82 FR 61192 - 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 247 (December 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 247 (December 27, 2017)
| Page Range | 61192-61193 | |
| FR Document | 2017-27840 |
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)] [Proposed Rules] [Pages 61192-61193] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27840] ======================================================================== 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. 247 / Wednesday, December 27, 2017 / Proposed Rules [[Page 61192]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2017-N-5476] 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 that appeared in the Federal Register of September 21, 2017, proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (15) 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 in the Federal Register of September 21, 2017 (82 FR 44128). Submit either electronic or written comments by January 26, 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 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 26, 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-N-5476 for ``Food Additives Permitted in Feed and Drinking Water of Animals; glyceryl polyethylene glycol (15) 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 (HFV-224), 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 (82 FR 44128), 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 [[Page 61193]] Drinking Water of Animals (21 CFR part 573) to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal 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. 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. 2017-27840 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
![61192
Proposed Rules Federal Register
Vol. 82, No. 247
Wednesday, December 27, 2017
This section of the FEDERAL REGISTER service acceptance receipt is on or between 9 a.m. and 4 p.m., Monday
contains notices to the public of the proposed before that date. through Friday.
issuance of rules and regulations. The • Confidential Submissions—To
purpose of these notices is to give interested Electronic Submissions submit a comment with confidential
persons an opportunity to participate in the Submit electronic comments in the information that you do not wish to be
rule making prior to the adoption of the final made publicly available, submit your
following way:
rules.
• Federal eRulemaking Portal: comments only as a written/paper
https://www.regulations.gov. Follow the submission. You should submit two
DEPARTMENT OF HEALTH AND instructions for submitting comments. copies total. One copy will include the
HUMAN SERVICES Comments submitted electronically, information you claim to be confidential
including attachments, to https:// with a heading or cover note that states
Food and Drug Administration www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The
21 CFR Part 573 comment will be made public, you are Agency will review this copy, including
solely responsible for ensuring that your the claimed confidential information, in
[Docket No. FDA–2017–N–5476] comment does not include any its consideration of comments. The
confidential information that you or a second copy, which will have the
Akzo Nobel Surface Chemistry AB; third party may not wish to be posted, claimed confidential information
Filing of Food Additive Petition such as medical information, your or redacted/blacked out, will be available
(Animal Use); Reopening of the anyone else’s Social Security number, or for public viewing and posted on
Comment Period confidential business information, such https://www.regulations.gov. Submit
as a manufacturing process. Please note both copies to the Dockets Management
AGENCY: Food and Drug Administration, Staff. If you do not wish your name and
that if you include your name, contact
HHS. contact information to be made publicly
information, or other information that
ACTION: Notification; petition for identifies you in the body of your available, you can provide this
rulemaking; reopening of the comment comments, that information will be information on the cover sheet and not
period. posted on https://www.regulations.gov. in the body of your comments and you
SUMMARY: The Food and Drug • If you want to submit a comment must identify this information as
with confidential information that you ‘‘confidential.’’ Any information marked
Administration (FDA or the Agency) is as ‘‘confidential’’ will not be disclosed
reopening the comment period for the do not wish to be made available to the
public, submit the comment as a except in accordance with 21 CFR 10.20
notice of petition that appeared in the and other applicable disclosure law. For
Federal Register of September 21, 2017, written/paper submission and in the
manner detailed (see ‘‘Written/Paper more information about FDA’s posting
proposing that the food additive of comments to public dockets, see 80
regulations be amended to provide for Submissions’’ and ‘‘Instructions’’).
FR 56469, September 18, 2015, or access
the safe use of glyceryl polyethylene Written/Paper Submissions the information at: https://www.gpo.gov/
glycol (15) ricinoleate as an emulsifier fdsys/pkg/FR-2015-09-18/pdf/2015-
Submit written/paper submissions as
in animal food that does not include 23389.pdf.
follows:
food for cats, dogs, vitamin premixes, or
• Mail/Hand delivery/Courier (for Docket: For access to the docket to
aquaculture. FDA is reopening the read background documents or the
written/paper submissions): Dockets
comment period to allow additional electronic and written/paper comments
Management Staff (HFA–305), Food and
time for comments on environmental received, go to https://
Drug Administration, 5630 Fishers
impacts. www.regulations.gov and insert the
Lane, Rm. 1061, Rockville, MD 20852.
DATES: FDA is reopening the comment • For written/paper comments docket number, found in brackets in the
period on the notice of petition submitted to the Dockets Management heading of this document, into the
published in the Federal Register of Staff, FDA will post your comment, as ‘‘Search’’ box and follow the prompts
September 21, 2017 (82 FR 44128). well as any attachments, except for and/or go to the Dockets Management
Submit either electronic or written information submitted, marked and Staff, 5630 Fishers Lane, Rm. 1061,
comments by January 26, 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 Chelsea Trull, Center for Veterinary
untimely filed comments will not be must include the Docket No. FDA– Medicine (HFV–224), Food and Drug
considered. Electronic comments must 2017–N–5476 for ‘‘Food Additives Administration, 7519 Standish Pl.,
be submitted on or before January 26, Permitted in Feed and Drinking Water Rockville, MD 20855, 240–402–6729,
daltland on DSKBBV9HB2PROD with PROPOSALS
2018. The https://www.regulations.gov of Animals; glyceryl polyethylene glycol Chelsea.trull@fda.hhs.gov.
electronic filing system will accept (15) ricinoleate.’’ Received comments, SUPPLEMENTARY INFORMATION: In the
comments until midnight Eastern Time those filed in a timely manner (see Federal Register of September 21, 2017
at the end of January 26, 2018. ADDRESSES), will be placed in the docket (82 FR 44128), FDA gave notice that
Comments received by mail/hand and, except for those submitted as Akzo Nobel Surface Chemistry AB had
delivery/courier (for written/paper ‘‘Confidential Submissions,’’ publicly filed a petition to amend Title 21 of the
submissions) will be considered timely viewable at https://www.regulations.gov Code of Federal Regulations in part 573
if they are postmarked or the delivery or at the Dockets Management Staff Food Additives Permitted in Feed and
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![Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Proposed Rules 61193
Drinking Water of Animals (21 CFR part SUMMARY: This proposed rule revises I. Paperwork Reduction Act
573) to provide for the safe use of regulations addressing electric power J. National Environmental Policy Act
glyceryl polyethylene glycol (15) utilities of the Colorado River, Flathead, K. Effects on the Energy Supply (E.O.
ricinoleate as an emulsifier in animal and San Carlos Indian irrigation projects 13211)
L. Clarity of This Regulation
food that does not include food for cats, to use plain language, update
dogs, vitamin premixes, or aquaculture. definitions, lengthen a regulatory I. Background
Interested persons were originally deadline, and make other minor
changes. Various statutes provide the Bureau of
given until October 23, 2017, to
Indian Affairs (BIA) with authority to
comment on the petitioner’s DATES: Comments must be received on issue this regulation and for
environmental assessment. or before February 26, 2018. administering electric power utilities for
The environmental assessment was ADDRESSES: You may submit comments the Colorado River, Flathead (Mission
not placed on public display until by any of the following methods: Valley Power), and San Carlos Indian
October 13, 2017. On our own initiative, • Federal eRulemaking Portal: irrigation projects. For example, see 5
we are reopening the comment period to www.regulations.gov. Search for Docket U.S.C. 301; 25 U.S.C. 13; 25 U.S.C. 385c;
allow potential respondents to No. BIA–2016–0002 and follow the 43 Stat. 475–76; 45 Stat. 210–13; 49 Stat.
thoroughly evaluate and address instructions for submitting comments. 1039–40; 49 Stat. 1822–23; 54 Stat. 422;
pertinent environmental issues. The • Mail, Hand Delivery, or Courier: 62 Stat. 269–73; 65 Stat. 254; 99 Stat.
Agency believes that a 30-day extension Elizabeth Appel, Director, Office of 319–20. Each of these power projects
allows adequate time for interested Regulatory Affairs and Collaborative provides energy, transmission, and
persons to submit comments without Action—Indian Affairs, Attn: 1076– distribution of electrical services to
significantly delaying rulemaking on AF31, U.S. Dept. of the Interior, 1849 C customers in their respective service
this important issue. Street NW, Mail Stop 3642, Washington, areas. BIA (or the contracting/
Dated: December 20, 2017. DC 20240. compacting Indian Tribe) provides
Leslie Kux, FOR FURTHER INFORMATION CONTACT: oversight and limited technical
Associate Commissioner for Policy. Elizabeth Appel, Director, Office of assistance for power projects and
[FR Doc. 2017–27840 Filed 12–26–17; 8:45 am] Regulatory Affairs and Collaborative conducts operations and maintenance of
BILLING CODE 4164–01–P
Action, Office of the Assistant the distribution systems.
Secretary—Indian Affairs; telephone The regulations addressing BIA’s
(202) 273–4680, elizabeth.appel@ administration of the power utilities are
bia.gov. at 25 CFR part 175, Indian Electric
DEPARTMENT OF THE INTERIOR SUPPLEMENTARY INFORMATION: Power Utilities. These regulations were
I. Background last updated in 1991.
Bureau of Indian Affairs II. Description of Changes
III. Procedural Requirements II. Description of Changes
25 CFR Part 175 A. Regulatory Planning and Review (E.O.s
12866 and 13563) and Reducing The revisions being proposed today
[167A2100DD/AAKC001030/ Regulation and Controlling Regulatory are intended to make the regulations
A0A501010.999900 253G] Costs (E.O. 13771) more user-friendly through plain
B. Regulatory Flexibility Act language. The proposed rule would also
RIN 1076–AF31 C. Small Business Regulatory Enforcement update definitions, lengthen the time by
Fairness Act which BIA must issue a decision on an
Indian Electric Power Utilities D. Unfunded Mandates Reform Act appeal from 30 days to 60 days (by
E. Takings (E.O. 12630)
AGENCY: Bureau of Indian Affairs, F. Federalism (E.O. 13132) referring to 25 CFR 2.19(a)), and require
Interior. G. Civil Justice Reform (E.O. 12988) publication of rate adjustments in the
H. Consultation With Indian Tribes (E.O. Federal Register. The following tables
ACTION: Proposed rule.
13175) summarize the proposed changes:
Current 25 CFR Proposed 25 CFR section Summary of proposed changes
section
175.1 Definitions ........................... 175.100 What terms should I Deletes the definitions of ‘‘appellant’’ and ‘‘officer-in-charge.’’
know for this part? Adds definitions for ‘‘bill,’’ ‘‘CFR,’’ ‘‘day(s),’’ ‘‘delinquent,’’ ‘‘due date,’’
‘‘electric energy,’’ ‘‘energy,’’ ‘‘fee,’’ ‘‘I, me, my, you, and your,’’
‘‘must,’’ ‘‘past due bill,’’ ‘‘power,’’ ‘‘public notice,’’ ‘‘purchased
power,’’ ‘‘taxpayer identification number,’’ ‘‘utility(ies),’’ and ‘‘we, us,
and our.’’
Replaces definition of ‘‘Area Director’’ with a definition of ‘‘BIA.’’
Revises the definition of ‘‘customer,’’ ‘‘electric power utility,’’ ‘‘electric
service,’’ ‘‘operations manual,’’ ‘‘service,’’ ‘‘service fee.’’
Revises the definition of ‘‘power rate’’ and replaces it with the terms
‘‘rate’’ and ‘‘electric power rate.’’
Revises the definition of ‘‘service agreement’’ and replaces it with the
daltland on DSKBBV9HB2PROD with PROPOSALS
term ‘‘agreement.’’
Revises the definition of ‘‘special contract’’ and replaces it with the
term ‘‘special agreement.’’
175.2 Purpose .............................. 175.105 What is the purpose of Revises for plain language.
this part?
175.3 Compliance ......................... 175.110 Does this part apply to Revises for plain language.
me?
175.4 Authority of area director .... N/A ................................................. Deletes provisions containing delegations of authority to eliminate
possible conflicts with the Departmental Delegations of Authority.
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Document Created: 2017-12-27 02:23:03
Document Modified: 2017-12-27 02:23:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification; petition for rulemaking; reopening of the comment period. | |
| Dates | FDA is reopening the comment period on the notice of petition published in the Federal Register of September 21, 2017 (82 FR 44128). Submit either electronic or written comments by January 26, 2018. | |
| Contact | Chelsea Trull, Center for Veterinary Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected] | |
| FR Citation | 82 FR 61192 |
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