E7-2071. 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 e-mail 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

Determining Stakeholder Awareness and the Use and Impact of Products Developed by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Model Project—New—National Center for Chronic Disease Prevention and Health Promotion/National Office of Public Health Genomics (NOPHG), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

More than 1,000 genetic tests are currently available in clinical practice. Most are used for diagnosis of rare genetic diseases, but a growing number have population-based applications, and the potential for broad public health impact.

A number of issues have been raised about the current status of genetic testing implementation, including the need to develop evidence to establish validity and utility of genetic tests before tests are commercialized. Advisory panels, professional organizations, and clinical experts have produced recommendations on the development and clinical implementation of safe and effective genetic tests. In response to the need for a coordinated approach for effectively integrating genomic tests into clinical practice and health policy, CDC's National Office of Public Health Genomics (NOPHG) initiated the (Evaluation of Genomic Applications in Practice and Prevention) EGAPP model project in 2004 to establish a systematic, evidence-based process for assessing genetic tests in transition from research to practice. To support this goal, an independent, non-federal, multidisciplinary EGAPP Working Group was established to identify, prioritize, and select genetic tests to be reviewed; establish review methods and processes; monitor progress of the reviews; and develop conclusions and recommendations based on the evidence.

The plan for surveying key stakeholders described here represents a large component of the overall project evaluation plan. The study will be conducted in collaboration with a consultant, Judith L. Johnson, PhD, under a CDC task order with the McKing Consulting Corporation. Dr. Johnson and McKing Consulting Corporation worked with CDC on study design, and will collect data for the study, conduct data analyses, and develop written reports of results.

The purpose of this study is to collect information on the value and impact of the EGAPP products developed and disseminated (e.g., evidence reports, recommendations) by surveying members of key stakeholder groups considered by project advisors to have the most immediate need and interest in EGAPP products. The four key stakeholder groups are healthcare providers, healthcare payers and purchasers, policy makers (e.g., medical professional organizations, healthcare policy organizations), as well as targeted consumer groups and Web site visitors. Healthcare providers/payers have expressed interest in evidence-based information on emerging genetic tests, and will receive the first surveys about six months after the release of the first evidence reports and EGAPP Working Group recommendations; these groups will be surveyed again one year later. Policy makers, consumers, and healthcare purchasers are likely to identify and be impacted by information developed by EGAPP over a somewhat longer timeline. Therefore, these groups will be surveyed twelve months after the first products are released, and surveyed again one year later. During two specified periods of time one year apart, individuals accessing the EGAPP website will be given the option to participate in an EGAPP survey.

There are no costs to the respondents other than their time. The total estimated annualized burden hours are 448.52.

Estimated Annualized Burden Hours

Type of respondent	Survey name	Number of respondents	Number of responses per respondent	Average response per respondent
Healthcare Providers:	Healthcare Provider Survey.
Primary Care Providers		385	1	10/60
Specialists		385	1	10/60
Genetic Counselors		200	1	10/60
Mid-level Practitioners		385	1	10/60
Nurses		385	1	10/60
Healthcare Payers and Purchasers:
Healthcare Payers	Policy/Payer Survey	100	1	10/60
Healthcare Purchasers	Purchaser Survey	19 31	1	10/60
Healthcare Policy Makers	Policy Survey	50	1	10/60
Consumers:
Group members	General Survey	385	1	10/60
Website visitors		385	1	10/60

Dated: January 31, 2007.

Joan F. Karr,

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