[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32440-32441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-1376]


Cancer Clinical Trial Eligibility Criteria: Washout Periods and 
Concomitant Medications; Draft Guidance for Industry, Institutional 
Review Boards, and Clinical Investigators; 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the availability of a draft guidance for industry, institutional review 
boards (IRBs), and clinical investigators entitled ``Cancer Clinical 
Trial Eligibility Criteria: Washout Periods and Concomitant 
Medications.'' This draft guidance is one in a series of guidances that 
provide recommendations regarding eligibility criteria for clinical 
trials of investigational drugs regulated by the Center for Drug 
Evaluation and Research (CDER) and the Center for Biologics Evaluation 
Research (CBER) for the treatment of cancer. Specifically, this draft 
guidance includes recommendations regarding the appropriate use of 
washout periods and concomitant medication exclusions.

DATES: Submit either electronic or written comments on the draft 
guidance by June 25, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2024-D-1376 for ``Cancer Clinical Trial Eligibility Criteria: 
Washout Periods and Concomitant Medications.'' 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 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: Jamie Brewer, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2319, Silver Spring, MD 20993, 240-402-
4463; or Vishal Bhatnagar, Oncology Center of Excellence, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2113, Silver 
Spring, MD 20993, 240-402-3696; or James Myers, 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.

[[Page 32441]]


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for 
industry, IRBs, and clinical investigators entitled ``Cancer Clinical 
Trial Eligibility Criteria: Washout Periods and Concomitant 
Medications.'' The purposes of eligibility criteria are to select the 
intended patient population and reduce potential risks to trial 
participants. However, eligibility criteria are sometimes more 
restrictive than necessary, and expanding eligibility criteria to be 
more inclusive is one trial design consideration that may improve the 
diversity of clinical trial populations. This draft guidance is one in 
a series of guidances that provide recommendations regarding 
eligibility criteria for clinical trials of investigational drugs 
regulated by CDER and CBER for the treatment of cancer. Specifically, 
this draft guidance includes recommendations regarding the appropriate 
use of washout periods and concomitant medication exclusions and is 
intended to assist interested parties, including sponsors and IRBs, who 
are responsible for the development and oversight of clinical trials.
    A clinical trial's eligibility criteria (for inclusion and 
exclusion) are essential components of the trial, defining the 
characteristics of the study population. Because there is variability 
in investigational drugs and trial objectives, eligibility criteria 
should be developed taking into consideration the mechanism of action 
of the drug, the targeted disease or patient population, the 
anticipated safety of the investigational drug, the availability of 
adequate safety data, and the ability to recruit trial participants 
from the patient population to meet the objectives of the clinical 
trial. The Agency recognizes that some eligibility criteria may have 
become commonly accepted over time or used as a template across trials, 
but such criteria should be carefully considered and be appropriate for 
a specific trial context. Unnecessarily restrictive eligibility 
criteria may slow patient accrual, limit patients' access to clinical 
trials, and lead to trial results that do not fully represent treatment 
effects in the patient population that will ultimately use the drug.
    Appropriately broadening cancer trial eligibility criteria can 
improve the generalizability of trial results and provide a more 
detailed characterization of the therapy's benefit-risk profile across 
the patient population likely to use the drug in clinical practice.
    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 on ``Cancer 
Clinical Trial Eligibility Criteria: Washout Periods and Concomitant 
Medications.'' 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. The 
previously approved collections of information are subject to review by 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3521). 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; 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 
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: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09038 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P