^6349 
Federal Register / 
.iversUy of Sochaster indicated their 
veniion to iubmit a human gene 
jierapy prctccci to the Human Gene 
Therapy Subcommittee and :he 
Recombinant DNA Advisory Committee. 
The title of this protocol is “Gene 
Therapy for Cancer Treatment (I]." 
rV. Addition to the "Points to Consider" 
Cocament to Expedite Minor 
Modification oo Approved Protocols 
During the June 1 meeting, the Human 
Gene Therapy Subcommittee 
recommended a procedure for 
e.xpedlting reviews on approved hiunan 
gene therapy protocols. The fcllou-ing 
policy is proposed for discussion, 
approval, and addition to the documenl 
entitled. “Poinis to Consider in the 
Design and Submission of Protocols for 
the Ti’ansfer of Recc.mbinant DMA into 
the Genome of Human Subjects." The 
proposal is as follows: 
A tninor change in a protocol approved by 
tha Human Gena Therapy Subconunittee. that 
is. a change that does not significantiy alter 
the basic design of a protocol and that docs 
cot increase risk to the subjects, .’nay be 
approved by the Cha>r of tiie Subcommittee if 
the change has also been .approved by the 
■•ievant LR3 and by the relevant institutional 
tsafety Conunittee. The Chair -.vi!! report 
. any such approvals at the ne.xt .’agulariy 
■heduled xeeeti.r.g of the S'jbcoTn.'nittee 
V. .Addition to Appendix D of the NThl 
Guidelines Regnrding a Human Gena 
Transfer Clinical Protccol-Drs. Brenner. 
Ihle, Mirro 
In a letter dated June 22. ItJGO. Drs. M. 
JC Brenner. J. Ihle, J. Mirro of the St. Jude 
Children's Research Hosptial indicated 
Vol. 55. >}o. 124 / Wednesday. June 
their intention to iubm.it a human gene 
transfer clinical protocol to the Human 
Gene Therapy Subcomimittee and the 
Recombinant DMA Advisory Committee. 
The title of this protocol is "Use of 
Marker Genes to Investigate the Biology 
of Marrow Reconstitution and Relapse 
of Malignant Disease Following 
Autologous Bone Marrow 
Traasplantatioa." 
VI. Addition to Appendix D of the NIH 
Guidelines Regard'mg a Human Gene 
Transfer Clinical Protocol/ Dr. Cometta 
In a letter dated June 22, 1990. Dr. 
Cometta of 2ia University of Wisconsin 
indicated his intenticn to subm.it a 
human gens Lni.nsfer clinical protocol to 
the Human Gene Therapy Subcommittee 
and the Recombinant DMA Advnsory 
Committee. The title of this protocol is 
"Retroviral-Mediated Gene Tra.nsfer of 
Bone Marrow Cells During .Autologous 
Bone Marrow Transplaniation for .Acute 
Leukemia: Understandmg Disease 
Recurrence." 
VII. .Addidon to A.ppendLx D of the NTH 
Guidelines Regarding a Human Gens 
Transfer Clinical Protocol /Dr. Lolze 
In a letter dated June 22. 1990, Dr. M. 
T. Lotze of ±e Pittsburgh Cancer 
Institute. University of Pittsburgh 
‘indicated his intention to submJt a 
human gene transfer clinical protocol to 
the Human Gene Therapy Subcommittee 
and the Recombinant DMA Advisory 
Committee. The title of this protocol is 
"The Treatment of Patients with 
Advanced Ca.ncer Using Interleukin 2. 
Interleukin 4 and T=mior Infiltrating 
Lymphccytes." 
27. 190 / Notices 
.Additional documentation supporting 
these requests will be distributed at the 
meeting. This .material also is ivailab!" 
upon request from the Cffico of 
Recombinant D.MA .Audvrities. 
OMB's "Manaatcry Infcrmadun - 
Require.ments for Federal .Assistance 
Program .Armouncements" (45 FR 392921 
requires a statement ccncemmg the 
official government programs contained 
in the Catalog of Federal Domestic 
.Assistance. Normally NTH lists in its 
announcements the number and title uf 
affected individual programs for ±e 
guidance of die pubiic. Because the 
guidance in this notice covers not only 
virtually every .NTH program but also 
essentially every Federal rasearch 
program in whic.h DMA recombinant 
molecule techniques could 'oe used, it 
has been determined to be not cost 
effective or In the public interest to 
attempt to list these programs. Such a 
list wo>uId likely require several 
additional pages. In addition. NIH could 
not 'oe certain Lhat every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow 
NTH Guidelines. In lieu of the individual 
program listing, the NIH invites ."saders 
to direct questions to the information 
address above about whether individual 
programs listod in the Catalog of Federal 
Domestic .Assistancs are affected. 
Deled: July 14. 1990. 
Jay Moskowitz. 
AssceJaCe Dirsc'or. ofSuiar.ce Patlcy 
arid Lagisiaiicn. Ncdoral [!:s::luies of Uecltn. 
[FR Doc. 90-14S41 Filed 6-2B-90; 3; !S sm! 
BIU.WQ coot 4140-31-M 
Recombinant DNA Research, Volume 14 
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