59612 
Federal Register / VoL 58. No.. 215 / Tuesday, November 9, 1993 / 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 December 2-3, 1993. The 
meeting will be held at the National 
Institutes of Health, Building 31C, 6th 
Floor, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20892, starting at approximately 9 a.m. 
on December 2, 1993, to adjournment at 
approximately 5 p.m. on December 3, 
1993. The meeting will be open to the 
public 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. 
Dr. Nelson A. Wivel, Director, Officer 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892, 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 
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: October 29, 1993. 
Susan K. Feldman, 
Committee Management Officer. NIH. 
(FR Doc. 93-27571 Filed 11-8-93; 8:45 am) 
BiLUNQ CODE 4140-Ot-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 December 2-3, 1993. 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 
November 22, 1993, will be reproduced 
and distributed to the RAC for 
consideration at its December 2-3, 1993, 
meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to JQc. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
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 
Transfer Protocol/Dr. Chang 
On October 6, 1993, Dr. Alfred E. 
Chang of the University of Michigan 
Medical Center, Ann Arbor, Michigan, 
submitted a human gene transfer 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: Adoptive Immunotherapy of 
Melanoma with Activated Lymph Node 
Cells Primed In Vivo with Autologous 
Tumor Cells Transduced with the IL—4 
Gene. 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Haubrich 
On October 6, 1993, Dr. Richard 
Haubrich of the University of California 
at San Diego Treatment Center, San 
Diego, California (sponsored by Viagene, 
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: An Open Label, 
Phase I/H Clinical Trial to Evaluate the 
Safety and Biological Activity of HTV- 
IT(V) (HIV-1 II Benv/rev-Retroviral 
Vector) in HTV— 1-Infected Subjects. 
EQ. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/D rs. Liu and Young 
On October 7, 1993, Drs. Johnson M. 
Liu and Neal S. Young of the National 
Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Retroviral Medicated Gene 
Transfer of the Fanconi Anemia 
Complementation Group C Gene to 
Hematopoietic Progenitors of Group C 
Patients. 
TV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Oldfield and 
Ram 
On October 1, 1993, Drs. Edward H. 
Oldfield and Zvi Ram of the National 
Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Intrathecal Gene Therapy for 
the Treatment of Leptomeningeal 
Carcinomatosis. 
[506] 
Recombinant DNA Research, Volume 18 
