Federal Register / Vol. 59, No. 215 / Tuesday, November 8. 1994 / Notices 
55797 
IV. Addition to Appendix D of the N1H 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Grossman and 
Woo 
In a letter dated September 27. 1994, 
Drs. Robert Grossman and Savio Woo of 
the Baylor College of Medicine & 
Methodist Hospital, Houston, Texas, 
submitted a human gene transfer 
protocol entitled: Phase I Study of 
Adenoviral Vector Delivery of the HSV- 
TK Gene and the Intravenous 
Administration of Ganciclovir in Adults 
with Malignant Tumor of the Central 
Nervous System to the Recombinant 
DNA Advisory Committee for formal 
review and approval. 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. dayman 
In a letter dated October 5, 1994, Dr. 
Gary dayman. of the MD Anderson 
Cancer Center, Houston, Texas, 
submitted 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 to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
VI. Addition to Appendix D of the NTH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Dorkin and 
Lapey 
In a letter dated October 11, 1994, Dr. 
Henry Dorkin of the New England 
Medical Center, Boston, Massachusetts, 
and Dr. Allen Lapey of Massachusetts 
General Hospital, Harvard Medical 
School, Boston. Massachusetts, 
submitted a human gene therapy 
protocol entitled: Adenovirus Mediated 
Gene Transfer for Cystic Fibrosis: Safety 
of Single Administration in the Lung to 
the Recombinant DNA Advisory 
Committee for formal review and 
approval. 
VII. 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. 
VIII. Working Group on Data 
Management 
Dr. Brian Smith, 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. 
IX. Amendments to Appendix B of the 
NIH Guidelines Regarding Updating the 
Classification.of Microorganisms/ 
Fleming 
In a letter dated June 24, 1993, Dr. 
Diane Fleming, President of the Mid- 
Atlantic Biological Safety Association 
requested updating Appendix B, 
Classification of Microorganisms on the 
Basis of Hazard. The Mid- Atlantic 
Biological Safety Association submitted 
an updated list of the classification of 
microorganisms for the Committee to 
review which included the latest 
taxonomy and agent risk group 
classifications as defined by the Centers 
for Disease Control and Prevention. This 
request was published for public 
comment in the Federal Register 
(August 18, 1994, 58 FR 44098). 
During the September 9-10, 1993, 
meeting, the Recombinant DNA 
Advisory Committee recommended by 
consensus that the current classification 
of etiological agents described in the 
Biosafety in Microbiological and 
Biomedical Laboratories, 3rd edition. 
May 1993, U.S. Department of Health 
and Human Services, should be 
endorsed by the Committee. The 
Committee retains the option to adopt 
any modification to the CDC listing. The 
Committee recommended that the 
revised Appendix B, Classification of 
Microorganisms on the Basis of Hazard, 
submitted by Dr. Fleming should not be 
adopted until the Committee receives 
letters of concurrence from both the 
Centers for Disease Control and 
Prevention and the NIH Division of 
Safety. 
In a telephone call on October 20; 
1994. Dr. Fleming stated that Appendix 
B. Classification of Microorganisms on 
the Basis of Hazard, would be reviewed 
by experts from the Centers for Disease 
Control and Prevention and the 
American Society for Microbiology. The 
revised Appendix B will be submitted to 
the Committee for the December 1-2. 
1994, meeting for review and 
discussion. If accepted, the revised. 
Appendix B will be published in the 
Federal Register for public comment, 
and voted on during the March meeting. 
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, NIH 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: October 31, 1994. 
Daryl A. Chamblee, 
Acting Deputy Director for Science Policy and 
Technology Transfer. 
(FR Doc. 94-27575 Filed 11-7-94; 8;45 ami 
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