Draft Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability, 33438-33440 [08-1350]
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Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
III. Paperwork Reduction Act of 1995
This electronic ICSR draft guidance
refers to proposed collections of
information required by Public Law
109–462 and subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (the PRA) (44 U.S.C. 3501–
3520). As required by the PRA, FDA is
now requesting public comment (see
DATES) on these proposed collections of
information. The agency’s analysis and
estimates of the proposed collections of
information in the electronic ICSR draft
guidance that are required by Public
Law 109–462 have been described
previously in FDA’s notice of
availability for a draft guidance entitled
‘‘Postmarketing Adverse Event
Reporting for Nonprescription Human
Drug Products Marketed Without an
Approved Application’’ (72 FR 58316,
October 15, 2007) (the October 2007
PRA analysis). For burden estimates for
the proposed collections of information
in the electronic ICSR draft guidance,
see the October 2007 PRA analysis.
This electronic ICSR draft guidance
also refers to previously approved
collections of information found in FDA
regulations. The collections of
information in 21 CFR 310.305, 314.80,
600.80, and 1271.350 have been
approved under OMB control numbers
0910–0291, 0910–0230, 0910–0308, and
0910–0543 respectively.
IV. Electronic Access
Persons with access to the Internet
may obtain the document athttps://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://
www.regulations.gov.
Dated: June 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–13269 Filed 6–11–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[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Draft Guidance for Industry on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.
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
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 https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12JNN1.SGM
12JNN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
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
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
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
https://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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
33439
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
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33440
Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
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 BURDEN1
No. of
Respondents
Justification submitted as general
correspondence and in the annual report
1 There
No. of Responses per
Respondent
2
Hours Per
Response
Total Responses
1
2
Total Hours
16
Food and Drug Administration
applications have agreed in writing to
permit FDA to withdraw approval of the
applications and have waived their
opportunity for a hearing.
[Docket No. FDA–2008–0321]
IV. Electronic Access
DATES:
Hospira, Inc., et al.; Withdrawal of
Approval of One New Drug Application
and Two Abbreviated New Drug
Applications
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
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]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4160–01–S
Notice.
Application No.
Effective June 12, 2008.
FDA
informed the holders of the following
applications that the agency believes a
potential problem associated with
edetate disodium is sufficiently serious
that the following drug products should
be removed from the market:
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is withdrawing
approval of one new drug application
(NDA) and two abbreviated new drug
applications (ANDAs) for edetate
disodium injection. The holders of these
SUMMARY:
Drug
Applicant
NDA 11–355
ENDRATE (edetate disodium) Injection
Hospira, Inc., 275 North Field Dr.,
Lake Forest, IL 60045– 5046
ANDA 40–376
Edetate Disodium Injection
Apotex Inc., 150 Signet Dr., Toronto,
Ontario, Canada M9L 1T9
ANDA 40–437
mstockstill on PROD1PC66 with NOTICES
32
are no capital costs or operating and maintenance costs associated with this collection of information.
Edetate Disodium Injection
Bioniche Pharma, 272 E. Deerpath Rd.,
suite 304, Lake Forest, IL 60045
Edetate disodium is indicated for the
treatment of hypercalcemia and for the
control of ventricular arrhythmias
associated with digitalis toxicity.
Hospira, Inc. (Hospira), Apotex Inc.
(Apotex), and Bioniche Pharma
(Bioniche) have agreed in writing to
permit FDA to withdraw approval of
their respective applications (listed in
the table of this document), and to
voluntarily remove their respective
products from the market, under
§ 314.150(d) (21 CFR 314.150(d)).
On January 16, 2008, FDA issued a
public health advisory to alert patients
and healthcare professionals about
important safety information concerning
the drug edetate disodium (see ‘‘FDA
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
Public Health Advisory: Edetate
Disodium (Marketed as ENDRATE and
Generic Products),’’ available on the
Internet at https://www.fda.gov/cder/
drug/infopage/edetateldisodium/
default.htm). As noted in the January
16, 2008, Public Health Advisory, there
have been cases where children and
adults have died when they were
mistakenly given edetate disodium
instead of edetate calcium disodium
(calcium disodium versenate) or when
edetate disodium was used for
indications other than those approved
by FDA. FDA asked Hospira, Apotex,
and Bioniche to voluntarily remove
their products (listed in the table of this
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
document) from the market because of
safety concerns.
Hospira’s NDA 11–355 for ENDRATE
was initially approved in 1959 solely on
the basis of safety. The 1962
amendments to the Federal Food, Drug,
and Cosmetic Act (the act) required that
drugs be shown to be effective as well.
To accomplish this, FDA initiated the
Drug Efficacy Study Implementation
(DESI) review to evaluate the
effectiveness of drugs that had been
previously approved on safety grounds
alone. In its DESI review of edetate
disodium, FDA concluded that edetate
disodium was effective for the treatment
of hypercalcemia and for the control of
ventricular arrhythmias associated with
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33438-33440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1350]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Hours Per
Respondents per Respondent Total Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Justification submitted as general correspondence and 2 1 2 16 32
in the annual report
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://www.fda.gov/cder/guidance/index.htm or https://
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
