Federal Register / Vol. 53, No. 171 / Friday, September 2, 1988 / Notices 
34247 
may be submitted to N1H in lieu of 
compliance with the N1H Guidelines. 
Alternatively, if the host country does not 
have such rules, written acceptance by an 
appropriate government office of the host 
country is necessary in lieu of compliance 
with the NIH Guidelines. The NIH reserves 
the right to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
After extensive discussion of this 
proposed amendment of Section I-C and 
attempts to draft revised language, the 
RAC recommended that the many issues 
raised be referred back to another 
working group for further consideration. 
A Working Group on International 
Projects met at the NIH on August 15. 
1988. After extensive discussion, the 
working group recommended that the 
following proposed revision of the last 
paragraph of Section I-C be published 
for comment: 
The NIH Guidelines are also applicable to 
recombinant DNA projects done abroad: 
1. if they are supported by NIH funds; or 
2. if they involve deliberate release into the 
environment or testing in humans of 
materials containing recombinant DNA 
developed with NIH funds, and if the 
institution that developed those materials 
sponsors or participates in those projects. 
Participation includes research collaboration 
or contractual agreements, but not mere 
provision of research materials. 
If the host country has established rules for 
the conduct of recombinant DNA projects. 
then the project must be in compliance with 
those rules. If the host country does not have 
such rules, the proposed project must be 
reviewed by an NIH approved 1BC or 
equivalent review body and accepted in 
writing by an appropriate national 
governmental authority The safety practices 
to be employed abroad must be reasonably 
consistent with the NIH Guidelines. 
II. Human Gene Transfer Protocol 
The RAC will consider a human gene 
transfer protocol submitted by Drs. 
Steven A. Rosenberg. R. Michael Blaese, 
and W. French Anderson of the National 
Institutes of Health to mark tumor 
infiltrating lymphocytes (TIL) and to 
study their distribution and survival in 
the body. The proposal was initially 
reviewed by the RAC Human Gene 
Therapy Subcommittee at a meeting on 
July 29. 1988. 
III. Proposed Amendment of Section I-B 
Dr. Anne Vidaver of the University of 
Nebraska and a member of the RAC has 
proposed that the following paragraph 
regarding transposons be added to 
Section I-B. Definition of Recombinant 
DNA Molecules: 
Unmodified transposons (wild-type) that 
become inserted into a genome, even if 
carried by a recombinant vector or plasmid, 
are not subject to these guidelines. For 
example, it is common to use vectors that 
either are naturally unstable (suicide vector) 
in a desired host or that can be rendered 
unstable by manipulating physiological 
conditions. In the process of suicide (inability 
of the vector to replicate), transposon 
transfer may occur. This process is not 
considered recombinant DNA. 
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 not only virtually every NIH 
program but also essentially every Federal 
research program in which DNA recombinant 
molecule techniques could be used, it has 
been determined to be not 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: August 30. 1988. 
James C Hill, 
Acting Director. National Institute of Allergy 
and Infectious Diseases. 
(FR Doc. 88-20047 Filed 9-1-88; 8:45 am] 
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