[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Pages 49684-49685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0419]


Draft Guidance for Industry on Acute Bacterial Exacerbations of 
Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary 
Disease: Developing Antimicrobial 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availability of a draft guidance for industry entitled ``Acute 
Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic 
Obstructive Pulmonary Disease: Developing Antimicrobial 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 The purpose of this draft guidance is to assist clinical 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 acute bacterial exacerbations of chronic 
bronchitis in patients with chronic obstructive pulmonary disease 
(ABECB-COPD). The agency's thinking in this area has evolved in recent 
years, and this draft guidance, when finalized, will inform sponsors of 
the changes in our recommendations. In addition, it will fulfill a 
statutory requirement enacted in the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) to publish such a guidance.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 November 20, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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: Steven Gitterman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6134, Silver Spring, MD 20993-0002, 301-
796-1600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acute Bacterial Exacerbations of Chronic Bronchitis in 
Patients With Chronic Obstructive Pulmonary Disease: Developing 
Antimicrobial 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 ABECB-COPD. 
This guidance revises the draft guidance regarding ABECB published in 
1998. Section 911 of FDAAA (Public Law 110-85) adds section 511 to the 
Federal Food, Drug, and Cosmetic Act that directs the Secretary of 
Health and Human Services to ``issue guidance for the conduct of 
clinical trials with respect to antibiotic drugs, including 
antimicrobials to treat * * * acute bacterial exacerbation of chronic 
bronchitis.''
    The design of ABECB clinical trials was discussed at a meeting of 
the Anti-Infective Drugs Advisory Committee on February 19, 2002, and 
an IDSA/PhRMA/FDA workshop on November 19 and 20, 2002. In addition, 
other advisory committee meetings have focused on the development of 
specific drugs for this indication. As a result of these public 
discussions, as well as review of applications at FDA, the agency's 
thinking in this area has evolved in recent years, and this draft 
guidance informs sponsors of the changes in our recommendations. 
Specifically, this draft guidance recommends that ABECB-COPD clinical 
trials be designed as superiority rather than noninferiority trials, 
and discusses some possible study designs that might be employed in an 
ABECB-COPD trial designed to show superiority. This draft guidance 
discusses patient-reported outcome instruments for assessing clinical 
response, and the use of time to resolution of symptoms as a possible 
approach to assessing the primary endpoint in clinical studies.
    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 developing 
drugs for the treatment of ABECB-COPD. 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; the collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 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 number 
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

[[Page 49685]]

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

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: August 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19490 Filed 8-21-08; 8:45 am]
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