Secretary's Advisory Committee on Genetics, Health, and Society; Request for Public Comment, 34146 [E6-9135]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Page 34146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9135]



[[Page 34146]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Secretary's Advisory Committee on Genetics, Health, and Society; 
Request for Public Comment

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: 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.

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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 
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 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 scrutiny of and deliberation 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 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 appreciate the public's 
assessment of whether: (1) The policy issues identified in the draft 
report are appropriately focused; (2) any policy issues have been 
overlooked; and, (3) the issues are organized in appropriate categories 
and addressed in such a way as to give policy makers sufficient 
understanding of why the issue is important. In addition, the committee 
would value feedback on the sections of the draft report that discuss 
the importance of public engagement and the mechanisms that could be 
employed to achieve such engagement.
    SACGHS will be able to consider comments received by July 31, 2006, 
as it prepares its final report. The report and public comments will be 
discussed at a future SACGHS meeting.
    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: June 2, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
 [FR Doc. E6-9135 Filed 6-12-06; 8:45 am]
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