Proposed Data Collection Submitted for Public Comment and Recommendations, 18848-18850 [2015-08028]
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<![CDATA[
18848
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
Local Health Department Representative.
Older Adult—Screened Out ..............
Older Adult—Participant ...................
Interview Guide for Local Health Department Representative.
Senior Village Survey .......................
Senior Village Survey .......................
15
1
30/60
8
1,431
1,550
1
1
1/60
20/60
24
517
Total ...........................................
...........................................................
........................
........................
........................
580
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–08027 Filed 4–7–15; 8:45 am]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
asabaliauskas on DSK5VPTVN1PROD with NOTICES
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the initial
review of applications in response to
(FOA) DP15–001, Natural Experiments
of the Impact of Population-targeted
Health Policies to Prevent Diabetes and
its Complications.
Time And Date: 11 a.m.–6 p.m., May
5–6, 2015 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters For Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Natural Experiments of the Impact of
Population-targeted Health Policies to
Prevent Diabetes and its Complications,
DP15–001, initial review.’’
Contact Person For More Information:
Brenda Colley Gilbert, Ph.D., M.S.P.H.,
Director, Extramural Research Program
Operations and Services, CDC, 4770
Buford Highway NE., Mailstop F–80,
Atlanta, Georgia 30341, Telephone:
(770) 488–6295, BJC4@cdc.gov.
Jkt 235001
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
[FR Doc. 2015–07997 Filed 4–7–15; 8:45 am]
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
17:55 Apr 07, 2015
[60Day–15–1005; Docket No. CDC–2015–
0018]
readiness to adopt mobility-protective
behaviors in older adults.
DATES: Written comments must be
received on or before June 8, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0018 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the information collection
request for reinstatement with change of
the collection previously approved
under OMB control number 0920–
1005—‘‘Conduct an Older Adult
Mobility Assessment Tool Impact
Evaluation and Develop a
Dissemination Plan’’. This collection
will help evaluate whether the Mobility
Planning Tool is effective for promoting
SUMMARY:
PO 00000
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To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\08APN1.SGM
08APN1
18849
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited 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)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Conduct an Older Adult Mobility
Assessment Tool Impact Evaluation and
adults ages 60–74 with no known
mobility limitations. A total of 1,000
individuals will participate in the study.
Prospective respondents will answer a
series of screening questions.
Individuals who meet the screening
criteria and are willing to participate
will complete a baseline and follow-up
interview each lasting approximately 10
minutes.
NCIPC will analyzed the collected
data using descriptive statistics and a
series of t-tests, chi-square analyses, and
Mann-Whitney U-tests. Multivariate
analyses will include a series of
repeated measures Analysis of Variance
(ANOVA), and logistic regressions.
The data collected from this study
will help CDC identify what further
revisions to the MPT might be necessary
before it is disseminated publicly.
Selected study findings may eventually
be presented in oral and poster
presentations and published in a peerreviewed journal. Without this
information collection, CDC will not
know whether the MPT is an effective
tool for promoting readiness to adopt
mobility-protective behaviors in older
adults and will not know whether
additional revisions to the tool are
necessary before the MPT is
disseminated publicly. Without this
study, CDC will have limited
information about what strategies are
most likely to be effective for
disseminating the MPT publicly to the
target audience.
The total estimated annual burden
hours are 734.
Develop a Dissemination Plan (OMB
Control No. 0920–1005)—Reinstatement
with Change—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC’s National Center for Injury
Prevention and Control (NCIPC)
requests approval for 3 years, from the
Office of Management and Budget
(OMB) for a reinstatement with change
for the previously approved OMB No.
0920–1005 (Exp. Date: 12–31–2014)
designed to evaluate whether the
Mobility Planning Tool is effective for
promoting readiness to adopt mobilityprotective behaviors in older adults and
assess potential strategies for
dissemination of the Mobility Planning
Tool. With this reinstatement, NCIPC
requests a change of title from ‘‘Older
Adult Safe Mobility Assessment Tool’’
to ‘‘Conduct an Older Adult Mobility
Assessment Tool Impact Evaluation and
Develop a Dissemination Plan.’’
The population of older adults in the
U.S. is growing rapidly. By 2030, this
segment of the population will increase
to an estimated 72 million (20% of the
U.S. population). A critical public
health issue for the older adult
population is mobility—how well
people are able to get to places they
need to go. The goals of this study are
to evaluate (1) whether the Mobility
Planning Tool (MPT) is effective for
promoting readiness to adopt mobilityprotective behaviors in older adults and
(2) assess potential strategies for
dissemination of the MPT.
NCIPC will collect study data using
telephone interviews. The study
population is community-living older
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Individuals Responding to Initial
Phone Call Who Refuse to be
Screened.
Individuals Responding to Initial
Phone Call Responding to Screening Questions.
Study Participants .............................
Study Participants .............................
Study Participants .............................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Type of respondents
Screening Interview Guide ...............
2,500
1
1/60
42
Screening Interview Guide ...............
1,500
1
5/60
125
Baseline Interview Guide .................
MPT ..................................................
Follow-up Interview Guide ...............
1,000
500
900
1
1
1
10/60
30/60
10/60
167
250
150
Total ...........................................
...........................................................
........................
........................
........................
734
VerDate Sep<11>2014
17:55 Apr 07, 2015
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18850
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–08028 Filed 4–7–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0986]
Center for Devices and Radiological
Health: Experiential Learning Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Devices and Radiological Health (CDRH
or Center) is announcing the 2015
Experiential Learning Program (ELP).
This training component is intended to
provide CDRH staff with an opportunity
to understand the policies, laboratory
practices, and challenges faced in
broader disciplines that impact the
device development life cycle. The
purpose of this document is to invite
medical device industry, academia, and
health care facilities to apply to
participate in this formal training
program for FDA’s medical device
review staff, or to contact CDRH for
more information regarding the ELP.
DATES: Submit either an electronic or
written request for participation in the
ELP by May 8, 2015. The proposal
should include a description of your
facility relative to focus areas described
in tables 1or 2). Please include the Area
of Interest (see tables 1or 2) that the site
visit will demonstrate to CDRH staff, a
SUMMARY:
contact person, site visit location(s),
length of site visit, proposed dates, and
maximum number of CDRH staff that
can be accommodated during a site
visit. Proposals submitted without this
minimum information will not be
considered. In addition, please include
an agenda outlining the proposed
training for the site visit. A sample
request and agenda are available on the
ELP Web site at https://www.fda.gov/
downloads/ScienceResearch/
ScienceCareerOpportunities/
UCM392988.pdf and https://
www.fda.gov/scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
Submit either electronic
requests to https://www.regulations.gov
or written requests to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Identify proposals with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Latonya Powell, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5232, Silver Spring,
MD 20993–0002, 301–796–6965, FAX:
301–827–3079, Latonya.powell@
fda.hhs.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is responsible for ensuring the
safety and effectiveness of medical
devices marketed in the United States.
Furthermore, CDRH assures that
patients and providers have timely and
continued access to high-quality, safe,
and effective medical devices. In
support of this mission, the Center
launched various training and
development initiatives to enhance
performance of its staff involved in
regulatory review and in the premarket
review process. One of these initiatives,
the ELP Pilot, was launched in 2012 and
fully implemented on April 2, 2013 (78
FR 19711). CDRH is committed to
advancing regulatory science; providing
industry with predictable, consistent,
transparent, and efficient regulatory
pathways; and helping to ensure
consumer confidence in medical
devices marketed in the United States
and throughout the world. The ELP is
intended to provide CDRH staff with an
opportunity to understand the policies,
laboratory practices, and challenges
faced in broader disciplines that impact
the device development life cycle. This
is a collaborative effort to enhance
communication and facilitate the
premarket review process. Furthermore,
CDRH is committed to understanding
current industry practices, innovative
technologies, regulatory impacts, and
regulatory needs.
These formal training visits are not
intended for FDA to inspect, assess,
judge, or perform a regulatory function
(e.g., compliance inspection), but rather,
they are an opportunity to provide
CDRH review staff a better
understanding of the products they
review. Through this notice, CDRH is
formally requesting participation from
companies, academia, and clinical
facilities, including those that have
previously participated in the ELP or
other FDA site visit programs.
II. ELP
A. ELP Training Component
In this training program, groups of
CDRH staff will observe operations at
research, manufacturing, academia, and
health care facilities. The focus areas
and specific areas of interest for visits
may include the following:
TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY
Specific areas of interest
Failure analysis of orthopedic devices.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Focus area
Methods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants
may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants
influences device design modifications.
Methods of radiologic analysis and associated data analyses; radiologic imaging core laboratories.
Radiologic analysis of orthopedic
devices.
Automated external defibrillators
(AEDs).
Diagnostic imaging catheters for
cardiovascular diseases.
Endovascular grafts for treatment of
aortic aneurysms.
Animal models for evaluation of hemostatic devices.
Hyaluronic acid in dermal tissue
fillers.
Minimally invasive glaucoma surgery (MIGS) devices.
VerDate Sep<11>2014
17:55 Apr 07, 2015
Manufacturing process; incoming component inspection; design verification testing; human factors testing;
returned product testing (as available).
Manufacturing process; design verification testing; returned product testing (as available); ultrasound, optical coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters.
Physician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical
planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology).
Models of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance
of the data generated from these models in evaluating hemostatic devices.
Manufacturing process; source materials; performance testing (e.g., material characterization, biocompatibility, residence time).
Observation of a MIGS procedure; surgical planning; surgical challenges.
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08APN1
]]>Agencies
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18848-18850]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08028]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-1005; Docket No. CDC-2015-0018]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the information
collection request for reinstatement with change of the collection
previously approved under OMB control number 0920-1005--``Conduct an
Older Adult Mobility Assessment Tool Impact Evaluation and Develop a
Dissemination Plan''. This collection will help evaluate whether the
Mobility Planning Tool is effective for promoting readiness to adopt
mobility-protective behaviors in older adults.
DATES: Written comments must be received on or before June 8, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0018 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the
[[Page 18849]]
collection to OMB for approval. To comply with this requirement, we are
publishing this notice of a proposed data collection as described
below.
Comments are invited 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) ways to enhance the quality,
utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.
Proposed Project
Conduct an Older Adult Mobility Assessment Tool Impact Evaluation
and Develop a Dissemination Plan (OMB Control No. 0920-1005)--
Reinstatement with Change--National Center for Injury Prevention and
Control (NCIPC), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC's National Center for Injury Prevention and Control (NCIPC)
requests approval for 3 years, from the Office of Management and Budget
(OMB) for a reinstatement with change for the previously approved OMB
No. 0920-1005 (Exp. Date: 12-31-2014) designed to evaluate whether the
Mobility Planning Tool is effective for promoting readiness to adopt
mobility-protective behaviors in older adults and assess potential
strategies for dissemination of the Mobility Planning Tool. With this
reinstatement, NCIPC requests a change of title from ``Older Adult Safe
Mobility Assessment Tool'' to ``Conduct an Older Adult Mobility
Assessment Tool Impact Evaluation and Develop a Dissemination Plan.''
The population of older adults in the U.S. is growing rapidly. By
2030, this segment of the population will increase to an estimated 72
million (20% of the U.S. population). A critical public health issue
for the older adult population is mobility--how well people are able to
get to places they need to go. The goals of this study are to evaluate
(1) whether the Mobility Planning Tool (MPT) is effective for promoting
readiness to adopt mobility-protective behaviors in older adults and
(2) assess potential strategies for dissemination of the MPT.
NCIPC will collect study data using telephone interviews. The study
population is community-living older adults ages 60-74 with no known
mobility limitations. A total of 1,000 individuals will participate in
the study. Prospective respondents will answer a series of screening
questions. Individuals who meet the screening criteria and are willing
to participate will complete a baseline and follow-up interview each
lasting approximately 10 minutes.
NCIPC will analyzed the collected data using descriptive statistics
and a series of t-tests, chi-square analyses, and Mann-Whitney U-tests.
Multivariate analyses will include a series of repeated measures
Analysis of Variance (ANOVA), and logistic regressions.
The data collected from this study will help CDC identify what
further revisions to the MPT might be necessary before it is
disseminated publicly. Selected study findings may eventually be
presented in oral and poster presentations and published in a peer-
reviewed journal. Without this information collection, CDC will not
know whether the MPT is an effective tool for promoting readiness to
adopt mobility-protective behaviors in older adults and will not know
whether additional revisions to the tool are necessary before the MPT
is disseminated publicly. Without this study, CDC will have limited
information about what strategies are most likely to be effective for
disseminating the MPT publicly to the target audience.
The total estimated annual burden hours are 734.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Individuals Responding to Screening 2,500 1 1/60 42
Initial Phone Call Who Refuse Interview Guide.
to be Screened.
Individuals Responding to Screening 1,500 1 5/60 125
Initial Phone Call Responding Interview Guide.
to Screening Questions.
Study Participants............ Baseline 1,000 1 10/60 167
Interview Guide.
Study Participants............ MPT............. 500 1 30/60 250
Study Participants............ Follow-up 900 1 10/60 150
Interview Guide.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 734
----------------------------------------------------------------------------------------------------------------
[[Page 18850]]
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-08028 Filed 4-7-15; 8:45 am]
BILLING CODE 4163-18-P
