
[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7479-7480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02591]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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. 
This guidance finalizes the draft guidance of the same name issued 
October 1, 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 Intra-Abdominal Infections: Developing Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
development of drugs for the treatment of cIAIs.
    Intra-abdominal infections including cIAIs are common in clinical 
practice and comprise a wide variety of clinical presentations and 
differing sources of infection. Different bacterial pathogens are 
responsible for cIAI, including Gram-negative aerobic bacteria, Gram-
positive bacteria, and anaerobic bacteria, including mixed infections. 
This guidance describes the efficacy endpoint of clinical success as 
resolution of the baseline signs and symptoms attributable to cIAI. The 
guidance provides a scientific justification for a noninferiority 
margin.
    This guidance finalizes the draft guidance of the same name issued 
October 1, 2012. After consideration of comments received in response 
to the draft guidance, FDA updated the guidance to include 
clarifications about the primary efficacy endpoint and the use of prior 
nontrial antibacterial drugs. In addition, issuance of this guidance 
fulfills a portion of the requirements of Title VIII, section 804 of 
the Food and Drug Safety and Innovation Act of 2012 (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.

[[Page 7480]]

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 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02591 Filed 2-9-15; 8:45 am]
BILLING CODE 4164-01-P


