[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Notices]
[Pages 5972-5973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2071]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-07-06BI]


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 e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
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.

[[Page 5973]]

    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
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                                                                                     Number of        Average
         Type of respondent                  Survey name             Number of     responses per   response per
                                                                    respondents     respondent      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
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    Dated: January 31, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-2071 Filed 2-7-07; 8:45 am]
BILLING CODE 4163-18-P