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Notice

Proposed Data Collections Submitted for Public Comment and Recommendations

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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 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.

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

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

Background and Brief Description

The success of the Human Genome Project has led to increasingly rapid translation of genomic information into clinical applications. Genetic tests for about 1,200 diseases have been developed, with more than 900 currently available for clinical testing. Most are used for diagnosis of rare genetic diseases, but a growing number have population-based applications, including carrier identification, predictive testing for inherited risk for common diseases, and pharmacogenetic testing for variation in drug response. These tests have the potential for broad public health impact. Currently, most genetic testing offered in the United States does not involve the use of U.S. Food and Drug Administration (FDA) approved test kits. Tests are developed as in-house or “home brew” assays and marketed by laboratories as clinical laboratory services with limited oversight. A number of issues have been raised about the current status of genetic testing implementation, including the need to develop evidence to establish efficacy and cost-effectiveness before tests are commercialized. There is also an increasingly urgent need for timely and reliable information that allows health professionals to distinguish genetic tests that have demonstrated validity and utility in clinical practice.

Recommendations on the development of safe and effective genetic tests have been produced by advisory panels (e.g. Task Force on Genetic Testing, Secretary's Advisory Committee on Genetic Testing), professional organizations, and clinical experts since 1995. However, a Start Printed Page 36344coordinated approach for effectively translating genomic applications into clinical practice and health policy is still needed. In response to this need, CDC's Office of Genomics and Disease Prevention (OGDP) initiated the EGAPP Project in fall 2004. The ultimate goal of the project is to develop and evaluate a coordinated, systematic process for assessing genetic tests and other genomic applications in transition from research to clinical and public health practice. To support this goal, an independent, non-federal, multidisciplinary EGAPP Working Group was established in April, 2005. The roles of the Working Group are to prioritize and select genomic applications for evaluation, establish methods and processes, monitor progress of commissioned evidence reports, and develop conclusions and recommendations based on the evidence. The knowledge and experience gained through the project will be used to inform the development of a sustainable process for assessing the safety and efficacy of emerging genetic tests.

We are proposing an evaluation research activity to assess outcomes of the EGAPP Project. The study will be conducted in collaboration with outside consultants who will work with CDC to design the study, collect data for the study, conduct data analyses, and develop written reports of results.

The purpose of this evaluation research activity is to collect information on the value and impact of the EGAPP process and the products developed and disseminated (e.g., evidence reviews, published evidence summaries, published Working Group recommendations, informational messages) by surveying members of four key stakeholder groups identified for the EGAPP pilot project. The four key stakeholder groups selected are: Healthcare providers (e.g., physicians, mid-level practitioners, nurses), policy makers, healthcare payers (e.g., health plans, insurers) and purchasers (e.g., organizations purchasing healthcare), and consumers. Surveying of consumers will be targeted to advocacy and disease-specific support groups and OGDP Web site visitors.

Surveys will be administered during four survey periods staggered at intervals of six months. Feedback from healthcare providers and payers suggests that they are the most interested and ready to receive and use EGAPP products (e.g., evidence reports and Working Group recommendations). Therefore, they will be the subjects of Survey 1 (about 6 months after release of products) and Survey 3 (one year later). Consumers, policy makers, and healthcare purchasers are expected to receive and be impacted by information developed by EGAPP later. Therefore, these groups will be the subjects of Survey 2 (6 months after Survey 1) and Survey 4 (one year later).

The second mechanism for identifying participants will be through the EGAPP Web site. During specified periods of time, individuals accessing the Web site will be asked to participate. There is no cost to the respondents other than their time.

Estimated Annualized Burden Hours

RespondentFormNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden hours
Healthcare Providers:
Primary Care ProvidersHealthcare Provider Survey385110/6064
Specialists385110/6064
Genetic Counselors200110/6033
Mid-level Practitioners385110/6064
Nurses385110/6064
Targeted ConsumersGeneral Survey770110/60128
Healthcare PayersPolicy/Payer Survey100110/6017
Policy MakersPolicy Survey50110/608
Healthcare PurchasersPurchase Survey31110/605
Total Burden447
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Dated: June 20, 2006.

Joan F. Karr,

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

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[FR Doc. E6-10003 Filed 6-23-06; 8:45 am]

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