[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45113-45114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1802]


Cancer Clinical Trial Eligibility Criteria: Available Therapy in 
Non-Curative Settings; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Cancer 
Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative 
Settings.'' The guidance provides recommendations to sponsors of 
clinical trials of investigational cancer drugs regarding the inclusion 
of patients who have not previously received available therapy 
(commonly referred to as existing treatment options) for their cancer 
in the non-curative setting. This guidance finalizes the draft guidance 
of the same title issued on June 24, 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on July 27, 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-2020-D-1802 for ``Cancer Clinical Trial Eligibility Criteria: 
Available Therapy in Non-Curative Settings.'' 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

[[Page 45114]]

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 or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Jennifer Gao, Oncology Center of 
Excellence, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 2135, Silver Spring, MD 20993-0002, 240-402-4683; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Cancer Clinical Trial Eligibility Criteria: Available 
Therapy in Non-Curative Settings.'' The guidance provides 
recommendations regarding the inclusion of patients who have not 
received available therapy for their cancer in clinical trials of 
investigational cancer drugs and biological products in the non-
curative setting. For the purposes of this guidance, non-curative is 
generally defined as: (1) unresectable, locally advanced, or metastatic 
disease in solid tumors or (2) hematologic malignancies with 
unfavorable long-term overall survival.
    Under 21 CFR part 312, which applies to clinical investigations of 
drugs and biological products, FDA must determine that study subjects 
are not exposed to an unreasonable and significant risk of illness or 
injury (312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed. 
Therefore, in clinical trials evaluating investigational cancer drugs, 
eligibility criteria should generally require that patients have 
received available therapy(ies) that offer the potential for cure in a 
substantial proportion of patients. Alternatively, such available 
therapy should be administered to all patients in the trial, where the 
investigational drug is added to such therapy. However, eligibility 
criteria in which patients receive an investigational drug(s) in lieu 
of available therapy are reasonable in the non-curative setting when 
patients have been provided with adequate information to make an 
informed decision on trial participation. The guidance describes 
information that should be included in the informed consent and 
includes recommendations regarding evaluation of results when this 
approach is taken.
    This guidance finalizes the draft guidance entitled ``Cancer 
Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative 
Settings'' issued on June 24, 2021 (86 FR 33710). FDA considered 
comments received on the draft guidance as the guidance was finalized. 
Changes from the draft to the final guidance include additional 
recommendations for safety evaluation in early stage dose escalation 
studies.
    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 ``Cancer Clinical Trial Eligibility 
Criteria: Available Therapy in Non-Curative Settings.'' 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 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; and the collections of 
information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16074 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P


