02-9092. Notice of Meetings: Secretary's Advisory Committee on Genetic Testing

Pursuant to Public Law 92-463, notice is hereby given of two meetings of the Secretary's Advisory Committee on Genetic Testing (SACGT), U.S. Public Health Service. An education conference, Genetic Testing and Public Policy: Preparing Health Professionals, will be held from 8:30 a.m. to 5 p.m. on May 13, 2002. SACGT's thirteenth meeting will be held from 9 a.m. to 5:30 p.m. on May 14, 2002 and 8 a.m. to 2:30 p.m. on May 15, 2002. Both meetings will be held at the Hyatt Regency, 300 Light Street, Baltimore, MD and are free and open to the public with attendance limited to space available. Pre-registration is encouraged for the May 13 education conference. Online registration for the May 13 conference is available at http://www4.od.nih.gov/​oba/​sacgt.htm or by calling Abbe Smith at 301-897-7423. A catered luncheon is offered on May 13 at a cost of $30 and requires advance registration.

The one-day education conference will consider the challenges of integrating genetic testing into clinical and public health practice for the wide range of health professionals likely to be affected by this expanding field. Through a combination of plenary presentations and panel discussions, the conference will explore the integration of genetics into primary care and discuss the various roles of healthcare providers in the provision of genetics services. Afternoon focus groups will concentrate on several different areas of genetics education, training, and integration. Conference participants will be asked to consider a number of public policy questions of interest to SACGT, including how are health professions schools responding to changes and challenges brought about by genetics and genetic testing; are future health professionals being taught what they need to know to integrate new health technologies and services into the clinical and public health settings; are current health professionals, who were trained long long before the explosion of genetics knowledge, receiving the training they need to continue to practice effectively; are they being taught about the proper use and interpretation of genetic tests and about their ethical, legal, and social implications; are the revolutionary advances in genetics having an equally revolutionary effect on our educational methods; what changes are already underway; are they sufficient; are they occurring quickly enough; is government doing as much as it should do? On the following day during its regular Committee meeting, SACGT will consider these issues and develop its recommendations to the Secretary.

Reviewing the outcomes of the SACGT Education Conference will be the Committee's first order of business at its May 14-15 meeting. In addition, four of the SACGT work groups will be presenting reports to the Committee: The ACCESS Work Group will present a draft report on billing and reimbursement for genetic education and counseling services; the Informed Consent/Institutional Review Board Work Group will present its revised recommendations on decision making and informed consent for clinical and public health genetic tests; the Data Work Group will present three case studies on the development and clinical application of a genetic test; and the Rate Disease Work Group will present a report on genetic testing for rare diseases. Presentations will also be made on the development of a “Frequently Asked Questions” document on Clinical Laboratory Improvement Amendments certification and the Food and Drug Administration's progress in the development in the development of a pre-market review of genetic tests. Time will be provided for public comment and interested individuals should notify the contact person listed below.

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 SACGT to advise and make recommendations to the Secretary through the Assistant Secretary for Health on all aspects of the development and use of genetic tests. SACGT is directed to (1) recommend policies and procedures for the safe and effective incorporation of genetic technologies into health care; (2) assess the effectiveness of existing and future measures for oversight of genetic tests; and (3) identify research needs related to the Committee's purview.

The draft meeting agenda and other information about SACGT will be available at the following Web site: http://www4.od.nih.gov/​oba/​sacgt/​htm. Individuals who wish to provide public comment or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the SACGT Executive Secretary, Ms. Sarah Carr, by telephone at 301-496-9838 or e-mail at [e-mail]. The SACGT office is located at 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892.

Dated: April 5, 2002.

Sarah Carr,

Executive Secretary, Secretary's Advisory Committee on Genetic Testing.