[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71794-71795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29183]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

 [30Day-13-0840]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC or 
by fax to (202) 395-5806. Written comments should be received within 30 
days of this notice.

Proposed Project

    Formative Research and Tool Development--(OMB  0920-0840, 
Exp. 1/31/2013)--Revision--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 request approval for 
a revision and a 3 year approval for the previously approved Formative 
Research and Tool Development. This information collection request has 
been revised to include one additional type of formative research 
information collection activity, additional detail regarding the 
previously approved categories of formative research, and instrument 
testing for data collection activities used to inform many aspects of 
surveillance, communications, health promotion, and research project 
development for NCHHSTP's 4 priority diseases (HIV/AIDS, sexually 
transmitted diseases/infections (STD/STI), viral hepatitis, and 
tuberculosis elimination. 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.
    Formative research is an integral part of developing 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.
    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 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 assessment 
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.

[[Page 71795]]

    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. Participation of respondents is 
voluntary. The total estimated burden is 55820 hours.
    There is no cost to participants other than their time.

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                                                                                     Number of
          Type of respondent                    Form name             No. of       responses per   Average hours
                                                                    respondents     respondent     per response
----------------------------------------------------------------------------------------------------------------
General public and health care          Screener................           97440               1           10/60
 providers.
General public and health care          Consent Forms...........           48720               1            5/60
 providers.
General public and health care          Individual interview....            7920               1               1
 providers.
General public and health care          Group interview.........            4800               1               2
 providers.
General public and health care          Survey of Individual....           36000               1           30/60
 providers.
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    Dated: November 26, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-29183 Filed 12-3-12; 8:45 am]
BILLING CODE 4163-18-P