[Federal Register Volume 74, Number 179 (Thursday, September 17, 2009)]
[Notices]
[Pages 47804-47805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0408]


Draft Guidance for Industry on Microbiological Data for Systemic 
Antibacterial Drug Products--Development, Analysis, and Presentation; 
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availability of a draft guidance for industry entitled 
``Microbiological Data for Systemic Antibacterial Drug Products--
Development, Analysis, and Presentation.'' The draft guidance informs 
industry of FDA's current thinking regarding the types of 
microbiological studies, assessments, and clinical trials needed to 
support an investigational new drug application (IND) and a new drug 
application (NDA) for a systemic antibacterial drug product. 
Recommendations in this guidance cover microbiological considerations 
in the three major areas of conducting general nonclinical studies; 
conducting animal and human studies and clinical trials; and 
establishing and updating in vitro susceptibility test methods, quality 
control (QC) parameters, and interpretive criteria. This guidance also 
recommends the content and format for presentation of microbiological 
data for antibacterial drug products in the Microbiology subsection of 
labeling.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 December 16, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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:  Fred Marsik, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6108, Silver Spring, MD 20993-0002, 301-
796-7956; or
    Edward Cox, Center for Drug Evaluation and Research, Food and Drug 
Administration, 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 ``Microbiological Data for Systemic Antibacterial Drug 
Products--Development, Analysis, and Presentation.'' This guidance 
provides recommendations on the type of information to provide in 
submissions to the clinical microbiology section of INDs and NDAs for 
systemic antibacterial drug products. The in vitro microbiological data 
and in vivo animal studies (e.g., spectrum of activity in vitro and in 
appropriate animal models of human disease) support the justification 
of testing in humans. Sponsors usually submit data from nonclinical 
investigations to provide proof of concept of clinical activity before 
commencing human phase 2 studies and clinical trials and to aid in the 
development of provisional interpretive criteria for use in phase 3 
clinical trials. Microbiological data submitted to an NDA will be used 
to substantiate the microbiological information contained in the 
labeling.
    Specific topics discussed in the guidance include validating in 
vitro susceptibility testing methods; mechanism of action studies; 
mechanism of resistance studies; use of animal models; clinical trial 
protocols; establishment of QC parameters and interpretive criteria; 
submission and placement of microbiology information in the NDA 
submission; format and content of the Microbiology subsection of the 
labeling; and revision of existing susceptibility testing methods, QC 
parameters, or interpretive criteria.
    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 
microbiological data for systemic antibacterial drug products. 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 found in FDA regulations. These collections of information 
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).
    (1) The draft guidance provides recommendations on the type of 
information to include in submissions of the clinical microbiology 
section of INDs and NDAs for systemic antibacterial drug products. The 
microbiology section of an NDA is required under 21 CFR 314.50(d)(4) 
and this information collection is approved under OMB Control Number 
0910-0001. For INDs, this information is required under 21 CFR 
312.23(a) and approved under OMB Control Number 0910-0014.
    (2) The draft guidance also recommends the types of data that 
should be submitted in a labeling supplement to update the microbiology 
information in approved labeling if an application holder chooses to 
update this information without relying on a standard recognized by 
FDA. The submission of labeling supplements is required under 21 CFR 
314.70(b)(2)(v) and 201.56(a)(2) and this information collection is 
approved under OMB Control Numbers 0910-0001 and 0910-0572, 
respectively.
    (3) Appendix A of the draft guidance describes the content of the 
Microbiology subsection of labeling. This labeling is covered under 21 
CFR 201.57(c)(13)(i) and the information collection is approved under 
OMB Control Number 0910-0572.
    (4) The draft guidance also references the guidance for industry 
entitled ``Updating Labeling for Susceptibility Test Information in 
Systemic Antibacterial Drug Products and Antimicrobial Susceptibility 
Testing Devices'' for updating labeling information. The information 
collection in this guidance has been approved under OMB Control Number 
0910-0638.

[[Page 47805]]

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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22380 Filed 9-16-09; 8:45 am]
BILLING CODE 4160-01-S