[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44901-44902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18363]



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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Male Breast Cancer: Developing Drugs for Treatment; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Male 
Breast Cancer: Developing Drugs for Treatment.'' This draft guidance 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 Specifically, this draft guidance recommends the 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.

DATES: Submit either electronic or written comments on the draft 
guidance by October 28, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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.gpo.gov/fdsys/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.
    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 Office of Communication, Outreach and Development, CBER, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002; Division of Drug Information, CDER, Food 
and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 
4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. The 
draft 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 draft 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 draft guidance for industry 
entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This 
draft 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

[[Page 44902]]

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 draft guidance recommends sponsors discuss their breast cancer 
drug development plan early in development with CDER or CBER, as 
applicable. The draft 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 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 ``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. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). The 
collections of information in 21 CFR 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 
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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: August 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18363 Filed 8-26-19; 8:45 am]
 BILLING CODE 4164-01-P