Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting, 34134 [06-5335]
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34134
Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator;
American Health Information
Community Biosurveillance
Workgroup Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
sixth of the American Health
Information Community Biosurveillance
Workgroup in accordance with the
Federal Advisory Committee Act (Pub.
L. 92–463, 5 U.S.C., App.)
DATES: June 22, 2006 from 1 p.m. to 3
p.m.
ADDRESSES: Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
bio_main.html.
SUPPLEMENTARY INFORMATION: The
meeting will be available via Web cast
as https://www.eventcenterlive.com/
cfmx/ec/login/login1.cfm?BID=67.
Kathryn Barr,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–5335 Filed 6–12–06; 8:45 am]
BILLING CODE 4150–24–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Secretary’s Advisory Committee on
Genetics, Health, and Society; Request
for Public Comment
Office of the Secretary, HHS.
A request for public comment
on a draft report to the Secretary of
Health and Human Services on policy
issues raised by the prospect of a U.S.
large population cohort project for the
study of genetic variation, the
environment, and common disease.
AGENCY:
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ACTION:
SUMMARY: The Secretary’s Advisory
Committee on Genetics, Health, and
Society (SACGHS) is requesting public
comment on a draft report on policy
issues raised by the prospect of the U.S.
undertaking a large population cohort
project for the study of genes,
environment, and disease. A copy of the
report, ‘‘Policy Issues Associated with
Undertaking a Large U.S. Population
Cohort Project on Genes, Environment,
and Disease,’’ is available electronically
at
https://www4.od.nih.gov/oba/sacghs/
public_comments.htm. A copy may also
be obtained from the National Institutes
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16:40 Jun 12, 2006
Jkt 208001
of Health (NIH) Office of Biotechnology
Activities (OBA) by e-mailing Ms. Amita
Mehrotra at mehrotraa@od.nih.gov or
calling 301–496–9838.
DATES: In order for public comments to
be considered by SACGHS in finalizing
its report to the Secretary, the public is
asked to submit comments by July 31,
2006.
ADDRESSES: Public comments on the
draft report should be addressed to Reed
V. Tuckson, M.D., Chair, SACGHS, and
transmitted to SACGHS via an e-mail to
Ms. Mehrotra at mehrotraa@od.nih.gov.
Comments may also be submitted by
mailing or faxing a copy to NIH OBA at
6705 Rockledge Drive, Suite 750,
Bethesda, MD, 20892 NIH OBA’s fax
number is 301–496–9839.
FOR FURTHER INFORMATION CONTACT: Ms.
Amita Mehrotra, NIH OBA, 6705
Rockledge Drive, Suite 750, Bethesda,
MD 20892, 301–496–9838,
mehrotraa@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 human health and
societal 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 its Web site:
https://www4.od.nih.gov/oba/
sacghs.htm. In a 2004 priority-setting
process, SACGHS determined that
opportunities and challenges associated
with conducting large population cohort
studies aimed at understanding the
relationships of genes, the environment,
and common, complex diseases
warranted in-depth study. A large
population initiative raises many policy
issues for a number of reasons,
including: (1) It will involve an
unprecedented number of people
(500,000 to 1,000,000 or more
individuals) and, thereby, will have a
significant public profile and a direct
impact on many people; (2) it requires
a relatively large investment of public
resources and, as such, warrants
deliberation and a broad consensus
about the relative value to science,
society, and the Nation; and (3) the
nature of the information that will be
derived from it raises ethical, legal,
social and public policy concerns could
be unique and/or significant,
particularly in view of the number of
potential participants.
NIH Director, Elias A. Zerhouni, M.D.,
specifically requested SACGHS’s advice
on the scientific, public, and ethical
processes and pathways that might help
NIH or HHS make decisions about
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undertaking such an effort. Dr. Zerhouni
specified that the Committee could be
most helpful to the Secretary by
conducting an inquiry that includes the
following steps:
• Step 1: Delineate the questions that
need to be addressed in order for
policymakers to determine whether the
U.S. Government should undertake, in
any form, a large population project to
elucidate the influence of genetic
variation and environmental factors on
common, complex disease.
• Step 2: Explore the ways in which,
or processes by which, the questions
that are identified in Step 1 can be
addressed, including the need for any
intermediate research studies, pilot
projects, or policy analysis efforts.
• Step 3: Taking into account the
possible ways in which the questions
could be addressed, determine which
approaches are optimal and feasible and
recommend a specific course of action
for moving forward.
SACGHS has developed a draft report
that summarizes its findings and
conclusions relevant to the development
of a large population research initiative
in the United States. The report focuses
on preliminary and intermediate
questions, steps, and strategies in five
areas that should be addressed before an
informed decision can be made about
whether the United States should
undertake such a project. These five
areas are: (1) Research policy; (2)
research logistics; (3) regulatory and
ethical issues; (4) public health
implications of research results; and (5)
social implications of research results.
The report also identifies options for
how these issues might be addressed. A
central theme of the report is that
decisions about such a project must take
account of public views and attitudes
and that public engagement must be
sought in planning for and
implementing a large population
project.
In view of the wide range of public
policy issues and questions raised in the
draft report, SACGHS hopes to receive
input from the wide range of
individuals, communities and groups
who may have an interest in whether a
large population cohort project is
undertaken in the U.S. These include
but are certainly not limited to members
of the general public and patient
community; scientists in many fields
but certainly genomics, environmental
health, epidemiology, and public health;
health professionals; bioethicists; and
legal, public policy, and public
engagement experts. Comments on any
aspect of the draft report are welcome.
In particular, the committee would
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[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Page 34134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5335]
[[Page 34134]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator; American Health Information
Community Biosurveillance Workgroup Meeting
ACTION: Announcement of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the sixth of the American Health
Information Community Biosurveillance Workgroup in accordance with the
Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
DATES: June 22, 2006 from 1 p.m. to 3 p.m.
ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT: https://www.hhs.gov/healthit/ahic/
bio_main.html.
SUPPLEMENTARY INFORMATION: The meeting will be available via Web cast
as https://www.eventcenterlive.com/cfmx/ec/login/login1.cfm?BID=67.
Kathryn Barr,
Director, American Health Information Community, Office of Programs and
Coordination, Office of the National Coordinator.
[FR Doc. 06-5335 Filed 6-12-06; 8:45 am]
BILLING CODE 4150-24-M
