[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46094-46096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day 12-0840]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Kim Lane, CDC Reports Clearance Officer, 1600 
Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to 
[email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including

[[Page 46095]]

whether the information shall have practical utility; (b) the accuracy 
of the agency's estimate of the burden of the proposed collection of 
information; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; and (d) ways to minimize the burden of 
the collection of information on respondents, including through the use 
of automated collection techniques or other forms of information 
technology. Written comments should be received within 60 days of this 
notice.

Proposed Project

    Formative Research and Tool Development--(OMB  0920-0840, 
Exp. 3/31/2013)--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 to 
collect formative research and tool development data over a three-year 
period. 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 four 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 research that occurs before a program is 
designed and implemented, or while a program is being conducted and is 
and 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 also an integral part of 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 tuberculosis (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.
    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 
consist of healthcare providers and the general public as respondents 
and 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.
    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.
    There is no cost to participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of                    Total response
      Type of respondent            Form name        Number of     responses per   Average hours      burden
                                                    respondents     respondent     per response       (hours)
----------------------------------------------------------------------------------------------------------------
General public and health care  Screener........           97440               1           10/60           16240
 providers.
General public and health care  Consent Forms...           48720               1            5/60            4060
 providers.
General public and health care  Individual                  7920               1               1            7920
 providers.                      interview.
General public and health care  Group interview.            4800               1               2            9600
 providers.
General public and health care  Survey of                  36000               1           30/60           18000
 providers.                      Individual.
                                                 ---------------------------------------------------------------
    Total.....................  ................          194880  ..............  ..............           55820
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[[Page 46096]]

Kimberly S. Lane,
Deputy Director, Office of Science Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-18851 Filed 8-1-12; 8:45 am]
BILLING CODE 4163-18-P