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, 27061-27062 [2011-11359]
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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.
jlentini on DSKJ8SOYB1PROD with NOTICES
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
27062
Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
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.
In the Federal Register of December
23, 2010 (75 FR 80823), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
(in hours)
Number of respondents
Number of
responses per
respondent
Justification Submitted as General Correspondence and in
the Annual Report ............................................................
2
1
2
16
32
Total ..............................................................................
........................
........................
........................
........................
32
1 There
[FR Doc. 2011–11359 Filed 5–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0326]
Biologics Price Competition and
Innovation Act of 2009; Options for a
User Fee Program for Biosimilar and
Interchangeable Biological Product
Applications for Fiscal Years 2013
Through 2017; Request for Comments
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
issuing this document to request
comments relating to the development
of a user fee program for biosimilar and
interchangeable biological product
(351(k)) applications submitted under
the Public Health Service Act (PHS Act).
FDA is requesting input on the
identified principles for development of
a 351(k) user fee program, FDA’s
proposed structure for a 351(k) user fee
program that would adhere to these
SUMMARY:
jlentini on DSKJ8SOYB1PROD with NOTICES
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Total annual
responses
VerDate Mar<15>2010
18:02 May 09, 2011
Jkt 223001
principles, and performance goals for
this program. FDA plans to review the
comments submitted to the docket, hold
meetings with public stakeholders, and
hold industry stakeholder meetings to
develop proposed recommendations for
a user fee program for 351(k)
applications for fiscal years (FYs) 2013
through 2017.
DATES: Submit either electronic or
written comments by June 9, 2011.
Submit notification of interest in
participating in public stakeholder
meetings or industry stakeholder
meetings on or before June 3, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Public and
industry stakeholders who have not yet
notified FDA of their interest in
participating in these meetings should
e-mail complete contact information to
BiosimilarsUserFeeProgram@
fda.hhs.gov. (See sections VI.B and VI.C
of this document for additional
information.)
FOR FURTHER INFORMATION CONTACT:
Sunanda Bahl, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168,
Silver Spring, MD 20993–0002, 301–
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
796–3584, FAX: 301–847–8443, e-mail:
sunanda.bahl@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On March 23, 2010, President Obama
signed into law the Affordable Care Act
(Pub. L. 111–148). The Affordable Care
Act contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) that
amends the PHS Act and other statutes
to create an abbreviated approval
pathway for biological products shown
to be highly similar (biosimilar) to, or
interchangeable with, an FDA-licensed
reference biological product. (See
sections 7001 through 7003 of the
Affordable Care Act.) Section 351(k) of
the PHS Act (42 U.S.C. 262(k)), added
by the BPCI Act, allows a company to
submit an application for licensure of a
biosimilar or interchangeable biological
product.
The BPCI Act amends section 735 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 379g) to
include 351(k) applications in the
definition of ‘‘human drug application’’
for the purposes of the prescription drug
user fee provisions. (See section
7002(f)(3)(A) of the Affordable Care
Act.) Accordingly, under section 736 of
the FD&C Act (21 U.S.C. 379h), the fee
for a biologics license application (BLA)
is currently the same regardless of
whether the application is submitted
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27061-27062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0631]
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 June 9,
2011.
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: 202-395-7285, 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.
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.
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--(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
[[Page 27062]]
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.
In the Federal Register of December 23, 2010 (75 FR 80823), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Justification Submitted as 2 1 2 16 32
General Correspondence and in
the Annual Report..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11359 Filed 5-9-11; 8:45 am]
BILLING CODE 4160-01-P
