Agency Forms Undergoing Paperwork Reduction Act Review, 73112-73113 [2016-25601]
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73112
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
NCCCP and NSBT grantee program
implementation, and achievement of
CDC priorities and goals.
CDC will use findings from the
assessment to inform development of
future TTA efforts that utilize the core
elements across the two models to more
effectively and efficiently support
NCCCP’s partner organizations.
CDC seeks a two-year approval to
collect the required information.
Participation is voluntary and
respondents will not receive incentives
for participation. There are no costs to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
DP13–1314 and DP13–1315 Awardee Organizations.
DP13–1314 Program Directors/Managers.
Worksheet for Identifying Case
Study Interviewees.
Case Study Interview Guide for
DP13–1314 Program Managers.
Case Study Follow-Up Interview
Guide for DP13–1314 Program
Managers.
Case Study Interview Guide for
DP1–1315 Program Managers.
Case Study Follow-Up Interview
Guide for DP1–1315 Program
Managers.
Case Study Interview Guide for
DP1–1314 Evaluators.
Case Study Interview Guide for
DP1–1315 Evaluators.
Case Study Interview Guide for
DP1–1314 Partners.
Case Study Interview Guide for
DP1–1315 Partners.
Survey ..............................................
NSBT Program DirecPartners, and Coalition
Total ...........................................
DP13–1315 Program Directors/Managers.
DP13–1314 Evaluators .....................
DP13–1315 Evaluators .....................
DP13–1314 Partners ........................
DP13–1315 Partners ........................
NCCCP and
tors, Staff,
Members.
NCCCP and
tors, Staff,
Members.
NSBT Program DirecPartners, and Coalition
60/60
10
16
1
90/60
24
16
1
60/60
16
4
1
90/60
6
4
1
60/60
4
16
1
60/60
16
4
1
60/60
4
32
1
60/60
32
8
1
60/60
8
1560
1
15/60
390
TTA Recipient Interview Guide ........
10
1
30/60
5
...........................................................
........................
........................
........................
515
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–17–16AVC]
Agency Forms Undergoing Paperwork
Reduction Act Review
sradovich on DSK3GMQ082PROD with NOTICES
Total burden
(in hours)
1
[FR Doc. 2016–25671 Filed 10–21–16; 8:45 am]
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
17:42 Oct 21, 2016
Average
burden per
response
(in hours)
10
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.
VerDate Sep<11>2014
Number of
responses per
respondent
Number of
respondents
Type of respondents
Jkt 241001
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: 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
CDC/ATSDR Formative Research and
Tool Development—New — Office of
the Director, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention requests approval for a new
generic information collection plan
entitled CDC/ATSDR Formative
Research and Tool Development. This
E:\FR\FM\24OCN1.SGM
24OCN1
73113
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
information collection plan is designed
to allow CDC to conduct formative
research information collection
activities for developing new tools and
methodologies to support agency
research, surveillance, program
evaluation, communications, health
promotion, and research project
development. It helps researchers
identify and understand the
characteristics of target populations that
influence their decisions and actions.
Formative research is integral in
developing programs as well as
improving existing and ongoing
programs. Formative research looks at
the community in which a public health
intervention is planned or will be
implemented and helps the project staff
understand the interests, attributes and
needs of different populations and
persons in that community. Formative
research occurs before a program is
designed and implemented, or while a
program is being conducted.
CDC conducts formative research to
develop public-sensitive and effective
communication messages and data
collection tools. To develop
scientifically valid and appropriate
methods, interventions, and
instruments, cycles of interviews and
focus groups are designed to inform the
development of a product.
Products from these formative
research studies will be used for
prevention of illness and disease.
Findings from these studies may also be
presented as evidence to disease-
specific National Advisory Committees,
to support revisions to recommended
prevention and intervention methods, as
well as new recommendations.
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods—
timeframes that accommodate the
standard Federal process for approving
data collections. Short term qualitative
interviewing and cognitive research
techniques have previously proven
invaluable in the development process.
This request may include studies
investigating the utility and
acceptability of proposed sampling and
recruitment methods, intervention
contents and delivery, questionnaire
domains, individual questions, and
interactions with project staff or
electronic data collection equipment.
These activities will also provide
information about how respondents
answer questions and ways in which
question response bias and error can be
reduced.
This request may include the
collection of information from public
health programs to assess needs related
to initiation of a new program activity
or expansion or changes in scope or
implementation of existing program
activities to adapt them to current
needs. The information collected will be
used to advise programs and provide
capacity-building assistance tailored to
the identified needs.
Overall, these development activities
are intended to provide information that
Form name
General public and health care providers.
Total response
burden (Hrs.)
1
15/60
1,250
5,000
5,000
5,000
Interview ...........................................
Focus Group Interview .....................
Survey ..............................................
[FR Doc. 2016–25601 Filed 10–21–16; 8:45 am]
Average hours
per response
5,000
Screener ...........................................
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.
Number of
responses per
respondent
1
1
1
1
2
30/60
5,000
10,000
2,500
Number of
respondents
Type of respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3180–N4]
Food and Drug Administration
BILLING CODE 4163–18–P
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2010–N–0308]
Program for Parallel Review of Medical
Devices
Food and Drug Administration;
Centers for Medicare & Medicaid
Services, HHS.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
17:42 Oct 21, 2016
Jkt 241001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
will increase the success of surveillance
or research projects through increasing
response rates and decreasing response
error, thereby decreasing future data
collection burden to the public. The
studies that will be covered under this
request will include one or more of the
following investigational modalities: (1)
Structured and qualitative interviewing
for surveillance, research, interventions
and material development, (2) cognitive
interviewing for development of specific
data collection instruments, (3)
methodological research (4) usability
testing of technology-based instruments
and materials, (5) field testing of new
methodologies and materials, (6)
investigation of mental models for
health decision-making, to inform
health communication messages, and (7)
organizational needs assessments to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
Participation of respondents is
voluntary. There is no cost to
participants other than their time.
Annual estimated burden is 18,750
hours.
The Food and Drug
Administration (FDA) and the Centers
for Medicare & Medicaid Services (CMS)
(the Agencies) are informing the public
that the Parallel Review of medical
devices pilot program will be fully
implemented and extended indefinitely.
The Agencies are soliciting nominations
from manufacturers of innovative
medical devices to participate in the
‘‘Program for Parallel Review of Medical
Devices.’’ The Parallel Review program
is a collaborative effort that is intended
to reduce the time between FDA
marketing approval or FDA’s granting of
a de novo request and Medicare
coverage decisions through CMS’s
National Coverage Determination (NCD)
SUMMARY:
E:\FR\FM\24OCN1.SGM
24OCN1
Agencies
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73112-73113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25601]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-17-16AVC]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: 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
CDC/ATSDR Formative Research and Tool Development--New -- Office of
the Director, Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention requests approval
for a new generic information collection plan entitled CDC/ATSDR
Formative Research and Tool Development. This
[[Page 73113]]
information collection plan is designed to allow CDC to conduct
formative research information collection activities for developing new
tools and methodologies to support agency research, surveillance,
program evaluation, communications, health promotion, and research
project development. It helps researchers identify and understand the
characteristics of target populations that influence their decisions
and actions.
Formative research is integral in developing programs as well as
improving existing and ongoing programs. Formative research looks at
the community in which a public health intervention is planned or will
be implemented and helps the project staff understand the interests,
attributes and needs of different populations and persons in that
community. Formative research occurs before a program is designed and
implemented, or while a program is being conducted.
CDC conducts formative research to develop public-sensitive and
effective communication messages and data collection tools. To develop
scientifically valid and appropriate methods, interventions, and
instruments, cycles of interviews and focus groups are designed to
inform the development of a product.
Products from these formative research studies will be used for
prevention of illness and disease. Findings from these studies may also
be presented as evidence to disease-specific National Advisory
Committees, to support revisions to recommended prevention and
intervention methods, as well as new recommendations.
Much of CDC's health communication takes place within campaigns
that have fairly lengthy planning periods-- timeframes that accommodate
the standard Federal process for approving data collections. Short term
qualitative interviewing and cognitive research techniques have
previously proven invaluable in the development process.
This request may include studies investigating the utility and
acceptability of proposed sampling and recruitment methods,
intervention contents and delivery, questionnaire domains, individual
questions, and interactions with project staff or electronic data
collection equipment. These activities will also provide information
about how respondents answer questions and ways in which question
response bias and error can be reduced.
This request may include the collection of information from public
health programs to assess needs related to initiation of a new program
activity or expansion or changes in scope or implementation of existing
program activities to adapt them to current needs. The information
collected will be used to advise programs and provide capacity-building
assistance tailored to the identified needs.
Overall, these development activities are intended to provide
information that will increase the success of surveillance or research
projects through increasing response rates and decreasing response
error, thereby decreasing future data collection burden to the public.
The studies that will be covered under this request will include one or
more of the following investigational modalities: (1) Structured and
qualitative interviewing for surveillance, research, interventions and
material development, (2) cognitive interviewing for development of
specific data collection instruments, (3) methodological research (4)
usability testing of technology-based instruments and materials, (5)
field testing of new methodologies and materials, (6) investigation of
mental models for health decision-making, to inform health
communication messages, and (7) organizational needs assessments to
support development of capacity. Respondents who will participate in
individual and group interviews (qualitative, cognitive, and computer
assisted development activities) are selected purposively from those
who respond to recruitment advertisements.
In addition to utilizing advertisements for recruitment,
respondents who will participate in research on survey methods may be
selected purposively or systematically from within an ongoing
surveillance or research project. Participation of respondents is
voluntary. There is no cost to participants other than their time.
Annual estimated burden is 18,750 hours.
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Form name Number of responses per Average hours Total response
respondents respondent per response burden (Hrs.)
----------------------------------------------------------------------------------------------------------------
General public and health care Screener........ 5,000 1 15/60 1,250
providers.
Interview....... 5,000 1 1 5,000
Focus Group 5,000 1 2 10,000
Interview.
Survey.......... 5,000 1 30/60 2,500
----------------------------------------------------------------------------------------------------------------
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. 2016-25601 Filed 10-21-16; 8:45 am]
BILLING CODE 4163-18-P