[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35172-35173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Uncomplicated Gonorrhea: 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment.'' The purpose of this draft 
guidance is to assist sponsors in the development of new antibacterial 
drugs for the treatment of uncomplicated gonorrhea.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 17, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Joseph G. 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-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
development of new antibacterial drugs for the treatment of 
uncomplicated gonorrhea.
    This draft guidance describes approaches for trial designs for the 
evaluation of new drugs for the treatment of uncomplicated gonorrhea. 
The draft guidance focuses on the noninferiority trial design and 
describes an efficacy endpoint for which there is a well-defined 
treatment effect. The draft guidance also provides the justification 
for the noninferiority margin. In addition, this guidance reflects 
recent developments in scientific information that pertain to drugs 
being developed for the treatment of uncomplicated gonorrhea.
    Issuance of this draft guidance fulfills a portion of the 
requirements of Title VIII, section 804, of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) that 
requires FDA to ``. . . review and, as appropriate, revise not fewer 
than 3 guidance documents per year . . . for the conduct of clinical 
trials with respect to antibacterial and antifungal drugs. . . .'' In 
1998, FDA published a draft guidance entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment'' (1998 draft guidance). In a 
Federal Register notice dated August 7, 2013 (78 FR 48175), FDA 
announced an initiative in the Center for Drug Evaluation and Research 
involving the review of draft guidance documents issued before 2010 to 
determine their status and to decide whether those guidances should be 
withdrawn, revised, or finalized with only minor changes. In the August 
7, 2013, Federal Register notice, FDA announced that the 1998 draft 
guidance, as well as other draft guidances, was being withdrawn (78 FR 
48175). FDA is now issuing a new draft guidance that revises the 
recommendations in the 1998 draft

[[Page 35173]]

guidance. Issuance of the new draft guidance constitutes a revision of 
a previously published draft guidance and fulfills a portion of the 
requirements of Public Law 112-144.
    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 Agency's current thinking on developing 
drugs for the treatment of uncomplicated gonorrhea. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
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 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14303 Filed 6-18-14; 8:45 am]
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