44098 
Federal Register / Vol. 58, No. 158 / Wednesday, August 18, 1993 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes ot 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 September 9-10, 1993. 
The meeting will be held at the National 
Institutes of Health, Shannon Building, 
Building 1, Wilson Hall, 3rd Floor, 9000 
Rockville Pike, Bethesda, Maryland 
20892, starting at approximately 9 a.m. 
on September 9, 1993, to adjournment at 
approximately 5 p.m. on September 10, 
1993. The meeting will be open to the 
public to discuss Proposed Actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(51 FR 16958) and other matters to be 
considered by the Committee. The 
Proposed Actions to be discussed will 
follow this notice of meeting. 
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) 496-9638, 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'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: August 3, 1993. 
Susan K. Feldman, 
Committee Management Officer, MIH. 
[FR Doc. 93-20063 Filed 8-17-93; 8:45 ami 
BILLING CODE 4UO-01-M 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
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 September 9-10, 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. 
DATES: Comments received by 
September 1, 1993, will be reproduced 
and distributed to the RAC for 
consideration at its September 9-10, 
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 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 Proloco L/Drs. Economou, 
Glaspy 
On July 12, 1993, Drs. James S. 
Economou and John Glaspy of the 
University of California, Los Angeles, 
California, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Genetically Engineered 
Autologous Tumor Vaccines Producing 
Interleukin-2 for the Treatment of 
Metastatic Melanoma. 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. O’Shaughnessy 
In a letter dated September 9, 1992, a 
letter was received indicating the 
intention of Dr. Joyce A. 
O’Shaughnessy, National Institutes of 
Health, Bethesda, Maryland, to submit a 
human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Retroviral 
Mediated Transfer of the Human Multi- 
Drug Resistance Gene (MDR-1) into 
Hematopoietic Stem Cells During 
Autologous Transplantation After 
Intensive Chemotherapy for Breast 
Cancer. 
During the December 3-4, 1992, 
Recombinant DNA Advisory Committee 
meeting, approval of the protocol was 
deferred until the investigators returned 
to the committee with the following: 
(1) Data demonstrating that human 
CD34(+) cells can be transduced in vitro 
with the actual vector that will be used 
for the human clinical protocol; 
(2) A description of the methods that 
will be used to monitor gene expression 
in bone marrow and tumor cells; and 
(3) A description of the endpoint for 
determining bone marrow recovery, i.e., 
comparison of gene amplification and 
the rate of polymorphonuclear 
leukocyte recovery following taxol 
administration. 
On July 14, 1993, Dr. Joyce 
O’Shaughnessy of the National 
Institutes of Health, Bethesda, 
Maryland, resubmitted a human gene 
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Recombinant DNA Research, Volume 18 
