[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11133-11134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Complicated Urinary Tract 
Infections: 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availability of a draft guidance for industry entitled ``Complicated 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). Specifically, this guidance addresses FDA's current thinking 
regarding the overall drug development program for the treatment of 
cUTIs, including clinical trial designs to support approval of drugs.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 24, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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    FDA is announcing the availability of a draft guidance for industry 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 ``Complicated Urinary Tract Infections: Developing Drugs for 
Treatment.'' The purpose of this draft guidance is to assist sponsors 
and investigators in the development of drugs for the treatment of 
cUTIs. This draft guidance revises and replaces the draft guidance for 
industry entitled ``Complicated Urinary Tract Infections and 
Pyelonephritis--Developing Antimicrobial Drugs for Treatment'' 
published in 1998.
    Infections of the urinary tract occurring in patients with 
underlying functional or anatomic abnormalities of the urinary tract 
are defined as cUTIs. Infections of the kidney, called pyelonephritis, 
can occur in persons without underlying abnormalities of the urinary 
tract, but are also considered to be a subset of cUTI. Different types 
of bacteria can cause cUTI, but Gram-negative bacteria are most often 
associated with cUTI.
    This draft 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 trials for the 
treatment of cUTI. The draft guidance provides a scientific 
justification for a noninferiority margin based on historical 
observational data compared to the results of previously conducted 
clinical trials. The draft guidance also provides a discussion about 
patients with unmet need who have an infection caused by bacterial 
pathogens that show resistance to most antibacterial drugs on in vitro 
susceptibility testing.
    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 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.

[[Page 11134]]

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. The collections of information referred to in the 
guidance for clinical trial sponsors ``Establishment and Operation of 
Clinical Trial Data Monitoring Committees'' have been approved under 
OMB control number 0910-0581.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4290 Filed 2-23-12; 8:45 am]
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