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Notice

Office of the Director; Notice of Meeting and Request for Public Comment: Secretary's Advisory Committee on Genetics, Health, and Society

 

Pursuant to 92, notice is hereby given of the second meeting of the Secretary's Advisory Committee on Genetics, Health,and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 9 a.m. to 5 p.m. on October 22, 2003 and 8:30 a.m. to 5 p.m. on October 23, 2003 at the Loews L'Enfant Plaza Hotel, 480 L'Enfant Plaza, Washington, DC. The meeting will be open to the public with attendance limited to space available.

On the first day of the meeting, the Committee will review the roles, activities, and plans of the Federal regulatory agencies with regard to the oversight of genetic technologies, including pharmacogenomic technologies, to determine whether further study of this area is warranted. Program officials from the Food and Drug Administration, Centers for Medicare Medicaid Services, Centers for Disease Control and Prevention, and Federal Trade Commission will brief the Committee about current and planned regulatory approaches with respect to genetic technologies. On the second day, the Committee will review Federal efforts to address the adequacy of the genetics workforce and the education and training of health professionals in genetics. Reports will also be provided on the efforts of professional societies and organizations to enhance the preparedness of health professionals in genetics. The Committee will also hold a session on related international activities at which representatives of the Human Genetics Commission of the United Kingdom and the Australian Law Reform Commission will report on their countries' efforts to address emerging issues raised by advances in genetic technologies. Under authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services 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 technologies and, as warranted, to provide advice on these issues.

SACGHS welcomes receiving comments from the public on any issues related to its mandate. For the October meeting in particular, the Committee would welcome public comment on: (1) The adequacy of the education and training of health professionals in genetics and the genetics workforce and whether current efforts to prepare health professionals to use genetic technologies are adequate and, if not, what the gaps are and how should they be addressed; and (2) the role, current activities, and plans of the Federal regulatory agencies to assure the safety and appropriate marketing of genetic tests. Written comments submitted to the Committee by October 1, 2003 will be considered part of the Committee's deliberations. Time will also be provided during the meeting for public commentary. Written public comments should be submitted by mail, e-mail, or fax to the following. Edward R.B. McCabe, M.D., PhD., Chair, Secretary's Advisory Committee on Genetics, Health and Society, c/o NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9839 (fax), sc112c@nih.gov.

Members of the public who wish to make a statement to the Committee during the meeting should notify the SACGHS Executive Secretary, Ms. Sarah Carr, by telephone at (301) 496-9838 or e-mail at sc112c@nih.gov.

The draft meeting agenda and other information about SACGHS will be available at the following Web site: http://www4.od.nih.gov/oba/sacghs.htm. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, are asked to notify Ms. Carr in advance of the meeting by contacting her at the phone number or e-mail address listed above.

Dated: August 27, 2003.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory Committee Policy.

[FR Doc. 03-22827 Filed 9-8-03; 8:45 am]

BILLING CODE 4140-01-M

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