Meeting of the Secretary's Advisory Committee on Genetic Testing

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Meeting of the Secretary's Advisory Committee on Genetic Testing

AGENCY: Office of the Secretary, DHHS.

ACTION: Meeting notice.

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Pursuant to Public Law 92-463, notice is hereby given of the first

meeting of the Secretary's Advisory Committee on Genetic Testing

(SACGT), U.S. Public Health Service. The meeting will be held from 9

a.m. to 5 p.m. on June 30, 1999 at the National Institutes of Health,

Building 31, C Wing, Conference Room 10; 9000 Rockville Pike, Bethesda,

MD 20892. The meeting will be open to the public from 9 a.m to

adjournment with attendance limited to space available. The first SACGT

meeting will be for orientation and organizational purposes. There will

be a limited period of time provided for public comment and interested

individuals should contact the SACGT Executive Secretary as shown

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 the 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. The SACGT is directed to (1)

recommended 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; (3) and identify research needs related to the Committee's

purview. The establishment of the SACGT was recommended by the Task

Force on Genetic Testing (TFGT) of the NIH-DOE Working Group on the

Ethical, Legal, and Social Implications (ELSI) of the Human Genome

Project as well as the Joint NIH-DOE Committee to Evaluate the ELSI

Program of the Human Genome Project.

The SACGT is composed of 13 non-governmental experts in relevant

medical, scientific, and professional fields, including genetic

testing, medical genetics, genetic counseling, primary health care,

public health, clinical laboratory management, diagnostic technology,

ethics, law, psychology, and social sciences, as well as patient/

consumer advocates. Since the Clinical Laboratory Improvement Advisory

Committee (CDC) and the Medical Devices Advisory Committee (FDA) have

relevant roles in ensuring the quality and safety of genetic testing

laboratories and genetic test kits, one current member of each of these

committees serve on the SACGT. The heads, or their designees, of six

DHHS agencies are nonvoting, ex officio members of the SACGT. The

agencies are the Agency for Health Care Policy and Research; Centers

for Disease Control and Prevention; Food and Drug Administration;

Health Care Financing Administration; Health Resources and Services

Administration; and National Institutes of Health.

The draft meeting agenda and other information about the SACGT will

be available at the following web site: http://www.nih.gov/od/orda/

sacgtdocs.htm. Individuals who wish to provide public comments 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 [email protected]. The SACGT office is located

at 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892.

Dated: June 2, 1999.

David Satcher,

Assistant Secretary for Health and Surgeon General.

[FR Doc. 99-14531 Filed 6-8-99; 8:45 am]

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