[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1874-1875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00255]


-----------------------------------------------------------------------

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Draft Guidance for Industry on Community-Acquired Bacterial 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Community-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.'' The 
purpose of this draft guidance is to assist clinical trial sponsors and 
investigators in the development of antibacterial drugs for the 
treatment of community-acquired bacterial pneumonia (CABP). 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advanced in recent years, and this draft guidance informs sponsors of 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 This draft guidance revises the draft 
guidance of the same name that published March 20, 2009.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 10, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 1875]]


FOR FURTHER INFORMATION CONTACT: Sumati 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-
796-1300; or 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 ``Community-Acquired 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 CABP. Issues in CABP clinical trials were 
discussed at a 2008 workshop cosponsored by FDA and professional 
societies. Recently, there have been additional discussions about 
clinical trial design and endpoints for CABP at several meetings 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 revised draft guidance supersedes the draft guidance published 
in March 2009 and informs sponsors of the changes in our 
recommendations. Although we acknowledge the challenges in conducting 
clinical trials of investigational antibacterial drugs in CABP, this 
revised draft guidance incorporates changes intended to attain a 
greater degree of balance between the practicability of conducting CABP 
clinical trials and the trial procedures needed for a scientifically 
sound and interpretable trial. We are specifically requesting input 
from the public on these changes for consideration before finalizing 
the guidance. Specifically, the changes from the 2009 draft guidance 
include:
     A description of two potential primary efficacy endpoints 
for CABP clinical trials: (1) Improvement in patient symptoms early in 
the course of therapy for CABP (at day 3 to day 5) and (2) all-cause 
mortality.
     A justification for a noninferiority margin based on 
clinical responses observed early in the course of therapy, as well as 
a justification for all-cause mortality as a primary efficacy endpoint.
     Suggestions for efficacy analyses based on: (1) An overall 
ITT population and (2) a microbiological intent-to-treat population 
consisting of those patients who have a documented bacterial pathogen 
known to cause CABP.
     An approach for accommodating enrollment of patients who 
have received prior antibacterial therapy, provided certain constraints 
are met.
    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 (Publ. 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 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 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.

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: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00255 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P