81 FR 96405 - Novus International, Inc.; 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 81, Issue 251 (December 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 251 (December 30, 2016)
| Page Range | 96405-96406 | |
| FR Document | 2016-31606 |
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)] [Proposed Rules] [Pages 96405-96406] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31606] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2016-F-3880] Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notice of petition, published in the Federal Register of November 8, 2016 (81 FR 78528), proposing that the food additive regulations be amended to provide for the safe use of poly (2- vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food. FDA is reopening the comment period to allow additional time for comments on environmental impacts. DATES: Submit either electronic or written comments by January 30, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-F-3880 for ``Food Additives Permitted in Feed and Drinking Water of Animals; 2-Vinylpyridine-Co-Styrene.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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.'' 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 http://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 [[Page 96406]] 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 http://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: 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 November 8, 2016 (81 FR 78528), Novus Inc. proposed regulations be amended to provide for the safe use of poly (2-vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food. Interested persons were originally given until December 8, 2016, to comment on the petitioner's environmental assessment. The November 8, 2016, notice of petition was published with the incorrect docket number. A correction published in the Federal Register of November 29, 2016 (81 FR 85972). On our own initiative, we are reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent environmental issues. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31606 Filed 12-29-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules 96405
comments to public dockets, see 80 FR DEPARTMENT OF HEALTH AND do not wish to be made available to the
56469, September 18, 2015, or access HUMAN SERVICES public, submit the comment as a
the information at: http://www.fda.gov/ written/paper submission and in the
regulatoryinformation/dockets/ Food and Drug Administration manner detailed (see ‘‘Written/Paper
default.htm. Submissions’’ and ‘‘Instructions’’).
21 CFR Part 573
Docket: For access to the docket to Written/Paper Submissions
read background documents or the [Docket No. FDA–2016–F–3880]
Submit written/paper submissions as
electronic and written/paper comments follows:
Novus International, Inc.; Filing of
received, go to https://
Food Additive Petition (Animal Use); • Mail/Hand delivery/Courier (for
www.regulations.gov and insert the Reopening of the Comment Period written/paper submissions): Division of
docket number, found in brackets in the Dockets Management (HFA–305), Food
heading of this document, into the AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts HHS. Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Division of Dockets ACTION:Notice of petition; reopening of • For written/paper comments
Management, 5630 Fishers Lane, Rm. the comment period. submitted to the Division of Dockets
1061, Rockville, MD 20852. Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
FOR FURTHER INFORMATION CONTACT: Administration (FDA) is reopening the except for information submitted,
Vincent de Jesus, Center for Food Safety comment period for the notice of marked and identified, as confidential,
and Applied Nutrition (HFS–830), Food petition, published in the Federal if submitted as detailed in
and Drug Administration, 5001 Campus Register of November 8, 2016 (81 FR ‘‘Instructions.’’
Dr., College Park, MD 20740, 240–402– 78528), proposing that the food additive Instructions: All submissions received
1450. regulations be amended to provide for must include the Docket No. FDA–
the safe use of poly (2-vinylpyridine-co- 2016–F–3880 for ‘‘Food Additives
SUPPLEMENTARY INFORMATION: In the styrene) as a nutrient protectant for Permitted in Feed and Drinking Water
Federal Register of September 28, 2016, methionine hydroxy analog in animal of Animals; 2-Vinylpyridine-Co-
we published a notice announcing the food for beef cattle, dairy cattle, and Styrene.’’ Received comments will be
establishment of a docket to receive replacement dairy heifers. Additionally, placed in the docket and, except for
information and comments on the use of the petition proposes that the food those submitted as ‘‘Confidential
the term ‘‘healthy’’ in the labeling of additive regulations be amended to Submissions,’’ publicly viewable at
human food products. The notice provide for the safe use of ethyl http://www.regulations.gov or at the
discussed FDA’s position regarding the cellulose as a binder for methionine Division of Dockets Management
use of the term ‘‘healthy’’, the events hydroxy analog to be incorporated into between 9 a.m. and 4 p.m., Monday
that prompted us to establish a docket animal food. FDA is reopening the through Friday.
to request information and comments on comment period to allow additional • Confidential Submissions—To
this issue, and specific issues for time for comments on environmental submit a comment with confidential
impacts. information that you do not wish to be
consideration. We provided a 120-day
comment period that was scheduled to DATES: Submit either electronic or made publicly available, submit your
written comments by January 30, 2017. comments only as a written/paper
end on January 26, 2017.
ADDRESSES: You may submit comments submission. You should submit two
We have received requests to extend copies total. One copy will include the
as follows:
the comment period. The requests information you claim to be confidential
conveyed concern that the current 120- Electronic Submissions with a heading or cover note that states
day comment period does not allow Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
sufficient time to develop meaningful or following way: CONFIDENTIAL INFORMATION.’’ The
thoughtful comments to the questions • Federal eRulemaking Portal: http:// Agency will review this copy, including
and issues we presented in the notice. www.regulations.gov. Follow the the claimed confidential information, in
We have considered the requests and instructions for submitting comments. its consideration of comments. The
are extending the comment period for Comments submitted electronically, second copy, which will have the
including attachments, to http:// claimed confidential information
90 days, until April 26, 2017. We
www.regulations.gov will be posted to redacted/blacked out, will be available
believe that a 90-day extension allows
the docket unchanged. Because your for public viewing and posted on http://
adequate time for interested persons to
comment will be made public, you are www.regulations.gov. Submit both
submit comments. copies to the Division of Dockets
solely responsible for ensuring that your
Dated: December 27, 2016. comment does not include any Management. If you do not wish your
Leslie Kux, confidential information that you or a name and contact information to be
Associate Commissioner for Policy. third party may not wish to be posted, made publicly available, you can
[FR Doc. 2016–31734 Filed 12–29–16; 8:45 am] such as medical information, your or provide this information on the cover
anyone else’s Social Security number, or sheet and not in the body of your
BILLING CODE 4164–01–P
confidential business information, such comments and you must identify this
srobinson on DSK5SPTVN1PROD with PROPOSALS
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
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![96406 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules
the information at: http://www.fda.gov/ DEPARTMENT OF TREASURY Background
regulatoryinformation/dockets/
Internal Revenue Service This document contains proposed
default.htm.
regulations to amend the Employment
Docket: For access to the docket to Tax Regulations (26 CFR 31) under
26 CFR Part 31
read background documents or the section 3402 of the Internal Revenue
electronic and written/paper comments Code relating to withholding from
[REG–123841–16]
received, go to http:// gambling winnings for horse races, dog
www.regulations.gov and insert the RIN 1545–BN58 races, and jai alai. The proposed
docket number, found in brackets in the regulations update and clarify other
heading of this document, into the Withholding on Payments of Certain provisions of § 31.3402(q)–1 and make
‘‘Search’’ box and follow the prompts Gambling Winnings conforming changes to § 31.3406(g)–2.
and/or go to the Division of Dockets Section 3402(q)(1) requires every
Management, 5630 Fishers Lane, Rm. AGENCY: Internal Revenue Service (IRS),
person, including the United States
1061, Rockville, MD 20852. Treasury.
government, a state, a political
ACTION: Notice of proposed rulemaking. subdivision thereof, or any
FOR FURTHER INFORMATION CONTACT:
SUMMARY: This document contains instrumentality of the foregoing, that
Carissa Doody, Center for Veterinary
proposed regulations under section makes any payment of gambling
Medicine (HFV–228), Food and Drug
3402(q) with respect to withholding on winnings to deduct and withhold tax on
Administration, 7519 Standish Pl., certain payments at the third-lowest tax
Rockville, MD 20855, 240–402–6283, certain payments of gambling winnings
from horse races, dog races, and jai alai rate applicable under section 1(c),
carissa.doody@fda.hhs.gov. which for the 2016 tax year is 25
and on certain other payments of
SUPPLEMENTARY INFORMATION: In the gambling winnings. The proposed percent. Section 3402(q)(2) provides an
Federal Register of November 8, 2016 regulations affect both payers and exemption from withholding under this
payees of the gambling winnings subject section for payments of winnings to
(81 FR 78528), Novus Inc. proposed
to withholding under section 3402(q). nonresident aliens and foreign
regulations be amended to provide for
corporations subject to withholding
the safe use of poly (2-vinylpyridine-co- DATES: Written or electronic comments under sections 1441(a) or 1442(a).
styrene) as a nutrient protectant for and requests for a public hearing must Section 3402(q)(3) describes the
methionine hydroxy analog in animal be received by March 30, 2017. winnings subject to withholding as
food for beef cattle, dairy cattle, and ADDRESSES: Send submissions to: proceeds from a wager determined in
replacement dairy heifers. Additionally, CC:PA:LPD:PR (REG–123841–16), Room accordance with the rules in that
the petition proposes that the food 5203, Internal Revenue Service, P.O. subsection.
additive regulations be amended to Box 7604, Ben Franklin Station, Whether winnings are subject to
provide for the safe use of ethyl Washington, DC 20044. Submissions withholding depends on the type of
cellulose as a binder for methionine may be hand-delivered Monday through wagering transaction, the proceeds from
hydroxy analog to be incorporated into Friday between the hours of 8 a.m. and a wager, and in some cases the odds
animal food. 4 p.m. to CC:PA:LPD:PR (REG–123841– associated with a wager. Under sections
Interested persons were originally 16), Courier’s Desk, Internal Revenue 3402(q)(3)(B) and (C)(i), payers generally
Service, 1111 Constitution Avenue NW., must withhold if the proceeds from a
given until December 8, 2016, to
Washington, DC 20224, or sent wager exceed $5,000 in a State-
comment on the petitioner’s
electronically, via the Federal conducted lottery, other lottery,
environmental assessment. The
eRulemaking Portal at http:// sweepstakes, or wagering pool. Under
November 8, 2016, notice of petition www.regulations.gov (IRS REG–123841–
was published with the incorrect docket section 3402(q)(3)(A) and (C)(ii), in the
16). case of a wagering transaction in a
number. A correction published in the
FOR FURTHER INFORMATION CONTACT: parimutuel pool with respect to horse
Federal Register of November 29, 2016
Concerning the proposed regulations, races, dog races, or jai alai, the payer
(81 FR 85972). On our own initiative,
David Bergman, (202) 317–6845; must withhold if the proceeds exceed
we are reopening the comment period to concerning submissions of comments or $5,000 and are at least 300 times as large
allow potential respondents to to request a public hearing, Regina as the amount wagered. Winnings from
thoroughly evaluate and address Johnson, (202) 317–6901 (not toll-free bingo, keno, and slot machines are
pertinent environmental issues. numbers). exempted from withholding under
Dated: December 23, 2016. SUPPLEMENTARY INFORMATION: section 3402(q)(1) by section 3402(q)(5).
Leslie Kux,
Paperwork Reduction Act Proceeds From a Wager and Identical
Associate Commissioner for Policy. Wagers
[FR Doc. 2016–31606 Filed 12–29–16; 8:45 am] The collection of information
BILLING CODE 4164–01–P
contained in this notice of proposed Section 3402(q)(4) provides that
rulemaking has been approved by the proceeds from a wager are determined
Office of Management and Budget by reducing the amount received by the
through Form W–2G (OMB No. 1545– amount of the wager, and proceeds
srobinson on DSK5SPTVN1PROD with PROPOSALS
0238) in accordance with the Paperwork which are not money are taken into
Reduction Act of 1995 (44 U.S.C. account at fair market value. The
3507(d)). Notice and an opportunity to current regulations provide rules for
comment on the proposed changes to determining the amount of proceeds
burden hours for the forms related to from a wager, including a special rule
this proposed rule will be published in for ‘‘identical wagers.’’ The rule treats
a separate notice in the Federal ‘‘identical wagers’’ as paid with respect
Register. to a single wager for purposes of
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Document Created: 2016-12-30 05:16:02
Document Modified: 2016-12-30 05:16:02
| 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 | Notice of petition; reopening of the comment period. | |
| Dates | Submit either electronic or written comments by January 30, 2017. | |
| Contact | Carissa Doody, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected] | |
| FR Citation | 81 FR 96405 |
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