
[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47804-47805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se09-48]

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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Draft Guidance for Industry on Microbiological Data for Systemic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availability of a draft guidance for industry entitled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 The draft guidance informs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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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
