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Federal Register / Vol. 58, No. 28 / Friday, February 12, 1993 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Notice of Meeting 
Pursuant to Public Law 92—463, 
notice is hereby given of a meeting of 
the Recombinant DNA Advisory 
Committee on March 1-2, 1993. The 
meeting will be held at the National 
Institutes of Health, Building 31C, 
Conference Room 6. 9000 Rockville 
Pike, Bethesda, Maryland 20892, 
starting at approximately 9 a.m. on 
March 1, 1993, to adjournment at 
approximately 5 p.m. on March 2, 1993. 
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): 
Proposed Major Actions to the NIH 
Guidelines; 
Additions to Appendix D of the NIH 
Guidelines regarding ten (10) Human 
Gene Therapy/Gene Transfer 
Protocols; 
Discussion regarding the Human Gene 
Therapy Protocol Materials submitted 
to the Food and Drug Administration 
for Approval on a Compassionate Plea 
Basis; 
Amendment to the Points to Consider in 
the Design and Submission of 
Protocols for the Transfer of 
Recombinant DNA into the Genome of 
Human Subjects Regarding the Use of 
Compassionate Plea; 
Amendment to the Points to Consider 
Regarding the Separation of the Gene 
Marking Informed Consent Document 
from the Therapeutic Informed 
Consent Document; 
Amendment to the Points to Consider 
Regarding Safety of Delivery/ 
Expression Systems and Review 
Report on Murine Replication- 
Competent Retrovirus Assays; 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. VVivel, Director, Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892, Phone (301) 496-9838. FAX 
(301) 496-9839, will provide materials 
to be discussed at this meeting, roster of 
committee members, and substantive 
program information. Individuals who 
plan to attend and need special 
assistance, such as sign language 
interpretation or other reasonable 
accommodations, should contact Dr. 
Wivel in advance of the meeting. A 
summary of the meeting will be 
available at a later date. 
OMB’8 “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 of 
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: February 8. 1993. 
Susan K. Feldman, 
Committee Management Officer. NIH. 
(FR Doc 93-3434 Filed 2-11-93; 8:45 ami 
BJUJNO CODE 4140-01 -M 
Recombinant DNA Research; 
Proposed Actions Under the 
Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
ACTION: Notice of proposed actions 
under the NIH 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 (51 FR 
16958). 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 March 1-2, 1993. 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. 
OATES: Comments received by February 
22, 1993, will be reproduced and 
distributed to the RAC for consideration 
at its March 1-2, 1993, meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
Building 31, room 4B11, 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 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 
Therapy Protocol/Drs. Cassileth and 
Podack. 
In a letter dated December 22, 1992, 
Drs. Peter A. Cassileth and Eckhard 
Podack, University of Miami, Miami, 
Florida, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Phase I Study of Transfected 
Cancer Cells Expressing the Interleukin- 
2 Gene Product in Limited Stage Small- 
Cell Lung Cancer. 
n. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Bank. 
In a letter dated December 18, 1992, 
Dr. Arthur Bank, Columbia University, 
New York, New York, submitted a 
human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Phase I Study of 
Gene Therapy for Breast Cancer. 
IH. Addition to Appendix D of the 
NIH Guidelines Regarding a Human 
Gene Therapy Protocol/Drs. Wilmott, 
Whitsett, Trapnell. 
In a letter dated December 23, 1992, 
Drs. Robert W Wilmott and Jeffrey 
Whitsett of Children’s Hospital Medical 
Center, Cincinnati, Ohio, and Dr. Bruce 
Trapnell of Genetic Therapy, Inc., in 
Gaithersburg, Maryland, indicated the 
intention to submit a human gene 
Recombinant DNA Research, Volume 17 
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