[Federal Register Volume 72, Number 214 (Tuesday, November 6, 2007)]
[Notices]
[Page 62650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21755]


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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 public comment on a draft report on the oversight 
of genetic testing.

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SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and 
Society (SACGHS) is requesting public comment on a draft report on the 
oversight of genetic testing.

DATES: Written or electronic comments should be submitted between 
November 5, 2007 and December 21, 2007.

ADDRESSES: Comments should be e-mailed to SACGHS in care of Cathy 
Fomous, PhD, at [email protected]. Comments can also be mailed or 
faxed to Dr. Fomous's attention at the NIH Office of Biotechnology 
Activities, 6705 Rockledge Drive, Suite 700, Bethesda, MD, 20892 or fax 
number 301-496-9839.

FOR FURTHER INFORMATION CONTACT: Cathy Fomous, PhD, NIH Office of 
Biotechnology Activities, at [email protected] or 6705 Rockledge 
Drive, Suite 700, Bethesda, MD 20892, 301-496-9838.

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. For more information about the Committee, please visit the Web 
site: http://www4.od.nih.gov/oba/sacghs.htm.
    In 2004, SACGHS recognized that oversight of genetic testing was a 
high-priority issue that required ongoing monitoring. In 2006, SACGHS 
began an in-depth fact-finding process on the oversight roles of 
Federal, State, and private sector entities. In March 2007, the Office 
of the Secretary of HHS outlined a specific charge to SACGHS to focus 
the Committee's inquiry. The charge reads as follows:

    Undertake the development of a comprehensive map of the steps 
needed for evidence development and oversight for genetic and 
genomic tests, with improvement of health quality as the primary 
goal. Consider and address the following questions:
     What evidence of harm exists regarding genetic tests? 
Is that harm attributable to analytic validity, clinical validity, 
or clinical utility of the tests? If evidence does not exist, what 
threats are not currently being addressed? What public health 
benefits are not accruing as quickly as they might?
     What distinguishes genetic tests from other laboratory 
tests for oversight purposes?
     What are the existing pathways that examine the 
analytic validity, clinical validity, and clinical utility of 
genetic tests? Consider the use of case studies.
     What organizations are currently involved with each of 
these aspects, and what are they doing to address these issues? Who 
should be responsible for each of these aspects?
     What resources (e.g., standards reagents/materials) are 
needed to develop proficiency testing kits or protocols for genetic 
tests? What is currently available in terms of proficiency testing 
kits or protocols for genetic tests? What information is provided by 
proficiency testing? Is the current level of proficiency testing for 
genetic tests adequate and are the results of such laboratory 
performance assessments sufficiently transparent?
     What are the potential pathways to communicate clear 
information to guide test and treatment selection by the provider?
     What new approaches or models should be considered for 
private and public-private sector engagement in demonstrating 
clinical validity and clinical utility for developing effectiveness 
measures of genetic tests in clinical practice?
     Would additional or revised Government oversight add 
value for patients, and if so, how and where?

SACGHS organized a task force to explore the questions outlined in the 
Secretary's charge and gather facts and perspectives on how best to 
address them. With the help of the task force, SACGHS drafted a report 
that addresses the issues and offers a number of recommendations for 
enhancing the oversight of genetic testing in the U.S. A copy of the 
draft report, U.S. System of Oversight of Genetic Testing: A Response 
to the Charge of the Secretary of HHS, will be available from November 
5, 2007 to December 21, 2007 at http://www4.od.nih.gov/oba/sacghs/public_comments.htm. A paper or electronic copy also can be obtained 
through the NIH Office of Biotechnology Activities at 301-496-9838 or 
by e-mailing Dr. Fomous at [email protected].
    SACGHS would welcome comments on any aspect of the report. In 
particular, SACGHS would appreciate input on whether the draft report: 
(1) Fully responds to questions posed by the HHS Secretary; (2) 
proposes appropriate remedies to close gaps in the current system; and 
(3) adequately anticipates future developments in the field of 
genetics/genomics that may bear on the oversight of genetic testing. In 
addition to submitting written comments, the public will have an 
opportunity at the SACGHS meeting on November 19-20, 2007 to provide 
testimony on this topic. The meeting is being held at the Ronald Reagan 
Building, Washington, DC (see http://www4.od.nih.gov/oba/SACGHS/SACGhsMTGIndex.HTM for a meeting agenda). All comments received by 
December 21, 2007 will be considered by SACGHS in preparing its final 
draft report. Public comments will be available for public inspection 
at the NIH Office of Biotechnology Activities Monday through Friday 
between the hours of 8:30 a.m. and 5 p.m.

    Dated: October 29, 2007.
Sarah Carr,
Executive Secretary, SACGHS.
 [FR Doc. E7-21755 Filed 11-5-07; 8:45 am]
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