9708 
Fedaral Re^sOec / V(^ 56v No. 45> / Thursdayv'March 7r 1981 f Notkrea 
approximately 9 eun. to adjournment at - 
approximately 5 p.m. 
The meeting wUl be opea to the public 
to discuss the following proposed 
actions under the NIH GuideFines for 
Research Involving Recombinant DNA 
Molecules (51 FR 16958): 
I. Additioii to appendix D of the *'N1H 
Guidelinea” Regarding a Human Gene 
Transfer Protocol/Ik. Lotze 
In a letter dated September 13, 1990, 
Dr. Michael T. Lotze of the University of 
Pittsburgh School of Medidne indicated 
his intention to submit a human gene 
transfer protocol to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol isr 
The Administration of 6iterfeukin-2; 
Interleukin-*, and Tamor Infiltrating 
Lyn^pfaotytes to IHitienta with MefeaKHaa 
Theprotocof was reviewed durmg; the 
Human Gene Therapy SubcommittBe 
meeting on November 30, 1990; and 
forwarded lo die Recorabmant EWA 
Advisory Comnnttee oft Febrnary 4, 
1991, for their approval. The- 
Recombinant IhllAAdviscsy Committee 
deferred approval and soit the protocol 
back to the Human Gene Therapy 
Subctnnmittee forfozther debbraation at 
its Bextmeeting on Aprili 5, 1991. 
n. Addition to appendix D of the "NIH 
Guidelines” Regarding a Human Gene 
Transfer Protocol/Dr. Cometta 
In a letter dated ]uly 25. 1990, Dr. Ken 
Cometta of the. Univetsity of 
Wfsconsih/MadlacaL indicated his 
intention to subaiit a human gpne 
transfer protocol to the Human Gene 
Therapy Subconunittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: 
BMT 9049 — ^Retraviral-Mediafed Gene 
Transfer of Bone Marrow Cells During 
Autologous Bone Marrow Transplantation for 
Acute Leukemia: Undentaadrag EMsease 
Recurrence 
The protocol v»s revi^a^ during, the 
Human Gene Therapy Subcommittee 
meeting on November 30,. 1990. The 
protocol was deferred with the request 
for additional data and further 
consideration at the next meeting on 
April 5, 1991. 
III. Addition to Appendix D of the “NIH 
Guidelines” Regarding Human Gene 
TransferProtocals/Dr. Brenner 
In a letter dated February 22, 1991, Dr. 
Malcolm K. Brenner of St. Jude 
Children's Research Hospital indicated 
his intention to submit two bomea gene 
transfer protocols to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. 
The first protocol is entitled: 
A Phase I/H Trial of High-Dose Carboplatin 
and Etoposide With Autologous Marrow 
Support for Treatment of Stage D 
Neuroblastoma in First Remission: Use of 
Marker Genes to Investigate the Biology of 
Marrow Reconstitution and the Mechanism 
of Relapse 
The second ^otocol is entitled: 
A niase B Trial of Hi^'-Dose Carboplatin 
and Etoposide Widr Autologous Marrow 
Suppcut for Treatment of Relapse/Refractory 
Neuroblastomk Without Apparent Bone 
Marrow Invc^vement Use of Marker Genes, 
to Investigate the Biology of Marrow 
Reconstitution and the Mechanism of Refuse 
This second protoccd waa reviewed 
during the Human Gene: Therapy 
Subcommittee meeting on. November 30% 
1990, The protocol waa deferred with e 
request fin: addition^ data and further 
conmderatioa at the next meeting on 
April 5, 1991. 
rv. Addition to Append. D of. die “NIH 
Guidelines” Regar^g a Himaaa Gene 
Transfer Protocol/Dr. Deisseroth. 
In a lett^ (fated December 20% 1900, 
Dr. Albert B. Deisseroth cd MD 
Anderson Cancer Center indicated hia 
intention to submit a human gene 
transfer protocol to the Human Gene 
Therapy Subcommittee and the 
Recam^inanf BNA Advwory Committee 
for formai review and approved. The title 
of this protocol is: 
Autologous Transplantation for Clonic 
Myelogenous Leukemia: Retroviral Marking 
to Discriminaie Between Relapses Arising 
From Residual Systemic Disease vs. Residual 
Contammatitwr of Autologous Marrow 
V. Addition to Appendix Dof the “NIH 
Guidelines” Re^icding a Humsm Gene 
Therapy Pmt(xx>l^Dr8. Ledley and Woe- 
In a letter dated December 19, 1990, 
Drs. Fred Ek Ledley and Savio L C. Woo 
of theBaylop of Medicine 
imScated fhetrinfentfonifa sulnnit a 
human gene flierapy lootocel to toe 
Hmaan Gene Therapy Subcommittee 
and the Recombmanf DNA Advisory 
Committee for fimnal review and 
approvaL The title of tins protocol is: 
Hepatocellular Transplantation in Acute 
Hepatic Failure and 'Targeting Genetic 
Markers to Hepatic CeEs 
V. Other Matters To Be Considered by 
the Committee 
Protoccds which are approved by toe 
Human Gene Therapy Subcommittee 
will be forwarded to the Recombinant 
DNA Advisory Committee for 
consideration during their May 31, 1991, 
meeting. 
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, telephone (30IJ 496-9838, fax 
(301) 49B-9839, wilt provide materials to 
be discussed at this meeting, roster of 
committee members, and substantive 
program infonnation. A summary of the 
meeting will be available at a later date. 
OMB's “Mandatory Information 
Requirements forFed^^l Assistance 
Pro^am Announcements" (45 FR 39592, 
June 11, 1980) requires a statement 
concerning the official Government 
programs (motamed in the Catalog of 
Federal Domestic Assistance, Normally 
NIH lists in its annouDcemeHts the 
number andtitle of affected individual 
programs foe the guidance of the public. 
Because the guidanee in this, notice 
covers not ordy virtoally every NOT 
program bat essmttiallry ev^y 
Federal research program in vitodtto DNA 
recombinant motecnle techniques could 
be used, it has been determined not to 
be cost effective or in the pabUc interest 
to attempt to list these intograms. Sneh a 
list would likely reqmxe several: 
additional pages. In additkn, NIH could 
not be certakk that every Federal 
program wotddbe mduded as mai^ 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NUi Gtddelines, In tieo of toe individual 
program listing,. NIH invites readers to 
direct questions to the information 
address above about whether individual 
programs listed in the Catalog of 
Federal Dom^ic Assistance are 
affected. 
Dated: February 28, 1991. 
Betty ). Beveridga, 
Committee Managemeat Officer, NIH. 
[FR Doc. 90t-5a24 Ffied 8o45 am) 
BILLING CODE 414»-01-W 
DEPARTMENT OF HOUSING AND 
URBAN DEVELOPMENT 
Office of Administration 
[Docket Mo. N-91-3223I 
Submission of Proposed fnformatron 
Collection to 0MB 
agency: Office of Housing. 
ACTION: Mortgagee letter. 
Recombinant DNA Research, Volume 14 
[553] 
