E9-5103. 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 404-639-5960 or send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including 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—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 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.

Products from these 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 new recommendations which cannot be developed without formative research.

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 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).

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.

CDC estimates that in a given year, 46,529 individuals will participate in 10 different information collection activities each year, each lasting between 6-12 months.

Participation of respondents is voluntary and there is no cost to the respondents other than their time.

Estimated Annualized Burden Table

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average hours per response	Total response burden (hrs)
General public and health care providers	Screener	81200	1	10/60	13533
General public and health care providers	Consent Forms	40600	1	5/60	3383
General public and health care providers	Individual interview	6600	1	1	6600
General public and health care providers	Group interview	4000	1	2	8000
General public and health care providers	Individual Survey	30000	1	30/60	15000
Total					46517

Dated: March 3, 2009.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.