C702 
Federal Register / Vol. 59, No. 29 / Friday, February 11, 1994 / 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 March 3—4, 1994. The 
meeting will be held at the National 
Institutes of Health, Building 3lC, 6th 
Floor, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20892, starting at approximately 9 a.m. 
on March 3, 1994, to adjournment at 
approximately 5 p.m. on March 4, 1994. 
The meeting will be open to the pubic 
to discuss Proposed Actions under the 
NIH Guidelines for Research involving 
Recombinant DNA Molecules (51 FR 
16958) and other matters to be 
considered by the Committee. The 
proposed Actions to be discussed will 
follow this notice of meeting. 
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 
20902, 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. Individuals who 
plan to attend and need special 
assistance, such as sign language 
interpretation or other reasonable 
accommodations, should contact Dr. 
Wivel in advance of the meeting. A^ 
summeiry 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 os 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: February 7. 1994. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
(FR Doc. 94-3179 Filed 2-10-94; 8:45 ami 
BH-UNQ CODE 4140-01-M 
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 (51 FR 
16958). 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 March 3-4, 1994. 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 February 
24, 1994, will be reproduced and 
distributed to the RAC for consideration 
at its March 3—4, 1994, meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
Building 31. room 4Bll, 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 4Bll, 
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 
Transfer Protocol/Drs. Hersh, 
Akporiaye, Harris, Stopeck, Unger, and 
Wameke 
On December 23, 1993, Dr. Evan 
Hersh of the Arizona Cancer Center and 
Drs. Akporiaye, Harris. Stopeck. Unger, 
and Wameke of the University of 
Arizona, Tucson, Arizona (co-sponsored 
by Vical, San Diego, California), 
submitted a human gene transfer 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: Phase I Study of Immunotherapy of 
Malignant Melanoma by Direct Gene 
Transfer. 
II. Addition to Appendix D of the NIH 
Guidelines Regaling a Human Gene 
Transfer Protocol/Dr. Walker 
On January 4, 1994, Dr. Robert Walker 
of the National Institutes of Health, 
Bethesda, Maryland (co-sponsored by 
Cell Genesys, Foster City, California), 
submitted a human gene transfer 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: A Phase I/II Pilot Study of the Safety 
of the Adoptive Transfer of Syngeneic 
Gene-Modified Cytotoxic T- 
Lymphocytes in HIV-Infected Identical 
Twins. 
III. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Rosenblatt and 
Seeger 
On January 5, 1994, Drs. Joseph 
Rosenblatt of the University of 
California, Los Angeles. California, and 
Robert Seeger of the Childrens Hospital, 
Los Angeles, California, submitted a 
human gene transfer protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is; A Phase I Study 
of Immunization with Gamma Interferon 
Transduced Neuroblastoma Cells. 
IV. Addition to Appendix D of the NIH 
Guideline Regarding a Human Gene 
Transfer Protocol/Dr. Brigham 
On January 6, 1994, Dr. Kenneth 
Brigham of Vanderbilt University, 
Nashville, Tennessee, submitted a 
human gene transfer protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Expression of an 
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Recombinant DNA Research, Volume 19 
