Federal Regteter / Vol. 55, No. 177 / Wednesday, September 12, 1990 / Notices 
37567 
Chair of die Recombinanl DMA Advisory 
Committee may ^ve approval- It is expected 
that the Chairs of either committee will 
consult widi one or more members of the 
committee, as necessary. The Chairs will 
report on any such approvals at the next 
regularly scheduled meetings of the 
respective committees. 
I accept this recommendatioii, and 
section V will be added to the ^'Points to 
Considei^ document 
n. Siunmaiy of Actions 
A. Amendment of Appendix D-XIII of 
the "NIH Guidelines’’ 
The amended version of Appendix D- 
XIII reads as follows: 
Approval is based on the following four 
stipulations: 
1. There will be no limitation of the number 
of patients in the continuing trial. 
2. The patients selected will have a life 
expectancy of about 90 days. 
3. The patients give hdly infonned consent 
to participate in the trial: and 
4. The investigators will provide additional 
data before inserting a gene for therapeutic 
purposes. 
B. Addition of Appendix D-XV to the 
“NIH Guidelines” 
The foUowipg section is added to 
Appendix D: 
Appendix D-XV 
Drs. R. Michael Blease and W. French 
Anderson of the National Institutes of Health, 
Bethesda, Maryland, can conduct 
experiments in which a gene coding for 
adenosine deaminase (ADA) will be inserted 
into T lymphocytes of patients with severe 
combined immunodehdency disease, using a 
retroviral vector, LNLB. Following insertion of 
the gene, these T lymphocytes will be 
reinfused into die patients. The patients will 
then be followed &r evidence of clinical 
improvement in the disease state, and 
measurement idr multiple p£trameters of 
immune function by laboratory testing. 
Approval is based on the following two 
stipulations: 
1. That intraperitoneal administration of 
transduced T lymphocytes not be used before 
clearance by ^e Chairs of the Human Gene 
Therapy Suboommittee and the Recombinant 
DNA Advisory Committee; and 
2. That the number of research patients be 
limited to 10 at this time. 
C. Addition of Appendix D-XVI of the 
“NTH Guidelines” 
The following section is added to 
Appendix D: 
Appendix D-XVI 
Dr. Steven A Rosenbetg of the National 
Institutes of Health. Bethesda, Maryland, can 
conduct experiments on patients with 
advanced melanoma who have failed all 
effective therapy. These patients will be 
treated with escalating doses of autologous 
tumor infiltrating lymphocytes (TTL) 
transduced with a gene coding for tumor 
Recombinant DNA Research, 
necrosis factor. Escalating numbers of 
transduced TIL will be administered at three 
weekly Intervals along with the 
administration of interleuldn-2. The objective 
is to evaluate tiie toxicity and possible 
therapeutic efficacy of the administration of 
tumor infiltrating lymihocytes (TIL) 
transduced with the gene coding for tumor 
necrosis factor (INFj. 
D. Admendment to the “Points to 
Consider in the Design and Submission 
of Protocols for the Transfer of 
Recombinant DNA into the Genome of 
Human- Subjects ” 
The following section is added to the 
"Points to Consider in the Design and 
Submission of Protocols for the Transfer 
of Recombinant DNA into the Genome 
of Human Subjects:” 
V. Minor Modifications 
A minor change in protocol approved by 
the Human Gene Iherapy Subcommittee and 
the Recombinant DNA Advisory Committee 
is a change that does not signifUrantly alter 
the basic design of a protocol and that does 
not increase xi^ to the subjects, if the change 
has been approved by the relevant 
Institution^ Review Board, Institutional 
Biosafety Committee, and Chair of the 
Human Gene Therapy Subcommittee, then 
the Chair of the Recombinant DNA Advisory 
Committee may then give approval It is 
expected that the Chairs of either committee 
will consult with one or more members of tiie 
committees, as necessary. The Chairs will 
report on einy such approvals at the next 
regularly scheduled meetings of the 
respective committees. 
OMB’s Mandaioiy Information 
Reqiurements 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 file public. Because the 
guidance in this notice covers not only 
virtually eveiy NIH program but also 
essenti^y every Federal research 
program in whu^ 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. 
Volume 14 
Dated; September 6, 1990. 
William F. Raub. 
PLD. Acting Director. National Institutes of 
Health. 
(FR Doc. 90-21490 Filed 9-11-90; 8/45 am] 
BILU4G CODE 4149-OMN . 
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