[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Draft Guidance for Industry on Hospital-Acquired Bacterial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availability of a draft guidance for industry entitled ``Hospital-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 The purpose of this draft
guidance is to assist clinical trial sponsors and investigators in the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draft guidance informs sponsors of our current recommendations for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 This draft
guidance revises the draft guidance of the same name that published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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 5, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.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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