Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Office of the Secretary

# 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                         *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,                     *http://oba.od.nih.gov/​sacghs/​sacghs_​home.html*.                          ( print 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