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, 80823-80824 [2010-32276]
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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
cannot be compared to physician
responses and that this comparison is
not relevant to the regulation of DTC
advertisements. Indeed, the primary
reason for conducting the study with
physicians is to explore their processing
of the prescribing information (PI),
wholly separate from the consumer
study. Nevertheless, since we have the
two samples, we are conducting some
exploratory analyses to compare the
responses of consumers to information
about a drug to the physicians’
understanding of the drug. While this
does have relevance to the regulation of
DTC advertising (e.g., a DTC ad that
features a presentation of information
that brings consumers closer to the
assessment of the physician will be
preferred over that same ad with a
presentation of information that moves
them farther away), we are approaching
this comparison as a first, exploratory
attempt at this type of analysis.
Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
In the
Federal Register of May 7, 2010 (75 FR
25267), the Agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0650. The
approval expires on December 31, 2012.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: December 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32277 Filed 12–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–32278 Filed 12–22–10; 8:45 am]
Food and Drug Administration
BILLING CODE 4160–01–P
[Docket No. FDA–2010–N–0631]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0074]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail:
Jonnalynn.Capezzuto@fda.hhs.gov.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
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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.
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
SUMMARY:
PO 00000
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80823
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 https://
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)
E:\FR\FM\23DEN1.SGM
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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
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
Number of
responses per
respondent
Number of
respondents
Total
responses
Hours per
response
Total
hours
Justification submitted as general correspondence and in
the annual report ..............................................................
2
1
2
16
Total ..............................................................................
........................
........................
........................
32
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]
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Justification submitted as 2 1 2 16 32
general correspondence and in
the annual report..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. 32
----------------------------------------------------------------------------------------------------------------
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
