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, 65403-65405 [2014-26140]
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<![CDATA[
65403
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
State Grant Application ....................................................................................
Tribal Grant Application ...................................................................................
State Domestic Violence Coalition Application ................................................
State FVPSA Grant Performance Progress Report ........................................
Tribal FVPSA Grant Performance Progress Report ........................................
State Domestic Violence Coalition Performance Progress Report .................
Estimated Total Annual Burden
Hours: 4,430.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
Number of
responses per
respondent
53
150
56
53
150
56
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–26101 Filed 11–3–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Annual Statistical Report on
Children in Foster Homes and Children
Average
burden hours
per response
1
1
1
1
1
1
Total burden
hours
10
5
10
10
10
10
530
750
560
530
1,500
560
in Families Receiving Payment in
Excess of the Poverty Income Level from
a State Program Funded Under Part A of
Title IV of the Social Security Act.
OMB No.: 0970–0004.
Description: The Department of
Health and Human Services is required
to collect these data under section 1124
of Title I of the Elementary and
Secondary Education Act, as amended
by Public Law 103–382. The data are
used by the U.S. Department of
Education for allocation of funds for
programs to aid disadvantaged
elementary and secondary students.
Respondents include various
components of State Human Service
agencies.
Respondents: The 52 respondents
include the 50 States, the District of
Columbia, and Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Annual Statistical Report on Children in Foster Homes and Children Receiving Payments in Excess of the Poverty Level From a State Program
Funded Under Part A of Title IV of the Social Security Act ........................
rmajette on DSK3VPTVN1PROD with NOTICES
Instrument title
52
1
264.35
13,746.20
Estimated Total Annual Burden
Hours: 13,746.20.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–26138 Filed 11–3–14; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0341]
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:
Frm 00032
Fmt 4703
Sfmt 4703
E:\FR\FM\04NON1.SGM
Notice.
04NON1
65404
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
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 December
4, 2014.
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 emailed 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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
rmajette on DSK3VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
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. 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 numbers 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 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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 April 7,
2014 (79 FR 19099), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment. The comment expressed
support for FDA’s efforts to review
updated breakpoints published by
appropriate nationally or internationally
recognized standard setting bodies, and
then determine whether to recognize
these recommendations in an annual
Federal Register notice based upon the
best available scientific and clinical
evidence. The comment also urged FDA
and outside organizations to prioritize
the harmonization of breakpoints, taking
into account possible differences in
doses and dosing schedules used in
different parts of the world. The
comment also expressed support for the
provisions in the Antibiotic
Development to Advance Patient
Treatment (ADAPT) Act, H.R. 3742. The
comment said that the ADAPT Act
would direct FDA to publish quarterly
on its Web site new or updated
breakpoints set by an appropriate
standard setting organization and
recognized by the Agency. The
comment said it would also support
additional statutory changes to remove
breakpoint information from the paper
labeling of antibacterial drugs and
establish a scheme whereby FDA may
clear antimicrobial susceptibility testing
devices that incorporate breakpoints
that have been set by an outside
standard setting body and recognized by
the FDA.
FDA appreciates the comment and we
will continue our efforts on 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.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\04NON1.SGM
04NON1
65405
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number
of respondents
Activity
Number of
responses per
respondent
2
1
Justification Submitted as General Correspondence and in
the Annual Report ............................................................
1 There
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd.; COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
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.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2014–26140 Filed 11–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0420]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Testing
Communications on Food and Drug
Administration-Regulated Products
Used in Animals
Food and Drug Administration,
HHS.
ACTION:
2
16
Total hours
32
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Average
burden per
response
Total annual
responses
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.
DATES: Fax written comments on the
collection of information by December
4, 2014.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0689. Also
include the FDA docket number found
SUMMARY:
Testing Communications on FDA/
Center for Veterinary Medicine (CVM)Regulated Products Used in Animals
(21 U.S.C. 393 (d)(2)(D))—OMB Control
Number 0910–0689—Reinstatement
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of CVM-regulated
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. FDA expects that improving
communications about the safety of
regulated animal drugs, feed, food
additives, and devices will involve
many research methods, including
individual indepth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about the use of FDAregulated products for use in animals.
Knowledge of consumer and veterinary
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, labels, and
labeling. These communications will
aim to improve public understanding of
the risks and benefits of using regulated
animal drugs, feed, food additives, and
devices by providing users with a better
context in which to place risk
information more completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
In the Federal Register of June 16,
2014 (79 FR 34312) FDA published a 60day notice requesting public comment
on the proposed collection of
information. One comment was
submitted; however, it was not
responsive to the four collection of
information topics solicited and
therefore is not discussed in this
document.
FDA estimates the burden of this
collection of information based on
recent prior experience with the various
types of data collection methods
described in this document:
rmajette on DSK3VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 U.S.C. 393(d)(2)(D)
Individual Indepth Interviews ...............................................
General Public Focus Group Interviews ..............................
Intercept Interviews: Central Location .................................
Intercept Interviews: Telephone ...........................................
Self-Administered Surveys ...................................................
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
PO 00000
Frm 00034
Number of
responses per
respondent
360
288
600
2 10,000
2,400
Fmt 4703
Sfmt 4703
1
1
1
1
1
Total annual
responses
360
288
600
10,000
2,400
E:\FR\FM\04NON1.SGM
04NON1
Average
burden per
response
0.75
1.5
0.25
0.08
0.25
Total hours
270
432
150
800
600
]]>Agencies
[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65403-65405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0341]
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.
-----------------------------------------------------------------------
[[Page 65404]]
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
December 4, 2014.
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 emailed 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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. 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 numbers
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 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.
In the Federal Register of April 7, 2014 (79 FR 19099), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. The comment
expressed support for FDA's efforts to review updated breakpoints
published by appropriate nationally or internationally recognized
standard setting bodies, and then determine whether to recognize these
recommendations in an annual Federal Register notice based upon the
best available scientific and clinical evidence. The comment also urged
FDA and outside organizations to prioritize the harmonization of
breakpoints, taking into account possible differences in doses and
dosing schedules used in different parts of the world. The comment also
expressed support for the provisions in the Antibiotic Development to
Advance Patient Treatment (ADAPT) Act, H.R. 3742. The comment said that
the ADAPT Act would direct FDA to publish quarterly on its Web site new
or updated breakpoints set by an appropriate standard setting
organization and recognized by the Agency. The comment said it would
also support additional statutory changes to remove breakpoint
information from the paper labeling of antibacterial drugs and
establish a scheme whereby FDA may clear antimicrobial susceptibility
testing devices that incorporate breakpoints that have been set by an
outside standard setting body and recognized by the FDA.
FDA appreciates the comment and we will continue our efforts on
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.
FDA estimates the burden of this collection of information as
follows:
[[Page 65405]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Justification Submitted as 2 1 2 16 32
General Correspondence and in
the Annual Report..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26140 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P
