[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26515-26517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-0840]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Formative Research and Tool Development''
to the Office of Management and Budget (OMB) for review and approval.
CDC previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on February 12, 2021 to
obtain comments from the public and affected agencies. CDC received one
non-substantive public comment related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
[[Page 26516]]
Proposed Project
Formative Research and Tool Development--Extension--National Center
for HIV/AIDS, Viral Hepatitis, STD, TB Prevention (NCHHSTP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
This purpose of this information collection request is to allow the
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), to conduct formative research information collection
activities used to inform many aspects of surveillance, communications,
health promotion, and research project development for NCHHSTP's four
priority diseases (HIV/AIDS, sexually transmitted diseases/infections
(STD/STI), viral hepatitis, tuberculosis elimination) and the Division
of School and Adolescent Heath (DASH).
The Centers for Disease Control and Prevention (CDC), and NCHHSTP
request approval for an Extension and a three-year approval for the
previously approved Generic Clearance, ``Formative Research and Tool
Development.'' Formative research is the basis for developing effective
strategies including communication channels for influencing behavior
change. It helps researchers identify and understand the
characteristics, interests, behaviors, and needs 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 also looks at the community in
which a public health intervention is being, 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 can occur before a program is designed and implemented, or
while a program is being conducted.
NCHHSTP formative research is necessary for developing new programs
or adapting programs that deal with the complexity of behaviors, social
context, cultural identities, and health care that underlie the
epidemiology of HIV/AIDS, viral hepatitis, STDs, and TB in the U.S, as
well as for school and adolescent health. CDC conducts formative
research to develop public-sensitive communication messages and user-
friendly tools prior to developing or recommending interventions, or
care. Sometimes these studies are entirely behavioral but most often
they are cycles of interviews and focus groups designed to inform the
development of a product.
Products from these formative research studies will be used for
prevention of HIV/AIDS, Sexually Transmitted Infections (STI), viral
Hepatitis, and Tuberculosis. 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 lengthy planning
periods, or 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 of scientifically valid and population-appropriate methods,
interventions, and instruments.
This request includes studies investigating the utility and
acceptability of proposed sampling and recruitment methods,
intervention content and delivery, questionnaire domains, individual
questions, and interactions with project staff or electronic data
collection equipment. These activities will provide information about
how respondents answer questions and ways in which question response
bias and error can be reduced.
This request also includes 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 identified needs.
Overall, these development activities are intended to provide
information that will increase the success of the 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.
The total annualized burden hours requested for this collection is
46,516. Participation of respondents is voluntary. There is no cost to
participants other than their time.
Estimated Annualized Burden Hours
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Number of
Type of respondent Form name Number of responses per Average hours
respondents respondent per response
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General public........................ Screener................ 56,840 1 10/60
Health care providers................. Screener................ 24,360 1 10/60
General public........................ Consent Forms........... 28,420 1 5/60
Health care providers................. Consent Forms........... 12,180 1 5/60
General public........................ Individual Interview.... 4,620 1 1
Health care providers................. Individual Interview.... 1,980 1 1
General public........................ Focus Group Interview... 2,800 1 2
Health care providers................. Focus Group Interview... 1,200 1 2
General public........................ Survey of Individual.... 21,000 1 30/60
[[Page 26517]]
Health care providers................. Survey of Individual.... 9,000 1 30/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-10149 Filed 5-13-21; 8:45 am]
BILLING CODE 4163-18-P