Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Draft Guidance for Industry; Availability, 11719-11720 [2022-04370]

Download as PDF Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 representing a growing segment of the population of cancer patients. Therefore, more information is needed to better inform treatment decisions for older adults with cancer. The issue persists in oncology despite FDA’s efforts to increase the inclusion of older adults in clinical trials. The guidance recommends that sponsors of cancer trials consider the age demographics of their target population early in development and that a strategy for inclusion of older adults be informed by any known information for older adults. The final guidance includes recommendations for inclusion of older adults related to early clinical development; clinical trials, including considerations for trial design, recruitment, and developing and reporting discrete age subgroups; and the postmarket setting. This guidance finalizes the draft guidance entitled ‘‘Inclusion of Older Adults in Cancer Clinical Trials’’ issued on March 6, 2020 (85 FR 13167). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include capture of comorbidity information, clarification that this guidance applies to both small and large studies, added guidance on decentralization and recruitment efforts for community oncologists, an improved definition of adequate representation in a study trial, clarification of trial design stratification, and added references to other guidances. This 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 ‘‘Inclusion of Older Adults in Cancer Clinical Trials.’’ 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 part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control VerDate Sep<11>2014 17:34 Mar 01, 2022 Jkt 256001 number 0910–0001; the collections of information in 21 CFR part 601 have been approved under 0910–0338; and the collections of information in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: February 24, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–04399 Filed 3–1–22; 8:45 am] BILLING CODE 4164–01–P 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; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #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. When finalized, this guidance will replace Compliance Policy Guide (CPG) Sec. 680.100 Tracers in Animal Feed. DATES: Submit either electronic or written comments on the draft guidance by May 2, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 11719 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 E:\FR\FM\02MRN1.SGM 02MRN1 lotter on DSK11XQN23PROD with NOTICES1 11720 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 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. 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 draft guidance to the Policy and 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 draft 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 Place, 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 Place, Rockville, MD 20855, 240–402–0670, Rebecca.Owen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Veterinary Medicine receives inquiries regarding the use of ‘‘tracers’’ in animal food, medicated feeds, and Type A medicated articles. Tracers are ingredients added to these products 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. When finalized, this guidance will replace CPG Sec. 680.100 Tracers in Animal Feed. This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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. I. Background [FR Doc. 2022–04370 Filed 3–1–22; 8:45 am] FDA is announcing the availability of a draft guidance for industry #258 entitled ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.’’ FDA’s Center for BILLING CODE 4164–01–P VerDate Sep<11>2014 17:34 Mar 01, 2022 Jkt 256001 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 draft guidance at https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: February 24, 2022. Lauren K. Roth, Associate Commissioner for Policy. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2777] Expansion Cohorts: Use in First-inHuman Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Expansion Cohorts: Use in First-inHuman Clinical Trials to Expedite Development of Oncology Drugs and Biologics.’’ The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. This guidance finalizes the draft guidance of the same name issued in August 2018. DATES: The announcement of the guidance is published in the Federal Register on March 2, 2022. ADDRESSES: You may submit either electronic or written comments on 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 E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11719-11720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04370]


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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; Draft 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 draft guidance for industry #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. When 
finalized, this guidance will replace Compliance Policy Guide (CPG) 
Sec. 680.100 Tracers in Animal Feed.

DATES: Submit either electronic or written comments on the draft 
guidance by May 2, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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

[[Page 11720]]

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.
    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 draft guidance to 
the Policy and 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 draft 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 Place, 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 Place, Rockville, MD 20855, 240-
402-0670, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#258 entitled ``Use of Tracers in Animal Food, Type A Medicated 
Articles, and Medicated Feeds.'' FDA's Center for Veterinary Medicine 
receives inquiries regarding the use of ``tracers'' in animal food, 
medicated feeds, and Type A medicated articles. Tracers are ingredients 
added to these products 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. When finalized, 
this guidance will replace CPG Sec. 680.100 Tracers in Animal Feed.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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 draft guidance 
at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04370 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P

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