[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Page 73107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29799]



[[Page 73107]]

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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Draft Guidance for Industry on Hospital-Acquired Bacterial 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availability of a draft guidance for industry entitled ``Hospital-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 The purpose of this draft 
guidance is to assist clinical trial sponsors and investigators in the 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 antimicrobial drugs for the treatment of hospital-
acquired bacterial pneumonia (HABP) and ventilator-associated bacterial 
pneumonia (VABP). The science of clinical trial design and our 
understanding of these diseases have advanced in recent years, and this 
draft guidance, when finalized, will inform sponsors of the 
recommendations for clinical development.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 28, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 antimicrobial drugs for the 
treatment of HABP and VABP. This guidance revises and replaces the 
draft guidance regarding nosocomial pneumonia published in 1998. The 
guidance also addresses the clinical development of new drugs to treat 
drug-resistant bacterial pathogens implicated in HABP/VABP.
    The issues in HABP/VABP clinical trials were discussed at a 2009 
workshop co-sponsored by FDA and professional societies. The science of 
clinical trial design and our understanding of these diseases have 
advanced in recent years, and this draft guidance informs sponsors of 
the changes in our recommendations. Specifically, the guidance defines 
a primary efficacy endpoint of all-cause mortality and provides a 
justification for a noninferiority margin for the design of active-
controlled clinical trials that can be used to provide evidence of 
efficacy for the treatment of HABP/VABP.
    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 guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget 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 0910-0014, the collections of information in 21 CFR part 314 have 
been approved under 0910-0001, and the collections of information 
referred to in the guidance ``Establishment and Operation of Clinical 
Trial Data Monitoring Committees'' have been approved under 0910-0581.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29799 Filed 11-26-10; 8:45 am]
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