Please see below.

Lori Williamson, MS, CGC

-----Original Message-----
From: [nsgc-list] Katherine Kolor [mailto:[log in to unmask]] 
Sent: Monday, November 05, 2007 8:23 PM
To: Williamson, Lori L. (HSC)
Subject: Public comment requested: SACGHS oversight of genetic testing
report

REQUEST FOR PUBLIC COMMENTS BY DECEMBER 21, 2007

U.S. System of Oversight of Genetic Testing: 
SACGHS' Draft Response to the Charge of the Secretary of HHS


The Secretary's Advisory Committee on Genetics, Health, and Society
(SACGHS)
is seeking public comment on a draft report to the Secretary of Health
and
Human Services (HHS) on the oversight of genetic testing. The draft
report
is available at: http://www4.od.nih.gov/oba/SACGHS/public_comments.htm

SACGHS was established by the Department of Health and Human Services
(HHS)
to serve as a public forum for deliberations on the broad range of
policy
issues raised by the development and use of genetic and genomic
technologies
and, as warranted, to provide advice on these issues. For more
information
about the Committee, please visit: 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 of 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.  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). 

Comments received by December 21, 2007 will be considered by SACGHS in
preparing its final report.  Please submit comments to SACGHS by
emailing
them to Cathy Fomous, Ph.D. at [log in to unmask]  Alternatively,
comments
may be mailed or faxed to: 

Secretary's Advisory Committee on Genetics, Health, and Society
Attn: Cathy Fomous, Ph.D.
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 700
Bethesda, MD, 20892 (20817 for non-US Postal Service mail)
Fax:  301-496-9839


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