E9-21676. 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 [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. 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 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

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
General public and health care providers	Screener	81,200	1	10/60
General public and health care providers	Consent Forms	40,600	1	5/60
General public and health care providers	Individual interview	6,600	1	1
General public and health care providers	Group interview	4,000	1	2
General public and health care providers	Individual Survey	30,000	1	30/60

Dated: September 2, 2009.

Maryam I. Daneshvar,

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