[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
----------------------------------------------------------------------------------------------------------------
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