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Federal Register / Vol. 57, No. 88 / Wednesday, May 8, 1992 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
tlonal 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 June 1-2, 1992. The meeting will be 
held at the National Institutes of Health 
(N1H), building 31C, Conference Room 6. 
9000 Rockville Pike, Bethesda, Maryland 
20892, starting at approximately 9 a.m. 
on June 1 1992, to adjournment at 
approximately 5 p.m. on June 2, 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; 
Eleven additions to appendix D of the 
NIH Guidelines Regarding Human Gene 
Therapy/Gene Transfer Protocols: 
An addition to section IV-C-2 of the 
NIH Guidelines Regarding Conflicts of 
Interest; 
Addition to the Points to Consider in 
the Design and Submission of Protocols 
'or the Transfer of Recombinant DNA 
to the Genome of Human Subjects 
.igarding Submission Requirements for 
Human Gene Transfer/Gene Therapy 
Protocols; 
Other Matters To Be Considered by 
! the Committee. 
Attendance by the public will be 
' limited to space available. Members of 
i 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) 
498-9839, 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’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 
overs 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: April 29, 1992. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
(FR Doc. 92-10663 Filed 5-5-92; 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 June 
1-2, 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. 
OATES: Comments received by May 18, 
1992, will be reproduced and distributed 
to the RAC for consideration at its June 
1-2, 1992, 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, 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 Protocol/Dr. Brenner 
In a letter dated January 21, 1992, Dr. 
Malcolm Brenner of the St. Jude 
Children’s Research Hospital Memphis, 
Tennessee, 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: 
“Phase I Study of Cytokine-Gene 
Modified Autologous Neuroblastoma 
Cells for Treatment of Relapsed/ 
Refractory Neuroblastoma.” 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Oldfield 
In a letter dated February 14, 1992, Dr. 
Edward H. Oldfield of the National 
Institutes of Health, Bethesda^ 
Maryland, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: “Gene Therapy for the 
Treatment of Brain Tumors Using Intra- 
Tumoral Transduction with the 
Thymidine Kinase Gene and 
Intravenous Ganciclovir." 
III. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Bank 
In a letter dated April 14, 1992, Dr. 
Arthur Bank of 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: "Use of Human MDR 
Gene in Patients with Advanced 
Cancer." 
IV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Smith 
In a letter dated April 9, 1992, Dr. Clay 
Smith of Memorial Sloan Kettering 
Cancer Center, New York, New York, 
submitted a human gene therapy 
. protocol to the Recombinant DNA 
Advisory Committee for formal review 
Recombinant DNA Research, Volume 15 
[661] 
