Federal Register / Vol. 57, No. 181 / Wednesday. August 19, 1992 / Notices 
37681 I 
Versus Relapse due to Residual 
Neoplastic Cells in Autologous Marrow 
Following Purging in Patients with 
Chronic Lymphocytic Leukemia (CLL) 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Walker and 
Blaese 
In a letter dated July 20, 1992, Drs. 
Robert Walker and R. Michael Blaese. 
National Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: A Study of the Safety and 
Survival of the Adoptive Transfer of 
Genetically Marked Syngeneic 
Lymphocytes in HIV Infected Identical 
Twins. 
VI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Schuening 
In a letter dated July 17, 1992, Dr. 
Friedrich G. Schuening, Fred Hutchinson 
Cancer Research Center, Seattle, 
Washington, submitted three human 
gene transfer protocols to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
titles of these protocols are: (1) Phase 1/ 
11 Study of the Use of Recombinant 
Human Interleukin 3 (rhIL3) Stimulated 
Peripherial Blood Progenitor Cell 
Supplementation in Autologous Bone 
Marrow Transplanation in Patients with 
Breast Carcinoma or Hodgkin’s Disease: 
(2) Evaluation of the Use of 
Recombinant Human G-CSF Stimulated 
Peripheral Blood Progenitor Cell 
Supplementation in Autologous Bone 
Marrow Transplanation in Patients with 
Lymphoid Malignancies, and (3) A Trial 
of G-CFS Stimulated Peripheral Blood 
Stem Cells for F.ngraftment in Identical 
Twins. 
VII. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Brenner and 
Mills 
In a letter dated June 5, 1992, Dr. 
Malcolm K. Brenner of SL Jude 
Children’s Research Hospital, Memphis. 
Tennessee, and Dr. Bonnie J. Mills of 
Baxter Healthcare Corporatic:.. Santa 
Ana, California, indicated their intention 
to submit a human gene transfer 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: A Phase II Trial of the Baxter 
Neuroblastoma Bone Marrow Purging 
System using Gene Marking to Assess 
Efficacy. 
VIII. Addition to Appendix D of the NIH 
Guidelines Regarding Semliki Forest 
Virus/Dr. Temple 
In a letter dated July 20, 1992, Dr. Gary 
F. Temple, Life Technologies, Inc., 
Gaithersburg, Maryland, is requesting 
permission to conduct experiments with 
a Semliki Forest Virus (SFVJ-SQL helper 
expression system at Biosafety Level 2. 
IX. Addition to Appendix D of the NIH 
Guidelines Regarding the Introduction of 
a Gene Coding for Tetracycline 
Resistance into Porphyromonas 
gingivalis/Dr. Progulske — Fox 
In a letter dated July 1, 1992, Drs. 
Carolyn Keierleber and Ann Progulske- 
Fox of the University of Florida. 
Gainesville, Florida, are requesting 
permission to conduct experiments 
which involve the introduction of a gene 
coding for tetracycline resistance into 
Porphyromonas gingivalis at Biosafety 
Level 2. 
OMB's "Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592. 
June 11, 1980) requires a statement 
concerning the official government 
programs contained in the Catalog of 
Federal Domestic Assistance. Normally 
NTH 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 6, 1992. 
Daryl A. Chamblee, 
Acting Associate Director for Science Policy 
and Legislation. NIH 
[FR Doc. 92-19929 Filed 8-10-92; 8:45 am) 
BILLING CODE 4UO-01-M 
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Recombinant DNA Research, Volume 16 
