81 FR 73112 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 205 (October 24, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 205 (October 24, 2016)
| Page Range | 73112-73113 | |
| FR Document | 2016-25601 |
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)] [Notices] [Pages 73112-73113] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![73112 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
NCCCP and NSBT grantee program elements across the two models to more respondents will not receive incentives
implementation, and achievement of effectively and efficiently support for participation. There are no costs to
CDC priorities and goals. NCCCP’s partner organizations. respondents other than their time.
CDC will use findings from the CDC seeks a two-year approval to
assessment to inform development of collect the required information.
future TTA efforts that utilize the core Participation is voluntary and
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
DP13–1314 and DP13–1315 Award- Worksheet for Identifying Case 10 1 60/60 10
ee Organizations. Study Interviewees.
DP13–1314 Program Directors/Man- Case Study Interview Guide for 16 1 90/60 24
agers. DP13–1314 Program Managers.
Case Study Follow-Up Interview 16 1 60/60 16
Guide for DP13–1314 Program
Managers.
DP13–1315 Program Directors/Man- Case Study Interview Guide for 4 1 90/60 6
agers. DP1–1315 Program Managers.
Case Study Follow-Up Interview 4 1 60/60 4
Guide for DP1–1315 Program
Managers.
DP13–1314 Evaluators ..................... Case Study Interview Guide for 16 1 60/60 16
DP1–1314 Evaluators.
DP13–1315 Evaluators ..................... Case Study Interview Guide for 4 1 60/60 4
DP1–1315 Evaluators.
DP13–1314 Partners ........................ Case Study Interview Guide for 32 1 60/60 32
DP1–1314 Partners.
DP13–1315 Partners ........................ Case Study Interview Guide for 8 1 60/60 8
DP1–1315 Partners.
NCCCP and NSBT Program Direc- Survey .............................................. 1560 1 15/60 390
tors, Staff, Partners, and Coalition
Members.
NCCCP and NSBT Program Direc- TTA Recipient Interview Guide ........ 10 1 30/60 5
tors, Staff, Partners, and Coalition
Members.
Total ........................................... ........................................................... ........................ ........................ ........................ 515
Leroy A. Richardson, published to obtain comments from the responses; and (e) Assess information
Chief, Information Collection Review Office, public and affected agencies. collection costs.
Office of Scientific Integrity, Office of the To request additional information on
Written comments and suggestions
Associate Director for Science, Office of the the proposed project or to obtain a copy
Director, Centers for Disease Control and from the public and affected agencies
concerning the proposed collection of of the information collection plan and
Prevention.
information are encouraged. Your instruments, call (404) 639–7570 or
[FR Doc. 2016–25671 Filed 10–21–16; 8:45 am] send an email to omb@cdc.gov. Direct
comments should address any of the
BILLING CODE 4163–18–P written comments and/or suggestions
following: (a) Evaluate whether the
regarding the items contained in this
proposed collection of information is
notice to the Attention: CDC Desk
DEPARTMENT OF HEALTH AND necessary for the proper performance of
Officer, Office of Management and
HUMAN SERVICES the functions of the agency, including
Budget, Washington, DC 20503 or by fax
whether the information will have to (202) 395–5806. Written comments
Centers for Disease Control and practical utility; (b) Evaluate the
Prevention should be received within 30 days of
accuracy of the agencies estimate of the this notice.
burden of the proposed collection of
[30 Day–17–16AVC] information, including the validity of Proposed Project
the methodology and assumptions used; CDC/ATSDR Formative Research and
Agency Forms Undergoing Paperwork (c) Enhance the quality, utility, and
Reduction Act Review Tool Development—New — Office of
clarity of the information to be the Director, Centers for Disease Control
The Centers for Disease Control and collected; (d) Minimize the burden of
sradovich on DSK3GMQ082PROD with NOTICES
and Prevention (CDC).
Prevention (CDC) has submitted the the collection of information on those
following information collection request who are to respond, including through Background and Brief Description
to the Office of Management and Budget the use of appropriate automated, The Centers for Disease Control and
(OMB) for review and approval in electronic, mechanical, or other Prevention requests approval for a new
accordance with the Paperwork technological collection techniques or generic information collection plan
Reduction Act of 1995. The notice for other forms of information technology, entitled CDC/ATSDR Formative
the proposed information collection is e.g., permitting electronic submission of Research and Tool Development. This
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![Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices 73113
information collection plan is designed specific National Advisory Committees, will increase the success of surveillance
to allow CDC to conduct formative to support revisions to recommended or research projects through increasing
research information collection prevention and intervention methods, as response rates and decreasing response
activities for developing new tools and well as new recommendations. error, thereby decreasing future data
methodologies to support agency Much of CDC’s health communication collection burden to the public. The
research, surveillance, program takes place within campaigns that have studies that will be covered under this
evaluation, communications, health fairly lengthy planning periods— request will include one or more of the
promotion, and research project timeframes that accommodate the following investigational modalities: (1)
development. It helps researchers standard Federal process for approving Structured and qualitative interviewing
identify and understand the data collections. Short term qualitative for surveillance, research, interventions
characteristics of target populations that interviewing and cognitive research and material development, (2) cognitive
influence their decisions and actions. techniques have previously proven interviewing for development of specific
Formative research is integral in invaluable in the development process. data collection instruments, (3)
developing programs as well as This request may include studies methodological research (4) usability
improving existing and ongoing investigating the utility and testing of technology-based instruments
programs. Formative research looks at acceptability of proposed sampling and and materials, (5) field testing of new
the community in which a public health recruitment methods, intervention methodologies and materials, (6)
intervention is planned or will be contents and delivery, questionnaire investigation of mental models for
implemented and helps the project staff domains, individual questions, and health decision-making, to inform
understand the interests, attributes and interactions with project staff or health communication messages, and (7)
needs of different populations and electronic data collection equipment. organizational needs assessments to
persons in that community. Formative These activities will also provide support development of capacity.
research occurs before a program is information about how respondents Respondents who will participate in
designed and implemented, or while a answer questions and ways in which individual and group interviews
program is being conducted. question response bias and error can be (qualitative, cognitive, and computer
CDC conducts formative research to reduced. assisted development activities) are
develop public-sensitive and effective This request may include the selected purposively from those who
communication messages and data collection of information from public respond to recruitment advertisements.
collection tools. To develop health programs to assess needs related In addition to utilizing advertisements
scientifically valid and appropriate to initiation of a new program activity for recruitment, respondents who will
methods, interventions, and or expansion or changes in scope or participate in research on survey
instruments, cycles of interviews and implementation of existing program methods may be selected purposively or
focus groups are designed to inform the activities to adapt them to current systematically from within an ongoing
development of a product. needs. The information collected will be surveillance or research project.
Products from these formative used to advise programs and provide Participation of respondents is
research studies will be used for capacity-building assistance tailored to voluntary. There is no cost to
prevention of illness and disease. the identified needs. participants other than their time.
Findings from these studies may also be Overall, these development activities Annual estimated burden is 18,750
presented as evidence to disease- are intended to provide information that hours.
Number of
Number of Average hours Total response
Type of respondent Form name responses per
respondents per response burden (Hrs.)
respondent
General public and health care pro- Screener ........................................... 5,000 1 15/60 1,250
viders.
Interview ........................................... 5,000 1 1 5,000
Focus Group Interview ..................... 5,000 1 2 10,000
Survey .............................................. 5,000 1 30/60 2,500
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Chief, Information Collection Review Office, HUMAN SERVICES Administration (FDA) and the Centers
Office of Scientific Integrity, Office of the for Medicare & Medicaid Services (CMS)
Associate Director for Science, Office of the Centers for Medicare & Medicaid (the Agencies) are informing the public
Director, Centers for Disease Control and Services that the Parallel Review of medical
Prevention. devices pilot program will be fully
[CMS–3180–N4]
[FR Doc. 2016–25601 Filed 10–21–16; 8:45 am] implemented and extended indefinitely.
BILLING CODE 4163–18–P Food and Drug Administration The Agencies are soliciting nominations
from manufacturers of innovative
[Docket No. FDA–2010–N–0308] medical devices to participate in the
‘‘Program for Parallel Review of Medical
sradovich on DSK3GMQ082PROD with NOTICES
Program for Parallel Review of Medical Devices.’’ The Parallel Review program
Devices is a collaborative effort that is intended
AGENCY: Food and Drug Administration; to reduce the time between FDA
Centers for Medicare & Medicaid marketing approval or FDA’s granting of
Services, HHS. a de novo request and Medicare
coverage decisions through CMS’s
ACTION: Notice.
National Coverage Determination (NCD)
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Document Created: 2016-10-21 23:45:56
Document Modified: 2016-10-21 23:45:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 73112 |
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