81 FR 74451 - Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range		74451-74452
FR Document		2016-25788

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/ or arousal in women. Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74451-74452]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-25788]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2817]

Low Sexual Interest, Desire, and/or Arousal in Women: 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Drugs for Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Low Sexual
Interest, Desire, and/or Arousal in Women: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in
developing drugs for the treatment of low sexual interest, desire, and/
or arousal in women. Specifically, this guidance addresses FDA's
current thinking regarding the overall clinical development program,
with a focus on phase 3 trial designs, to support an indication for the
treatment of these conditions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-2817 for Low Sexual Interest, Desire, and/or Arousal in
Women: Developing Drugs for Treatment; Draft Guidance for Industry;
Availability. Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Mercier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301-
796-0957.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Low Sexual Interest, Desire, and/or Arousal in Women:
Developing Drugs

[[Page 74452]]

for Treatment.'' The purpose of this draft guidance is to assist
sponsors in developing drugs for the treatment of low sexual interest,
desire, and/or arousal in women. Specifically, this draft guidance
addresses FDA's current thinking regarding the overall clinical
development program, with a focus on phase 3 trial designs, to support
an indication for the treatment of these conditions.
On October 27, 2014, FDA convened a public patient-focused drug
development meeting and heard directly from women suffering from female
sexual desire and arousal disorders. The following day, FDA held a
public scientific workshop with invited experts in sexual medicine to
discuss scientific challenges involved in developing drugs to treat
these disorders, including diagnostic criteria, endpoints, and patient-
reported outcome instruments. Comments from the public and experts that
were communicated during these proceedings, as well as comments
submitted to FDA through the public docket, were used to inform this
draft guidance.
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 developing
drugs for the treatment of low sexual interest, desire, and/or arousal
in women. 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. The 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 part 314 have been approved under
OMB Control Number 0910-0001.

III. Electronic Access

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

Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25788 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P

74452 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices

for Treatment.’’ The purpose of this Dated: October 20, 2016. products to establish standardized
draft guidance is to assist sponsors in Leslie Kux, format and content requirements for the
developing drugs for the treatment of Associate Commissioner for Policy. labeling of all marketed OTC drug
low sexual interest, desire, and/or [FR Doc. 2016–25788 Filed 10–25–16; 8:45 am] products in part 201 (21 CFR part 201).
arousal in women. Specifically, this BILLING CODE 4164–01–P
The regulations in part 201 require OTC
draft guidance addresses FDA’s current drug product labeling to include
thinking regarding the overall clinical uniform headings and subheadings,
development program, with a focus on DEPARTMENT OF HEALTH AND presented in a standardized order, with
phase 3 trial designs, to support an HUMAN SERVICES minimum standards for type size and
other graphical features. Specifically,
indication for the treatment of these
Food and Drug Administration the 1999 labeling final rule added new
conditions.
§ 201.66 to part 201. Section 201.66 sets
On October 27, 2014, FDA convened [Docket No. FDA–2013–N–0823]
content and format requirements for the
a public patient-focused drug Agency Information Collection Drug Facts portion of labels on OTC
development meeting and heard directly Activities; Submission for Office of drug products.
from women suffering from female Management and Budget Review; On June 20, 2000 (65 FR 38191), we
sexual desire and arousal disorders. The Comment Request; Format and published a Federal Register final rule
following day, FDA held a public Content Requirements for Over-the- that required all OTC drug products
scientific workshop with invited experts Counter Drug Product Labeling marketed under the OTC monograph
in sexual medicine to discuss scientific system to comply with the labeling
challenges involved in developing drugs AGENCY: Food and Drug Administration, requirements in § 201.66 by May 16,
to treat these disorders, including HHS. 2005, or sooner (65 FR 38191 at 38193).
diagnostic criteria, endpoints, and ACTION: Notice. Currently marketed OTC drug products
patient-reported outcome instruments. are already required to be in compliance
SUMMARY: The Food and Drug with these labeling requirements, and
Comments from the public and experts Administration (FDA or we) is thus will incur no further burden to
that were communicated during these announcing that a proposed collection comply with Drug Facts labeling
proceedings, as well as comments of information has been submitted to the requirements in § 201.66. Modifications
submitted to FDA through the public Office of Management and Budget of labeling already required to be in
docket, were used to inform this draft (OMB) for review and clearance under Drug Facts format are usual and
guidance. the Paperwork Reduction Act of 1995 customary as part of routine redesign
This draft guidance is being issued (the PRA). practice, and thus do not create
consistent with FDA’s good guidance DATES: Fax written comments on the additional burden within the meaning
practices regulation (21 CFR 10.115). collection of information by November of the PRA. Therefore, the burden to
The draft guidance, when finalized, will 25, 2016. comply with the labeling requirements
represent the current thinking of FDA ADDRESSES: To ensure that comments on in § 201.66 is a one-time burden
on developing drugs for the treatment of the information collection are received, applicable only to new OTC drug
low sexual interest, desire, and/or OMB recommends that written products introduced to the marketplace
arousal in women. It does not establish comments be faxed to the Office of under new drug applications (NDAs),
any rights for any person and is not Information and Regulatory Affairs, abbreviated new drug applications
binding on FDA or the public. You can OMB, Attn: FDA Desk Officer, FAX: (ANDAs), or an OTC drug monograph,
use an alternative approach if it satisfies 202–395–7285, or emailed to oira_ except for products in ‘‘convenience
the requirements of the applicable submission@omb.eop.gov. All size’’ packages.1 New OTC drug
comments should be identified with the products must comply with the labeling
statutes and regulations.
OMB control number 0910–0340. Also requirements in § 201.66 as they are
II. The Paperwork Reduction Act of include the FDA docket number found introduced to the marketplace.
1995 in brackets in the heading of this Based on a March 1, 2010, estimate
document. provided by the Consumer Healthcare
This draft guidance refers to Products Association (75 FR 49495 at
previously approved collections of FOR FURTHER INFORMATION CONTACT: FDA 49496, August 13, 2010), we estimated
information found in FDA regulations. PRA Staff, Office of Operations, Food that approximately 900 new OTC drug
and Drug Administration, Three White product stock-keeping units (SKUs) are
These collections of information are
Flint North, 10A63, 11601 Landsdown introduced to the marketplace each
subject to review by the Office of
St., North Bethesda, MD 20852,
Management and Budget (OMB) under
PRAStaff@fda.hhs.gov. 1 In a final rule published in the Federal Register
the Paperwork Reduction Act of 1995
SUPPLEMENTARY INFORMATION: In of April 5, 2002, the Agency delayed the
(44 U.S.C. 3501–3520). The collections compliance dates for the 1999 labeling final rule for
compliance with 44 U.S.C. 3507, FDA
of information in 21 CFR part 314 have all OTC drug products that: (1) Contain no more
has submitted the following proposed
been approved under OMB Control collection of information to OMB for
than two doses of an OTC drug and (2) because of
their limited available labeling space, would require
Number 0910–0001. review and clearance. more than 60 percent of the total surface area
asabaliauskas on DSK3SPTVN1PROD with NOTICES

III. Electronic Access available to bear labeling to meet the requirements
Format and Content Requirements for set forth in § 201.66(d)(1) and (9) and, therefore,
Persons with access to the Internet OTC Drug Product Labeling—21 CFR qualify for the labeling modifications currently set
Part 201—OMB Control Number 0910– forth in § 201.66(d)(10) (67 FR 16304 at 16306). The
may obtain the draft guidance at either Agency issued this delay in order to develop
0340—Extension
http://www.fda.gov/Drugs/Guidance additional rulemaking for these ‘‘convenience size’’
In the Federal Register of March 17, products (December 12, 2006; 71 FR 74474). These
ComplianceRegulatoryInformation/ products are not currently subject to the
Guidances/default.htm or http:// 1999 (64 FR 13254) (the 1999 labeling requirements of § 201.66. PRA approval for any
www.regulations.gov. final rule), we amended our regulations requirements to which they may be subject in the
governing requirements for human drug future will be handled in a separate rulemaking.

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Document Created: 2016-10-26 02:17:42
Document Modified: 2016-10-26 02:17:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 27, 2016.
Contact		Jennifer Mercier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301- 796-0957.
FR Citation		81 FR 74451

81 FR 74451 - Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration