[Federal Register Volume 73, Number 75 (Thursday, April 17, 2008)]
[Notices]
[Pages 20925-20926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8216]


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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 [email protected] 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, [email protected].

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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