43686 Federal Register / Vol, 56, No. 170 / Tuesday, September 3, 1991 / 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 October 7-8, 1991. The meeting will 
be held at the National Institutes of 
Health (NIH), Building 31C, Conference 
Room 6, 9000 Rockville Pike, Bethesda, 
Maryland 20892, starting at 
approximately 9 a.m. on October 7 to 
adjournment at approximately 5 p.m. on 
October 8. The meeting will be open to 
the public to discuss the following 
proposed actions under the NIH 
Guidelines for Research Involving 
Recombinant DNA Molefcules (51 FR 
16958): 
Proposed Major Actions to the NIH 
Guidelines: 
Four additions to Appendix D of the 
NIH Guidelines Regarding Human Gene 
Transfer Protocols; 
. Amend Appendices B-I-B-l and B-I- 
B-2 of the NIH Guidelines to include 
only pathogenic genera and species of 
the bacterial order, Actinomycetales, in 
the current list of microorganisms. 
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 
20392, 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. 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 27, 1991. 
Jeanne N. Ketley, 
Acting Committee Management Officer, NIH. 
[FR Doc. 91-21057 Filed 8-30-91; 8:45 am] 
BILUNG 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 
October 7-8, 1991. 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 25, 1991, will be reproduced 
and distributed to the RAC for 
consideration at its October 7-8, 1991, 
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: 
I. Addition to Appendix D of the “NIH 
Guidelines” Regarding a Human Gene 
Therapy Protocol/Dr. Freeman 
: In a letter dated May 10, 1990, Dr. 
Scott M. Freeman of the University of 
Rochester School of Medicine indicated 
his intention to submit a human gene 
therapy protocol to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: "Gene Transfer for 
the Treatment of Chncer.” 
The protocol was reviewed during the 
Human Gene Therapy Subcommittee 
meeting on July 29-30, 1991. Provisional 
approval was given with the stipulation 
that the PA-1 ovarian cancer cell line be 
tested for potential pathogens as per 
FDA guidelines. Further, it was 
requested that there should be more 
preclinical studies on the MFG vector to 
assure that it does not contain 
replication competent retroviruses. 
The Human Gene Therapy 
Subcommittee forwarded the protocol to 
the Recombinant DNA Advisory 
Committee for consideration during the 
October 7-8, 1991, meeting. 
II. Additions to Appendix D of the "NIH 
Guidelines” Regarding Human Gene 
Therapy Protocols/Dr. Rosenberg 
In a letter dated June 6, 1991, Dr. 
Steven A. Rosenberg of the National 
Institutes of Health indicated his 
intention to submit two human gene 
therapy protocols to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. 
The first protocol is entitled: 
"Immunization of Cancer Patients Using 
Autologous Cancer Cells Modified by 
Insertion of the Gene for Tumor 
Necrosis Factor.” 
The second protocol is entitled: 
"Immunization of Cancer Patients Using 
Autologous Cancer Cells Modified by 
Insertion of the Gene for Interleukin-2." 
The protocol was reviewed during the 
Human Gene Therapy Subcommittee 
(HGTS) meeting on July 29-30, 1991. 
Provisional approval was granted with 
the following stipulations. Although the 
NIH Institutional Biosafety Committee 
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Recombinant DNA Research, Volume 15 
