[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Pages 26257-26258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0589]


Draft Guidance for Industry on Hospital-Acquired Bacterial 
Pneumonia and Ventilator-Associated Bacterial Pneumonia: 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availability of a draft guidance for industry entitled ``Hospital-
Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial 
Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft 
guidance is to assist clinical trial sponsors and investigators in the 
development of antibacterial drugs for the treatment of hospital-
acquired bacterial pneumonia and ventilator-associated bacterial 
pneumonia (HABP/VABP). The science of clinical trial design and our 
understanding of this disease have advanced in recent years, and this 
draft guidance informs sponsors of our current recommendations for 
clinical development. FDA is specifically requesting comment on 
critical areas of scientific interest including the appropriate primary 
efficacy endpoints, the use of an intent-to-treat (ITT) population for 
the primary analysis population, and the use of antibacterial therapy 
by patients before participating in clinical trials. This draft 
guidance revises the draft guidance of the same name that published 
November 29, 2010.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 5, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.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 ``Hospital-Acquired Bacterial Pneumonia and Ventilator-
Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The 
purpose of this draft guidance is to assist clinical trial sponsors and 
investigators in the development of antibacterial drugs for the 
treatment of HABP/VABP. Issues in HABP/VABP clinical trials were 
discussed at a 2009 workshop cosponsored by FDA and professional 
societies. Recently, there have been additional discussions about 
clinical trial design and endpoints for HABP/VABP at a meeting of the 
Anti-Infective Drugs Advisory Committee. As a result of these public 
discussions, the science of clinical trial design and our understanding 
of endpoints and approaches to clinical development have advanced.
    This draft guidance revises the draft guidance published in 
November 2010 (75 FR 73107) and informs sponsors of the changes in our 
recommendations. We acknowledge the challenges in conducting clinical 
trials of investigational antibacterial drugs in HABP/VABP. This 
revised draft guidance incorporates changes intended to attain a 
greater degree of balance between the practicability of conducting 
HABP/VABP clinical trials and the trial procedures needed for a 
scientifically sound and interpretable trial. We are requesting input 
from the public on these changes, for consideration before finalizing 
the guidance. Specifically, the changes from the 2010 draft guidance 
include:
     A description of two potential primary efficacy endpoints 
for HABP/VABP clinical trials: (1) All-cause mortality and (2) all-
cause mortality or disease-related complications.
     A justification for a noninferiority margin based on all-
cause mortality.
     Suggestions for efficacy analyses based on: (1) An overall 
ITT population and (2) a microbiological ITT population consisting of 
those patients who have a documented bacterial pathogen known to cause 
HABP/VABP.
     Recommendations for enrolling patients who have received 
prior effective antibacterial drug therapy.
    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 of 2012 (Pub. L. 112-144), which requires FDA to 
``review and, as appropriate, revise not fewer than 3 guidance 
documents per year . . . for the conduct of clinical trials with 
respect to antibacterial and antifungal drugs. . . . ''
    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.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulation. These collections of information 
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 part 312 have been approved under 
OMB control number 0910-0014 and the collections of information in 21 
CFR part 314 have been approved under OMB control number 0910-0001.

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.

[[Page 26258]]

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: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10409 Filed 5-6-14; 8:45 am]
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