19776 
Federal Register / Vol. 56, No. 82 / Monday, April 29, 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 May 30-31, 1991. The meeting will be 
held at the Embassy Suites Hotel, 4300 
Military Road, NW., Washington, DC 
20015, in the Chevy Chase Rooms 1 and 
2, starting at approximately 9 a.m. on 
May 30 to adjournment at 
approximately 3 p.m. on May 31. 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, May 7, 1986): 
Proposed Major Actions to the NIH 
Guidelines: 
Five additions to appendix D of the 
NIH Guidelines Regarding Human Gene 
Transfer Protocols; 
Amend Section I-C-2 and delete 
Section III-A-2 in its entirety of the NIH 
Guidelines regarding deliberate release 
into the environment of any organism 
containing recombinant DNA, except 
certain plants as described in Appendix 
L. 
Amend the Points to Consider in the 
Design and Submission of Protocols for 
the Transfer of Recombinant DNA into 
the Genome of Human Subjects: (1) To 
eliminate the review responsibilities of 
the Humm Gene Therapy Subcmnmittee 
from the approval process of human 
gene therapy protocols as described in 
the Introduction, Sections 4, 6, 7, 9, 10, 
12; (2) to totally transfer the review 
responsibilities of the Human Gene 
Therapy Subcommittee to the parent 
committee, the Recombinant DNA 
Advisory Committee, as described in the 
Introduction, Section 1 and 4; and (3) to 
have more explicit directives fOT animal 
model systems and cell culture studies 
in Section I-B-2. 
Amend Appendices B-l-B-1 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. 
Review the proposal for a registry of 
gene transfer patients entitled: "The 
Gene Transfer Patient and Provider 
Network (GENTRANET)". 
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, telephone (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 W'ill 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. Nonnally 
NIH lists in its aimouncements die 
number and title of affected individual 
programs for the guidance of the public. 
Because the guidance in this notice 
covers not only virtually every NM 
program but also essentially every 
Federal research program in which. IB^A 
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, NTH 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 ofFederal 
Domratic Assistance are affected. 
Dated: April 22, 1991. 
Betty ). Beveridge, 
Committee Management Officer, NIH. 
(FR Doc. 91-9999 Filed 4-26-91; 8:45 am] 
BnXINQ CODE 414(M>1-M 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Recombfinant 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, May 7. 1986). 
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 May 
30-31, 1991. After consideration of these 
proposals and comments by the RAC. 
the Director of the National Institutes of 
Health will issue decisions in 
accordance w'ith the NIH Guidelines. 
DATES: Comments received by May 20, 
1991, will be reproduced and distributed 
to the RAC for consideration at its May 
30-31, 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. 
FOn FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
fitnn the Office of Recombinant DNA 
Activities, Building 31, room 4B11, 
National Institutes of Health, Bethesda. 
Mmyland 20892, (301) 496-9836 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involvmg Recombinant DNA Molecules: 
I. Achfition to Appendix D of the “NIH 
Guidelines” Regarding a Human Gene 
Transfer Protocol/Dr.-Lotze 
In a letter dated September 13, 1990, 
Dr. Michael T. Lotze of the University of 
Pittsburgh School of Medicine indicated 
his intention to submit a human gene 
transfer protocol to the Human Gene 
Therapy Subcommittee and the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: 
“The Administration of Interleukin-2, 
Inte-leukin-4, and Tumor Infiltrating 
Lymphocytes to Patients with 
M^anoma." 
The protocol was reviewed during the 
Human Gene Therapy Subcommittee 
meeting on November 30, 1990, and 
forwarded to the Recombinant DNA 
Advisory Committee on February 4, 
1991. for their approval. The 
Recombinant DNA Advisory Committee 
deferred approval and sent the protocol 
back to the Human Gene Therapy 
Subcommittee for further deliberations 
on April 5, 1991. 
On April 5. 1991, the Human Gene 
Therapy Subcommittee gave provisional 
approval with the stipulation that more 
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Recombinant DNA Research, Volume 14 
