Legal Status
Legal Status
Notice
Office of Biotechnology Activities; Recombinant DNA Research: Notice
A Notice by the National Institutes of Health on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 02/18/2000
- Agencies:
- National Institutes of Health
- Dates:
- The RAC will consider this proposal on the afternoon of the first day of the meeting, March 8-10, 2000.
- Document Type:
- Notice
- Document Citation:
- 65 FR 8618
- Page:
- 8618 (1 page)
- Document Number:
- 00-4008
Document Details
-
Enhanced Content - Table of Contents
This tables of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.
Enhanced Content - Table of Contents
-
Enhanced Content - Submit Public Comment
- This feature is not available for this document.
Enhanced Content - Submit Public Comment
-
Enhanced Content - Read Public Comments
- This feature is not available for this document.
Enhanced Content - Read Public Comments
-
Enhanced Content - Sharing
- Shorter Document URL
- https://www.federalregister.gov/d/00-4008 https://www.federalregister.gov/d/00-4008
Enhanced Content - Sharing
-
Enhanced Content - Document Tools
These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.
-
These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.
Display Non-Printed Markup Elements
Enhanced Content - Document Tools
-
-
Enhanced Content - Developer Tools
This document is available in the following developer friendly formats:
- JSON: Normalized attributes and metadata
- XML: Original full text XML
- MODS: Government Publishing Office metadata
More information and documentation can be found in our developer tools pages.
Enhanced Content - Developer Tools
Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
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.
Start Further InfoFOR 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: ci4e@nih.gov, 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/.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start SignatureDated: 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