Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 74451-74452 [2016-25788]

Download as PDF Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices • These ACF Guiding Principles are intended solely to improve the internal awareness and management of the ACF. They may only be implemented to the extent permitted by statute and regulations and are not intended to and do not create any right or benefit, substantive or procedural, enforceable at law or equity by any party in any matter, civil or criminal, against the United States, its departments, agencies, officers, employees, or agents, or any other person. Dated: October 20, 2016. Mark H. Greenberg, Acting Assistant Secretary for Children and Families. Dated: October 20, 2016. Lillian Sparks Robinson, Commissioner, Administration for Native Americans. [FR Doc. 2016–25794 Filed 10–25–16; 8:45 am] BILLING CODE 4184–40–P 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[Docket No. FDA–2016–D–2817] Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.’’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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 27, 2016.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: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:25 Oct 25, 2016 Jkt 241001 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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 74451 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 E:\FR\FM\26OCN1.SGM 26OCN1 74452 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices 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 asabaliauskas on DSK3SPTVN1PROD with NOTICES 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. VerDate Sep<11>2014 18:25 Oct 25, 2016 Jkt 241001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0823] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-theCounter Drug Product Labeling AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by November 25, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0340. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: Format and Content Requirements for OTC Drug Product Labeling—21 CFR Part 201—OMB Control Number 0910– 0340—Extension In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999 labeling final rule), we amended our regulations governing requirements for human drug PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 products to establish standardized format and content requirements for the labeling of all marketed OTC drug products in part 201 (21 CFR part 201). The regulations in part 201 require OTC drug product labeling to include uniform headings and subheadings, presented in a standardized order, with minimum standards for type size and other graphical features. Specifically, the 1999 labeling final rule added new § 201.66 to part 201. Section 201.66 sets content and format requirements for the Drug Facts portion of labels on OTC drug products. On June 20, 2000 (65 FR 38191), we published a Federal Register final rule that required all OTC drug products marketed under the OTC monograph system to comply with the labeling requirements in § 201.66 by May 16, 2005, or sooner (65 FR 38191 at 38193). Currently marketed OTC drug products are already required to be in compliance with these labeling requirements, and thus will incur no further burden to comply with Drug Facts labeling requirements in § 201.66. Modifications of labeling already required to be in Drug Facts format are usual and customary as part of routine redesign practice, and thus do not create additional burden within the meaning of the PRA. Therefore, the burden to comply with the labeling requirements in § 201.66 is a one-time burden applicable only to new OTC drug products introduced to the marketplace under new drug applications (NDAs), abbreviated new drug applications (ANDAs), or an OTC drug monograph, except for products in ‘‘convenience size’’ packages.1 New OTC drug products must comply with the labeling requirements in § 201.66 as they are introduced to the marketplace. Based on a March 1, 2010, estimate provided by the Consumer Healthcare Products Association (75 FR 49495 at 49496, August 13, 2010), we estimated that approximately 900 new OTC drug product stock-keeping units (SKUs) are introduced to the marketplace each 1 In a final rule published in the Federal Register of April 5, 2002, the Agency delayed the compliance dates for the 1999 labeling final rule for all OTC drug products that: (1) Contain no more than two doses of an OTC drug and (2) because of their limited available labeling space, would require more than 60 percent of the total surface area available to bear labeling to meet the requirements set forth in § 201.66(d)(1) and (9) and, therefore, qualify for the labeling modifications currently set forth in § 201.66(d)(10) (67 FR 16304 at 16306). The Agency issued this delay in order to develop additional rulemaking for these ‘‘convenience size’’ products (December 12, 2006; 71 FR 74474). These products are not currently subject to the requirements of § 201.66. PRA approval for any requirements to which they may be subject in the future will be handled in a separate rulemaking. E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74451-74452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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