[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80823-80824]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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