[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46199-46200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21676]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-09-08AG]


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 
the CDC Reports Clearance Officer at (404) 639-4766 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) 395-5809. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Formative Research and Tool Development--New--National Center for 
HIV, viral hepatitis, STD, and TB Prevention (NCHSTP), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    CDC previously published a clearance mechanism to support 
behavioral projects for HIV/AIDS prevention and control (Federal 
Register, volume 73, number 33, page 492, January 3, 2008). This 
project has been expanded to include formative research, and instrument 
testing for, sexually transmitted infections (STI), viral hepatitis, 
and tuberculosis elimination.
    Formative research is the basis for developing effective strategies 
including

[[Page 46200]]

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 an intervention is being 
or planning to be implemented and helps the project staff understand 
the interests, attributes and needs of different populations and 
persons in their 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 formation of a product. 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. 
Products from the proposed studies will be used for sustainable 
projects for HIV/AIDS, Sexually Transmitted Infections (STI), viral 
Hepatitis, and Tuberculosis prevention that are presented as evidence 
to disease specific National Advisory Committees, in order to support 
revisions to existing prevention and intervention methods, and provide 
new recommendations which cannot be developed without formative 
research.
    This request includes studies investigating the utility and 
acceptability of proposed 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. Overall, these development activities are 
intended to provide information that will increase the success of the 
surveillance or research project 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) Focus group and individual interviews; (2) Cognitive 
interviews for development and testing of specific data collection 
instruments; (3) Component testing of instruments developed from 
qualitative research or communication methods; (4) testing of 
behavioral interventions; (5) public acceptance of intervention and 
prevention methods; (6) utilizing computer-assisted instruments 
(including web-based technology). The implementors may be health 
jurisdictions, non-governmental organizations including academia, for-
profit contractors, private health care facilities, pharmacies, or a 
combination of these agencies.
    Respondents who will participate in individual and group interviews 
(qualitative, cognitive, and computer-assisted development activities) 
are selected purposely 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. Participants may be offered 
cash or gift certificates as tokens of appreciation for participating.
    CDC estimates that the public will participate in 10 different 
information collection activities, each lasting between 6-12 months. 
Participation of respondents is always voluntary and there is no cost 
to the respondents other than their time. The estimated annual burden 
hours requested is 46,516 hours.

                                       Estimate of Annualized Burden Hours
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                                                                                  Number of      Average burden
         Type of respondent                Form name            Number of       responses per   per response (in
                                                               respondents       respondent          hours)
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General public and health care       Screener.............            81,200                 1             10/60
 providers.
General public and health care       Consent Forms........            40,600                 1              5/60
 providers.
General public and health care       Individual interview.             6,600                 1                 1
 providers.
General public and health care       Group interview......             4,000                 1                 2
 providers.
General public and health care       Individual Survey....            30,000                 1             30/60
 providers.
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    Dated: September 2, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-21676 Filed 9-4-09; 8:45 am]
BILLING CODE 4163-18-P