[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Notices]
[Pages 11730-11731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


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

SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and 
Society (SACGHS) is requesting public comments on a Draft Report to the 
Secretary of Health and Human Services, ``Public Consultation Draft 
Report on Gene Patents and Licensing Practices and Their Impact on 
Patient Access to Genetic Tests'' (available at http://oba.od.nih.gov/SACGHS/sacghs_public_comments.html).
    A copy can also be obtained from the National Institutes of Health 
(NIH) Office of Biotechnology Activities (OBA) by e-mailing 
[email protected] or calling 301-496-9838.

DATES: The public is asked to submit comments by May 15, 2009, in order 
to be considered by SACGHS in preparing its final report.

ADDRESSES: Comments on the draft report should be addressed to Steven 
Teutsch, M.D., M.P.H., Chair, SACGHS, and transmitted via an e-mail to 
[email protected]. 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 301-496-9838.

FOR FURTHER INFORMATION CONTACT: Darren Greninger, J.D., NIH OBA, 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 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, http://oba.od.nih.gov/sacghs/sacghs_home.html.

[[Page 11731]]

    The public consultation draft report is the result of work that 
began in 2004, when SACGHS identified the effect of gene patents and 
licensing practices on patient and clinical access to genetic tests as 
a high-priority issue that warranted further study. SACGHS activities 
in this area were deferred until the completion of a National Academy 
of Sciences (NAS) study on the granting and licensing of intellectual 
property rights to genetic and proteomic discoveries and the effects of 
these practices on research and innovation. In the fall of 2005, NAS 
released that study's report, Reaping the Benefits of Genomic and 
Proteomic Research: Intellectual Property Rights, Innovation, and 
Public Health. After reviewing the report, SACGHS decided that more 
information was needed regarding the effects of gene patents and 
licenses on patient and clinical access to genetic tests. In 2006, a 
task force was formed by SACGHS to guide its work in this area. The 
task force commissioned case studies, compiled relevant information 
through a review of the literature, and consulted with national and 
international experts and stakeholders.
    At the outset of its work, the task force decided to limit the 
scope of its inquiry to those genetic tests, whether used for 
diagnostic, predictive, or other clinical purposes, that rely on 
analysis of nucleic acid molecules to determine human genotype. As 
such, the kinds of patent claims that the Committee evaluated were 
nucleic acid-related patent claims associated with genetic tests for 
human genotype. This report does not address protein-based genetic 
tests or protein-related patent claims associated with tests designed 
to infer genotype.
    The public consultation draft report presents the Committee's 
preliminary findings. The draft report also includes policy options. 
These options do not necessarily correlate with any particular 
preliminary finding, but rather provide a framework within which to 
gather public input. The Committee developed these options to present a 
broad range of possible actions, but has not yet decided which, if any, 
of these policy options to support.
    Before SACGHS can develop specific recommendations for the 
Secretary, the Committee needs public input on several issues, 
including whether changes are needed in patenting and licensing 
practices that affect genetic testing, and the appropriateness, 
feasibility, and implications of the report's policy options. Members 
of the public are also invited to recommend specific policy options not 
included in the presented options and any needed modifications to 
existing options. SACGHS also encourages the public to provide any 
additional information and data regarding the positive or negative 
effects gene patenting or licensing practices have had, are having, or 
may have on patient and clinical access to genetic tests.
    The Committee will carefully consider public input in finalizing 
its report and developing any recommendations to the Secretary.
    Comments received by May 15, 2009, will be considered by SACGHS in 
preparing its final report. The public comments and revised report will 
be discussed during 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: March 11, 2009.
Sarah Carr,
Executive Secretary, SACGHS.
 [FR Doc. E9-5936 Filed 3-18-09; 8:45 am]
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