Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Information From United States Firms and Processors That Export to the European Community, 27061 [2011-11360]
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Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2010–N–0422]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Information From United States Firms
and Processors That Export to the
European Community
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Information From United States Firms
and Processors That Export to the
European Community’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In the
Federal Register of November 23, 2010
(75 FR 71444), 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 0910–0320. The
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
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SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:02 May 09, 2011
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0631]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
[FR Doc. 2011–11360 Filed 5–9–11; 8:45 am]
Food and Drug Administration
[FR Doc. 2011–11364 Filed 5–9–11; 8:45 am]
AGENCY:
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Jkt 223001
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.
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.
SUMMARY:
Fax written comments on the
collection of information by June 9,
2011.
DATES:
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0638. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
27061
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 antimicrobial susceptibility
testing 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 whether
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
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Page 27061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11360]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0422]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Information From United States Firms
and Processors That Export to the European Community
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Information From United States
Firms and Processors That Export to the European Community'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 23, 2010
(75 FR 71444), 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 0910-0320.
The approval expires on February 28, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11360 Filed 5-9-11; 8:45 am]
BILLING CODE 4160-01-P
