Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Guidance for Industry; Availability, 63501-63502 [2022-22705]

Download as PDF Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Comments received on or before October 26, 2022, will be provided to the committee. (3) On page 55009, in the third column, the first paragraph of the Procedure section of the SUPPLEMENTARY INFORMATION portion of the document is changed to read as follows: Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 26, 2022, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 26, 2022. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 27, 2022. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: October 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–22700 Filed 10–18–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jspears on DSK121TN23PROD with NOTICES [Docket No. FDA–2021–D–1246] Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:58 Oct 18, 2022 Jkt 259001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GIF) 258 entitled ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.’’ Tracers are ingredients added to animal food, medicated feed, and Type A medicated articles to identify a particular product. The purpose of this document is to provide guidance on the use of tracers in animal food, medicated feeds, and Type A medicated articles. This final guidance replaces Compliance Policy Guide (CPG) Sec. 680.100 ‘‘Tracers in Animal Feed.’’ DATES: The announcement of the guidance is published in the Federal Register on October 19, 2022. ADDRESSES: You may submit either electronic or written comments on any Agency guidances at any time as follows: SUMMARY: 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 63501 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– 2021–D–1246 for ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.’’ Received comments 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and E:\FR\FM\19OCN1.SGM 19OCN1 63502 Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding tracers used in animal food: Diego Paiva, Center for Veterinary Medicine (HFV–229), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6785, Diego.Paiva@fda.hhs.gov. Regarding tracers used in animal drug products: Rebecca Owen, Center for Veterinary Medicine (HFV–141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402– 0670, Rebecca.Owen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background jspears on DSK121TN23PROD with NOTICES II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 501.22 have been approved under OMB control number 17:58 Oct 18, 2022 III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: October 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–22705 Filed 10–18–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration In the Federal Register of March 2, 2022 (87 FR 11719), FDA published the notice of availability for a draft GIF #258 entitled ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds’’ giving interested persons until May 2, 2022, to comment on the draft guidance. FDA received one comment submission on the draft guidance and the comments in that submission were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated March 2, 2022. This guidance replaces CPG Sec. 680.100 ‘‘Tracers in Animal Feed.’’ This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the use of tracers in animal food, Type A medicated articles, and medicated feeds. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. VerDate Sep<11>2014 0910–0721. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. Jkt 259001 [Docket No. FDA–2019–N–2854] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by November 18, 2022. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0879. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Premarket Tobacco Product Applications and Recordkeeping Requirements—21 CFR 1114 OMB Control Number 0910–0879— Extension This information collection supports the requirements for the content, format, submission recordkeeping, and postmarket reporting requirements of a premarket tobacco product application (PMTA). Section 910(a) (21 U.S.C. 387j(a)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) established requirements for premarket review of new tobacco products and the implementing regulations are found in part 1114 (21 CFR part 1114), subchapter K. An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under this part until FDA has issued a marketing granted order for the product (§ 1114.5). Further, § 1114.7 describes the required content and format of the PMTA. The PMTA must contain sufficient information for FDA to determine whether any of the grounds for denial specified in section 910(c)(2) of the FD&C Act apply. The application must contain the following sections: general information, descriptive information, product samples, labeling, a statement of compliance with 21 CFR part 25, a summary, product formulation, manufacturing, health risk investigations, effect on the population as a whole, and a certification statement. Submitters can visit the following web page which describes the process for submitting a PMTA (https:// www.fda.gov/tobacco-products/marketand-distribute-tobacco-product/ premarket-tobacco-productapplications). After submission of a PMTA, FDA may request, and an applicant may submit, an amendment to a pending PMTA. FDA generally expects that when an applicant submits a PMTA, the submission will include all information required by section 910(b)(1) of the FD&C Act and part 1114 to enable FDA to determine whether it should authorize the marketing of a new tobacco product. However, FDA recognizes that additional information E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63501-63502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22705]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1246]


Use of Tracers in Animal Food, Type A Medicated Articles, and 
Medicated Feeds; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry (GIF) 258 entitled 
``Use of Tracers in Animal Food, Type A Medicated Articles, and 
Medicated Feeds.'' Tracers are ingredients added to animal food, 
medicated feed, and Type A medicated articles to identify a particular 
product. The purpose of this document is to provide guidance on the use 
of tracers in animal food, medicated feeds, and Type A medicated 
articles. This final guidance replaces Compliance Policy Guide (CPG) 
Sec. 680.100 ``Tracers in Animal Feed.''

DATES: The announcement of the guidance is published in the Federal 
Register on October 19, 2022.

ADDRESSES: You may submit either electronic or written comments on any 
Agency guidances at any time as follows:

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-2021-D-1246 for ``Use of Tracers in Animal Food, Type A Medicated 
Articles, and Medicated Feeds.'' Received comments 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and

[[Page 63502]]

Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding tracers used in animal food: 
Diego Paiva, Center for Veterinary Medicine (HFV-229), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6785, 
[email protected].
    Regarding tracers used in animal drug products: Rebecca Owen, 
Center for Veterinary Medicine (HFV-141), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-402-0670, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 2, 2022 (87 FR 11719), FDA 
published the notice of availability for a draft GIF #258 entitled 
``Use of Tracers in Animal Food, Type A Medicated Articles, and 
Medicated Feeds'' giving interested persons until May 2, 2022, to 
comment on the draft guidance. FDA received one comment submission on 
the draft guidance and the comments in that submission were considered 
as the guidance was finalized. The guidance announced in this notice 
finalizes the draft guidance dated March 2, 2022. This guidance 
replaces CPG Sec. 680.100 ``Tracers in Animal Feed.''
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on the use of tracers in animal food, Type 
A medicated articles, and medicated feeds. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR 501.22 have been approved under OMB control 
number 0910-0721. The collections of information in 21 CFR part 514 
have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22705 Filed 10-18-22; 8:45 am]
BILLING CODE 4164-01-P

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