Proposed Information Collection Activity; Comment Request, 54985-54986 [2014-21918]
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Federal Register / Vol. 79, No. 178 / Monday, September 15, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Formative Data Collections for
Policy Research.
OMB No.: 0970–0356.
Description: The Office of Planning,
Research and Evaluation (OPRE), in the
Administration for Children and
Families (ACF) at the U.S. Department
of Health and Human Services (HHS)
intends to request approval from the
Office of Management and Budget
(OMB) for renewal of a generic
clearance to allow OPRE to conduct a
variety of formative data collections
with more than nine respondents. The
data collections will inform future
research but will not be highly
systematic nor intended to be
statistically representative.
OPRE conducts research on a wide
variety of policy and programmatic
areas. OPRE’s research serves to provide
further understanding of current
programs and service populations,
explore options for program
improvement, and assess alternative
policy and program designs. OPRE uses
this formative data collection generic
clearance to employ a variety of
information collection techniques,
including semi-structured discussions,
focus groups and interviews. These
activities inform the development of
54985
OPRE research, help OPRE maintain a
research agenda that is rigorous and
relevant, and ensure that research
products are as current as possible.
Following standard OMB
requirements, OPRE will submit a
change request for each individual data
collection activity under this generic
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, and any supplementary
documents. OPRE requests OMB review
within 10 days of receiving each change
request.
Respondents: Key stakeholder groups
involved in ACF projects, state or local
government officials or service
providers, or experts in fields pertaining
to ACF research.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Annual
number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
Semi-Structured Discussion and Information-Gathering Protocols .......................
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
1,600
533
1
1
1,600
533
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
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
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17:10 Sep 12, 2014
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comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2014–21917 Filed 9–12–14; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Pre-testing of Evaluation
Surveys.
OMB No.: 0970–0355.
Description: The Office of Planning,
Research and Evaluation (OPRE), in the
Administration for Children and
Families (ACF) at the U.S. Department
of Health and Human Services (HHS)
intends to request approval from the
Office of Management and Budget
(OMB) for renewal of a generic
clearance to allow OPRE to pre-test data
collection instruments with more than
nine participants to identify and resolve
any question or procedural problems in
survey administration.
OPRE studies ACF programs, and the
populations they serve, through rigorous
research and evaluation projects. These
include evaluations of existing
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
programs, evaluations of innovative
approaches to helping low-income
children and families, research
syntheses and descriptive and
exploratory studies. To improve the
development of its research and
evaluation surveys, OPRE uses the pretesting of evaluation surveys generic
clearance to employ a variety of
techniques including cognitive and
usability laboratory and field
techniques, behavior coding,
exploratory interviews, respondent
debriefing questionnaires, split sample
experiments, focus groups, and pilot
studies/pre-tests. These activities allow
OPRE to identify if and when a survey
may be simplified for respondents,
respondent burden may be reduced, and
other possible improvements.
Following standard OMB
requirements, OPRE will submit a
change request for each individual data
collection activity under this generic
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, and any supplementary
documents. OPRE requests OMB review
within 10 days of receiving each change
request.
Respondents: Participants in ACF
programs being evaluated; participants
in ACF demonstrations; comparison
group members; and other relevant
populations, such as individuals at risk
of needing ACF services.
E:\FR\FM\15SEN1.SGM
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54986
Federal Register / Vol. 79, No. 178 / Monday, September 15, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
Survey development field tests, respondent debriefing questionnaires, cognitive
interviews, split sample experiments,
focus groups .........................................
5100
1700
1
.75
3,825
1,275
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
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.
Karl Koerper, Reports
Clearance Officer.
[FR Doc. 2014–21918 Filed 9–12–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4184–79–P
VerDate Mar<15>2010
17:10 Sep 12, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0649]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
External Pacemaker Pulse Generator;
Withdrawal of Draft Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of the draft guidance
entitled ‘‘Class II Special Controls
Guidance Document: External
Pacemaker Pulse Generator,’’ dated
October 2011, in response to the
requirements of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) and new input received
during a panel meeting.
DATES: The withdrawal is effective
September 15, 2014.
FOR FURTHER INFORMATION CONTACT:
Hina Pinto, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 1652, Silver Spring,
MD 20993, 301–796–6351.
SUPPLEMENTARY INFORMATION:
In a notice published in the Federal
Register of October 17, 2011 (76 FR
64228), FDA announced the availability
of a draft special controls guidance
document that, if finalized, would serve
as a special control if FDA reclassified
these devices. FDA believed that the
special controls described in the draft
guidance entitled, ‘‘Class II Special
Controls Guidance Document: External
Pacemaker Pulse Generator’’ would be
sufficient to mitigate the risks to health
associated with the external pacemaker
pulse generator (EPPG) (Ref. 1).
On July 9, 2012, FDASIA (Pub. L.
112–144) was enacted. Section 608(a) of
FDASIA amended section 513(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c(a))
changing the process for reclassifying a
device from rulemaking to an
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
administrative order. Subsequent to the
publication of the proposed rule,
FDASIA’s amendments to section 513 of
the FD&C Act required FDA to hold a
classification panel (an FDA advisory
committee) meeting to discuss the
classification of this device type. On
September 11, 2013, a meeting of the
Circulatory System Devices Panel (the
Panel) was held to discuss whether
EPPG devices should be reclassified or
remain as class III devices (Ref. 2). The
Panel recommended that EPPG devices
be reclassified to class II with special
controls when intended for cardiac rate
control or prophylactic arrhythmia
prevention.
FDA provided an opportunity for
interested parties to comment on the
special control guidance on EPPG. FDA
did not receive any comments to the
docket. As a result of the Panel
recommendation and the amendment to
section 513(e) of the FD&C Act, FDA
will now include the special controls for
EPPG devices in a proposed order
published elsewhere in this issue of the
Federal Register and withdraw the draft
guidance through this notice.
References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Class II Special Controls Draft
Guidance Document: External
Pacemaker Pulse Generator, available at
https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM275703.pdf.
2. The transcript and other meeting
materials for the September 11, 2013,
Circulatory System Devices Panel are
available on FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
MedicalDevices/
E:\FR\FM\15SEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Pages 54985-54986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Pre-testing of Evaluation Surveys.
OMB No.: 0970-0355.
Description: The Office of Planning, Research and Evaluation
(OPRE), in the Administration for Children and Families (ACF) at the
U.S. Department of Health and Human Services (HHS) intends to request
approval from the Office of Management and Budget (OMB) for renewal of
a generic clearance to allow OPRE to pre-test data collection
instruments with more than nine participants to identify and resolve
any question or procedural problems in survey administration.
OPRE studies ACF programs, and the populations they serve, through
rigorous research and evaluation projects. These include evaluations of
existing programs, evaluations of innovative approaches to helping low-
income children and families, research syntheses and descriptive and
exploratory studies. To improve the development of its research and
evaluation surveys, OPRE uses the pre-testing of evaluation surveys
generic clearance to employ a variety of techniques including cognitive
and usability laboratory and field techniques, behavior coding,
exploratory interviews, respondent debriefing questionnaires, split
sample experiments, focus groups, and pilot studies/pre-tests. These
activities allow OPRE to identify if and when a survey may be
simplified for respondents, respondent burden may be reduced, and other
possible improvements.
Following standard OMB requirements, OPRE will submit a change
request for each individual data collection activity under this generic
clearance. Each request will include the individual instrument(s), a
justification specific to the individual information collection, and
any supplementary documents. OPRE requests OMB review within 10 days of
receiving each change request.
Respondents: Participants in ACF programs being evaluated;
participants in ACF demonstrations; comparison group members; and other
relevant populations, such as individuals at risk of needing ACF
services.
[[Page 54986]]
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number of Annual number responses per hours per Total burden Annual burden
respondents of respondents respondent response hours hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey development field tests, respondent 5100 1700 1 .75 3,825 1,275
debriefing questionnaires, cognitive interviews,
split sample experiments, focus groups...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email
address: OPREinfocollection@acf.hhs.gov. All requests should be
identified by the title of the information collection.
The Department specifically requests comments on (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) 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.
Karl Koerper, Reports
Clearance Officer.
[FR Doc. 2014-21918 Filed 9-12-14; 8:45 am]
BILLING CODE 4184-79-P
