82_FR_61166 82 FR 60920 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period

82 FR 60920 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 246 (December 26, 2017)

Page Range60920-60921
FR Document2017-27785

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 22, 2017, proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed. FDA is reopening the comment period to allow additional time for comments on environmental impacts.

Federal Register, Volume 82 Issue 246 (Tuesday, December 26, 2017)
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Proposed Rules]
[Pages 60920-60921]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27785]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / 
Proposed Rules

[[Page 60920]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-4399]


Zinpro Corp.; Filing of Food Additive Petition (Animal Use); 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking; reopening of the comment 
period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice of petition that appeared 
in the Federal Register of September 22, 2017, proposing that the food 
additive regulations be amended to provide for the safe use of chromium 
DL-methionine as a nutritional source of chromium in cattle feed. FDA 
is reopening the comment period to allow additional time for comments 
on environmental impacts.

DATES: FDA is reopening the comment period on the notice of petition 
published September 22, 2017 (82 FR 44367). Submit either electronic or 
written comments by January 25, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 25, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-F-4399 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Chromium DL-Methionine.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carissa Doody, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6283, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 22, 
2017 (82 FR 44367), FDA gave notice that Zinpro Corp. had filed a 
petition to amend Title 21 of the Code of Federal Regulations in part 
573 Food Additives Permitted in Feed and Drinking Water of Animals (21 
CFR part 573) to provide for the safe use of chromium DL-

[[Page 60921]]

methionine as a nutritional source of chromium in cattle feed.
    Interested persons were originally given until October 23, 2017, to 
comment on the petitioner's environmental assessment. The environmental 
assessment was not placed on public display until October 13, 2017. On 
our own initiative, we are reopening the comment period to allow 
potential respondents to thoroughly evaluate and address pertinent 
environmental issues. The Agency believes that a 30-day extension 
allows adequate time for interested persons to submit comments without 
significantly delaying rulemaking on this important issue.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27785 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P



                                                 60920

                                                 Proposed Rules                                                                                                Federal Register
                                                                                                                                                               Vol. 82, No. 246

                                                                                                                                                               Tuesday, December 26, 2017



                                                 This section of the FEDERAL REGISTER                    Electronic Submissions                                   • Confidential Submissions—To
                                                 contains notices to the public of the proposed                                                                submit a comment with confidential
                                                 issuance of rules and regulations. The                    Submit electronic comments in the
                                                                                                                                                               information that you do not wish to be
                                                 purpose of these notices is to give interested          following way:
                                                                                                                                                               made publicly available, submit your
                                                 persons an opportunity to participate in the              • Federal eRulemaking Portal:                       comments only as a written/paper
                                                 rule making prior to the adoption of the final          https://www.regulations.gov. Follow the               submission. You should submit two
                                                 rules.                                                  instructions for submitting comments.                 copies total. One copy will include the
                                                                                                         Comments submitted electronically,                    information you claim to be confidential
                                                                                                         including attachments, to https://                    with a heading or cover note that states
                                                 DEPARTMENT OF HEALTH AND                                www.regulations.gov will be posted to
                                                 HUMAN SERVICES                                                                                                ‘‘THIS DOCUMENT CONTAINS
                                                                                                         the docket unchanged. Because your                    CONFIDENTIAL INFORMATION.’’ The
                                                                                                         comment will be made public, you are                  Agency will review this copy, including
                                                 Food and Drug Administration
                                                                                                         solely responsible for ensuring that your             the claimed confidential information, in
                                                                                                         comment does not include any                          its consideration of comments. The
                                                 21 CFR Part 573                                         confidential information that you or a                second copy, which will have the
                                                                                                         third party may not wish to be posted,                claimed confidential information
                                                 [Docket No. FDA–2017–F–4399]                            such as medical information, your or                  redacted/blacked out, will be available
                                                                                                         anyone else’s Social Security number, or              for public viewing and posted on
                                                 Zinpro Corp.; Filing of Food Additive                   confidential business information, such               https://www.regulations.gov. Submit
                                                 Petition (Animal Use); Reopening of                     as a manufacturing process. Please note               both copies to the Dockets Management
                                                 the Comment Period                                      that if you include your name, contact                Staff. If you do not wish your name and
                                                                                                         information, or other information that                contact information to be made publicly
                                                 AGENCY:    Food and Drug Administration,                identifies you in the body of your
                                                 HHS.                                                                                                          available, you can provide this
                                                                                                         comments, that information will be                    information on the cover sheet and not
                                                 ACTION: Notification; petition for                      posted on https://www.regulations.gov.                in the body of your comments and you
                                                 rulemaking; reopening of the comment                      • If you want to submit a comment                   must identify this information as
                                                 period.                                                 with confidential information that you                ‘‘confidential.’’ Any information marked
                                                                                                         do not wish to be made available to the               as ‘‘confidential’’ will not be disclosed
                                                 SUMMARY:   The Food and Drug                            public, submit the comment as a                       except in accordance with 21 CFR 10.20
                                                 Administration (FDA or the Agency) is                   written/paper submission and in the                   and other applicable disclosure law. For
                                                 reopening the comment period for the                    manner detailed (see ‘‘Written/Paper                  more information about FDA’s posting
                                                 notice of petition that appeared in the                 Submissions’’ and ‘‘Instructions’’).                  of comments to public dockets, see 80
                                                 Federal Register of September 22, 2017,                 Written/Paper Submissions                             FR 56469, September 18, 2015, or access
                                                 proposing that the food additive                                                                              the information at: https://www.gpo.gov/
                                                 regulations be amended to provide for                     Submit written/paper submissions as                 fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                 the safe use of chromium DL-                            follows:                                              23389.pdf.
                                                 methionine as a nutritional source of                     • Mail/Hand delivery/Courier (for                      Docket: For access to the docket to
                                                 chromium in cattle feed. FDA is                         written/paper submissions): Dockets                   read background documents or the
                                                 reopening the comment period to allow                   Management Staff (HFA–305), Food and                  electronic and written/paper comments
                                                 additional time for comments on                         Drug Administration, 5630 Fishers                     received, go to https://
                                                 environmental impacts.                                  Lane, Rm. 1061, Rockville, MD 20852.                  www.regulations.gov and insert the
                                                                                                           • For written/paper comments                        docket number, found in brackets in the
                                                 DATES: FDA is reopening the comment                     submitted to the Dockets Management                   heading of this document, into the
                                                 period on the notice of petition                        Staff, FDA will post your comment, as                 ‘‘Search’’ box and follow the prompts
                                                 published September 22, 2017 (82 FR                     well as any attachments, except for                   and/or go to the Dockets Management
                                                 44367). Submit either electronic or                     information submitted, marked and                     Staff, 5630 Fishers Lane, Rm. 1061,
                                                 written comments by January 25, 2018.                   identified, as confidential, if submitted             Rockville, MD 20852.
                                                 ADDRESSES:   You may submit comments                    as detailed in ‘‘Instructions.’’                      FOR FURTHER INFORMATION CONTACT:
                                                 as follows. Please note that late,                        Instructions: All submissions received              Carissa Doody, Center for Veterinary
                                                 untimely filed comments will not be                     must include the Docket No. FDA–                      Medicine (HFV–228), Food and Drug
                                                 considered. Electronic comments must                    2017–F–4399 for ‘‘Food Additives                      Administration, 7519 Standish Pl.,
                                                 be submitted on or before January 25,                   Permitted in Feed and Drinking Water                  Rockville, MD 20855, 240–402–6283,
                                                 2018. The https://www.regulations.gov                   of Animals; Chromium DL-Methionine.’’                 carissa.doody@fda.hhs.gov.
                                                 electronic filing system will accept                    Received comments, those filed in a                   SUPPLEMENTARY INFORMATION: In the
ethrower on DSK3G9T082PROD with PROPOSALS




                                                 comments until midnight Eastern Time                    timely manner (see ADDRESSES), will be                Federal Register of September 22, 2017
                                                 at the end of January 25, 2018.                         placed in the docket and, except for                  (82 FR 44367), FDA gave notice that
                                                 Comments received by mail/hand                          those submitted as ‘‘Confidential                     Zinpro Corp. had filed a petition to
                                                 delivery/courier (for written/paper                     Submissions,’’ publicly viewable at                   amend Title 21 of the Code of Federal
                                                 submissions) will be considered timely                  https://www.regulations.gov or at the                 Regulations in part 573 Food Additives
                                                 if they are postmarked or the delivery                  Dockets Management Staff between 9                    Permitted in Feed and Drinking Water
                                                 service acceptance receipt is on or                     a.m. and 4 p.m., Monday through                       of Animals (21 CFR part 573) to provide
                                                 before that date.                                       Friday.                                               for the safe use of chromium DL-


                                            VerDate Sep<11>2014   16:59 Dec 22, 2017   Jkt 244001   PO 00000   Frm 00001   Fmt 4702   Sfmt 4702   E:\FR\FM\26DEP1.SGM   26DEP1


                                                                      Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules                                         60921

                                                 methionine as a nutritional source of                   2018. The https://www.regulations.gov                 or at the Dockets Management Staff
                                                 chromium in cattle feed.                                electronic filing system will accept                  between 9 a.m. and 4 p.m., Monday
                                                    Interested persons were originally                   comments until midnight Eastern Time                  through Friday.
                                                 given until October 23, 2017, to                        at the end of January 25, 2018.                          • Confidential Submissions—To
                                                 comment on the petitioner’s                             Comments received by mail/hand                        submit a comment with confidential
                                                 environmental assessment. The                           delivery/courier (for written/paper                   information that you do not wish to be
                                                 environmental assessment was not                        submissions) will be considered timely                made publicly available, submit your
                                                 placed on public display until October                  if they are postmarked or the delivery                comments only as a written/paper
                                                 13, 2017. On our own initiative, we are                 service acceptance receipt is on or                   submission. You should submit two
                                                 reopening the comment period to allow                   before that date.                                     copies total. One copy will include the
                                                 potential respondents to thoroughly                                                                           information you claim to be confidential
                                                                                                         Electronic Submissions
                                                 evaluate and address pertinent                                                                                with a heading or cover note that states
                                                 environmental issues. The Agency                          Submit electronic comments in the                   ‘‘THIS DOCUMENT CONTAINS
                                                 believes that a 30-day extension allows                 following way:                                        CONFIDENTIAL INFORMATION.’’ The
                                                 adequate time for interested persons to                   • Federal eRulemaking Portal:
                                                                                                                                                               Agency will review this copy, including
                                                 submit comments without significantly                   https://www.regulations.gov. Follow the
                                                                                                                                                               the claimed confidential information, in
                                                 delaying rulemaking on this important                   instructions for submitting comments.
                                                                                                                                                               its consideration of comments. The
                                                 issue.                                                  Comments submitted electronically,
                                                                                                                                                               second copy, which will have the
                                                                                                         including attachments, to https://
                                                   Dated: December 20, 2017.                                                                                   claimed confidential information
                                                                                                         www.regulations.gov will be posted to
                                                 Leslie Kux,                                                                                                   redacted/blacked out, will be available
                                                                                                         the docket unchanged. Because your
                                                 Associate Commissioner for Policy.                                                                            for public viewing and posted on
                                                                                                         comment will be made public, you are
                                                 [FR Doc. 2017–27785 Filed 12–22–17; 8:45 am]
                                                                                                                                                               https://www.regulations.gov. Submit
                                                                                                         solely responsible for ensuring that your
                                                                                                                                                               both copies to the Dockets Management
                                                 BILLING CODE 4164–01–P                                  comment does not include any
                                                                                                                                                               Staff. If you do not wish your name and
                                                                                                         confidential information that you or a
                                                                                                                                                               contact information to be made publicly
                                                                                                         third party may not wish to be posted,
                                                 DEPARTMENT OF HEALTH AND                                                                                      available, you can provide this
                                                                                                         such as medical information, your or
                                                 HUMAN SERVICES                                                                                                information on the cover sheet and not
                                                                                                         anyone else’s Social Security number, or
                                                                                                                                                               in the body of your comments and you
                                                                                                         confidential business information, such
                                                 Food and Drug Administration                                                                                  must identify this information as
                                                                                                         as a manufacturing process. Please note
                                                                                                                                                               ‘‘confidential.’’ Any information marked
                                                                                                         that if you include your name, contact
                                                 21 CFR Part 573                                                                                               as ‘‘confidential’’ will not be disclosed
                                                                                                         information, or other information that
                                                                                                                                                               except in accordance with 21 CFR 10.20
                                                 [Docket No. FDA–2017–F–4375]                            identifies you in the body of your
                                                                                                                                                               and other applicable disclosure law. For
                                                                                                         comments, that information will be
                                                 Akzo Nobel Surface Chemistry AB;                                                                              more information about FDA’s posting
                                                                                                         posted on https://www.regulations.gov.
                                                 Filing of Food Additive Petition                          • If you want to submit a comment                   of comments to public dockets, see 80
                                                 (Animal Use); Reopening of the                          with confidential information that you                FR 56469, September 18, 2015, or access
                                                 Comment Period                                          do not wish to be made available to the               the information at:https://www.gpo.gov/
                                                                                                         public, submit the comment as a                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                 AGENCY:    Food and Drug Administration,                                                                      23389.pdf.
                                                 HHS.                                                    written/paper submission and in the
                                                                                                         manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                 ACTION: Notification; petition for                      Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                 rulemaking; reopening of the comment                                                                          electronic and written/paper comments
                                                 period.                                                 Written/Paper Submissions                             received, go to https://
                                                                                                            Submit written/paper submissions as                www.regulations.gov and insert the
                                                 SUMMARY:   The Food and Drug
                                                                                                         follows:                                              docket number, found in brackets in the
                                                 Administration (FDA or the Agency) is
                                                                                                            • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                                 reopening the comment period for the
                                                                                                         written/paper submissions): Dockets                   ‘‘Search’’ box and follow the prompts
                                                 notice of petition, published in the
                                                                                                         Management Staff (HFA–305), Food and                  and/or go to the Dockets Management
                                                 Federal Register of September 21, 2017,
                                                                                                         Drug Administration, 5630 Fishers                     Staff, 5630 Fishers Lane, Rm. 1061,
                                                 revising food additive regulations to
                                                                                                         Lane, Rm. 1061, Rockville, MD 20852.                  Rockville, MD 20852.
                                                 provide for the safe use of glyceryl                       • For written/paper comments
                                                 polyethylene glycol (200) ricinoleate as                                                                      FOR FURTHER INFORMATION CONTACT:
                                                                                                         submitted to the Dockets Management
                                                 an emulsifier in animal food that does                                                                        Chelsea Trull, Center for Veterinary
                                                                                                         Staff, FDA will post your comment, as
                                                 not include food for cats, dogs, vitamin                                                                      Medicine, Food and Drug
                                                                                                         well as any attachments, except for
                                                 premixes, or aquaculture. FDA is                                                                              Administration, 7519 Standish Pl.,
                                                                                                         information submitted, marked and
                                                 reopening the comment period to allow                                                                         Rockville, MD 20855, 240–402–6729,
                                                                                                         identified, as confidential, if submitted
                                                 additional time for comments on                                                                               Chelsea.trull@fda.hhs.gov.
                                                                                                         as detailed in ‘‘Instructions.’’
                                                 environmental impacts.                                     Instructions: All submissions received             SUPPLEMENTARY INFORMATION:     In the
                                                 DATES: FDA is reopening the comment                     must include the Docket No. FDA–                      Federal Register of September 21, 2017,
                                                 period on the notice of petition                        2017–F–4375 for ‘‘Food Additives                      FDA gave notice that Akzo Nobel
ethrower on DSK3G9T082PROD with PROPOSALS




                                                 published September 21, 2017 (82 FR                     Permitted in Feed and Drinking Water                  Surface Chemistry AB had filed a
                                                 44129). Submit either electronic or                     of Animals; glyceryl polyethylene glycol              petition to amend Title 21 of the Code
                                                 written comments by January 25, 2018.                   (200) ricinoleate.’’ Received comments,               of Federal Regulations in part 573 Food
                                                 ADDRESSES: You may submit comments                      those filed in a timely manner (see                   Additives Permitted in Feed and
                                                 as follows. Please note that late,                      ADDRESSES), will be placed in the docket              Drinking Water of Animals (21 CFR part
                                                 untimely filed comments will not be                     and, except for those submitted as                    573) to provide for the safe use of
                                                 considered. Electronic comments must                    ‘‘Confidential Submissions,’’ publicly                glyceryl polyethylene glycol (200)
                                                 be submitted on or before January 25,                   viewable at https://www.regulations.gov               ricinoleate as an emulsifier in animal


                                            VerDate Sep<11>2014   16:59 Dec 22, 2017   Jkt 244001   PO 00000   Frm 00002   Fmt 4702   Sfmt 4702   E:\FR\FM\26DEP1.SGM   26DEP1



Document Created: 2017-12-23 03:07:48
Document Modified: 2017-12-23 03:07:48
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; petition for rulemaking; reopening of the comment period.
DatesFDA is reopening the comment period on the notice of petition published September 22, 2017 (82 FR 44367). Submit either electronic or written comments by January 25, 2018.
ContactCarissa Doody, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected]
FR Citation82 FR 60920 

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