82_FR_12223 82 FR 12184 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Reopening of Comment Period

82 FR 12184 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Reopening of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

Page Range12184-12185
FR Document2017-03929

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled ``Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry'' that appeared in the Federal Register of December 14, 2016. The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations. We are taking this action in response to requests to allow interested persons additional time to submit comments.

Federal Register, Volume 82 Issue 39 (Wednesday, March 1, 2017)
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Proposed Rules]
[Pages 12184-12185]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-D-4120]


Fruit Juice and Vegetable Juice as Color Additives in Food; Draft 
Guidance for Industry; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the notice entitled ``Fruit Juice and Vegetable 
Juice as Color Additives in Food; Draft Guidance for Industry'' that 
appeared in the Federal Register of December 14, 2016. The draft 
guidance, when finalized, will help manufacturers determine whether a 
color additive derived from a plant material meets the specifications 
under certain FDA color additive regulations. We are taking this action 
in response to requests to allow interested persons additional time to 
submit comments.

DATES: FDA is reopening the comment period for the proposed rule 
published December 14, 2016 (81 FR 90267). Submit either electronic or 
written comments by May 1, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 12185]]

     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-4120 for ``Fruit Juice and Vegetable Juice as Color 
Additives in Food; Draft Guidance for Industry.'' 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 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: 
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: Laura A. Dye, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1275.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 14, 2016 
(81 FR 90267), we published a notice of availability of a draft 
guidance for industry entitled ``Fruit Juice and Vegetable Juice as 
Color Additives in Food.'' The draft guidance, when finalized, will 
help manufacturers determine whether a color additive derived from a 
plant material meets the specifications for fruit juice under Sec.  
73.250 (21 CFR 73.250) or vegetable juice under Sec.  73.260 (21 CFR 
73.260). Although you can comment on any guidance at any time, to 
ensure that we consider comments on this draft guidance before we begin 
work on the final version, interested persons were originally given 
until February 13, 2017, to comment on the draft guidance.
    We have received requests to extend the comment period for the 
draft guidance. The requests conveyed concern that the original 60-day 
comment period would not allow sufficient time to develop a meaningful 
or thoughtful response to various issues presented in the draft 
guidance and to our interpretation of our regulations. We have 
considered the requests but were unable to issue a document extending 
the comment period for the draft guidance before February 13, 2017. 
Consequently, we are reopening the comment period for an additional 60 
days. Interested parties have until May 1, 2017. We believe that this 
action allows adequate time for interested persons to submit comments 
on the draft guidance without significantly delaying finalizing the 
guidance.

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03929 Filed 2-28-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                    12184

                                                    Proposed Rules                                                                                                Federal Register
                                                                                                                                                                  Vol. 82, No. 39

                                                                                                                                                                  Wednesday, March 1, 2017



                                                    This section of the FEDERAL REGISTER                    maximum extent practicable, to                        reasons cited above, FNS finds that
                                                    contains notices to the public of the proposed          establish cooperative agreements with                 notice and solicitation of comment
                                                    issuance of rules and regulations. The                  gaming entities in the State to identify              regarding the brief extension of the
                                                    purpose of these notices is to give interested          SNAP recipients with substantial                      comment period is impracticable,
                                                    persons an opportunity to participate in the            winnings. Section 4015 requires all                   unnecessary, or contrary to the public
                                                    rule making prior to the adoption of the final
                                                    rules.
                                                                                                            State agencies to have a system in place              interest pursuant to 5 U.S.C. 553(b)(B).
                                                                                                            to verify income, eligibility and                     FNS believes that affected parties need
                                                                                                            immigration status.                                   to be informed as soon as possible of the
                                                    DEPARTMENT OF AGRICULTURE                               DATES: The comment period for the                     extensions and their length.
                                                                                                            proposed rule published December 1,                     Dated: February 16, 2017.
                                                    Food and Nutrition Service                              2016 (81 FR 86614) is re-opened until                 Jessica Shahin,
                                                                                                            March 31, 2017. Written comments                      Acting Administrator, Food and Nutrition
                                                    7 CFR Parts 271, 272 and 273                            must be received on or before March 31,               Service.
                                                    [FNS 2015–0038]                                         2017, to be assured of consideration.                 [FR Doc. 2017–03713 Filed 2–28–17; 8:45 am]
                                                                                                            ADDRESSES: The Food and Nutrition                     BILLING CODE 3410–30–P
                                                    RIN 0584–AE41
                                                                                                            Service, USDA, invites interested
                                                    Supplemental Nutrition Assistance                       persons to submit written comments on
                                                    Program: Student Eligibility, Convicted                 this proposed rule. Comments may be                   DEPARTMENT OF HEALTH AND
                                                    Felons, Lottery and Gambling, and                       submitted in writing by one of the                    HUMAN SERVICES
                                                    State Verification Provisions of the                    following methods:
                                                    Agricultural Act of 2014; Extension of                     • Preferred Method: Federal                        Food and Drug Administration
                                                    Comment Period                                          eRulemaking Portal: Go to http://
                                                                                                            www.regulations.gov. Follow the online                21 CFR Part 73
                                                    AGENCY:  Food and Nutrition Service                     instructions for submitting comments.
                                                                                                                                                                  [Docket No. FDA–2016–D–4120]
                                                    (FNS), USDA.                                               • Fax: Submit comments by facsimile
                                                    ACTION: Proposed rule. Extension of                     transmission to: Sasha Gersten-Paal,                  Fruit Juice and Vegetable Juice as
                                                    comment period.                                         Certification Policy Branch, Fax number               Color Additives in Food; Draft
                                                                                                            703–305–2486.                                         Guidance for Industry; Reopening of
                                                    SUMMARY:    The Department of                              • Mail: Send comments to Sasha
                                                    Agriculture’s Food and Nutrition                                                                              Comment Period
                                                                                                            Gersten-Paal, Branch Chief, Certification
                                                    Service (FNS) is re-opening the                         Policy Branch, Program Development                    AGENCY:    Food and Drug Administration,
                                                    comment period for the proposed rule                    Division, FNS, 3101 Park Center Drive,                HHS.
                                                    published December 1, 2016. The                         Alexandria, Virginia 22302, 703–305–                        Notification; reopening of
                                                                                                                                                                  ACTION:
                                                    proposed action would implement four                    2507.                                                 comment period.
                                                    sections of the Agricultural Act of 2014                   All written comments submitted in
                                                    (2014 Farm Bill), affecting eligibility,                                                                      SUMMARY:   The Food and Drug
                                                                                                            response to this proposed rule will be
                                                    benefits, and program administration                                                                          Administration (FDA or we) is
                                                                                                            included in the record and made
                                                    requirements for the Supplemental                                                                             reopening the comment period for the
                                                                                                            available to the public. Please be
                                                    Nutrition Assistance Program (SNAP).                                                                          notice entitled ‘‘Fruit Juice and
                                                                                                            advised that the substance of comments
                                                    Section 4007 clarifies that participants                                                                      Vegetable Juice as Color Additives in
                                                                                                            and the identity of individuals or
                                                    in a SNAP Employment & Training                                                                               Food; Draft Guidance for Industry’’ that
                                                                                                            entities submitting the comments will
                                                    (E&T) program are eligible for benefits if                                                                    appeared in the Federal Register of
                                                                                                            be subject to public disclosure. FNS will
                                                    they are enrolled or participate in                                                                           December 14, 2016. The draft guidance,
                                                                                                            make written comments publicly
                                                    specific programs that will assist SNAP                                                                       when finalized, will help manufacturers
                                                                                                            available online at http://
                                                    recipients in obtaining the skills needed                                                                     determine whether a color additive
                                                                                                            www.regulations.gov.
                                                    for the current job market. Section 4008                                                                      derived from a plant material meets the
                                                    prohibits anyone convicted of Federal                   FOR FURTHER INFORMATION CONTACT:                      specifications under certain FDA color
                                                    aggravated sexual abuse, murder, sexual                 Sasha Gersten-Paal, Branch Chief,                     additive regulations. We are taking this
                                                    exploitation and abuse of children,                     Certification Policy Branch, Program                  action in response to requests to allow
                                                    sexual assault, or similar State laws, and              Development Division, Food and                        interested persons additional time to
                                                    who are also not in compliance with the                 Nutrition Service, 3101 Park Center                   submit comments.
                                                    terms of their sentence or parole or are                Drive, Alexandria, Virginia 22302, 703–               DATES: FDA is reopening the comment
                                                    a fleeing felon, from receiving SNAP                    305–2507.                                             period for the proposed rule published
                                                    benefits. Section 4009 prohibits                        SUPPLEMENTARY INFORMATION: FNS is re-                 December 14, 2016 (81 FR 90267).
jstallworth on DSK7TPTVN1PROD with PROPOSALS




                                                    households containing a member with                     opening the comment period for 30 days                Submit either electronic or written
                                                    substantial lottery and gambling                        as noted under the DATES section to                   comments by May 1, 2017.
                                                    winnings from receiving SNAP benefits,                  ensure that the public has sufficient                 ADDRESSES: You may submit comments
                                                    until the household meets the allowable                 time to review and comment on the                     as follows:
                                                    financial resources and income                          proposed rule. To the extent that 5
                                                    eligibility requirements of the program.                U.S.C. 553(b)(A) applies to this action,              Electronic Submissions
                                                    Section 4009 also provides that State                   it is exempt from notice and comment                    Submit electronic comments in the
                                                    SNAP agencies are required, to the                      rulemaking for good cause and for                     following way:


                                               VerDate Sep<11>2014   14:30 Feb 28, 2017   Jkt 241001   PO 00000   Frm 00001   Fmt 4702   Sfmt 4702   E:\FR\FM\01MRP1.SGM   01MRP1


                                                                           Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Proposed Rules                                                 12185

                                                      • Federal eRulemaking Portal:                         will review this copy, including the                  sufficient time to develop a meaningful
                                                    https://www.regulations.gov. Follow the                 claimed confidential information, in its              or thoughtful response to various issues
                                                    instructions for submitting comments.                   consideration of comments. The second                 presented in the draft guidance and to
                                                    Comments submitted electronically,                      copy, which will have the claimed                     our interpretation of our regulations. We
                                                    including attachments, to https://                      confidential information redacted/                    have considered the requests but were
                                                    www.regulations.gov will be posted to                   blacked out, will be available for public             unable to issue a document extending
                                                    the docket unchanged. Because your                      viewing and posted on https://                        the comment period for the draft
                                                    comment will be made public, you are                    www.regulations.gov. Submit both                      guidance before February 13, 2017.
                                                    solely responsible for ensuring that your               copies to the Division of Dockets                     Consequently, we are reopening the
                                                    comment does not include any                            Management. If you do not wish your                   comment period for an additional 60
                                                    confidential information that you or a                  name and contact information to be                    days. Interested parties have until May
                                                    third party may not wish to be posted,                  made publicly available, you can                      1, 2017. We believe that this action
                                                    such as medical information, your or                    provide this information on the cover                 allows adequate time for interested
                                                    anyone else’s Social Security number, or                sheet and not in the body of your                     persons to submit comments on the
                                                    confidential business information, such                 comments and you must identify this                   draft guidance without significantly
                                                    as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                  delaying finalizing the guidance.
                                                    that if you include your name, contact                  information marked as ‘‘confidential’’                  Dated: February 23, 2017.
                                                    information, or other information that                  will not be disclosed except in                       Leslie Kux,
                                                    identifies you in the body of your                      accordance with 21 CFR 10.20 and other
                                                    comments, that information will be                                                                            Associate Commissioner for Policy.
                                                                                                            applicable disclosure law. For more
                                                    posted on https://www.regulations.gov.                                                                        [FR Doc. 2017–03929 Filed 2–28–17; 8:45 am]
                                                                                                            information about FDA’s posting of
                                                      • If you want to submit a comment                     comments to public dockets, see 80 FR                 BILLING CODE 4164–01–P
                                                    with confidential information that you                  56469, September 18, 2015, or access
                                                    do not wish to be made available to the                 the information at: http://www.fda.gov/
                                                    public, submit the comment as a                         regulatoryinformation/dockets/                        DEPARTMENT OF HOMELAND
                                                    written/paper submission and in the                     default.htm.                                          SECURITY
                                                    manner detailed (see ‘‘Written/Paper                       Docket: For access to the docket to
                                                    Submissions’’ and ‘‘Instructions’’).                    read background documents or the                      Coast Guard
                                                    Written/Paper Submissions                               electronic and written/paper comments
                                                                                                            received, go to https://                              33 CFR Part 117
                                                       Submit written/paper submissions as                  www.regulations.gov and insert the                    [Docket No. USCG–2016–1006]
                                                    follows:                                                docket number, found in brackets in the
                                                       • Mail/Hand delivery/Courier (for                                                                          RIN 1625–AA09
                                                                                                            heading of this document, into the
                                                    written/paper submissions): Division of
                                                                                                            ‘‘Search’’ box and follow the prompts                 Drawbridge Operation Regulation;
                                                    Dockets Management (HFA–305), Food
                                                                                                            and/or go to the Division of Dockets                  Connecticut River, East Haddam, CT
                                                    and Drug Administration, 5630 Fishers
                                                                                                            Management, 5630 Fishers Lane, Rm.
                                                    Lane, Rm. 1061, Rockville, MD 20852.                                                                          AGENCY:   Coast Guard, DHS.
                                                       • For written/paper comments                         1061, Rockville, MD 20852.
                                                    submitted to the Division of Dockets                    FOR FURTHER INFORMATION CONTACT:                      ACTION:   Notice of proposed rulemaking.
                                                    Management, FDA will post your                          Laura A. Dye, Center for Food Safety
                                                                                                            and Applied Nutrition (HFS–265), Food                 SUMMARY:   The Coast Guard proposes to
                                                    comment, as well as any attachments,                                                                          modify the operating schedule that
                                                    except for information submitted,                       and Drug Administration, 5001 Campus
                                                                                                            Dr., College Park, MD 20740, 240–402–                 governs the Route 82 Bridge (East
                                                    marked and identified, as confidential,                                                                       Haddam Swing Bridge) across the
                                                    if submitted as detailed in                             1275.
                                                                                                                                                                  Connecticut River, mile 16.8, at East
                                                    ‘‘Instructions.’’                                       SUPPLEMENTARY INFORMATION: In the
                                                                                                                                                                  Haddam, Connecticut. The bridge owner
                                                       Instructions: All submissions received               Federal Register of December 14, 2016
                                                                                                                                                                  submitted a request to reduce scheduled
                                                    must include the Docket No. FDA–                        (81 FR 90267), we published a notice of
                                                                                                                                                                  openings of the span for recreational
                                                    2016–D–4120 for ‘‘Fruit Juice and                       availability of a draft guidance for
                                                                                                                                                                  vessels in the boating season and to
                                                    Vegetable Juice as Color Additives in                   industry entitled ‘‘Fruit Juice and
                                                                                                                                                                  allow the bridge owner to require six
                                                    Food; Draft Guidance for Industry.’’                    Vegetable Juice as Color Additives in
                                                                                                                                                                  hours notice for bridge openings at night
                                                    Received comments will be placed in                     Food.’’ The draft guidance, when
                                                                                                                                                                  in the winter season. It is expected this
                                                    the docket and, except for those                        finalized, will help manufacturers
                                                                                                                                                                  change to the regulations will better
                                                    submitted as ‘‘Confidential                             determine whether a color additive
                                                                                                                                                                  serve the needs of the community while
                                                    Submissions,’’ publicly viewable at                     derived from a plant material meets the
                                                                                                                                                                  continuing to meet the reasonable needs
                                                    https://www.regulations.gov or at the                   specifications for fruit juice under
                                                                                                                                                                  of navigation.
                                                    Division of Dockets Management                          § 73.250 (21 CFR 73.250) or vegetable
                                                    between 9 a.m. and 4 p.m., Monday                       juice under § 73.260 (21 CFR 73.260).                 DATES: Comments and related material
                                                    through Friday.                                         Although you can comment on any                       must reach the Coast Guard on or before
                                                       • Confidential Submissions—To                        guidance at any time, to ensure that we               May 1, 2017.
                                                    submit a comment with confidential                      consider comments on this draft                       ADDRESSES: You may submit comments
                                                    information that you do not wish to be                  guidance before we begin work on the                  identified by docket number USCG–
jstallworth on DSK7TPTVN1PROD with PROPOSALS




                                                    made publicly available, submit your                    final version, interested persons were                2016–1006 using the Federal
                                                    comments only as a written/paper                        originally given until February 13, 2017,             eRulemaking Portal at http://
                                                    submission. You should submit two                       to comment on the draft guidance.                     www.regulations.gov.
                                                    copies total. One copy will include the                    We have received requests to extend                   See the ‘‘Public Participation and
                                                    information you claim to be confidential                the comment period for the draft                      Request for Comments’’ portion of the
                                                    with a heading or cover note that states                guidance. The requests conveyed                       SUPPLEMENTARY INFORMMATION section
                                                    ‘‘THIS DOCUMENT CONTAINS                                concern that the original 60-day                      below for instructions on submitting
                                                    CONFIDENTIAL INFORMATION.’’ We                          comment period would not allow                        comments.


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Document Created: 2017-03-01 03:39:01
Document Modified: 2017-03-01 03:39:01
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; reopening of comment period.
DatesFDA is reopening the comment period for the proposed rule published December 14, 2016 (81 FR 90267). Submit either electronic or written comments by May 1, 2017.
ContactLaura A. Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1275.
FR Citation82 FR 12184 

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