[Federal Register Volume 65, Number 34 (Friday, February 18, 2000)]
[Notices]
[Page 8618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4008]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: [email protected], 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.
[FR Doc. 00-4008 Filed 2-17-00; 8:45 am]
BILLING CODE 4140-01-M