[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 This guidance finalizes the draft
guidance of the same name issued on January 3, 2018.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]
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