233-1-3 Federal Register / 
CEPAHTMENT OF HEALTH AND 
HU^!AN SERVICES 
National Institutes of Health 
Human Gene Therapy Subcommittee 
End the Recombinant DNA Advisory 
Committee; Meetings 
Pursuant to Public Law 92— i63. notice 
is hereby given of a meeting of the 
Human Gene Therapy Subcommittee (a 
subcommittee of die Recombinant DNA 
Advisory Committee] on July 30. 1S90, 
followed by a meeting of the 
Recombinant DNA Advisory’ Committee 
on July 31, 1990. Both meetings will be 
held at the National Institutes of Health 
(NTHJ, Building 3lC, Conference Room 0. 
fiOC-0 Rccicville Pike, Bethesda, Maryland 
2G3S2, starting at approximately 9 a.m. 
to adjournment at approximately 5 pm. 
These meetings will be open to the 
public to discuss the following proposed 
actions imder the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules: 
Proposed Major Actions to the NTH 
Guidallnes 
Three Additions to appendix D of the 
NTH Guidelines Regarding Human Gene 
Therapy Protocols: 
Three Additions to Appendix D of the 
NTH Guidelines Regarding Human Gene 
Transfer Clinical Protocols; 
Addition to the Points to Consider in 
the Design and Submission of Protocols 
for the Transfer of Recombinant DNA 
into the Genome of Human Subjects to 
Expedite Minor Modification on 
Approved Protocols; and 
Other Matters To Ee Considered by tha 
Committees 
Attendance by the public will ba 
limited to space available. Members of 
the public wishing to speak at these 
meetings may be givan such opportunity 
et the discretion of the Chair. 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities. 
National Institutes of Health, Building 
31. Room 4311, Bethesda, Maryland 
2G392, telephone (301) 496-9833, fax 
(3G1 j 498-9839, will provide materials to 
be discussed at these meetings, rosters 
cf committee members, and substantive 
program information. A summary of the 
meetings will be available at a later 
date. 
GME's “Mandatory Information 
Req’airements for Federal Assistance 
Program Announcements” (45 FK 39592, 
June 11. 1950) req’jires a statement 
concerning the official government 
programs contained in the Catalog of 
Federal Domestic A.ssistance. Normally 
NUi lists in its announcements tha 
Vol. 65. No. 124 / Wednesday, J’une 
number and title of affected indi’/idual 
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 esrtain that every Federal 
program ’A’culd be included as many 
Federal agencies, as Vi/ell as private 
erganiaations. both national and 
international, have elected to follow the 
NIH Guidelines. In lie’j of the individual 
program listing, NTH invites readers to 
direct questions to the information 
address above about whether indi'/idual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: June 31. 1990. 
Betty ]. Baveridga. 
Conimittae Management Officer, NIH. 
[FR Doc. 90-14842 Filed 9-29-90; 8:45 am] 
eraJtM: cocs 414 q-oi-m 
DEPARTrdE.NT CF HEALTH AND 
HUMAN SE.RV5CSS 
Recombinant DNA Research; 
Fropcced Acilona Under Guidelines 
A5ENCY; National Institutes of Health, 
PKS, DKKS. 
ACttOti: Notice of Proposed Actions 
Under the NTH Guidelines for Research 
Invob/ing Recombinant DNA Molecules. 
summary: Thia notice sets forth 
proposed actions to be taken under the 
National Institutes of Health (NEHJ 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning this proposal. 
These proposals will be considered by 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on July 
31. 1990. After consideration of these 
proposals and comments by the RAC, 
the D’lrector of the National Institutes of 
Health will issue decisions in 
accordance with the NIK Guidelines. 
CATE3 Ccmmsnts received by July 23, 
1990, will be reproduced and distributed 
to the RAC for consideration at its Judy 
31. 1990, meeting. 
ACORESm Written comments and 
rcccmmsndations should be submitted 
to Dr. Nelson A. WiveL Director, Office 
of Recombinant DNA Activities, 
Building 31. room 4Bll, National 
Institutes of Health, Bethesda, Maryland 
2CS92, or sent by fax to 301-493-9839. 
I 
t 
i 
} 
27, ISO / Notices J 
Adi comments received in timely 
response to this notice will be 
considereiand will be available for 
public inspection in the above cTfice on 
weekdays between the hours of 8:30 
a.m. and 5 p.m. 
FCn 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 2C592, (301) 496-9338. 
SUPFLEMErJTARY INFORMATION: The NIH 
will consider the following actions 
under the IHH Guidelines for Research 
Involving Recombinant DNA Molecules: 
L Ad-diticn to AppendLx D of the NIH 
Guidelines Regarding a Human Cene 
Therapy Frolocol/Drs. Blaese, 
Anderson, Culver 
A. continued discussion of the human 
gene therapy protocol by Drs..R. Michael 
Blaese, W. French Andersom and 
Kenneth VI. Culver of the National 
Institutes of Health which is entitled, 
“Treatment of Severs Combined 
Iramunodaficiency Disease (SCID) Due 
to Adenosine Deaminase AJDA 
Deficiency with Autologous 
Lymphocytes Transduced with a Human 
ADA Gene." During tha Human Gene 
Therapy Subcommittee on June 1. 
conditional approval was given. The 
Human Gene Therapy Subcommittae 
will meet on July 30 to review mere 
documentation and vote of formal 
recommendation for approval to the 
Recombinant DNA Ad’/iscry Committee. 
If recommendation for approval is given, 
the Recombinant DNA Advisory 
Committee will consider this protocol on 
July 31. 
E. Addilicn to Appendix D of tha NTH 
Guidelines Rsgar^g a Human Gena 
Therapy Protccol/Dr. Rosenberg 
In a letter dated June 13, ItJSO, Dr. 
Steven A Rosenberg of the National 
Institutes of Health indicated his 
intention to submit a human gene 
therapy prctccol to the H’uman Gena 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee. 
The title of this protocol is “Gene 
Therapy of Patients with A.dvanced 
Cancer using Tumor Infiltrating 
Lymphocytes Transduced with the Gene 
Coding for Tumor Necrosis Factor.” 
m. Addition to AppendLx D cf tha a 
G uidelines Regarding a Human Gene 
Therapy Prolocol/Drs. Freeman 
Abraham, Dipersio 
Drs. Scott A. Freeman, Georgs N. 
Abraham, and John Dipersio of the 
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Recombinant DNA Research, Volume 14 
