[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33438-33440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1350]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0339]
Draft Guidance for Industry on Updating Labeling for
Susceptibility Test Information in Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility Testing Devices; 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availability of a draft guidance for industry entitled ``Updating
Labeling for Susceptibility Test Information in Systemic Antibacterial
Drug Products and Antimicrobial Susceptibility Testing Devices.'' 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. This draft guidance informs industry
of how FDA intends to comply with the FDAAA requirement. Specifically,
the draft guidance describes procedures and responsibilities for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. This
draft guidance also describes procedures for making corresponding
changes to susceptibility test interpretive criteria for antimicrobial
susceptibility testing (AST) devices.
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 comments 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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 August 11, 2008. Submit written comments on the proposed collection
of information by August 11, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 or the
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850-4307. Send one self-addressed adhesive
label to assist that office in processing your requests. Submit written
comments on the draft guidance, including comments regarding proposed
collection of information, 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:
Regarding antibacterial drug products: Edward Cox, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6414, Silver Spring, MD 20993-0002, 301-
796-1300, or
Regarding AST devices: Freddie Poole, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0712.
SUPPLEMENTARY INFORMATION:
I. Background
Antibacterial susceptibility testing is used to determine if
bacteria that are isolated from a patient with an infection are likely
to be killed or inhibited by a particular antibacterial drug product at
the concentrations of the drug that are attainable at the site of
infection using the dosing regimen(s) indicated in the drug product's
labeling. The results from antibacterial susceptibility testing
generally categorize bacteria as ``susceptible,'' ``intermediate,'' or
``resistant'' to each of the antibacterial drugs that are tested. When
available, culture and susceptibility testing results are one of the
factors that physicians consider when selecting an antimicrobial drug
product for treating a patient.
The numerical values generated by susceptibility testing to
determine whether a particular microorganism is susceptible to a
particular antimicrobial drug--the antimicrobial susceptibility test
interpretive criteria--are commonly referred to as breakpoints. These
breakpoints are specified in the antimicrobial drug product's label.
The antimicrobial susceptibility test interpretive criteria can be used
to interpret results from either manual or automated AST devices.
On September 27, 2007, the President signed FDAAA (Public Law 110-
85) into law. Section 1111 of FDAAA requires FDA to identify and
periodically update susceptibility test interpretive criteria for
antibacterial drug products and to make those findings publicly
available. By enacting section 1111 of FDAAA, Congress recognized the
importance of maintaining updated susceptibility test interpretive
criteria.
FDA is announcing the availability of a draft guidance for industry
entitled ``Updating Labeling for Susceptibility Test Information in
Systemic Antibacterial Drug Products and Antimicrobial Susceptibility
Testing Devices'' to inform industry of how FDA intends to comply with
section 1111 of FDAAA. The draft guidance explains
[[Page 33439]]
the importance of making available to health care providers the most
current information regarding susceptibility test interpretive criteria
for antibacterial drug products. The draft guidance describes
procedures for FDA, drug application holders, and AST device
manufacturers to ensure that updated susceptibility test information is
available to health care providers for the following reasons: (1) 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 and (2) to comply
with the new requirements of section 1111 of FDAAA. Where appropriate,
FDA intends to 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. Drug application holders of approved
antibacterial drug products will then have the option of relying on FDA
recognized standards to update their product labeling.
The draft guidance describes possible approaches that holders of
new drug applications (NDAs) and those abbreviated new drug
applications (ANDAs) that are designated as a reference listed drug can
use to meet their responsibilities to update their product labeling for
systemic antibacterial drug products. Application holders can use the
following approaches:
Submit a labeling supplement that relies upon a standard
recognized by the agency.
Submit a labeling supplement that includes data supporting
a proposed change to the microbiology information in the labeling that
differs from the agency's recognized standard.
Alternatively, in the event that application holders do not believe
that any labeling changes are necessary, they should provide written
justification in support of the current information in the Microbiology
subsection of the product labeling.
The agency will make the updated information available by publicly
posting changes to the product labeling within 30 days of approval of a
supplement that includes a change to the Microbiology subsection of the
product labeling.
The draft guidance also describes how manufacturers of in vitro
diagnostic AST devices should update the susceptibility test
information in their labeling to incorporate an FDA recognized standard
or a change in labeling for a relevant antibacterial drug product.
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 this topic.
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. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following 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
estimated 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) 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.
Application holders can use one of the following approaches to meet
their responsibilities to update their product labeling under the draft
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 draft 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. This justification should explain 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 also 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
[[Page 33440]]
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 2 applicants will submit the written justification described
previously and in the draft guidance. We also estimate 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\1\
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No. of No. of Responses Hours Per
Respondents per Respondent Total Responses Response Total Hours
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Justification submitted as general correspondence and 2 1 2 16 32
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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.
Dated: June 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1350 Filed 6-10-08; 11:31 am]
BILLING CODE 4160-01-S