Agency Forms Undergoing Paperwork Reduction Act Review, 77835-77836 [2011-32027]
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Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
• A current product label, if
applicable (preferably an electronic PDF
file).
• Information identifying published
randomized controlled trials and
observational studies relevant to the
clinical outcomes. Please provide both a
list of citations and reprints if possible.
• Information identifying
unpublished randomized controlled
trials and observational studies relevant
to the clinical outcomes. If possible,
please provide a summary that includes
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to withdrawn/follow-up/
analyzed, and effectiveness/efficacy and
safety results.
• Registered ClinicalTrials.gov
studies. Please provide a list including
the ClinicalTrials.gov identifier,
condition, and intervention.
Your contribution is very beneficial to
this program. AHRQ is not requesting
and will not consider marketing
material, health economics information,
or information on other indications.
This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter. In addition to your scientific
information please submit an index
document outlining the relevant
information in each file along with a
statement regarding whether or not the
submission comprises all of the
complete information available.
mstockstill on DSK4VPTVN1PROD with NOTICES
Please Note: The contents of all
submissions, regardless of format, will be
available to the public upon request unless
prohibited by law. The draft of this review
will be posted on AHRQ’s EHC program Web
site and available for public comment for a
period of 4 weeks. If you would like to be
notified when the draft is posted, please sign
up for the email list at: https://
effectivehealthcare.AHRQ.gov/index.cfm/
join-the-email-list1/.
Key Questions
• Key Question 1: For patients
undergoing diagnostic coronary
angiography to evaluate the presence/
extent of Coronary Artery Disease (CAD)
in order to decide on the necessity for
coronary intervention, what is the
impact of using an IVDx technique—
when compared to angiography alone—
on the diagnostic thinking and
therapeutic decision making, short-term
outcomes, and long-term outcomes?
• Key Question 2: For patients
undergoing Percutaneous Coronary
Intervention (PCI), what is the impact of
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using an Intravascular Diagnostic Device
(IVDx) technique to guide the PCI
procedure (either immediately prior to
or during the procedure)—when
compared to angiography-guided PCI—
on the diagnostic thinking and
therapeutic decision making, short-term
outcomes, and long-term outcomes?
• Key Question 3: For patients having
just undergone a PCI, what is the impact
of using an IVDx technique to evaluate
the success of PCI immediately after the
procedure—when compared to
angiography alone—on the diagnostic
thinking and therapeutic decision
making, short-term outcomes, and longterm outcomes?
• Key Question 4: How do different
IVDx techniques compare to each other
in their effects on the diagnostic
thinking and therapeutic decision
making, short-term outcomes, and longterm outcomes?
• During diagnostic coronary
angiography for the evaluation of the
presence/extent of CAD and the
potential necessity of coronary
intervention?
• During PCI to guide the procedure?
• Immediately after PCI to evaluate
the success of PCI?
• Key Question 5: What factors (e.g.,
patient/physician characteristics,
availability of prior noninvasive testing,
type of PCI performed) influence the
effect of IVDx techniques—when
compared to angiography (or among
different IVDx techniques)—on the
diagnostic thinking and therapeutic
decision making, short-term outcomes,
and long-term outcomes?
• During diagnostic coronary
angiography for the evaluation of the
presence/extent of CAD and the
potential need for coronary
intervention?
• During PCI to guide the procedure?
• Immediately after PCI to evaluate
the success of PCI?
Dated: November 23, 2011.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2011–32048 Filed 12–13–11; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-12–12BW]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
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77835
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery—new—Centers for
Disease Control and Prevention (CDC),
National Center on Birth Defects and
Developmental Disabilities (NCBDDD).
As part of a Federal Government-wide
effort to streamline the process to seek
feedback from the public on service
delivery, the CDC has submitted a
Generic Information Collection Request
(Generic ICR): ‘‘Generic Clearance for
the Collection of Qualitative Feedback
on Agency Service Delivery ’’ to OMB
for approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et.
seq.).
To request additional information,
please contact Daniel L. Holcomb,
Reports Clearance Officer, Centers for
Disease Control and Prevention, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The information collection
activity will garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
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77836
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: the
target population to which
generalizations will be made, the
The Agency received no comments in
response to the 60-day notice published
in the Federal Register of December 22,
2010 (75 FR 80542).
This is a new collection of
information. Respondents will be
screened and selected from Individuals
and Households, Businesses
Organizations, and/or State, Local or
Tribal Government. Below we provide
CDC’s projected average estimates for
the next three years. There is no cost to
respondents other than their time. The
estimated annualized burden hours for
this data collection activity are 18,667.
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
Type of collection
Average
number of
respondents
per activity
Annual
frequency per
response
Average
number of
activities
Average hours
per response
Online surveys, Surveys, Focus Groups .........................................
7,000
1
4
40/60
Dated: December 7, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–32027 Filed 12–13–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
BILLING CODE 4163–18–P
Title: Financial Status Reporting Form
for State Councils on Developmental
Disabilities Program.
OMB No. 0980–0212.
Description
For the program of the State Councils
on Developmental Disabilities, funds are
awarded to State agencies contingent on
fiscal requirements in subtitle B of the
Developmental Disabilities Assistance
and Bill of Rights Act. The SF–425,
ordinarily mandated in the revised OMB
Circular A–102, provides no accounting
breakouts necessary for proper
stewardship. Consequently, the
proposed streamlined from will
substitute for the SF–425 and will allow
compliance monitoring and proactive
compliance maintenance and technical
assistance.
Respondents
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
Financial Status Reporting Form for State Councils on Developmental Disabilities Program ..........................................................................................
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Instrument
55
3
5.10
841.5
Estimated Total Annual Burden
Hours: 841.5.
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 Administration,
Office Planning, Research and
Evaluation, 370 L’Enfant Promenade
SW., Washington, DC 20447, Attn: ACF
Reports Clearance Officer. Email
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address: infocollection@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
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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.
[FR Doc. 2011–32051 Filed 12–13–11; 8:45 am]
BILLING CODE 4184–01–P
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]]>Agencies
[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77835-77836]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32027]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-12-12BW]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery--new--Centers for Disease Control and
Prevention (CDC), National Center on Birth Defects and Developmental
Disabilities (NCBDDD).
As part of a Federal Government-wide effort to streamline the
process to seek feedback from the public on service delivery, the CDC
has submitted a Generic Information Collection Request (Generic ICR):
``Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery '' to OMB for approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
To request additional information, please contact Daniel L.
Holcomb, Reports Clearance Officer, Centers for Disease Control and
Prevention, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an
email to omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
Abstract: The information collection activity will garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Administration's commitment to improving
service delivery. By qualitative feedback we mean information that
provides useful insights on perceptions and opinions, but are not
statistical surveys that yield quantitative results that can be
generalized to the population of study. This feedback will provide
insights into customer or stakeholder perceptions, experiences and
expectations, provide an early warning of issues with service, or focus
attention on areas where communication, training or changes in
operations might improve delivery of products or services. These
collections will allow for ongoing, collaborative and actionable
communications between the Agency and its customers and stakeholders.
It will also allow feedback to contribute directly to the improvement
of program management.
[[Page 77836]]
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: the target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
The Agency received no comments in response to the 60-day notice
published in the Federal Register of December 22, 2010 (75 FR 80542).
This is a new collection of information. Respondents will be
screened and selected from Individuals and Households, Businesses
Organizations, and/or State, Local or Tribal Government. Below we
provide CDC's projected average estimates for the next three years.
There is no cost to respondents other than their time. The estimated
annualized burden hours for this data collection activity are 18,667.
----------------------------------------------------------------------------------------------------------------
Average number
Type of collection of respondents Annual frequency Average number Average hours
per activity per response of activities per response
----------------------------------------------------------------------------------------------------------------
Online surveys, Surveys, Focus 7,000 1 4 40/60
Groups.............................
----------------------------------------------------------------------------------------------------------------
Dated: December 7, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-32027 Filed 12-13-11; 8:45 am]
BILLING CODE 4163-18-P
