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Federal Register / Vol. 57, No. 161 / Wednesday, August 19, 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 September 14-15, 1992. The meeting 
will be held at the Marriott Hotel of 
Bethesda, 5151 Pooks Hill Road, 
Bethesda, Maryland 20814, starting at 
approximately 9 a.m. on September 14, 
1992, to adjournment at approximately 5 
p.m. on September 15, 1992. 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 Nine Human Gene 
Therapy /Gene Transfer Protolcols, a 
new expression vector system derived 
from Semliki Forest Virus, and 
Introduction of a Gene Coding for 
Tetracycline Resistance into 
Porphyromonas gingivalis; 
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) 490-9838, 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 infonnation 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: August 11, 1992. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
[FR Doc. 92-19928 Filed 8-18-92; 8:45 am] 
BILLING CODE 4140-01-M 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
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. 
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 14-15, 1992. 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 August 
25, 1992, will be reproduced and 
distributed to the RAC for consideration 
at its September 14-15, 1992, meeting. 
ADDRESSES: 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, 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: 
l. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol /Dr. Bank 
In a letter dated May 14, 1992, Dr. 
Arthur Bank, Columbia University, New 
York, New York, indicated his intention 
to submit a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: Use of Human MDR Gene in Patients 
with Advanced Cancer. 
BL Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol /Dr. Roth 
In a letter dated March 19, 1992, Dr. 
Jack A. Roth, MD, Anderson Cancer 
Center, University of Texas, Houston, 
Texas, indicated his intention to submit 
a human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: Clinical Protocol for 
Modification of Oncogene and Tumor 
Suppressor Gene Expression in Non- 
Small Cell Lung Cancer (NSCLC). 
m. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Lotze 
In a letter dated May 1, 1992, Dr. 
Michael T. Lotze, University of 
Pittsburgh, Pittsburgh, Pennsylvania, 
indicated his intention to submit a 
human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: Gene Therapy of 
Cancer A Pilot Study of IL-4 Gene 
Modified Antitumor vaccines. 
IV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Deisseroth 
In a letter dated June 8, 1992, Dr. 
Albert D. Deisseroth, MD, Anderson 
Cancer Center, University of Texas, 
Houston, Texas, indicated his intention 
to submit a human gene transfer 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: Use of Retroviral Markers to Evaluate 
the Efficacy of Purging and to 
Discriminate Between Relapse which 
Arises from Systemic Disease 
Remaining after Preparative Therapy 
Recombinant DNA Research, Volume 16 
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