[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14577-14578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1532]


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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.

SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and 
Society (SACGHS) is requesting public comment on a draft report to the 
Secretary of Health and Human Services (HHS) on pharmacogenomics. A 
copy of the draft report is available electronically at http://www4.od.nih.gov/oba/sacghs/public_comments.htm. A copy also may be 
obtained by e-mailing Ms. Suzanne Goodwin at [email protected] or 
calling 301-496-9838.

DATES: In order for public comments to be considered by SACGHS in 
finalizing its report to the Secretary, comments should be submitted by 
June 1, 2007.

ADDRESSES: Public comments on the draft report should be addressed to 
Reed V. Tuckson, MD, SACGHS Chair, and transmitted via an e-mail to Ms. 
Goodwin at [email protected]. Comments also may be mailed to SACGHS, 
Office of Biotechnology Activities, National Institutes of Health, 6705 
Rockledge Drive, Suite 750, Bethesda, MD 20892, or faxed 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 explore, analyze, and deliberate on the 
broad range of policy needs associated with the scientific, clinical, 
public health, ethical, economic, legal, and social issues raised by 
the development, use, and potential misuse of genetic and genomic 
technologies and make recommendations to the Secretary of HHS and other 
entities as appropriate. More information about the Committee is 
available at http://www4.od.nih.gov/oba/sacghs.htm.
    One area currently being explored by SACGHS is pharmacogenomics. 
SACGHS identified the emerging field of pharmacogenomics as a high 
study priority because it holds significant promise for improving the 
productivity of the drug development pipeline, increasing the safety 
and effectiveness of drugs by reducing adverse reactions, and 
ultimately resulting in a more efficient use of drugs. The draft report 
describes these opportunities while also

[[Page 14578]]

identifying the challenges associated with pharmacogenomics product 
development and integration into clinical and public health practice. 
It presents information and recommendations in three major areas: (1) 
Issues associated with research and development; (2) ``gatekeepers,'' 
i.e., those who have major roles in directing the course of 
pharmacogenomic technologies; and (3) implementation of 
pharmacogenomics to improve outcomes in clinical practice.
    SACGHS is requesting comments on all aspects of the draft report 
and recommendations. In particular, the Committee would welcome 
feedback on the following questions:
     Are the discussions of topics and issues accurate and 
complete?
     Have any significant opportunities, challenges, or other 
issues been missed?
     Does the report adequately describe the range of 
perspectives on the issues discussed in the report?
     Are the draft recommendations specific enough?
     Are there other strategies for addressing the issues?
     Which draft recommendations should be of highest priority 
for the Federal Government to address?
     Appendix A of the report identifies major pharmacogenomics 
activities in the public and private sector. Are there other relevant 
initiatives that should be included in the list?
    Comments received by June 1, 2007, will be considered by SACGHS in 
preparing the final report. The draft report and the public comments 
will be discussed at a future SACGHS meeting.
    Comments also will available for public inspection at the Office of 
Biotechnology Activities, Monday through Friday, between the hours of 9 
a.m. and 5 p.m.

    Dated: March 22, 2007.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 07-1532 Filed 3-26-07; 9:37 am]
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