Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period, 96405-96406 [2016-31606]

Download as PDF Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 1450. In the Federal Register of September 28, 2016, we published a notice announcing the establishment of a docket to receive information and comments on the use of the term ‘‘healthy’’ in the labeling of human food products. The notice discussed FDA’s position regarding the use of the term ‘‘healthy’’, the events that prompted us to establish a docket to request information and comments on this issue, and specific issues for consideration. We provided a 120-day comment period that was scheduled to end on January 26, 2017. We have received requests to extend the comment period. The requests conveyed concern that the current 120day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the questions and issues we presented in the notice. We have considered the requests and are extending the comment period for 90 days, until April 26, 2017. We believe that a 90-day extension allows adequate time for interested persons to submit comments. SUPPLEMENTARY INFORMATION: Dated: December 27, 2016. Leslie Kux, Associate Commissioner for Policy. srobinson on DSK5SPTVN1PROD with PROPOSALS [FR Doc. 2016–31734 Filed 12–29–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:43 Dec 29, 2016 Jkt 241001 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. Notice of petition; reopening of the comment period. ACTION: 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-costyrene) 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: SUMMARY: 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 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 96405 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-CoStyrene.’’ 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 E:\FR\FM\30DEP1.SGM 30DEP1 96406 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Proposed Rules 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: 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-costyrene) 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] srobinson on DSK5SPTVN1PROD with PROPOSALS BILLING CODE 4164–01–P VerDate Sep<11>2014 17:43 Dec 29, 2016 Jkt 241001 Background Internal Revenue Service This document contains proposed regulations to amend the Employment Tax Regulations (26 CFR 31) under section 3402 of the Internal Revenue Code relating to withholding from gambling winnings for horse races, dog races, and jai alai. The proposed regulations update and clarify other provisions of § 31.3402(q)–1 and make conforming changes to § 31.3406(g)–2. Section 3402(q)(1) requires every person, including the United States government, a state, a political subdivision thereof, or any instrumentality of the foregoing, that makes any payment of gambling winnings to deduct and withhold tax on certain payments at the third-lowest tax rate applicable under section 1(c), which for the 2016 tax year is 25 percent. Section 3402(q)(2) provides an exemption from withholding under this section for payments of winnings to nonresident aliens and foreign corporations subject to withholding under sections 1441(a) or 1442(a). Section 3402(q)(3) describes the winnings subject to withholding as proceeds from a wager determined in accordance with the rules in that subsection. Whether winnings are subject to withholding depends on the type of wagering transaction, the proceeds from a wager, and in some cases the odds associated with a wager. Under sections 3402(q)(3)(B) and (C)(i), payers generally must withhold if the proceeds from a wager exceed $5,000 in a Stateconducted lottery, other lottery, sweepstakes, or wagering pool. Under section 3402(q)(3)(A) and (C)(ii), in the case of a wagering transaction in a parimutuel pool with respect to horse races, dog races, or jai alai, the payer must withhold if the proceeds exceed $5,000 and are at least 300 times as large as the amount wagered. Winnings from bingo, keno, and slot machines are exempted from withholding under section 3402(q)(1) by section 3402(q)(5). 26 CFR Part 31 [REG–123841–16] RIN 1545–BN58 Withholding on Payments of Certain Gambling Winnings Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking. AGENCY: This document contains proposed regulations under section 3402(q) with respect to withholding on certain payments of gambling winnings from horse races, dog races, and jai alai and on certain other payments of gambling winnings. The proposed regulations affect both payers and payees of the gambling winnings subject to withholding under section 3402(q). DATES: Written or electronic comments and requests for a public hearing must be received by March 30, 2017. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG–123841–16), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG–123841– 16), Courier’s Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224, or sent electronically, via the Federal eRulemaking Portal at http:// www.regulations.gov (IRS REG–123841– 16). FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations, David Bergman, (202) 317–6845; concerning submissions of comments or to request a public hearing, Regina Johnson, (202) 317–6901 (not toll-free numbers). SUMMARY: Carissa Doody, Center for Veterinary Medicine (HFV–228), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6283, carissa.doody@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DEPARTMENT OF TREASURY SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collection of information contained in this notice of proposed rulemaking has been approved by the Office of Management and Budget through Form W–2G (OMB No. 1545– 0238) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Notice and an opportunity to comment on the proposed changes to burden hours for the forms related to this proposed rule will be published in a separate notice in the Federal Register. PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 Proceeds From a Wager and Identical Wagers Section 3402(q)(4) provides that proceeds from a wager are determined by reducing the amount received by the amount of the wager, and proceeds which are not money are taken into account at fair market value. The current regulations provide rules for determining the amount of proceeds from a wager, including a special rule for ‘‘identical wagers.’’ The rule treats ‘‘identical wagers’’ as paid with respect to a single wager for purposes of E:\FR\FM\30DEP1.SGM 30DEP1

Agencies

[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96405-96406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31606]


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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, carissa.doody@fda.hhs.gov.

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