[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33313-33315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13388]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1553]


Premenopausal Women With Breast Cancer: Developing Drugs for 
Treatment; 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 
``Premenopausal Women with Breast Cancer: Developing Drugs for 
Treatment.'' This guidance provides recommendations regarding the 
inclusion of premenopausal women in breast cancer clinical trials. The 
guidance is intended to assist stakeholders, including sponsors and 
institutional review boards, responsible for the development and 
oversight of clinical trials for breast cancer drugs. This guidance 
finalizes the draft guidance of the same title issued on October 8, 
2020.

DATES: The announcement of the guidance is published in the Federal 
Register on June 24, 2021.

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

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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-1553 for ``Premenopausal Women with Breast Cancer: 
Developing Drugs for Treatment.'' 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 
(CDER), Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2135, Silver Spring, MD 20993, 240-402-
4683; or Julia Beaver, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, 
Silver Spring, MD 20993, 240-402-0489; 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 ``Premenopausal Women with Breast Cancer: Developing Drugs for 
Treatment.'' This guidance provides recommendations regarding the 
inclusion of premenopausal women, as defined by serum hormonal levels 
(including but not limited to follicle-stimulating hormone and 
estradiol), in breast cancer clinical trials. The issues of fertility 
and fertility preservation when treating premenopausal women with 
breast cancer are outside the scope of this guidance.
    Historically, premenopausal women have been excluded from some 
trials that have investigated the efficacy of certain drugs that rely 
upon manipulation of the hormonal axis for the treatment of hormone 
receptor (HR) positive breast cancer. In some cases, separate studies 
have been conducted to confirm the benefit in this patient population. 
Certain groups of drugs, such as chemotherapy, immunotherapy, and 
targeted therapy (which act independent of the hormonal axis), have 
similar efficacy in pre- and postmenopausal women with breast cancer. 
Based on a review of the literature, FDA believes hormonal drugs 
administered to premenopausal women with HR-positive breast cancer, 
with adequate estrogen suppression, are likely to have the same 
efficacy and safety profile as in postmenopausal women.
    The guidance encourages sponsors to discuss their breast cancer 
drug development plan with CDER and CBER, as applicable, early in 
development. The guidance recommends that menopausal status should not 
be the basis for exclusion from breast cancer clinical trials. The 
guidance includes recommendations regarding eligibility criteria and 
study planning and design intended to facilitate the inclusion of 
premenopausal women in breast cancer clinical trials.
    This guidance finalizes the draft guidance entitled ``Premenopausal 
Women with Breast Cancer: Developing Drugs for Treatment'' issued on 
October 8, 2020 (85 FR 63559). FDA considered comments received on the 
draft guidance as the guidance was finalized. Changes from the draft to 
the final guidance include additional recommendations on the importance 
of clinical studies reflecting racial and ethnic diversity and to 
collect patient experience data throughout the development program. 
Other changes include updated recommendations on collection of clinical 
effects as part of the clinical development program or as part of a 
postmarketing requirement or commitment as applicable.
    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 ``Premenopausal Women with Breast Cancer: 
Developing Drugs for Treatment.'' 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

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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; 
and the collections of information in 21 CFR part 601 have been 
approved under 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: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13388 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P


