[Federal Register: June 26, 2006 (Volume 71, Number 122)]
[Notices]
[Page 36343-36344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn06-50]
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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 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
[[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
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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