[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Pages 48706-48708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2966]


Male Breast Cancer: Developing Drugs for Treatment; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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[[Page 48707]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Male 
Breast Cancer: Developing Drugs for Treatment.'' This guidance provides 
recommendations regarding the development and labeling of cancer drugs, 
including biological products, regulated by the Center for Drug 
Evaluation and Research (CDER) and the Center for Biologics Evaluation 
and Research (CBER) for the treatment of male patients with breast 
cancer. Specifically, this guidance recommends the inclusion of male 
patients in clinical trials of breast cancer drugs and provides 
recommendations on clinical development when males have either not been 
included in clinical trials for drugs to treat breast cancer or when 
inclusion of males in those trials is very limited. The development of 
drugs for male breast cancer may provide clinical data and additional 
FDA-approved treatment options to improve the clinical management of 
breast cancer in male patients. The guidance announced in this notice 
finalizes the draft guidance of the same title issued on August 27, 
2019.

DATES: The announcement of the guidance is published in the Federal 
Register on August 12, 2020.

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-2019-D-2966 for ``Male 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.
     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, or phone 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, CDER, 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, 
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. The 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 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 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This 
guidance provides recommendations for sponsors regarding the 
development and labeling of cancer drugs and biological products 
regulated by CDER and CBER for the treatment of male patients with 
breast cancer. Males have historically been excluded from clinical 
trials of breast cancer drugs because breast cancer in males is rare. 
This has resulted in limited FDA-approved treatment options for males. 
Clinical management of male breast cancer is generally based on 
experience with and data from females with breast cancer, rather than 
on data from prospective, randomized clinical trials.
    The final guidance recommends sponsors discuss their breast cancer

[[Page 48708]]

drug development plan early in development with CDER or CBER, as 
applicable. The guidance recommends that eligibility criteria for 
clinical trials of breast cancer drugs allow for inclusion of males. 
When males have not been included or when inclusion of males is very 
limited in clinical trials for breast cancer drugs, the guidance 
includes clinical development recommendations for when no difference in 
efficacy or safety is anticipated between males and females based on 
the drug's mechanism of action and for when there is a concern for 
differential efficacy or safety between males and females.
    This guidance finalizes the draft guidance entitled ``Male Breast 
Cancer: Developing Drugs for Treatment'' issued on August 27, 2019. FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include the 
addition of examples of topics for early discussion with FDA and 
expectations regarding nonclinical 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 ``Male 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

    This guidance refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
the 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; the collections of information in 21 CFR 
part 601 have been approved under OMB control number 0910-0338; the 
collections of information in 21 CFR 201.56 and 201.57 have been 
approved under OMB control number 0910-0572.

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, or https://www.regulations.gov.

    Dated: August 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17575 Filed 8-11-20; 8:45 am]
BILLING CODE 4164-01-P