Document ID: FDA-2017-D-6759-0003
Agency: fda
Document Type: Notice
Title: Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; Guidance for Industry; Availability
Posted Date: 2018-05-21T04:00Z

[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23461-23463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10732]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6759]

Establishing Effectiveness for Drugs Intended To Treat Male 
Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 23462]]

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Establishing 
Effectiveness for Drugs Intended to Treat Male Hypogonadotropic 
Hypogonadism Attributed to Nonstructural Disorders.'' This guidance 
provides recommendations for establishing clinical effectiveness for 
drugs intended to treat male hypogonadotropic hypogonadism associated 
with obesity and other conditions that do not cause structural 
disorders of the hypothalamus or pituitary gland. This guidance 
incorporates advice FDA received at a December 2014 advisory committee 
meeting on the appropriate indicated population for testosterone 
therapy and a December 2016 advisory committee meeting on 
hypogonadotropic hypogonadism. This guidance finalizes the draft 
guidance of the same name issued on January 3, 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on May 21, 2018.

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-2017-D-6759 for ``Establishing Effectiveness for Drugs Intended to 
Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural 
Disorders; Guidance for Industry; Availability.'' 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 this 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. 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: Jeannie Roule, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301-
796-3993.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Establishing Effectiveness for Drugs Intended to Treat Male 
Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.'' 
This guidance provides recommendations for establishing clinical 
effectiveness for drugs intended to treat male hypogonadotropic 
hypogonadism associated with obesity and other conditions that do not 
cause structural disorders of the hypothalamus or pituitary gland. This 
guidance incorporates advice FDA received at a December 2014 advisory 
committee meeting on the appropriate indicated population for 
testosterone therapy and a December 2016 advisory committee meeting on 
hypogonadotropic hypogonadism. This guidance finalizes the draft 
guidance of the same name issued on January 3, 2018 (83 FR 383). The 
guidance includes editorial changes and a new sentence clarifying that 
the recommendations do not apply to testosterones and testosterone 
esters seeking the traditional indication of replacement therapy in 
adult males for conditions associated with a deficiency or absence of 
endogenous testosterone.
    This guidance is being issued consistent with FDA's good guidance

[[Page 23463]]

practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on establishing effectiveness for drugs 
intended to treat male hypogonadotropic hypogonadism attributed to 
nonstructural disorders. 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. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10732 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P