[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Pages 9149-9150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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.

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
----------------------------------------------------------------------------------------------------------------
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