Secretary's Advisory Committee on Genetics, Health, and Society; Request for Public Comment, 11730-11731 [E9-5936]

Download as PDF 11730 Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices sroberts on PROD1PC70 with NOTICES to debar.21 If the Bureau decides to debar you, its decision will become effective upon the earlier of your receipt of a debarment notice or publication of the decision in the Federal Register.22 If and when your debarment becomes effective, you will be prohibited from participating in activities associated with or related to the schools and libraries support mechanism for at least three years from the date of debarment.23 The Bureau may, if necessary to protect the public interest, extend the debarment period.24 Please direct any response, if by messenger or hand delivery, to Marlene H. 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AGENCY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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 https://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 faunteroytd@od.nih.gov 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 greningerd@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– 9838. FOR FURTHER INFORMATION CONTACT: Darren Greninger, J.D., NIH OBA, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301–496–9838, greningerd@od.nih.gov. 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:// oba.od.nih.gov/sacghs/ sacghs_home.html. SUPPLEMENTARY INFORMATION: E:\FR\FM\19MRN1.SGM 19MRN1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 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 VerDate Nov<24>2008 17:17 Mar 18, 2009 Jkt 217001 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] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), CDC announces the following meeting of the aforementioned committee: Time and Date: 11 a.m.–5 p.m., Thursday, March 31, 2009. Place: Audio Conference Call via FTS Conferencing. The USA toll free dial in number is 1–866–659–0537 with a pass code of 9933701. Status: Open to the public, but without a public oral comment period. Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 11731 estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, most recently, August 3, 2007, and will expire on August 3, 2009. Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. Matters To Be Discussed: The agenda for the conference call includes: Dose Reconstruction Interview Scripts and Procedures; Special Exposure Cohort Petition Status Updates; Board Subcommittee and Work Group Updates; Update on Board Technical Support Contractor Activities; Future Plans. Due to administrative matters, this Federal Register Notice is being published on less than 15 calendar days notice to the public (41 CFR 102–3.150(b)). The agenda is subject to change as priorities dictate. Because there is no public comment period, written comments may be submitted. Any written comments received will be included in the official record of the meeting and should be submitted to the contact person below in advance of the meeting. Contact Person for More Information: Theodore M. Katz, M.P.A., Executive Secretary, NIOSH, CDC, 1600 Clifton Rd. NE., Mailstop: E–20, Atlanta, GA 30333, Telephone (513) 533–6800, Toll Free 1–800– CDC–INFO, E-mail ocas@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 12, 2009. Elaine L. 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Agencies

[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Notices]
[Pages 11730-11731]
From the Federal Register Online via the Government Printing 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 https://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 
faunteroytd@od.nih.gov 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 
greningerd@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 301-496-9838.

FOR FURTHER INFORMATION CONTACT: Darren Greninger, J.D., NIH OBA, 6705 
Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838, 
greningerd@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://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]
BILLING CODE 4140-01-P

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