81 FR 78528 - Novus International, Inc.; Filing of Food Additive Petition (Animal Use)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78528-78529 | |
| FR Document | 2016-26922 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Proposed Rules] [Pages 78528-78529] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26922] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2014-F-0452] Novus International, Inc.; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition 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. DATES: Submit either electronic or written comments on the petitioner's environmental assessment by December 8, 2016. 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 comment, 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-2014-F-0452 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 comment 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 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: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2295) has been filed by Novus International, Inc., 20 Research Park Dr., Saint Charles, MO 63304. The petition proposes to amend part 573 (21 CFR part 573) Food Additives Permitted in Feed and Drinking Water of Animals 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, and to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see ADDRESSES) for public review and comment. Interested persons may submit to the Division of Dockets Management (see DATES and ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the [[Page 78529]] heading of this document. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the Federal Register. If, based on its review, the Agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the Agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the Federal Register in accordance with 21 CFR 25.51(b). Dated: November 2, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016-26922 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![78528 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Proposed Rules
Management and Budget (OMB) under anyone else’s Social Security number, or sheet and not in the body of your
the Paperwork Reduction Act of 1995 confidential business information, such comments and you must identify this
(44 U.S.C. 3501–3520). The collections as a manufacturing process. Please note information as ‘‘confidential.’’ Any
of information in 21 CFR 1.230 through that if you include your name, contact information marked as ‘‘confidential’’
1.235 and 21 CFR 1.245 have been information, or other information that will not be disclosed except in
approved under OMB control number identifies you in the body of your accordance with 21 CFR 10.20 and other
0910–0502. comment, that information will be applicable disclosure law. For more
Dated: November 3, 2016. 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
Leslie Kux,
with confidential information that you 56469, September 18, 2015, or access
Associate Commissioner for Policy. do not wish to be made available to the the information at: http://www.fda.gov/
[FR Doc. 2016–26930 Filed 11–7–16; 8:45 am] public, submit the comment as a regulatoryinformation/dockets/
BILLING CODE 4164–01–P written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
HUMAN SERVICES Written/Paper Submissions
received, go to http://
Submit written/paper submissions as www.regulations.gov and insert the
Food and Drug Administration follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
21 CFR Part 573 written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
[Docket No. FDA–2014–F–0452] Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Novus International, Inc.; Filing of Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 1061, Rockville, MD 20852.
Food Additive Petition (Animal Use)
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
AGENCY: Food and Drug Administration, Management, FDA will post your Carissa Doody, Center for Veterinary
HHS. comment, as well as any attachments, Medicine (HFV–228), Food and Drug
ACTION: Notice of petition. except for information submitted, Administration, 7519 Standish Pl.,
marked and identified, as confidential, Rockville, MD 20855, 240–402–6283,
SUMMARY: The Food and Drug if submitted as detailed in carissa.doody@fda.hhs.gov.
Administration (FDA) is announcing ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
that Novus International, Inc., has filed Instructions: All submissions received Federal Food, Drug, and Cosmetic Act
a petition proposing that the food must include the Docket No. FDA– (section 409(b)(5) (21 U.S.C. 348(b)(5)),
additive regulations be amended to 2014–F–0452 for ‘‘Food Additives notice is given that a food additive
provide for the safe use of poly (2- Permitted in Feed and Drinking Water petition (FAP 2295) has been filed by
vinylpyridine-co-styrene) as a nutrient of Animals; 2-Vinylpyridine-Co- Novus International, Inc., 20 Research
protectant for methionine hydroxy Styrene.’’ Received comments will be Park Dr., Saint Charles, MO 63304. The
analog in animal food for beef cattle, placed in the docket and, except for petition proposes to amend part 573 (21
dairy cattle, and replacement dairy those submitted as ‘‘Confidential CFR part 573) Food Additives Permitted
heifers. Additionally, the petition Submissions,’’ publicly viewable at in Feed and Drinking Water of Animals
proposes that the food additive http://www.regulations.gov or at the to provide for the safe use of poly (2-
regulations be amended to provide for Division of Dockets Management vinylpyridine-co-styrene) as a nutrient
the safe use of ethyl cellulose as a between 9 a.m. and 4 p.m., Monday protectant for methionine hydroxy
binder for methionine hydroxy analog to through Friday. analog in animal food for beef cattle,
be incorporated into animal food. • Confidential Submissions—To dairy cattle, and replacement dairy
DATES: Submit either electronic or submit a comment with confidential heifers, and to provide for the safe use
written comments on the petitioner’s information that you do not wish to be of ethyl cellulose as a binder for
environmental assessment by December made publicly available, submit your methionine hydroxy analog to be
8, 2016. comment only as a written/paper incorporated into animal food.
ADDRESSES: You may submit comments submission. You should submit two The potential environmental impact
as follows: copies total. One copy will include the of this action is being reviewed. To
information you claim to be confidential encourage public participation
Electronic Submissions with a heading or cover note that states consistent with regulations issued under
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the National Environmental Policy Act
following way: CONFIDENTIAL INFORMATION.’’ The (40 CFR 1501.4(b)), the Agency is
• Federal eRulemaking Portal: http:// Agency will review this copy, including placing the environmental assessment
www.regulations.gov. Follow the the claimed confidential information, in submitted with the petition that is the
instructions for submitting comments. its consideration of comments. The subject of this notice on public display
Comments submitted electronically, second copy, which will have the at the Division of Dockets Management
including attachments, to http:// claimed confidential information (see ADDRESSES) for public review and
www.regulations.gov will be posted to redacted/blacked out, will be available comment. Interested persons may
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the docket unchanged. Because your for public viewing and posted on http:// submit to the Division of Dockets
comment will be made public, you are www.regulations.gov. Submit both Management (see DATES and ADDRESSES)
solely responsible for ensuring that your copies to the Division of Dockets either electronic or written comments
comment does not include any Management. If you do not wish your regarding this document. It is only
confidential information that you or a name and contact information to be necessary to send one set of comments.
third party may not wish to be posted, made publicly available, you can Identify comments with the docket
such as medical information, your or provide this information on the cover number found in brackets in the
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![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Proposed Rules 78529
heading of this document. FDA will also instructions for submitting comments. • Follow directions and organize your
place on public display any Once submitted, comments cannot be comments;
amendments to, or comments on, the edited or removed from Regulations.gov. • Explain why you agree or disagree;
petitioner’s environmental assessment The EPA may publish any comment • Suggest alternatives and substitute
without further announcement in the received to its public docket. Do not language for your requested changes;
Federal Register. If, based on its review, submit electronically any information • Describe any assumptions and
the Agency finds that an environmental you consider to be Confidential provide any technical information and/
impact statement is not required and Business Information (CBI) or other or data that you used;
this petition results in a regulation, the information whose disclosure is • If you estimate potential costs or
notice of availability of the Agency’s restricted by statute. Multimedia burdens, explain how you arrived at
finding of no significant impact and the submissions (audio, video, etc.) must be your estimate in sufficient detail to
evidence supporting that finding will be accompanied by a written comment. allow for it to be reproduced;
published with the regulation in the The written comment is considered the • Provide specific examples to
Federal Register in accordance with 21 official comment and should include illustrate your concerns, and suggest
CFR 25.51(b). discussion of all points you wish to alternatives;
make. The EPA will generally not • Explain your views as clearly as
Dated: November 2, 2016. possible, avoiding the use of profanity
consider comments or comment
Tracey H. Forfa, or personal threats; and,
contents located outside of the primary
Deputy Director, Center for Veterinary submission (i.e., on the web, cloud, or • Make sure to submit your
Medicine.
other file sharing system). For comments by the comment period
[FR Doc. 2016–26922 Filed 11–7–16; 8:45 am] additional submission methods, the full deadline identified.
BILLING CODE 4164–01–P EPA public comment policy, II. Background
information about CBI or multimedia On March 12, 2008, the EPA
submissions, and general guidance on promulgated a new NAAQS for ozone,
ENVIRONMENTAL PROTECTION making effective comments, please visit
AGENCY revising the levels of the primary and
http://www2.epa.gov/dockets/ secondary eight-hour ozone standards
commenting-epa-dockets. from 0.08 parts per million (ppm) to
40 CFR Part 52
FOR FURTHER INFORMATION CONTACT: 0.075 ppm (73 FR 16436, March 27,
[EPA–R08–OAR–2012–0933; FRL–9954–92– Abby Fulton, Air Program, U.S. 2008). Subsequently, on October 15,
Region 8] Environmental Protection Agency 2008, the EPA revised the level of the
(EPA), Region 8, Mail Code 8P–AR, primary and secondary Pb NAAQS from
Promulgation of State Implementation 1595 Wynkoop Street, Denver, Colorado
Plan Revisions; Infrastructure 1.5 micrograms per cubic meter (mg/m3)
80202–1129, (303) 312–6563, to 0.15 mg/m3 (73 FR 66964, Nov. 12,
Requirements for the 2008 Lead, 2008 fulton.abby@epa.gov.
Ozone, 2010 NO2, 2010 SO2, and 2012 2008). On January 22, 2010, the EPA
SUPPLEMENTARY INFORMATION: promulgated a new one-hour primary
PM2.5 National Ambient Air Quality
Standards; Wyoming I. General Information NAAQS for NO2 at a level of 100 parts
per billion (ppb) while retaining the
AGENCY: Environmental Protection What should I consider as I prepare my annual standard of 53 ppb. The 2010
Agency. comments for the EPA? NO2 NAAQS is expressed as the three-
ACTION: Proposed rule. 1. Submitting Confidential Business year average of the 98th percentile of the
Information (CBI). Do not submit CBI to annual distribution of daily maximum
SUMMARY: The Environmental Protection the EPA through http:// one-hour average concentrations. The
Agency (EPA) is proposing to approve www.regulations.gov or email. Clearly secondary NO2 NAAQS remains
elements of State Implementation Plan mark the part or all of the information unchanged at 53 ppb (75 FR 6474, Feb.
(SIP) revisions from the State of that you claim to be CBI. For CBI 9, 2010). On June 2, 2010, the EPA
Wyoming to demonstrate the State information on a disk or CD–ROM that promulgated a revised primary SO2
meets infrastructure requirements of the you mail to the EPA, mark the outside standard at 75 ppb, based on a three-
Clean Air Act (Act or CAA) for the of the disk or CD–ROM as CBI and then year average of the annual 99th
National Ambient Air Quality Standards identify electronically within the disk or percentile of one-hour daily maximum
(NAAQS) promulgated for ozone on CD–ROM the specific information that concentrations (75 FR 35520, June 22,
March 12, 2008, lead (Pb) on October is claimed as CBI. In addition to one 2010). Finally, on December 14, 2012,
15, 2008, nitrogen dioxide (NO2) on complete version of the comment that the EPA promulgated a revised annual
January 22, 2010, sulfur dioxide (SO2) includes information claimed as CBI, a PM2.5 standard by lowering the level to
on June 2, 2010, and fine particulate copy of the comment that does not 12.0 mg/m3 and retaining the 24-hour
matter (PM2.5) on December 14, 2012. contain the information claimed as CBI PM2.5 standard at a level of 35 mg/m3 (78
The EPA is also proposing to approve must be submitted for inclusion in the FR 3086, Jan. 15, 2013).
SIP revisions the State submitted public docket. Information so marked Under sections 110(a)(1) and (2) of the
regarding state boards. Section 110(a) of will not be disclosed except in CAA, states are required to submit
the CAA requires that each state submit accordance with procedures set forth in infrastructure SIPs to ensure their SIPs
a SIP for the implementation, 40 CFR part 2. provide for implementation,
maintenance and enforcement of each 2. Tips for preparing your comments. maintenance and enforcement of the
Lhorne on DSK30JT082PROD with PROPOSALS
NAAQS promulgated by the EPA. When submitting comments, remember NAAQS. These submissions must
DATES: Written comments must be to: contain any revisions needed for
received on or before December 8, 2016. • Identify the rulemaking by docket meeting the applicable SIP requirements
ADDRESSES: Submit your comments, number and other identifying of section 110(a)(2), or certifications that
identified by Docket ID No. EPA–R08– information (subject heading, Federal their existing SIPs for PM2.5, ozone, Pb,
OAR–2012–0933 at http:// Register volume, date, and page NO2, and SO2 already meet those
www.regulations.gov. Follow the online number); requirements. The EPA highlighted this
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Document Created: 2018-02-14 08:23:46
Document Modified: 2018-02-14 08:23:46
| 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. | |
| Dates | Submit either electronic or written comments on the petitioner's environmental assessment by December 8, 2016. | |
| 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 78528 |
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