[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33710-33712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13585]


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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: Approach to Available 
Therapy in Non-Curative Settings; Draft Guidance for Sponsors; 
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the availability of a draft guidance for sponsors entitled ``Cancer 
Clinical Trial Eligibility Criteria: Approach to Available Therapy in 
Non-Curative Settings.'' The draft guidance provides recommendations to 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. The draft guidance is intended to 
facilitate increased clinical trial options for patients with non-
curable cancers by recognizing that, with appropriate informed consent, 
it may be reasonable for patients to be eligible for inclusion in 
trials of investigational cancer drugs, regardless of whether they have 
received available therapy, in the non-curative setting.

DATES: Submit either electronic or written comments on the draft 
guidance by August 24, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 33711]]

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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: 
Approach to 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.
    <bullet> 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 draft 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 draft 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; Chana 
Weinstock, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2357, Silver 
Spring, MD 20993-0002, 240-402-2625; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for sponsors 
entitled ``Cancer Clinical Trial Eligibility Criteria: Approach to 
Available Therapy in Non-Curative Settings.'' The draft 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 purpose of this draft guidance, non-curative 
is defined as circumstances where there is extremely low likelihood for 
cure or for prolonged and/or near normal survival with available 
therapies (i.e., hematologic malignancies or solid tumors that are 
unresectable, locally advanced, or metastatic cancer with unfavorable 
long-term overall survival).
    For clinical trials of products regulated under part 312 (21 CFR 
part 312), FDA must determine that study subjects are not exposed to an 
unreasonable and significant risk of illness or injury (21 CFR 
312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed. 
Therefore, eligibility criteria should generally require that patients 
have received available therapy(ies) that offer the potential for cure 
in a substantial proportion of patients in clinical trials evaluating 
investigational cancer drugs. 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 draft guidance also 
describes information that should be included in the informed consent 
when this approach is taken. The draft guidance further includes 
recommendations regarding efficacy analyses when this approach is 
taken.
    This 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

[[Page 33712]]

on ``Cancer Clinical Trial Eligibility Criteria: Approach to 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 draft 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: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13585 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P