E9-6145. Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment.” This draft guidance informs industry of FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for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 This draft guidance does not address the development of drugs for other purposes or populations, such as treatment of patients with hospital-acquired pneumonia or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 This draft guidance revises the draft guidance for industry entitled “Community-Acquired Pneumonia-Developing Antimicrobial Drugs for Treatment” published July 1998.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by June 18, 2009.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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry entitled “Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment.”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:

• Noninferiority versus superiority design
• Justification of an appropriate noninferiority margin
• Classification of severity of illness
• Classification of CABP based on hospitalization (inpatient versus outpatient)
• Enrollment criteria
• Application of appropriate diagnostic criteria, including microbiologic diagnosis
• Use of appropriate definitions of clinical outcomes, including mortality
• Timing of outcome assessments
• 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 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.