[Federal Register Volume 74, Number 53 (Friday, March 20, 2009)]
[Notices]
[Pages 11963-11964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0136]


Draft Guidance for Industry on Community-Acquired Bacterial 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availability of a draft guidance for industry entitled ``Community-
Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' This 
draft guidance informs industry of FDA's current thinking regarding the 
overall development program and clinical trial designs for drugs to 
support an indication for treatment of community-acquired bacterial 
pneumonia (CABP). This draft guidance does not address the development 
of drugs for other purposes or populations, such as treatment of 
patients with hospital-acquired pneumonia or ventilator-associated 
pneumonia. This draft guidance revises the draft guidance for industry 
entitled ``Community-Acquired Pneumonia-Developing Antimicrobial Drugs 
for Treatment'' published July 1998.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by June 18, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Sumathi Nambiar, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6232, 
Silver Spring, MD 20993-0002, 301-796-1400; or
    Edward Cox, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6212, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Community-Acquired Bacterial Pneumonia: Developing Drugs for 
Treatment.'' Since FDA published the draft guidance on the development 
of antimicrobial drugs for the treatment of community-acquired 
pneumonia in 1998, there have been public discussions regarding 
clinical trial designs to study CABP, including an FDA-Infectious 
Disease Society of America (IDSA) workshop and a meeting of the Anti-
Infective Drugs Advisory Committee. These discussions have focused on 
clinical trial designs for CABP and other important issues such as the 
following:
    <bullet> Noninferiority versus superiority design
    <bullet> Justification of an appropriate noninferiority margin
    <bullet> Classification of severity of illness
    <bullet> Classification of CABP based on hospitalization (inpatient 
versus outpatient)
    <bullet> Enrollment criteria
    <bullet> Application of appropriate diagnostic criteria, including 
microbiologic diagnosis
    <bullet> Use of appropriate definitions of clinical outcomes, 
including mortality
    <bullet> Timing of outcome assessments
    <bullet> Use of prior antibacterial drugs
    Important changes from the 1998 draft guidance that are based on 
these discussions have been incorporated into this revised draft 
guidance.
    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 the 
development of antibacterial drugs for CABP including appropriate 
clinical trial designs to evaluate drugs for the treatment of CABP. 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

[[Page 11964]]

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 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 part 312 have been 
approved under OMB control no. 0910-0014; the collections of 
information in 21 CFR part 314 have been approved under OMB control no. 
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 OMB control no. 0910-
0581.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: March 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6145 Filed 3-19-09; 8:45 am]
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