Federal Register / Vol. 58, No., 215 / Tuesday, November 9, 1993 / Notices 
59613 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Schuening 
On September 29, 1993, Dr. Friedrich 
Schuening of the Fred Hutchinson 
Cancer Research Center, Seattle, 
Washington, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Retrovirus-Mediated 
Transfer of the cDNA for Human 
Glucocerebrosidase into Peripheral 
Blood Repopulating Cells of Patients 
with Gaucher’s Disease. 
VL Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Sorscher and 
Logan 
On October 6, 1993, Drs. Eric J. 
Sorscher and James J. Logan of the 
University of Alabama, Birmingham, 
Alabama, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Gene Therapy for Cystic 
Fibrosis Using Cationic Liposome 
Mediated Gene Transfer A Phase I Trial 
of Safety and Efficacy in the Nasal 
Airway. 
VII. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Sznol 
On October 7, 1993, Dr. Mario Sznol 
of the 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 Phase I Trial 
of B7-Transfected Lethally Irradiated 
Allogeneic Melanoma Ceil Lines to 
Induce Cell-Mediated Immunity Against 
Tumor- Associated Antigens Presented 
by HLA-A2 or HLA-Al in Patients with 
Stage IV Melanoma. 
VIIL Addition to Appendix D of the 
NIH Guidelines Regarding a Human 
Gene Transfer Protocol/Dr. Rubin 
On October 6, 1993, Dr. Joseph Rubin 
of the Mayo Clinic, Rochester, 
Minnesota (sponsored by Vical, Inc., 
San Diego, California), submitted a 
human gene transfer protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Phase I Study of 
Immunotherapy of Advanced Colorectal 
Carcinoma by Direct Gene Transfer into 
Hepatic Meta stases. 
DC. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Welsh 
On October 4, 1993, Dr. Michael J. 
Welsh of the Howard Hughes Medical 
Institute, Iowa City, Iowa, submitted a 
human gene transfer protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Adenovirus- 
Mediated Gene Transfer of CFTR to the 
Nasal Epithelium & Maxillary Sinus of 
Patients with Cystic Fibrosis. 
X. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Sobol and 
Royston 
On October 6, 1993, Drs. Robert E. 
Sobol and Ivor Royston of the San Diego 
Regional Cancer Center, San Diego, 
California, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Immunization of Colon 
Carcinoma Patients with Autologous 
Irradiated Tumor Cells and Fibroblasts 
Genetically Modified to Secrete 
Interleukin-2 (IL-2): A Phase I Study. 
XI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Sobol and 
Royston 
On October 6, 1993, Drs. Robert E. 
Sobol and Ivor Royston of the San Diego 
Regional Cancer Center, San Diego, 
California, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Immunization of 
Glioblastoma Patients with Tumor Cells 
Genetically Modified to Secrete 
Interleukin-2 (IL-2): A Phase I Study. 
XIL Report on Minor Modifications to 
NIH-Approved Human Gene Transfer 
Protocols 
Dr. LeRoy Walters, Chair of the 
Recombinant DNA Advisory Committee, 
will present an update on minor 
modifications to NIH-approved human 
gene transfer protocols. 
XHL Working Group on Data 
Management 
Dr. Brigid Leventhal, Chair of the 
Working Group on Data Management, 
will provide a summary of the reports 
submitted to the Office of Recombinant 
DNA Activities by the principal 
investigators of NIH-approved protocols, 
and make recommendations regarding 
actions to be taken in the event of non- 
reporting. 
XIV. Amendments to Footnotes 21 and 
22 and Section HI-A-3 of the NIH 
Guidelines Regarding Recombinant 
DNA Vaccines 
Dr. Stephen Straus, Chair of the 
Working Group on Vaccines, will 
present an overview of the proposed 
amendments to Footnotes 21 and 22 and 
Section HI-A-3. The proposed 
amendments will define those 
categories of experiments involving the 
administration of recombinant DNA 
vaccines that are exempt from 
Recombinant DNA Advisory Committee 
review and National Institutes of Health 
and Institutional Biosafety Committee 
approval. 
XV. Amendments to Sections HI, IV, V 
of the NIH Guidelines and the Points To 
Consider Regarding NIH (ORDA) 
Review and Approval of Certain 
Categories of Human Gene Transfer 
Experiments That Qualify for the 
Accelerated Review Process 
Dr. Robertson Parkman, Chair of the 
Working Group on Accelerated Review 
Protocols, will present an overview of 
the proposed amendments to the NIH 
Guidelines and the Points to Consider. 
The proposed amendments will: (1) 
Establish an accelerated review process 
for certain categories of human gene 
transfer experiments, (2) allow the 
National Institutes of Health (Office of 
Recombinant DNA Activities) to assign 
the appropriate review category to all 
human gene transfer proposals that are 
submitted in compliance with the NIH 
Guidelines, and (3) allow the National 
Institutes of Health (Office of 
Recombinant DNA Activities) to 
approve those categories of human gene 
transfer experiments that qualify for the 
accelerated review process in 
consultation with one or more 
Recombinant DNA Advisory Committee 
members, as necessary. Those human 
gene transfer experiments approved by 
the National Institutes of Health (Office 
of Recombinant DNA Activities) 
through the accelerated review process 
will be provided in a report by the Chair 
of the Recombinant DNA Advisory 
Committee at the next scheduled 
committee meeting. Those human gene 
transfer experiments approved by 
National Institutes of Health (Office of 
Recombinant DNA Activities) will be 
included in the list of approved 
experiments and will be available from 
the Office of Recombinant DNA 
Activities, Building 31, room 4B11, 
Bethesda, Maryland 20892. 
Recombinant DNA Research, Volume 18 
[507] 
