Federal Register / Vol. 56, No. 170 / Tuesday. Septembt. 3, 1991 / Notices 
43687 
had requested a preliminary experiment 
using tumor cells that were not gene- 
modified, the HGTS requested that only 
tumor cells transduced with the cytokine 
genes be used in these protocols. 
Further, the Principal Investigator was 
requested to report his results after the 
first Five patients have been studied; he 
was asked to measure the rate of cell 
growth at the injection site, and to do a 
polymerase chain reaction assay for 
cytokine DNA in the inguinal lymph 
nodes and in tumor biopsies at other 
sites in the body. 
The HGTS forwarded the protocol to 
the Recombinant DNA Advisory 
Committee for consideration during the 
October 7-8. 1991, meeting. 
III. Addition to Appendix D of the “NIH 
Guidelines” Regarding a Human Gene 
Therapy Protocol/Dr. Wilson 
In a letter dated June 7, 1991, Dr. 
James M. Wilson of the University of 
Michigan Medical Center indicated his 
intention to submit a human gene 
therapy protocol to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: “Gene Therapy of 
Familial Hypercholesterolemia." 
The protocol was reviewed during the 
Human Gene Therapy Subcommittee 
meeting on July 29-30, 1991. Provisional 
approval was granted with the following 
stipulations. It was requested that the 
Principal Investigator provide additional 
data about the quality control of the 
vector system and the characteristics of 
the packaging cell line. In addition, the 
consent form is to be reviewed following 
several requested changes. 
The Human Gene Therapy 
Subcommittee forwarded the protocol to 
the Recombinant DNA Advisory 
Committee for consideration during the 
October 7-8, 1991, meeting. 
IV. Amend Appendices B-I-B-l and B- 
I-B-2 and the “NIH Guidelines" 
regarding the Bacterial Order, 
“Actinomycetales" 
In a written request dated April 15, 
1991, Dr. Diane O. Fleming of Merck & 
Co., Inc., requested that only pathogenic 
genera and species of the bacterial 
order, Actinomycetales. be included in 
Appendix B-I-B-l of the NIH 
Guidelines. 
It was proposed that the following 
pathogens be included under Bacterial 
Agents in Appendix B-I-B-l of the NIH 
Guidelines as follows: 
Actinomadura madurae 
Actinomadura pelletieri 
Actinomyces bovis 
Actinomyces israelii 
Nocardia asteroides 
Nocardia brasiliensis 
In Appendix B-I-B-2, the entry under 
Actinomycetes would be deleted. 
This request was reviewed at the 
Recombinant DNA Advisory Committee 
meeting on May 30-31, 1991. Following a 
discussion there was agreement that the 
Actinomyces should be reclassified as 
bacteria and removed from the list of 
fungi. However, there was disagreement 
about the number of species to be listed 
as pathogens. The number was thought 
to be considerably larger than the six 
species proposed for inclusion. Dr. 
Fleming was asked to consult with 
leading experts in the field and return 
with a revised list of pathogens, which 
will be reviewed at the Recombinant 
DNA Advisory Committee meeting on 
October 7-8, 1991. 
V. Discussion of Future Role of Human 
Gene Therapy Subcommittee 
At its meeting on July 29-30, 1991, the 
Human Gene Therapy Subcommittee 
held a discussion about ways to shorten 
the review process for human gene 
therapy protocols. It was suggested by 
some members that consideration be 
given to merging the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
with the idea that the present system 
creates an unnecessary double hurdle. 
The Recombinant DNA Advisory 
Committee will consider the issues 
raised at the most recent Human Gene 
Therapy Subcommittee meeting. 
VI. Other Matters To Be Considered by 
the Committee 
Attendance by the public will be 
limited to space available. Members of 
the public wishing to speak at this 
meeting may be given such opportunity 
at the discretion of the Chair. 
Dr. Nelson A. Wivel, Director. Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892. Phone (301) 496-9838, FAX (301) 
496-9839, will provide materials to be 
discussed at this meeting, roster of 
committee members, and substantive 
program information. A summary of the 
meeting will be available at a later date. 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcement” (45 FR 39592, 
June 11, 1980) 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 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: August 23, 1991. 
Kurt Habel, 
Acting Associate Director for Science Policy 
and Legislation. NIH. 
[FR Doc. 91-21058 Filed 8-30-91; 8:45 am] 
BILLING CODE 4140-01-M 
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