00-4008. Office of Biotechnology Activities; Recombinant DNA Research: Notice

AGENCY:

National Institutes of Health (NIH), PHS, DHHS.

ACTION:

Notice.

SUMMARY:

The purpose of this document is to inform the public of an additional agenda item that will be considered during the upcoming meeting of the Recombinant DNA Advisory Committee (RAC) meeting. The RAC has been asked to consider a proposal from a member of the public that a moratorium be placed on some human somatic gene therapy protocols using viral vectors.

DATES:

The RAC will consider this proposal on the afternoon of the first day of the meeting, March 8-10, 2000.

FOR FURTHER INFORMATION CONTACT:

If you have questions, or require additional information about this agenda item, please contact the Office of Biotechnology Activities (OBA) by e-mail at: [e-mail], or telephone at: 301-496-9838. For additional information about the March 8-10, 2000, RAC meeting, please visit the NIH/OBA web site at: http://www.nin.gov/​od/​oba/​.

SUPPLEMENTARY INFORMATION:

In a letter dated November 22, 1999, Mr. Jeremy Rifkin, Foundation on Economic Trends, requested that the RAC consider the following:

Given the recent death of a patient undergoing somatic gene therapy at the University of Pennsylvania and the disclosure of six other deaths involving patients undergoing gene therapy, the Foundation on Economic Trends is formally requesting that the National Institutes of Health Recombinant DNA Advisory Committee (RCA) vote to impose an immediate moratorium on the consideration of any future human somatic gene therapy protocol that employs retro-, adeno-, or other viral vectors, except where the protocol can legitimately be considered a treatment of last resort for a life threatening illness.

OMB's “Mandatory Information Requirements for Federal Assistance Program Announcements” (45 FR 39592) requires a statement concerning the official government programs contained in the Catalog of Federal Domestic Assistance. Normally, NIH lists in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which recombinant DNA techniques could be used, it has been determined not to be cost effective or in the public interest to attempt to list these programs. Such a list would likely require several additional pages. In addition, NIH could not be certain that every Federal program would be included as many Federal agencies, as well as private organizations, both national and international, have elected to follow the NIH Guidelines. In lieu of the individual program listing, NIH invites readers to direct questions to the information address above about whether individual programs listed in the Catalog of Federal Domestic Assistance are affected.

Dated: February 10, 2000.

Amy Patterson,

Director, Office of Biotechnology Activities, National Institutes of Health.