62458 
Federal Register / Vol. 57, No. 251 / Wednesday, December 30, 1992 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Public Law 92—463, 
notice is hereby given of a meeting of 
the Recombinant DNA Advisory 
Committee on January 14, 1993. The 
meeting will be held at the National 
Institutes of Health (NIH), Building 1, 
Wilson Hall, 9000 Rockville Pike, 
Bethesda, Maryland 20892, starting at 
approximately 9 a.m. on January 14, 
1993, to adjournment at approximately 
3 p.m. The meeting will be open to the 
public to discuss a proposed major 
action under the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules (51 FR 16958) involving an 
addition to Appendix D regarding a 
human gene therapy protocol and other 
matters to be considered by the 
Committee. 
Attendance by the public will be 
limited to space available. Members of 
the public wishing to speak at this 
meeting may be given such opportunity 
at the discretion of the Chair. 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892, Phone (301) 496-9838, FAX 
(301) 496-6839, 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 
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: December 24, 1992. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
[FR Doc. 92-31762 Filed 12-29-92; 8:45 ami 
BRUNO CODE 41 40-01 -M 
Recombinant DNA Research: 
Proposed Actions Under the 
Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
ACTION: Notice of proposed action under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(51 FR 16958). 
SUMMARY: This notice sets forth a 
proposed action to be taken under the 
National Institutes of Health (NIH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. Interested 
parties are invited to submit comments 
concerning these proposals. This 
proposal will be considered by the 
Recombinant DNA Advisory Committee 
(RAC) at its meeting on January 14, 
1993. After consideration of this 
proposal and comments by the RAC, the 
Director of the National Institutes of 
Health will issue decisions in 
accordance with the NIH Guidelines. 
DATES: Comments received by January 8, 
1993, will be reproduced and 
distributed to the RAC for consideration 
at its January 14, 1993, meeting. 
ADDRESS: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, 
Building 31, rodm 4B 11, National' 
Institutes of Health, Bethesda, Maryland 
20892, or sent by FAX to 301-496-9839. 
All comments received in timely 
response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the office of Recombinant DNA 
Activities, Building 31, room 4B11, 
National Institutes of Health, Bethesda, 
Maryland 20892, (301) 496-9838. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following action under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
In a letter dated December 7, 1992, Dr. 
Ivor Royston, San Diego Regional 
Cancer Center, San Diego, California, 
requested approval for a human gene 
therapy protocol. The title of this 
protocol is: Phase I Study of Cytokine 
Therapy of Cancer, Active 
Immunotherapy of Glioblastoma with 
Tumor Cells or Fibroblasts Genetically 
Modified to Secrete Interleukin-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 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: December 24, 1992. 
Jay Moskowitz, 
Associate Director for Science Policy and 
Legislation, NIH. 
[FR Doc. 92-31763 Filed 12-29-92; 8:45 am] 
BRUNO CODE 4140-01 -M 
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Recombinant DNA Research, Volume 17 
