
[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59928-59929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24036]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0973]


Draft Guidance for Industry on Complicated Intra-Abdominal 
Infections: Developing Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Complicated 
Intra-Abdominal 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 intra-abdominal 
infections (cIAIs). Specifically, this guidance addresses FDA's current 
thinking regarding the overall drug development program for the 
treatment of cIAIs, 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 31, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 Intra-Abdominal 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 
cIAIs.
    Intra-abdominal infections are common in clinical practice and 
comprise a wide variety of clinical presentations and differing sources 
of infection. The infections can be diffuse across the entire 
peritoneal cavity or retroperitoneal spaces, or can be localized with 
one or more abscesses surrounding diseased or perforated viscera. A 
wide variety of bacterial pathogens are responsible for cIAIs, 
including Gram-negative aerobic bacteria, Gram-positive bacteria, and 
anaerobic bacteria, and there are also mixed infections.
    This draft guidance includes recommendations for an efficacy 
endpoint and a non-inferiority trial design. The efficacy endpoint of 
clinical success represents the desired outcome of an antibacterial 
treatment of a cIAI and has been used in previously conducted trials of 
treatment for cIAI. Clinical success is defined as the complete 
resolution of the baseline signs and symptoms attributable to cIAI at a 
fixed time point approximately 28 days following randomization. The 
draft guidance provides scientific support for a noninferiority margin 
based on the results of previously conducted clinical trials with 
various effective antibiotics. 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.

[[Page 59929]]

    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 an 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, and 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 
0910-0581.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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: September 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24036 Filed 9-28-12; 8:45 am]
BILLING CODE 4160-01-P


