[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50009-50010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0640]


Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment.'' The purpose of this 
guidance is to assist sponsors in the clinical development of drugs for 
the treatment of uncomplicated gonorrhea. This guidance finalizes the 
draft guidance of the same name issued on June 19, 2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Maria Allende or Joseph Toerner, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-
0002, 301-796-1400.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' 
The purpose of this guidance is to assist sponsors in the development 
of drugs for the treatment of uncomplicated gonorrhea.
    This guidance describes approaches for trial designs for the 
evaluation of new drugs for the treatment of uncomplicated gonorrhea. 
The guidance focuses on the noninferiority trial design and describes 
an efficacy endpoint for which there is a well-defined treatment 
effect. The guidance also provides the justification for the 
noninferiority margin. After careful consideration of comments received 
in response to the draft guidance issued on June 19, 2014 (79 FR 
35172), we added a brief discussion of the potential for pregnant women 
to be included in specific populations for drug development. In 
addition, this guidance

[[Page 50010]]

reflects recent developments in scientific information that pertain to 
drugs being developed for the treatment of uncomplicated gonorrhea.
    Issuance of this guidance fulfills a portion of the requirements of 
Title VIII, section 804, of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as 
appropriate, revise not fewer than three guidance documents per year 
for the conduct of clinical trials with respect to antibacterial and 
antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on developing drugs for the treatment of 
uncomplicated gonorrhea. 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 guidance refers to previously approved collections of 
information that 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceCompliance/RegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20306 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P