Proposed Data Collections Submitted for Public Comment and Recommendations, 36343-36344 [E6-10003]
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Federal Register / Vol. 71, No. 122 / Monday, June 26, 2006 / Notices
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[FR Doc. E6–10000 Filed 6–23–06; 8:45 am]
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have given notice under section 4 of the
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at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
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Jkt 208001
Board of Governors of the Federal Reserve
System, June 21, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–10018 Filed 6–23–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Centers for Disease Control and
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FEDERAL RESERVE SYSTEM
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express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
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[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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
36343
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
E:\FR\FM\26JNN1.SGM
26JNN1
36344
Federal Register / Vol. 71, No. 122 / Monday, June 26, 2006 / Notices
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
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.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per respondent
Average
burden per
response
(in hours)
Total burden
hours
Respondent
Form
Healthcare Providers:
Primary Care Providers .............
Specialists ..................................
Genetic Counselors ...................
Mid-level Practitioners ...............
Nurses ........................................
Targeted Consumers .................
Healthcare Payers .....................
Policy Makers ............................
Healthcare Purchasers ..............
Healthcare Provider Survey .............
...........................................................
...........................................................
...........................................................
...........................................................
General Survey ................................
Policy/Payer Survey .........................
Policy Survey ...................................
Purchase Survey ..............................
385
385
200
385
385
770
100
50
31
1
1
1
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
64
64
33
64
64
128
17
8
5
Total Burden .......................
...........................................................
........................
........................
........................
447
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[60Day–06–05CJ]
Centers for Disease Control and
Prevention
rwilkins on PROD1PC63 with NOTICES
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
VerDate Aug<31>2005
17:00 Jun 23, 2006
Jkt 208001
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 71, Number 122 (Monday, June 26, 2006)]
[Notices]
[Pages 36343-36344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10003]
=======================================================================
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondent Form respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
