* * * TABLE OF CONTENTS * * * 
I. Call to Order /Dr. Walters 5 
II-A. Chair Report on NIH-Approved Accelerated Review Protocols/Dr. Walters 6 
II-B. Chair Report on Minor Modifications of NIH-Approved Human 
Gene Transfer Protocols/Dr. Walters 6 
III. September 12-13, 1994, Recombinant DNA Advisory Committee Minutes 6 
IV. Update on NIH/FDA Consolidated Review of Human Gene Transfer 
Protocols/Drs. Wivel and Noguchi 6 
V-A. December 1-2, 1994, Data Management Report/Dr. Smith 9 
V-B. Update on Adverse Event Reports-Protocols Involving PA317/GlTklSvNa 
Vector Producer Cells/Drs. Berger and Marcus 14 
V-C. Future Directions of the Data Management Report/Drs. Noguchi and Smith 16 
VI. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene 
Transfer Protocol Entitled: Adenovirus Mediated Gene Transfer for 
Cystic Fibrosis: Safety of Single Administration in the Lung 
/Drs. Dorkin and Lapey 17 
VII. Discussion of Ethical Considerations Relative to In Utero Somatic 
Cell and Gene Therapies/Drs. Patterson, Zallen, Motulsky, and Mr. Capron 21 
VIII. Addition to Appendix D of the NIH Guidelines Regarding a Human 
Gene Transfer Protocol Entitled: Intratumoral Injection of 
Herpes Simplex Thymidine Kinase Vector Producer Cells 
(PA31 7/G1 He IS vNa. 7 ) and Intravenous Ganciclovir for the Treatment 
of Locally Recurrent or Persistent Head and Neck Cancer /Dr. Gluckman 22 
IX. Addition to Appendix D of the NIH Guidelines Regarding a Human 
Gene Transfer Protocol Entitled: Phase I Trial of Interleukin-2 
Plasmid DNA /DMRIE/DOPE Lipid Complex as an Immunotherepeutic Agent 
in Solid Malignant Tumors or Lymphomas by Direct Gene Transfer 
/Drs. Hersh, Akporiaye, Harris, Stopeck, Unger, and Warneke 26 
X. Addition to Appendix D of the NIH Guidelines Regarding a Human 
Gene Transfer Protocol Entitled: Clinical Protocol for 
Modification of Tumor Suppressor Gene Expression in Head and 
Neck Squamous Cell Carcinoma (HNSCC) with an Adenovirus Vector 
Expressing Wild-type p53/ Dr. dayman 29 
XI. Chair Remarks/Dr. Walters 35 
Recombinant DNA Research, Volume 20 
