03-6865. The President's Council on Bioethics; Request for Comments; Current Regulation of Assisted Reproduction, Embryo Research, and Human Genetics

AGENCY:

The President's Council on Bioethics, HHS.

ACTION:

Request for comments.

SUMMARY:

The President's Council on Bioethics requests that interested individuals and organizations submit written comments—normative as well as descriptive—on the current regulation of the biotechnologies that touch the beginnings of human life, more specifically on those technologies and practices that exist at the intersection of assisted reproduction, embryo research, and human genetics. The Council is especially interested to know commenters' opinions as to which human goods and values they think should animate any regulatory activities in this area, as well as on how well current practices promote and protect these goods and values. New technologies and practices, such as pre-implantation genetic diagnosis (PGD), greatly expand the power not simply to bring new life into existence in novel ways (as through in vitro fertilization) but also to select or even manipulate its character, fate, and future. The Council is thus deeply interested in how these activities are currently regulated, by whom, and to what effect. In an effort to better understand the contours of the current regulatory landscape, the Council has been studying: The legal authority and institutional competence of the Food and Drug Administration, professional self-regulation by practitioners of assisted reproduction, the current system of protecting human research subjects, and the patentability of human organisms, among other aspects of the subject. To ensure a thorough, accurate, and comprehensive understanding, the Council invites the public to submit written comment on this subject as well.

DATES:

Submissions must be received on or before April 15, 2003.

Form of Submission: Submissions should be written, no more than 3,000 words long, and addressed to The President's Council on Bioethics, attention: O. Carter Snead, General Counsel.

ADDRESSES:

E-mail (preferred): [e-mail]. Fax: [phone]. Mail: Suite 600, 1801 Pennsylvania Avenue, NW., Washington, DC 20006.

FOR FURTHER INFORMATION CONTACT:

O. Carter Snead, General Counsel, The President's Council on Bioethics (202/296-4669; [e-mail]).

SUPPLEMENTARY INFORMATION:

The President's Council on Bioethics was created by Executive Order 13237, on November 28, 2001, to advise the President on the ethical and policy questions arising from developments in biomedical science and technology. For more information about the Council, see http://www.bioethics.gov.

Dated: March 14, 2003.

Dean Clancy,

Executive Director, The President's Council on Bioethics.