[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7479-7480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02591]
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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.
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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This guidance finalizes the draft guidance of the same name issued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