[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47173-47174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0840]


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 April 23, 2018 to obtain 
comments from the public and affected agencies. CDC received one 
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 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, 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, 
Expiration 1/31/2019)--Extension--National Center for HIV/AIDS, Viral 
Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention, National Center for 
HIV/AIDS, 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, 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.

[[Page 47174]]

    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 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. The total burden hours 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
Health care providers.................  Survey of Individual....           9,000               1           30/60
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Jeffrey M. Zirger,
Acting 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. 2018-20245 Filed 9-17-18; 8:45 am]
BILLING CODE 4163-18-P