
[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Page 8325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0148]


Complicated Urinary Tract Infections: 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) is announcing the 
availability of a guidance for industry entitled ``Complicated Urinary 
Tract Infections: Developing Drugs for Treatment.'' The purpose of this 
guidance is to assist sponsors in the clinical development of drugs for 
the treatment of complicated urinary tract infections (cUTIs). This 
guidance finalizes the revised draft guidance of the same name issued 
on February 24, 2012.

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 Bldg., 4th Floor, Silver Spring, MD 20993. 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: 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 guidance for industry 
entitled ``Complicated Urinary Tract Infections: Developing Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
development of drugs for the treatment of cUTIs.
    This guidance includes recommendations for an efficacy endpoint and 
noninferiority trial design. The efficacy endpoint, based on resolution 
of clinical symptoms and eradication of bacteria from the urinary 
tract, was derived from previously conducted clinical trials for the 
treatment of cUTI. The guidance provides a scientific justification for 
a noninferiority margin based on historical observational data compared 
to the results of previously conducted clinical trials. After careful 
consideration of comments received in response to the revised draft 
guidance issued on February 24, 2012, important clarifications about 
trial populations and endpoints for cUTI were included in this 
guidance. In addition, this guidance reflects recent developments in 
scientific information that pertain to drugs being developed for the 
treatment of cUTI.
    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 
Agency's current thinking on this topic. 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 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: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03100 Filed 2-13-15; 8:45 am]
BILLING CODE 4164-01-P


