[Federal Register Volume 71, Number 122 (Monday, June 26, 2006)]
[Notices]
[Pages 36343-36344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-06-06BI]


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 
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 [email protected].
    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

[[Page 36344]]

coordinated 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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondent                  Form          respondents   responses  per   response (in        hours
                                                                    respondent        hours)
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Healthcare Providers:
    Primary Care Providers....  Healthcare                   385               1           10/60              64
                                 Provider Survey.
    Specialists...............  ................             385               1           10/60              64
    Genetic Counselors........  ................             200               1           10/60              33
    Mid-level Practitioners...  ................             385               1           10/60              64
    Nurses....................  ................             385               1           10/60              64
    Targeted Consumers........  General Survey..             770               1           10/60             128
    Healthcare Payers.........  Policy/Payer                 100               1           10/60              17
                                 Survey.
    Policy Makers.............  Policy Survey...              50               1           10/60               8
    Healthcare Purchasers.....  Purchase Survey.              31               1           10/60               5
                               ---------------------------------------------------------------------------------
        Total Burden..........  ................  ..............  ..............  ..............             447
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    Dated: June 20, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-10003 Filed 6-23-06; 8:45 am]
BILLING CODE 4163-18-P