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, 6634-6635 [E9-2682]
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6634
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
Dated: February 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. E9–2805 Filed 2–9–09; 8:45 am]
Dated: February 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–2680 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–90–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Advisory Committee to the Director,
Centers for Disease Control and
Prevention (ACD, CDC)
erowe on PROD1PC63 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned committee:
Time and Date: 3 p.m.–4:30 p.m., February
24, 2009.
Place: The teleconference call will
originate at the CDC. For details on accessing
the teleconference is located in the
supplementary information.
Status: Open to the public, teleconference
access limited only by availability of
telephone ports.
Purpose: The committee will provide
advice to the CDC Director on strategic and
other broad issues facing CDC.
Matters to be Discussed: The Advisory
Committee to the Director will discuss and
decide on recommendations from its Ethics
Subcommittee, National Biosurveillance
Advisory Subcommittee, and Budget
Workgroup. The Ethics Subcommittee will
make recommendations on using travel
restrictions for individuals with infectious
illnesses. The Ethics Subcommittee will also
discuss a draft charge that clearly articulates
the ethical foundation for focusing on health
protection activities and examining the social
determinants of health. The National
Biosurveillance Advisory Subcommittee will
seek approval on recommendations for
latitude to share specific points with key
members of the new administration. The
Budget Workgroup will provide
recommendations around principles for
change, in terms of the budget and the budget
structure and process for the CDC.
Agenda items are subject to change as
priorities dictate.
Supplementary Information: This
conference call is scheduled to begin at 3
p.m. Eastern Standard Time. To participate
in the teleconference, please dial 1 (888)
323–9787 and enter conference code
4735949.
Contact Person for More Information: Brad
Perkins, M.D., M.B.A., Executive Officer,
ACD, CDC, 1600 Clifton Road, NE., M/S D–
14, Atlanta, Georgia 30333. Telephone: (404)
639–7000.
The Director, Management Analysis and
Services office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Assessing the
Accuracy of Self-Report of HIV Testing
Behavior, Program Announcement
Number (PA) 09–002
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 8 a.m.–5 p.m., March 20,
2009 (Closed).
Place: Sheraton Gateway Hotel, Atlanta
Airport, 1900 Sullivan Road, Atlanta, GA
30337, Telephone (770) 997–1100.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Assessing the Accuracy of
Self-Report of HIV Testing Behavior, Program
Announcement Number (PA) 09–002.’’
Contact Person for More Information:
Gregory Anderson, M.P.H., M.S., Scientific
Review Administrator, Strategic Science and
Program Unit, Office of the Director,
Coordinating Center for Infectious Diseases,
CDC, 1600 Clifton Road, Mailstop E–60,
Atlanta, GA 30333, Telephone: (404) 498–
2275.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–2803 Filed 2–9–09; 8:45 am]
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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.
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
oira_submission@omb.eop.gov. 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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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6635
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
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 BURDEN1
Justification submitted as general correspondence and in
the annual report
1There
ACTION:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–E–0103, FDA–
2008–E–0110, FDA–2008–E–0113, and FDA–
2008–E–0114]
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Total
Responses
1
2
2
Hours per
Response
Total Hours
16
32
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]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LETAIRIS
AGENCY:
No. of
Responses
per Respondent
No. of
Respondents
Reporting Burden
Food and Drug Administration,
HHS.
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18:25 Feb 09, 2009
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Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LETAIRIS and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
PO 00000
Frm 00067
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Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6634-6635]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2682]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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\
----------------------------------------------------------------------------------------------------------------
No. of
Reporting Burden No. of Responses per Total Hours per Total Hours
Respondents Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
Justification submitted as general 2 1 2 16 32
correspondence and in the annual
report
----------------------------------------------------------------------------------------------------------------
\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]
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