Document ID: FDA-2010-N-0631-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products, etc.
Posted Date: 2010-12-23T05:00Z

[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80823-80824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32276]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0631]

Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on FDA's ``Guidance for Industry 
on Updating Labeling for Susceptibility Test Information in Systemic 
Antibacterial Drug Products and Antimicrobial Susceptibility Testing 
Devices.'' 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, and 
also describes procedures for making corresponding changes to 
susceptibility test interpretive criteria for antimicrobial 
susceptibility testing (AST) devices.

DATES: Submit either electronic or written comments on the collection 
of information by February 22, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth below in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4)

[[Page 80824]]

ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

Guidance for Industry on Updating Labeling for Susceptibility Test 
Information in Systemic Antibacterial Drug Products and Antimicrobial 
Susceptibility Testing Devices (OMB Control Number 0910-0638--
Extension)

    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. As a result of 
this provision, the guidance explains the importance of making 
available to health care providers the most current information 
regarding susceptibility test interpretive criteria for antibacterial 
drug products. To address concerns about antibacterial drug product 
labeling with out-of-date information on susceptibility test 
interpretive criteria, quality control parameters, and susceptibility 
test methods, the guidance describes procedures for FDA, applications 
holders, and AST device manufacturers to ensure that updated 
susceptibility test information is available to health care providers. 
Where appropriate, FDA will identify susceptibility test interpretive 
criteria, quality control parameters, and susceptibility test methods 
by recognizing annually in a Federal Register notice, standards 
developed by one or more nationally or internationally recognized 
standard development organizations. The FDA recognized standards will 
be available to application holders of approved antibacterial drug 
products for updating their product labeling.
    Application holders can use one of the following approaches to meet 
their responsibilities to update their product labeling under the 
guidance and FDA regulations: Submit a labeling supplement that relies 
upon a standard recognized by FDA in a Federal Register notice, or 
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. 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 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 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, and 
our experience with the FDAAA requirement and the guidance 
recommendations during the past 16 months, we estimate that, annually, 
approximately two applicants will submit the written justification 
described previously and in the guidance, and that each justification 
will take approximately 16 hours to prepare and submit to FDA as 
general correspondence and as part of the annual report.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of
                                     Number of     responses per       Total         Hours per     Total  hours
                                    respondents     respondent       responses       response
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Justification submitted as                     2               1               2              16              32
 general correspondence and in
 the annual report..............
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    Total.......................  ..............  ..............  ..............              32
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There are no capital costs or operating and maintenance costs associated with this information collection.

    Dated: December 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32276 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P