[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6634-6635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0339]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Updating Labeling for Susceptibility Test Information in Systemic 
Antibacterial Drug Products and Antimicrobial Susceptibility Testing 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
12, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Guidance for Industry on Updating Labeling for Susceptibility 
Test Information in Systemic Antibacterial Drug Products and 
Antimicrobial Susceptibility Testing Devices.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Updating Labeling for Susceptibility Test 
Information in Systemic Antibacterial Drug Products and Antimicrobial 
Susceptibility Testing Devices

    In the Federal Register of June 12, 2008 (73 FR 33438), FDA 
announced the availability of a draft guidance for

[[Page 6635]]

industry entitled ``Updating Labeling for Susceptibility Test 
Information in Systemic Antibacterial Drug Products and Antimicrobial 
Susceptibility Testing Devices.'' FDA is now in the process of 
finalizing this guidance.
    The Food and Drug Administration Amendments Act of 2007 (FDAAA) 
includes a requirement that FDA identify and periodically update 
susceptibility test interpretive criteria for antibacterial drug 
products and make those findings publicly available. The guidance 
informs industry of how FDA intends to comply with the FDAAA 
requirement. Specifically, the guidance describes procedures and 
responsibilities for updating information on susceptibility test 
interpretive criteria, susceptibility test methods, and quality control 
parameters in the labeling for systemic antibacterial drug products for 
human use. The guidance also describes procedures for making 
corresponding changes to susceptibility test interpretive criteria for 
antimicrobial susceptibility testing devices.
    Description of Respondents: Respondents to this collection of 
information are holders of new drug applications and abbreviated new 
drug applications.
    Burden Estimate: Application holders can use one of the following 
approaches to meet their responsibilities to update their product 
labeling under the guidance and FDA regulations: (1) Submit a labeling 
supplement that relies upon a standard recognized by FDA in a Federal 
Register notice or (2) submit a labeling supplement that includes data 
supporting a proposed change to the microbiology information in the 
labeling. In addition, application holders should include in their 
annual report an assessment of whether the information in the 
Microbiology subsection of their product labeling is current or changes 
are needed. For human drugs, this information collection is already 
approved by OMB under control number 0910-0572 (the requirement in 21 
CFR 201.56(a)(2) to update labeling when new information becomes 
available that causes the labeling to become inaccurate, false, or 
misleading) and OMB control number 0910-0001 (the requirement in 21 CFR 
314.70(b)(2)(v) to submit labeling supplements for certain changes in 
the product's labeling and the requirement in 21 CFR 314.81(b)(2)(i) to 
include in the annual report a brief summary of significant new 
information from the previous year that might affect the labeling of 
the drug product).
    In addition, under the guidance, if the information in the 
applicant's product labeling differs from the standards recognized by 
FDA in the Federal Register notice, and the applicant believes that 
changes to the labeling are not needed, the applicant should provide 
written justification to FDA explainimg why the recognized standard 
does not apply to its drug product and why changes are not needed to 
the Microbiology subsection of the product's labeling. This 
justification should be submitted as general correspondence to the 
product's application, and a statement indicating that no change is 
currently needed and the supporting justification should be included in 
the annual report. Based on our knowledge of the need to update 
information on susceptibility test interpretive criteria, 
susceptibility test methods, and quality control parameters in the 
labeling for systemic antibacterial drug products for human use, we 
estimate that, annually, only two applicants will submit the written 
justification described on the previous sentences and in the guidance. 
FDA also estimates that each justification will take approximately 16 
hours to prepare and submit to FDA as general correspondence and as 
part of the annual report.
    No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                              No. of
           Reporting Burden                 No. of        Responses  per      Total      Hours per   Total Hours
                                          Respondents       Respondent      Responses     Response
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Justification submitted as general                    2                 1            2           16           32
 correspondence and in the annual
 report
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2682 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S