[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Notices]
[Page 20925-20926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap08-47]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Secretary's Advisory Committee on Genetics, Health, and Society
AGENCY: Office of the Secretary, HHS.
ACTION: Request for suggestions on new SACGHS priority issues.
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SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and
Society (SACGHS) is updating its study priorities. SACGHS requests
suggestions on possible new topics for the Committee to address.
DATES: Written or electronic comments should be submitted by May 16,
2008.
ADDRESSES: Comments can be sent by mail to the following address:
Secretary's Advisory Committee on Genetics, Health, and Society, attn:
Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892. Comments also can be sent via e-
mail to Suzanne Goodwin at goodwins@od.nih.gov or via facsimile to 301-
496-9839.
FOR FURTHER INFORMATION CONTACT: Suzanne Goodwin, NIH Office of
Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD
20892, 301-496-9838, goodwins@od.nih.gov.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) established SACGHS to serve as a public forum for deliberations
on the broad range of policy issues raised by the development and use
of genetic technologies and, as warranted, to provide advice on these
issues to the HHS Secretary or other Federal entities as requested. The
scope of the Committee's charge includes assessing how genetic and
genomic technologies are being integrated into health care and public
health; studying the clinical, public health, ethical, economic, legal,
and societal implications of genetic and genomic technologies and
applications; identifying opportunities and gaps in research and data
collection and analysis efforts; examining the impact of current patent
policy and licensing practices on access to genetic and genomic
technologies; analyzing uses of genetic information in education,
employment, insurance, and law; and serving as a public forum for
discussion of issues raised by genetic and genomic technologies. For
more information about the Committee, please visit its Web site: http:/
/www4.od.nih.gov/oba/sacghs.htm.
In March 2004, SACGHS identified 11 issues relating to its charge
and developed a report that classified the relative priority of these
issues (the report is available at http://www4.od.nih.gov/oba/sacghs/
reports/SACGHSPriorities.pdf). The Committee has produced several work
products related to these 11 issues, and other projects are near
completion or underway:
1. Coverage and reimbursement of genetic technologies. SACGHS
issued a report, Coverage and Reimbursement of Genetic Tests and
Services, in February 2006. The report describes the current
[[Page 20926]]
state of coverage and reimbursement of genetic tests and services,
highlights concerns that affect patient access to tests and services,
and identifies nine steps that HHS and the private sector could take to
help improve access to and appropriate utilization of health-related
genetic tests and services.
2. Large population studies. In March 2007, SACGHS issued a report,
Policy Issues Associated with Undertaking a Large U.S. Population
Cohort Project on Genes, Environment, and Disease. The report
delineates the questions that need to be addressed for policymakers to
determine whether the U.S. Government should undertake a large
population project to elucidate the influence of genetic variation and
environmental factors on common, complex diseases.
3. Genetic discrimination. SACGHS has written three letters to the
HHS Secretary championing the enactment of Federal legislation to
prohibit discrimination based on genetic information by health insurers
and employers. The Committee also provided the Secretary with a legal
analysis of the adequacy of current law regarding genetic
discrimination, a compendium of public comments documenting public
fears and concerns about genetic discrimination, and a 10-minute DVD of
testimonies received from the public.
4. Genetics education and training of health professionals. SACGHS
issued a resolution that urged the HHS Secretary to take a series of
steps to ensure the adequacy of genetics education and training of
health care and public health professionals. Because of continuing
needs in this area, SACGHS created a Genetics Education and Training
Task Force in November 2007 to develop a plan to identify the education
and training needs of health professionals, lay health educators, and
the general public; outline the steps required to meet these needs; and
evaluate the effectiveness of existing educational and training
efforts.
5. Direct-to-consumer marketing of genetic technologies. SACGHS
wrote two letters to the HHS Secretary urging greater collaboration
among Federal agencies in addressing the advertising of laboratory-
developed genetic tests. These efforts led to the issuance of a Federal
Trade Commission Consumer Alert that cautions consumers that at-home
genetic tests have not been evaluated by FDA and urges them to be wary
of the claims made by companies marketing such tests.
6. Oversight of genetic technologies. In March 2007, the Office of
the HHS Secretary charged SACGHS with identifying the steps needed for
evidence development and oversight of genetic and genomic tests. A
final report on the issue is expected in May 2008.
7. Pharmacogenomics. In May 2008, SACGHS will issue its final
report on the opportunities and challenges associated with
pharmacogenomics research, development of pharmacogenomic applications,
and integration of these applications into clinical practice and public
health.
8. Patents and access. SACGHS is currently studying the positive
and negative effects of gene patent and licensing practices on patient
access to genetic tests and the public's health. A final report is
expected in 2009.
9. Access to genetic technologies. This was designated as an
overarching issue that cuts across all SACGHS work.
10. Public awareness and understanding of genetic technologies.
This was designated as an overarching issue that cuts across all SACGHS
work.
11. Genetic exceptionalism. This was designated as an overarching
issue that cuts across all SACGHS work.
SACGHS's work products can be found at: http://www4.od.nih.gov/oba/
sacghs/reports/reports.html.
As described above, SACGHS has completed several major projects
related to these 11 issues, and other projects are near completion. In
the coming months, the Committee will be identifying new priority
issues to address. SACGHS would welcome public perspectives about
issues within SACGHS's charter that are in need of attention and study.
Members of the public who wish to suggest an issue are asked to submit
a statement (approximately one paragraph in length) that:
(1) Describes a problem or policy challenge that needs exploration;
and (2) proposes actions the Committee could take to address the issue.
The submission of references or other background materials related to
the topic is encouraged.
The issues suggested should take into consideration the charge of
SACGHS, outlined above, and the following points:
The urgency and national importance of the issue.
The extent to which the Federal Government has
jurisdiction/authority over the issue.
The need for Federal guidance or regulation on this issue.
Whether the issue raises concerns that only the Federal
Government can address.
Whether the issue raises moral or ethical concerns that
warrant Federal Government involvement/leadership.
Whether SACGHS's policy advice on this issue would
significantly benefit society.
Whether failure to address the issue would prolong any
negative impact the issue may be having on society.
Whether sufficient data about the issue exist for SACGHS
to develop informed policy advice.
Whether another body is already addressing the issue or is
better equipped to address it.
Public comments received by May 16, 2008 will be considered by
SACGHS and discussed at its next meeting on July 7-8, 2008 in
Washington, DC.
Dated: April 7, 2008.
Sarah Carr,
SACGHS Executive Secretary, National Institutes of Health.
[FR Doc. E8-8216 Filed 4-16-08; 8:45 am]
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