82_FR_44550 82 FR 44367 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use)

82 FR 44367 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 183 (September 22, 2017)

Page Range44367-44368
FR Document2017-20195

The Food and Drug Administration (FDA) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium DL- methionine as a nutritional source of chromium in cattle feed.

Federal Register, Volume 82 Issue 183 (Friday, September 22, 2017) 
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Proposed Rules]
[Pages 44367-44368]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-4399]


Zinpro Corp.; Filing of Food Additive Petition (Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Zinpro Corp. has filed a petition proposing that the food additive 
regulations be amended to provide for the safe use of chromium DL-
methionine as a nutritional source of chromium in cattle feed.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by October 23, 2017.

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 October 23, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 23, 2017. 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 comment, 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-4399 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Chromium DL-Methionine.'' 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 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 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.

[[Page 44368]]


FOR FURTHER INFORMATION CONTACT: Carissa Doody, Center for Veterinary 
Medicine, 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 2300) has been filed by the Zinpro Corp., 
10400 Viking Dr., Suite 240, Eden Prairie, MN 55344. The petition 
proposes to amend Title 21 of the Code of Federal Regulations (CFR) in 
part 573 Food Additives Permitted in Feed and Drinking Water of Animals 
(21 CFR part 573) to provide for the safe use of chromium DL-methionine 
as a nutritional source of chromium in cattle feed.
    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 (EA) submitted with 
the petition that is the subject of this notice on public display at 
the Dockets Management Staff for public review and comment (see DATES 
and ADDRESSES). FDA will also place on public display any amendments 
to, or comments on, the petitioner's EA 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: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20195 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Proposed Rules 44367 PART 71—DESIGNATION OF CLASS A, SUMMARY: The Food and Drug • For written/paper comments B, C, D, AND E AIRSPACE AREAS; AIR Administration (FDA) is announcing submitted to the Dockets Management TRAFFIC SERVICE ROUTES; AND that Zinpro Corp. has filed a petition Staff, FDA will post your comment, as REPORTING POINTS proposing that the food additive well as any attachments, except for regulations be amended to provide for information submitted, marked and ■ 1. The authority citation for 14 CFR the safe use of chromium DL- identified, as confidential, if submitted part 71 continues to read as follows: methionine as a nutritional source of as detailed in ‘‘Instructions.’’ Authority: 49 U.S.C. 106(f), 106(g); 40103, chromium in cattle feed. Instructions: All submissions received 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, DATES: Submit either electronic or must include the Docket No. FDA– 1959–1963 Comp., p. 389. written comments on the petitioner’s 2017–F–4399 for ‘‘Food Additives § 71.1 [Amended] environmental assessment by October Permitted in Feed and Drinking Water 23, 2017. of Animals; Chromium DL-Methionine.’’ ■ 2. The incorporation by reference in ADDRESSES: You may submit comments Received comments, those filed in a 14 CFR 71.1 of FAA Order 7400.11B, as follows. Please note that late, timely manner (see ADDRESSES), will be Airspace Designations and Reporting untimely filed comments will not be placed in the docket and, except for Points, dated August 3, 2017, and considered. Electronic comments must those submitted as ‘‘Confidential effective September 15, 2017, is be submitted on or before October 23, Submissions,’’ publicly viewable at amended as follows: 2017. The https://www.regulations.gov https://www.regulations.gov or at the Paragraph 6005 Class E Airspace Areas Dockets Management Staff between 9 electronic filing system will accept Extending Upward From 700 Feet or More a.m. and 4 p.m., Monday through Above the Surface of the Earth. comments until midnight Eastern Time at the end of October 23, 2017. Friday. * * * * * Comments received by mail/hand • Confidential Submissions—To AGL WI E5 Milwaukee, WI [Amended] delivery/courier (for written/paper submit a comment with confidential Milwaukee, General Mitchell International submissions) will be considered timely information that you do not wish to be Airport, WI if they are postmarked or the delivery made publicly available, submit your (Lat. 42°56′49″ N., long. 87°53′49″ W.) service acceptance receipt is on or comment only as a written/paper Racine, Batten International Airport, WI before that date. submission. You should submit two (Lat. 42°45′40″ N., long. 87°48′50″ W.) copies total. One copy will include the Waukesha, Waukesha County Airport, WI Electronic Submissions information you claim to be confidential (Lat. 43°02′28″ N., long. 88°14′13″ W.) with a heading or cover note that states Submit electronic comments in the Milwaukee, Lawrence J. Timmerman Airport, ‘‘THIS DOCUMENT CONTAINS WI following way: (Lat. 43°06′37″ N., long. 88°02′04″ W.) • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The https://www.regulations.gov. Follow the Agency will review this copy, including That airspace extending upward from 700 feet above the surface within an 8.4-mile instructions for submitting comments. the claimed confidential information, in radius of General Mitchell International Comments submitted electronically, its consideration of comments. The Airport, and within a 6.6-mile radius of including attachments, to https:// second copy, which will have the Batten International Airport, and within a www.regulations.gov will be posted to claimed confidential information 7.5-mile radius of Waukesha County Airport, the docket unchanged. Because your redacted/blacked out, will be available and within 2 miles each side of the 282° comment will be made public, you are for public viewing and posted on bearing from Waukesha County Airport https://www.regulations.gov. Submit solely responsible for ensuring that your extending from the 7.5-mile radius to 10.5 both copies to the Dockets Management miles west of Waukesha County Airport, and comment does not include any within an 8.9-mile radius of Lawrence J. confidential information that you or a Staff. If you do not wish your name and Timmerman Airport. third party may not wish to be posted, contact information to be made publicly such as medical information, your or available, you can provide this Issued in Fort Worth, Texas, on September anyone else’s Social Security number, or information on the cover sheet and not 13, 2017. confidential business information, such in the body of your comments and you Vonnie Royal, as a manufacturing process. Please note must identify this information as Acting Manager, Operations Support Group, ‘‘confidential.’’ Any information marked ATO Central Service Center. that if you include your name, contact information, or other information that as ‘‘confidential’’ will not be disclosed [FR Doc. 2017–19948 Filed 9–21–17; 8:45 am] except in accordance with 21 CFR 10.20 identifies you in the body of your BILLING CODE 4910–13–P comment, that information will be and other applicable disclosure law. For posted on https://www.regulations.gov. more information about FDA’s posting • If you want to submit a comment of comments to public dockets, see 80 DEPARTMENT OF HEALTH AND with confidential information that you FR 56469, September 18, 2015, or access HUMAN SERVICES 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- Food and Drug Administration 23389.pdf. written/paper submission and in the manner detailed (see ‘‘Written/Paper Docket: For access to the docket to 21 CFR Part 573 read background documents or the Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2017–F–4399] electronic and written/paper comments Written/Paper Submissions received, go to https:// Zinpro Corp.; Filing of Food Additive Submit written/paper submissions as www.regulations.gov and insert the Petition (Animal Use) follows: docket number, found in brackets in the AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for heading of this document, into the HHS. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts Management Staff (HFA–305), Food and and/or go to the Dockets Management ACTION:Notification; petition for Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, rulemaking. Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. VerDate Sep<11>2014 16:19 Sep 21, 2017 Jkt 241001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\FR\FM\22SEP1.SGM 22SEP1

44368 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Proposed Rules FOR FURTHER INFORMATION CONTACT: LIBRARY OF CONGRESS https://app.crb.gov/ and search for Carissa Doody, Center for Veterinary docket number 15–CRB–0010–CA–S Medicine, Food and Drug Copyright Royalty Board (Sports Rule Proceeding). For Administration, 7519 Standish Pl., documents not yet uploaded to eCRB Rockville, MD 20855, 240–402–6283, 37 CFR Part 387 (because it is a new system), go to the carissa.doody@fda.hhs.gov. [Docket No. 15–CRB–0010–CA–S (Sports agency Web site at http://www.crb.gov/ Rule Proceeding)] or contact the CRB Program Specialist. SUPPLEMENTARY INFORMATION: Under the FOR FURTHER INFORMATION CONTACT: Federal Food, Drug, and Cosmetic Act Adjustment of Royalty Rates for Anita Blaine, CRB Program Specialist, (section 409(b)(5) (21 U.S.C. 348(b)(5)), Statutory Cable Retransmission by telephone at (202) 707–7658 or email notice is given that a food additive License at crb@loc.gov. petition (FAP 2300) has been filed by SUPPLEMENTARY INFORMATION: In May the Zinpro Corp., 10400 Viking Dr., AGENCY: Copyright Royalty Board (CRB), Library of Congress. 2017, the Copyright Royalty Judges Suite 240, Eden Prairie, MN 55344. The (Judges) published notice of an agreed petition proposes to amend Title 21 of ACTION: Request for comments. settlement and proposed rules to adjust the Code of Federal Regulations (CFR) SUMMARY: The Copyright Royalty Judges royalties payable by certain cable in part 573 Food Additives Permitted in solicit reply comments on the legal system operators for a license to Feed and Drinking Water of Animals (21 issue of the purported reach of the retransmit broadcast sports CFR part 573) to provide for the safe use proposed rules relating to a cable system programming (the Sports Surcharge of chromium DL-methionine as a license royalty surcharge for Rules). See 82 FR 24611 (May 30, 2017). nutritional source of chromium in cattle retransmission of broadcasts of certain Specifically, the rules as proposed feed. professional sports events. would be applicable to ‘‘Form 3’’ cable DATES: Reply comments are due on or systems 1 retransmitting ‘‘eligible The potential environmental impact before October 23, 2017. Surreplies from professional sports events.’’ The of this action is being reviewed. To proposed rules define ‘‘eligible encourage public participation original commenters are due on or before November 1, 2017. professional sports event’’ as a game consistent with regulations issued under involving member teams of Major the National Environmental Policy Act ADDRESSES: You may make replies and League Baseball, the National Basketball (40 CFR 1501.4(b)), the Agency is surreplies, identified by docket number Association, the National Football placing the environmental assessment 15–CRB–0010–CA–S (Sports Rule League, the National Hockey League, (EA) submitted with the petition that is Proceeding), by any of the following and the Women’s National Basketball the subject of this notice on public methods: Association.2 display at the Dockets Management Staff CRB’s electronic filing application: The Copyright Act (Act) directs that for public review and comment (see Submit comments online in eCRB at the Judges provide (1) an opportunity to https://app.crb.gov/. comment to nonparticipants who would DATES and ADDRESSES). FDA will also U.S. mail: Copyright Royalty Board, place on public display any be bound and (2) an opportunity to P.O. Box 70977, Washington, DC 20024– amendments to, or comments on, the comment and object to participants who 0977; or petitioner’s EA without further would be bound. See 11 U.S.C. Overnight service (only USPS Express announcement in the Federal Register. 801(b)(7)(A)(i). The Judges may decline Mail is acceptable): Copyright Royalty to adopt an agreement as a basis for If, based on its review, the Agency Board, P.O. Box 70977, Washington, DC statutory terms and rates for finds that an environmental impact 20024–0977; or Commercial courier: Address package ‘‘participants that are not parties to the statement is not required and this [settlement] agreement,’’ if a participant petition results in a regulation, the to: Copyright Royalty Board, Library of Congress, James Madison Memorial objects to the agreement and the Judges notice of availability of the Agency’s conclude that the settlement ‘‘does not finding of no significant impact and the Building, LM–403, 101 Independence Avenue SE., Washington, DC 20559– provide a reasonable basis for setting’’ evidence supporting that finding will be rates or terms. Id. at § 801(b)(7)(A)(ii). published with the regulation in the 6000. Deliver to: Congressional Courier The statutory language does not Acceptance Site, 2nd Street NE and D Federal Register in accordance with 21 prohibit the Judges from considering Street NE., Washington, DC; or CFR 25.51(b). Hand delivery: Library of Congress, whether the proposed provisions are Dated: September 15, 2017. James Madison Memorial Building, LM– contrary to statutory law. See [Register 401, 101 Independence Avenue SE., of Copyrights] Review of Copyright Anna K. Abram, Washington, DC 20559–6000. Royalty Judges Determination, Docket Deputy Commissioner for Policy, Planning, no. 2009–1, 74 FR 4537, 4540 (Jan. 26, Legislation, and Analysis. Instructions: Unless submitting online, commenters must submit an 2009) (Register’s Opinion).3 In the cited [FR Doc. 2017–20195 Filed 9–21–17; 8:45 am] original, five paper copies, and an 1 ‘‘Form 3’’ cable systems are those with semi- BILLING CODE 4164–01–P electronic version on a CD. All annual gross receipts, as defined by statute, greater submissions must include the CRB’s than $527,600. See 17 U.S.C. 111(d)(1)(B), (E), & (F). name and docket number. All 2 The proposed sports programming surcharge submissions received will be posted would also apply to an ‘‘eligible collegiate sports event’’ as that term is defined in the proposed without change to eCRB on https:// regulations. Eligible collegiate sports events are app.crb.gov including any personal limited to games that involve certain Division I information provided. football or men’s basketball teams. Proposed Rule Docket: For access to the docket to 387.2(e)(5). 3 The Act permits the Register of Copyrights read background documents or (Register) to review for legal error the Judges’ comments received, go to eCRB, the resolution of a material question of substantive law Copyright Royalty Board’s electronic under the Act ‘‘that underlies or is contained in a filing and case management system, at final determination’’ by the Judges. See 17 U.S.C. VerDate Sep<11>2014 16:19 Sep 21, 2017 Jkt 241001 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 E:\FR\FM\22SEP1.SGM 22SEP1


Document Created: 2017-09-22 01:53:04
Document Modified: 2017-09-22 01:53:04
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.
DatesSubmit either electronic or written comments on the petitioner's environmental assessment by October 23, 2017.
ContactCarissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected]
FR Citation82 FR 44367 
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