82_FR_61167 82 FR 60921 - Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period

82 FR 60921 - Akzo Nobel Surface Chemistry AB; 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 Range60921-60922
FR Document2017-27789

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition, published in the Federal Register of September 21, 2017, revising food additive regulations to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. 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 60921-60922]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27789]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-4375]


Akzo Nobel Surface Chemistry AB; 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, published in 
the Federal Register of September 21, 2017, revising food additive 
regulations to provide for the safe use of glyceryl polyethylene glycol 
(200) ricinoleate as an emulsifier in animal food that does not include 
food for cats, dogs, vitamin premixes, or aquaculture. 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 21, 2017 (82 FR 44129). 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-4375 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; glyceryl polyethylene glycol (200) ricinoleate.'' 
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: Chelsea Trull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 21, 
2017, FDA gave notice that Akzo Nobel Surface Chemistry AB 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 glyceryl polyethylene 
glycol (200) ricinoleate as an emulsifier in animal

[[Page 60922]]

food that does not include food for cats, dogs, vitamin premixes, or 
aquaculture.
    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.

    Dated: December 20, 2017
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27789 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P

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

60922 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules food that does not include food for cats, by February 26, 2018. Submit comments Instructions: All submissions received dogs, vitamin premixes, or aquaculture. on information collection issues under must include the Docket No. FDA– Interested persons were originally the Paperwork Reduction Act of 1995 by 2017–N–6730 for ‘‘Voluntary given until October 23, 2017, to February 26, 2018. See section IV of this Malfunction Summary Reporting comment on the petitioner’s document, the ‘‘Paperwork Reduction Program for Manufacturers.’’ Received environmental assessment. The Act of 1995.’’ comments, those filed in a timely environmental assessment was not ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed placed on public display until October as follows. Please note that late, in the docket and, except for those 13, 2017. On our own initiative, we are untimely filed comments will not be submitted as ‘‘Confidential reopening the comment period to allow considered. Electronic comments must Submissions,’’ publicly viewable at potential respondents to thoroughly be submitted on or before February 26, https://www.regulations.gov or at the evaluate and address pertinent 2018. The https://www.regulations.gov Dockets Management Staff between 9 environmental issues. electronic filing system will accept a.m. and 4 p.m., Monday through Dated: December 20, 2017 comments until midnight Eastern Time Friday. Leslie Kux, at the end of February 26, 2018. • Confidential Submissions—To Comments received by mail/hand submit a comment with confidential Associate Commissioner for Policy. delivery/courier (for written/paper information that you do not wish to be [FR Doc. 2017–27789 Filed 12–22–17; 8:45 am] submissions) will be considered timely made publicly available, submit your BILLING CODE 4164–01–P if they are postmarked or the delivery comments only as a written/paper service acceptance receipt is on or submission. You should submit two before that date. copies total. One copy will include the DEPARTMENT OF HEALTH AND Electronic Submissions information you claim to be confidential HUMAN SERVICES with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration following way: CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including 21 CFR Part 803 https://www.regulations.gov. Follow the the claimed confidential information, in [Docket No. FDA–2017–N–6730] instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the Center for Devices and Radiological including attachments, to https:// claimed confidential information Health; Medical Devices and www.regulations.gov will be posted to redacted/blacked out, will be available Combination Products; Voluntary the docket unchanged. Because your for public viewing and posted on Malfunction Summary Reporting comment will be made public, you are https://www.regulations.gov. Submit Program for Manufacturers solely responsible for ensuring that your both copies to the Dockets Management AGENCY: Food and Drug Administration, comment does not include any Staff. If you do not wish your name and HHS. confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this Notification; request for ACTION: such as medical information, your or comments. information on the cover sheet and not anyone else’s Social Security number, or in the body of your comments and you SUMMARY: The Food and Drug confidential business information, such must identify this information as Administration’s (FDA, Agency, or we) as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Center for Devices and Radiological that if you include your name, contact as ‘‘confidential’’ will not be disclosed Health and Center for Biologics information, or other information that except in accordance with 21 CFR 10.20 Evaluation and Research, is announcing identifies you in the body of your and other applicable disclosure law. For a proposed program for manufacturer comments, that information will be more information about FDA’s posting reporting of certain device malfunction posted on https://www.regulations.gov. of comments to public dockets, see 80 medical device reports (MDRs) in • If you want to submit a comment FR 56469, September 18, 2015, or access summary form—the Voluntary with confidential information that you the information at: https://www.gpo.gov/ Malfunction Summary Reporting do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- Program. This proposed voluntary public, submit the comment as a 23389.pdf. program reflects goals for streamlining written/paper submission and in the • Docket: For access to the docket to malfunction reporting outlined in the manner detailed (see ‘‘Written/Paper read background documents or the commitment letter agreed to by FDA Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments and industry and submitted to Congress, Written/Paper Submissions received, go to https:// as referenced in the Medical Device www.regulations.gov and insert the Submit written/paper submissions as User Fee Amendments Act of 2017 docket number, found in brackets in the follows: (MDUFA IV Commitment Letter). These • Mail/Hand delivery/Courier (for heading of this document, into the goals include permitting manufacturers written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts of devices in certain product codes to Management Staff (HFA–305), Food and and/or go to the Dockets Management report malfunctions on a quarterly basis Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, ethrower on DSK3G9T082PROD with PROPOSALS and in a summary format. In addition, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. this proposed program reflects FDA’s • For written/paper comments FOR FURTHER INFORMATION CONTACT: findings from a pilot program the submitted to the Dockets Management Isaac Chang, Center for Devices and Agency conducted to study summary Staff, FDA will post your comment, as Radiological Health, Food and Drug reporting formats for malfunction well as any attachments, except for Administration, 10903 New Hampshire MDRs. information submitted, marked and Ave., Bldg. 66, Rm. 3114, Silver Spring, DATES: Submit either electronic or identified, as confidential, if submitted MD 20993, 301–796–6670, MDRPolicy@ written comments on this notification as detailed in ‘‘Instructions.’’ fda.hhs.gov; or Stephen Ripley, Center VerDate Sep<11>2014 16:59 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\26DEP1.SGM 26DEP1


Document Created: 2017-12-23 03:07:47
Document Modified: 2017-12-23 03:07:47
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 21, 2017 (82 FR 44129). Submit either electronic or written comments by January 25, 2018.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation82 FR 60921 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR