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Federal Register / Vol. 55, No. 249 / Thursday December 27, 1990 / 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 February 4, 1991. The meeting will be 
held at the National Institutes of Health 
(NIH), Building 3lC, Conference Room 6, 
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 actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(51 ¥R 16958); 
Proposed Major Actions to the NIH 
Guidelines; 
Two additions to appendix D of the 
NIH Guidelines Regarding Human Gene 
Transfer Protocol; 
Revision of appendix K of the NIH 
Guidelines Regarding Establishment of 
Guidelines for Level of Containment 
Appropriate to Good Industrial Large 
Scale ftactices (GILSP); 
Amendment to appendix B-I-B-1 of 
the NIH Guidelines regarding 
Salmonella Typhimurium LT2. 
Report from the Planning 
Subcommittee in Charge oif Reviewing 
Comments Received During the Regional 
Hearings Conducted by the 
Recombinant DNA Advisory Conunittee 
Concerning Future Role of this . 
Committee; 
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, 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 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 19, 1990. 
Betty J. Beveridge, 
Conunittee Management Officer. NIH. 
[FR Doc. 90-30245 Filed 12-26-90; 8:45 am] 
BILUNG CODE 4140-01-M 
Recombinant DNA Research: 
Proposed Actions Under the. . . 
Guideiines ^ ^ . 
agency: National Institutes of Health, 
PHS, HHS. 
action: Notice of Proposed Actions 
Under the N/H Guidelines for Research 
Involving Recombinant DNA Molecules 
(51 FR 16958). 
SUMMARY: This notice sets forth 
proposed actions 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. 
These proposals will be considered by 
the Recombinant DNA Advisory ' 
Committee (RAC) at its meeting on 
February 4, 1991. After consideration of 
these proposals 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 
22, 1991, will be reproduced and 
distributed to the RAC for consideration 
at its February 4, 1991, meeting. 
ADDRESS: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, 
Building 31, room 4B11, National 
Institutes of Health,’ Bethesda, Maiyland 
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 actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
I. Addition to Appendix D of the “NIH 
Guidelines" Regarding a Human Gene 
Transfer Protocol/Dr. Lotze 
In a le^tter dated September 13, 1990, 
Dr. Michael T. Lotze of the University of 
Pittsburgh School of Medicine indicated 
his intention to submit a human gene 
transfer protocol to the Human Gene 
Therapy Subcommittee and the 
-Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: 
“The Administration of Interleukin-2. 
: Interleukin-4, and Tumor Infiltrating 
Lymphocytes to Patients with 
' Melanoma.” 
The protocol was reviewed by the 
Human Gene Therapy Subcommittee 
, during its November 30, 1990, meeting. 
The subcommittee recommended 
provisional approval pending receipt of 
the following additional information. 
The patient consent form is to be 
modified in response to the requests of 
the subcommittee. The investigator is to 
present a more detailed description of 
the studies designed to characterize the 
homing properties of tiunor-infiltrating 
lymphocytes. 
The Human Gene Therapy 
Subcommittee forwarded the protocol to 
the Recombinant DNA Advisory 
Committee for consideration during its 
February 4, 1991, meeting. 
II. Addition to Appendix D of the “NTH 
Guidelines" Regarding Human Gene 
Transfer Protocol/Dr. Brenner 
In a letter received on October 5. 1990. 
Dr. Malcolm K. Brenner of St. Jude 
Children’s Research Hospital of 
Memphis, Tennessee, indicated his 
intention to submit a human gene 
transfer protocol to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of the protocol is: 
“Autologous Bone Marrow Transplant 
for Children with Acute Myelogenous 
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Recombinant DNA Research, Volume 14 
