[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59929-59930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24035]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Acute Bacterial 
Exacerbations of Chronic Bronchitis in Patients With Chronic 
Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for 
Treatment.'' This guidance addresses FDA's current thinking regarding 
the overall development program and clinical trial designs for drugs to 
support an indication for treatment of acute bacterial exacerbations of 
chronic bronchitis in patients with chronic obstructive pulmonary 
disease (ABECB-COPD), and finalizes the revised draft guidance issued 
on August 22, 2008.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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 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 guidance is to 
assist sponsors in the overall clinical development program of drugs to 
support an indication for the treatment of ABECB-COPD. This guidance 
finalizes the revised draft guidance published on August 22, 2008 (73 
FR 49684), which in turn revised the draft guidance for industry 
entitled ``Acute Bacterial Exacerbations of Chronic Bronchitis--
Developing Antimicrobial Drugs for Treatment'' published in 1998. 
Changes from the revised draft guidance are incorporated into the 
appropriate sections of the guidance and were based on comments 
submitted to the docket for the draft guidance. In addition, 
developments in scientific and medical information and technology in 
the treatment of ABECB-COPD are reflected in this guidance. This 
guidance fulfills the requirement set forth in the Food and Drug 
Administration Amendments Act of 2007 that directed FDA to update the 
ABECB-COPD guidance within 5 years.\1\ This guidance also responds to 
the requirement set forth in the Food and Drug Administration Safety 
and Innovation Act of 2012 that FDA review guidances for the conduct of 
clinical trials with respect to antibacterial and antifungal drugs and 
revise such guidances as appropriate.\2\
---------------------------------------------------------------------------

    \1\ See Title IX, section 911, of the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85).
    \2\ See Title VIII, section 804(a)(1), of the Food and Drug 
Administration Safety and Innovation Act of 2012 (Pub. L. 112-144).
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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

[[Page 59930]]

part 314 have been approved under 0910-0001; and the collections of 
information referred to in the guidance for clinical trial sponsors 
entitled ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under 0910-0581.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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: September 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24035 Filed 9-28-12; 8:45 am]
BILLING CODE 4160-01-P