11718 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–5572] 

Inclusion of Older Adults in Cancer 

Clinical Trials; 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 entitled 

‘‘Inclusion of Older Adults in Cancer 

Clinical Trials.’’ This guidance provides 

recommendations regarding the 

inclusion of older adult patients in 

clinical trials of drugs for the treatment 

of cancer. For the purpose of this final 

guidance, older adults are those age 65 

years and older. The final guidance 

emphasizes the particular importance of 

including adults over age 75 years in 

cancer clinical trials. Specifically, this 

final guidance includes 

recommendations for including an 

adequate representation of older adults 

in cancer clinical trials to better enable 

evaluation of the benefit-risk profile of 

cancer drugs in this population. This 

guidance finalizes the draft guidance of 

the same title issued on March 6, 2020. 

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: 

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– 

2019–D–5572 for ‘‘Inclusion of Older 

Adults in Cancer Clinical Trials.’’ 

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 this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. 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: 

Bindu Kanapuru, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2119, 

Silver Spring, MD 20993–0002, 240 

402–1279. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Inclusion of Older Adults in Cancer 

Clinical Trials.’’ This final guidance 

provides recommendations for 

stakeholders, including sponsors and 

institutional review boards, responsible 

for the development and oversight of 

clinical trials regarding the inclusion of 

older adult patients (i.e., age 65 years 

and older) in clinical trials of drugs for 

the treatment of cancer. The final 

guidance emphasizes the particular 

importance of including adults over age 

75 years in cancer clinical trials. 

Enrolling an adequate representation 

of the range of patients in a clinical trial 

that may be exposed to a drug after 

approval can maximize the 

generalizability of the trial results. It 

provides the ability to understand the 

drug’s benefit-risk profile across the 

patient population likely to use the drug 

in clinical practice. Including 

information in the labeling describing 

use in older adults helps to promote the 

safe and effective use of these products 

and better informs treatment decisions 

in clinical practice. 

Older adults are underrepresented in 

cancer clinical trials despite 


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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 11719 

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 

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. 

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 


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