Federal Register / Vol. 55, No. 219 /^Tuesday, November 13,1990. / Notices-.- 
National Institutes of Health 
National Cancer institute; Notice of 
Meeting (President’s Cancer Panel) 
Pursuant to Public Law 92-463, notice 
is hereby given of the meeting of the 
President’s Cancer Panel, National 
Cancer Institute, November 16, 1990, at 
the National Cancer Institute, 9000 
Rockville Pike, Building 31, Room IIAIO, 
Bethesda, Maryland 20892. 
This meeting will be open to the 
public on November 16 from 9 a.m. to 
11:30 a.m. Attendance will be limited to 
space available. Agenda items will 
include reports by the Chairman, 
President’s Cancer Panel; the Director, 
NCI: staff cf the NCI. 
Dr. Elliott Stonehill, Executive 
Secretary, President's Cancer Panel, 
National Cancer Insitute, Building 31, 
Room 4A32, National Institutes of 
Health, Bethesda, Maryland 20892 [301/ 
496-1148) will provide a roster of the 
Panel members and substantive program 
information upon request. 
This notice is being published less 
than 15 days prior to the meeting due to 
the difficulty of coordinating the 
attendance of members because of 
conflicting schedules. 
Dated: November 7, 1990. 
Bettj' J. Beveridge, 
Committee Management Officer, NIH. 
(FR Doc. 90-26832 Filed 11-9-90; 8:45 am] 
BILUNG CODE <140-01-M 
Revision of the Guidelines 
Subcommittee; Meeting 
Pursuant to Public Law 92-463, notice 
is hereby given of a meeting of the 
Revision of the NIH Guidelines 
Subcommittee (a subcommittee of the 
Recombinant DNA Advisory 
Committee) on December 7, 1990. The 
meeting wdll be held at the National 
Institutes of Health (NIH), Building 3lC, 
Conference room 9, 9000 Rockville Pike, 
Bethesda, Maryland 20892, starting at 
approximately 9 a.m. to adjournment at 
approximately 5 p.m. 
The meeting will be open to the public 
to discuss the following proposed action 
under the Nlh Guidelines for Research 
Involving Recombinant DNA Molecules 
(51 FR 16958. May 7. 1986); 
I. Revision of appendix K 
Revision of Appendix K of the NIH 
Guidelines Regarding Establishment of 
Guidelines for Level of Containment 
Appropriate to Good Industrial Large 
Scale Practices (GILSP). In a letter dated 
June 28, 1990. the Industrial 
Biotechnology Association IIBA] and the 
Pharmaceutical Manufacturers 
Association (PMA) requested that the 
Recombinant DNA Advisory Committee 
revise Appendix K of the TV/// 
Guidelines to reflect a formalization of 
suitable containment practices arid 
facilities for the conduct of large-scale 
experiments involving recombinant 
DNA-derived industrial microorganisms. 
In attachments to this request, there are 
proposed definitions and requirements 
pertaining to the requested changes, - 
During the RAC meeting on October 16, 
1990, they considered the 
recommendations made by the Revision 
of the NIH Guidelines Subcommittee. 
Following a discussion, it was decided 
that further modifications of appendix K 
were necessary. Accordingly, the matter 
was referred back to the subcommittee. 
The Revision of the NIH Guidelines 
Subcommittee will report with 
recommendations to the Recombinant 
DNA Advisory Committee during their 
meeting on February 4, 1991. 
n. Other Matters To Be Considered by 
the Committee 
Attendance by the public will be 
limited to space available. Members of 
t'he public wishing to speak at this 
meeting may be given such opportunity 
at the discretion of the Chair. 
Dr. Nelson A. Wivel, Diosctor, Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892, telephone (301) 496-9838, fax 
(301) 496-9839, will provide materials to 
be discussed at this meeting, roster of 
committee members, and substantive 
program information. A summary of the 
meeting will be available at a later date. 
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 announcement 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 NIK 
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; November 8, 1990. 
Betty J. Beveridge, 
Committee Management Officer, NIH. 
[FR Doc. 90-26662 Filed 11-9-90; 8:45 am) 
BILLING CODE 4140-01-M 
Human Gene Therapy Subcommittee; 
Meeting 
Pmsuant to Public Law 92-463, notice 
is hereby given of a meeting of the 
Human Gene Therapy Subcommittee (a 
subcommittee of the Recombinant DNA 
Advisory Committee) on November 30, 
1990. The meeting will be held at the 
National Institutes of Health (NIH), 
Building 31, Conference room 6, 9000 
Rockville Pike, Bethesda, Maryland. 
20892, starting at approximately 9 a.m. 
to adjoumment at approximately 5 p.m. 
The meeting will be open to the public 
to discuss the following proposed 
actions under the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules (51 FR 16958 May 7, 1986): 
I. Addition to Appendix D of the “NIH 
Guidelines’* Regarding Human Gene 
Transfer Protocols/Dr. Brenner 
In a letter receive on October 5, 1990, 
Dr. Malcolm K. Brenner of St. Jude 
Children’s Research Hospital of 
Memphis, Teimessee, indicated his 
intention to submit two human gene 
transfer protocols to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
titles of these protocols are: 
1. "A Phase II Trial of High-Dose 
Carboplatin and Etoposide with 
Autologous Marrow Support for 
Treatment of Relapse/Refractory 
Neuroblastoma Without Apparent Bone 
Marrow Involvement: Use of Marker 
Genes to Investigate the Biology of 
Marrow Reconstitution and the 
Mechanism of Relapse;’’ and 
2. "Autologous Bone Mairow 
Transplant for Children with Acute 
Myelogenous Leukemia (AML) in First 
Complete Remission: Use of Marker 
Genes to Investigate the Biology of 
Marrow Reconstitution and the 
Mechanism of Relapse.” 
II. Addition to Appendix D of the “NIH 
Guidelines" Regarding a Human Gene 
Transfer Protocol/Dr. Lotze 
In a letter dated September 13, 1990, 
Dr. Michael T. Lotze of the University of 
Pittsburgh School of Medicine indicated 
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Recombinant DNA Research, Volume 14 
