Notice2024-02681
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 9, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 28 (Friday, February 9, 2024)</title>
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[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Pages 9149-9150]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-0840]
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 September 26, 2023 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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.
Proposed Project
Formative Research and Tool Development (OMB Control No. 0920-0840,
Exp. 7/31/2024)--Extension--National Center for HIV, Viral Hepatitis,
STD, TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
requests approval for an Extension and a three-year approval for the
previously approved Generic Clearance, ``Formative Research and Tool
Development''. This information collection request is designed to allow
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)).
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 is
research that occurs before a program is designed and implemented,
[[Page 9150]]
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 to develop new recommendations. Much of CDC's
health communication takes place within campaigns that have 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 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 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 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.
CDC requests OMB approval for an estimated 46,516 annual burden
hours. Participation by respondents is voluntary, and there is no cost
to participants other than their time.
Estimated Annualized Burden Hours
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Number of
Type of respondent Form mame 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
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 Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-02681 Filed 2-8-24; 8:45 am]
BILLING CODE 4163-18-P
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