[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Page 8325]
From the Federal Register Online via the Government Publishing 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guidance finalizes the revised draft guidance of the same name issued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