue 251 (Friday, December 30, 2016) 
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96404-96405]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]


Use of the Term ``Healthy'' in the Labeling of Human Food 
Products; Request for Information and Comments; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a docket to receive information and comments on the 
use of the term ``healthy'' in the labeling of human food products. We 
established the docket through a notice that appeared in the Federal 
Register of September 28, 2016. In the notice, we requested comments on 
the term ``healthy'', generally, and as a nutrient content claim in the 
context of food labeling; we also requested comments on specific 
questions contained in the notice. We are taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the notice that published 
in the Federal Register of September 28, 2016 (81 FR 66562). Submit 
either electronic or written comments by April 26, 2017.

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-D-2335 for ``Use of the Term 'Healthy' in the Labeling of 
Human Food Products; Request for Information and Comments.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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

[[Page 96405]]

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 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.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 
2016, we published a notice announcing the establishment of a docket to 
receive information and comments on the use of the term ``healthy'' in 
the labeling of human food products. The notice discussed FDA's 
position regarding the use of the term ``healthy'', the events that 
prompted us to establish a docket to request information and comments 
on this issue, and specific issues for consideration. We provided a 
120-day comment period that was scheduled to end on January 26, 2017.
    We have received requests to extend the comment period. The 
requests conveyed concern that the current 120-day comment period does 
not allow sufficient time to develop meaningful or thoughtful comments 
to the questions and issues we presented in the notice.
    We have considered the requests and are extending the comment 
period for 90 days, until April 26, 2017. We believe that a 90-day 
extension allows adequate time for interested persons to submit 
comments.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31734 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P

96404 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules Short name/acronym Commenter EPSA/P3 .................................................... Electric Power Supply Association and PJM Power Providers. EPSA/WPTF .............................................. Electric Power Supply Association and Western Power Trading Forum. Entergy ....................................................... Entergy Services, Inc. commented on behalf of the Entergy Operating Companies (Entergy Arkan- sas, Inc.; Entergy Louisiana, LLC; Entergy Mississippi, Inc.; Entergy New Orleans, Inc.; and Entergy Texas, Inc.). Exelon ........................................................ Exelon Corporation. Golden Spread Electric .............................. Golden Spread Electric Cooperative, Inc. IMG Midstream/Tangibl ............................. IMG Midstream LLC and Tangibl LLC. ISO–NE ...................................................... ISO New England Inc. LIPA ........................................................... Long Island Power Authority and Long Island Lighting Company d/b/a Power Supply Long Island. MISO .......................................................... Midcontinent Independent System Operator, Inc. PJM Market Monitor .................................. Monitoring Analytics, LLC. NYISO ........................................................ New York Independent System Operator, Inc. PJM ............................................................ PJM Interconnection, L.L.C. PSEG Companies ...................................... PSEG Companies (Public Service Electric and Gas Company; PSEG Power LLC; and PSEG En- ergy Resources & Trade LLC). SPP ............................................................ Southwest Power Pool, Inc. Westar ........................................................ Westar Energy, Inc. [FR Doc. 2016–30971 Filed 12–29–16; 8:45 am] ADDRESSES: You may submit comments marked and identified, as confidential, BILLING CODE 6717–01–P as follows: if submitted as detailed in ‘‘Instructions.’’ Electronic Submissions Instructions: All submissions received Submit electronic comments in the must include the Docket No. FDA– DEPARTMENT OF HEALTH AND following way: 2016–D–2335 for ‘‘Use of the Term HUMAN SERVICES • Federal eRulemaking Portal: ’Healthy’ in the Labeling of Human https://www.regulations.gov. Follow the Food Products; Request for Information Food and Drug Administration instructions for submitting comments. and Comments.’’ Received comments Comments submitted electronically, will be placed in the docket and, except 21 CFR Part 101 including attachments, to https:// for those submitted as ‘‘Confidential [Docket No. FDA–2016–D–2335] www.regulations.gov will be posted to Submissions,’’ publicly viewable at the docket unchanged. Because your https://www.regulations.gov or at the Use of the Term ‘‘Healthy’’ in the comment will be made public, you are Division of Dockets Management Labeling of Human Food Products; solely responsible for ensuring that your between 9 a.m. and 4 p.m., Monday Request for Information and comment does not include any through Friday. Comments; Extension of Comment confidential information that you or a • Confidential Submissions—To Period third party may not wish to be posted, submit a comment with confidential such as medical information, your or information that you do not wish to be AGENCY: Food and Drug Administration, anyone else’s Social Security number, or made publicly available, submit your HHS. confidential business information, such comments only as a written/paper Notification; extension of ACTION: as a manufacturing process. Please note submission. You should submit two comment period. that if you include your name, contact copies total. One copy will include the information, or other information that information you claim to be confidential SUMMARY: The Food and Drug identifies you in the body of your with a heading or cover note that states Administration (FDA or we) is comments, that information will be ‘‘THIS DOCUMENT CONTAINS extending the comment period for a posted on https://www.regulations.gov. CONFIDENTIAL INFORMATION.’’ We docket to receive information and • If you want to submit a comment will review this copy, including the comments on the use of the term with confidential information that you claimed confidential information, in our ‘‘healthy’’ in the labeling of human food do not wish to be made available to the consideration of comments. The second products. We established the docket public, submit the comment as a copy, which will have the claimed through a notice that appeared in the written/paper submission and in the confidential information redacted/ Federal Register of September 28, 2016. manner detailed (see ‘‘Written/Paper blacked out, will be available for public In the notice, we requested comments Submissions’’ and ‘‘Instructions’’). viewing and posted on https:// on the term ‘‘healthy’’, generally, and as www.regulations.gov. Submit both a nutrient content claim in the context Written/Paper Submissions copies to the Division of Dockets of food labeling; we also requested Submit written/paper submissions as Management. If you do not wish your comments on specific questions follows: name and contact information to be contained in the notice. We are taking • Mail/Hand delivery/Courier (for made publicly available, you can this action in response to requests for an written/paper submissions): Division of provide this information on the cover srobinson on DSK5SPTVN1PROD with PROPOSALS extension to allow interested persons Dockets Management (HFA–305), Food sheet and not in the body of your additional time to submit comments. and Drug Administration, 5630 Fishers comments and you must identify this DATES: FDA is extending the comment Lane, Rm. 1061, Rockville, MD 20852. information as ‘‘confidential.’’ Any period on the notice that published in • For written/paper comments information marked as ‘‘confidential’’ the Federal Register of September 28, submitted to the Division of Dockets will not be disclosed except in 2016 (81 FR 66562). Submit either Management, FDA will post your accordance with 21 CFR 10.20 and other electronic or written comments by April comment, as well as any attachments, applicable disclosure law. For more 26, 2017. except for information submitted, information about FDA’s posting of VerDate Sep<11>2014 17:43 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\30DEP1.SGM 30DEP1

Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules 96405 comments to public dockets, see 80 FR DEPARTMENT OF HEALTH AND do not wish to be made available to the 56469, September 18, 2015, or access HUMAN SERVICES public, submit the comment as a the information at: http://www.fda.gov/ written/paper submission and in the regulatoryinformation/dockets/ Food and Drug Administration manner detailed (see ‘‘Written/Paper default.htm. Submissions’’ and ‘‘Instructions’’). 21 CFR Part 573 Docket: For access to the docket to Written/Paper Submissions read background documents or the [Docket No. FDA–2016–F–3880] Submit written/paper submissions as electronic and written/paper comments follows: Novus International, Inc.; Filing of received, go to https:// Food Additive Petition (Animal Use); • Mail/Hand delivery/Courier (for www.regulations.gov and insert the Reopening of the Comment Period written/paper submissions): Division of docket number, found in brackets in the Dockets Management (HFA–305), Food heading of this document, into the AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts HHS. Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets ACTION:Notice of petition; reopening of • For written/paper comments Management, 5630 Fishers Lane, Rm. the comment period. submitted to the Division of Dockets 1061, Rockville, MD 20852. Management, FDA will post your SUMMARY: The Food and Drug comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: Administration (FDA) is reopening the except for information submitted, Vincent de Jesus, Center for Food Safety comment period for the notice of marked and identified, as confidential, and Applied Nutrition (HFS–830), Food petition, published in the Federal if submitted as detailed in and Drug Administration, 5001 Campus Register of November 8, 2016 (81 FR ‘‘Instructions.’’ Dr., College Park, MD 20740, 240–402– 78528), proposing that the food additive Instructions: All submissions received 1450. regulations be amended to provide for must include the Docket No. FDA– the safe use of poly (2-vinylpyridine-co- 2016–F–3880 for ‘‘Food Additives SUPPLEMENTARY INFORMATION: In the styrene) as a nutrient protectant for Permitted in Feed and Drinking Water Federal Register of September 28, 2016, methionine hydroxy analog in animal of Animals; 2-Vinylpyridine-Co- we published a notice announcing the food for beef cattle, dairy cattle, and Styrene.’’ Received comments will be establishment of a docket to receive replacement dairy heifers. Additionally, placed in the docket and, except for information and comments on the use of the petition proposes that the food those submitted as ‘‘Confidential the term ‘‘healthy’’ in the labeling of additive regulations be amended to Submissions,’’ publicly viewable at human food products. The notice provide for the safe use of ethyl http://www.regulations.gov or at the discussed FDA’s position regarding the cellulose as a binder for methionine Division of Dockets Management use of the term ‘‘healthy’’, the events hydroxy analog to be incorporated into between 9 a.m. and 4 p.m., Monday that prompted us to establish a docket animal food. FDA is reopening the through Friday. to request information and comments on comment period to allow additional • Confidential Submissions—To this issue, and specific issues for time for comments on environmental submit a comment with confidential impacts. information that you do not wish to be consideration. We provided a 120-day comment period that was scheduled to DATES: Submit either electronic or made publicly available, submit your written comments by January 30, 2017. comments only as a written/paper end on January 26, 2017. ADDRESSES: You may submit comments submission. You should submit two We have received requests to extend copies total. One copy will include the as follows: the comment period. The requests information you claim to be confidential conveyed concern that the current 120- Electronic Submissions with a heading or cover note that states day comment period does not allow Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS sufficient time to develop meaningful or following way: CONFIDENTIAL INFORMATION.’’ The thoughtful comments to the questions • Federal eRulemaking Portal: http:// Agency will review this copy, including and issues we presented in the notice. www.regulations.gov. Follow the the claimed confidential information, in We have considered the requests and instructions for submitting comments. its consideration of comments. The are extending the comment period for Comments submitted electronically, second copy, which will have the including attachments, to http:// claimed confidential information 90 days, until April 26, 2017. We www.regulations.gov will be posted to redacted/blacked out, will be available believe that a 90-day extension allows the docket unchanged. Because your for public viewing and posted on http:// adequate time for interested persons to comment will be made public, you are www.regulations.gov. Submit both submit comments. copies to the Division of Dockets solely responsible for ensuring that your Dated: December 27, 2016. comment does not include any Management. If you do not wish your Leslie Kux, confidential information that you or a name and contact information to be Associate Commissioner for Policy. third party may not wish to be posted, made publicly available, you can [FR Doc. 2016–31734 Filed 12–29–16; 8:45 am] such as medical information, your or provide this information on the cover anyone else’s Social Security number, or sheet and not in the body of your BILLING CODE 4164–01–P confidential business information, such comments and you must identify this srobinson on DSK5SPTVN1PROD with PROPOSALS as a manufacturing process. Please note information as ‘‘confidential.’’ Any that if you include your name, contact information marked as ‘‘confidential’’ information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access VerDate Sep<11>2014 17:43 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\30DEP1.SGM 30DEP1


Document Created: 2016-12-30 05:16:10
Document Modified: 2016-12-30 05:16:10
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
ActionNotification; extension of comment period.
DatesFDA is extending the comment period on the notice that published in the Federal Register of September 28, 2016 (81 FR 66562). Submit either electronic or written comments by April 26, 2017.
ContactVincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation81 FR 96404 
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