[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76120-76121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-3163]


Considerations for Generating Clinical Evidence From Oncology 
Multiregional Clinical Development Programs; Draft Guidance for 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the availability of a draft guidance for industry entitled 
``Considerations for Generating Clinical Evidence From Oncology 
Multiregional Clinical Development Programs.'' This draft guidance 
provides recommendations to sponsors who are planning global clinical 
development programs for drugs intended to treat cancer, on improving 
the evidence obtained from one or more multiregional clinical trials 
(MRCTs) intended to support a marketing application. This draft 
guidance expands on principles described in FDA's existing guidance 
documents related to this topic, by providing additional 
recommendations for the planning, design, conduct, and analysis of an 
oncology MRCT that may facilitate FDA's assessment of applicability of 
the data to the U.S. population with the cancer being investigated and 
to U.S. medical practice.

DATES: Submit either electronic or written comments on the draft 
guidance by November 18, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <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-

[[Page 76121]]

2024-D-3163 for ``Considerations for Generating Clinical Evidence From 
Oncology Multiregional Clinical Development Programs.'' 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: Lola Fashoyin-Aje, Oncology Center of 
Excellence, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 240-402-0205; or Sandra Casak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2200, Silver Spring, MD 20993, 301-796-
3812; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Considerations for Generating Clinical Evidence From 
Oncology Multiregional Clinical Development Programs.'' This draft 
guidance is intended for sponsors who are planning global oncology 
clinical development programs for drugs to support a marketing 
application. The paramount consideration for FDA when evaluating MRCTs 
is whether the results are applicable to the intended use population in 
the United States, and to U.S. standard oncological care. Therefore, 
when planning a multiregional clinical development program, which 
includes all clinical trials intended to support approval in the United 
States, including the pivotal trials, the evidence generated should be 
derived from study populations that enable the results to be 
interpretable in the context of U.S. patients with the disease or 
condition and U.S. medical practice.
    FDA is providing more detailed recommendations for MRCTs conducted 
to provide the evidence to support the safe and effective use of cancer 
drugs in the U.S. population. This guidance expands on principles 
described in FDA's existing guidance documents related to this topic, 
by providing additional recommendations for the planning, design, 
conduct, and analysis of an oncology MRCT that may facilitate FDA's 
assessment of applicability of the data to the U.S. population with the 
cancer being investigated and to U.S. medical 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 
``Considerations for Generating Clinical Evidence From Oncology 
Multiregional Clinical Development Programs.'' 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 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (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 draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20995 Filed 9-16-24; 8:45 am]
BILLING CODE 4164-01-P