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Federal Register / Vol. 59, No. 215 / Tuesday, November 8, 1994 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Notice of Meeting 
Pursuant to Public Law 92-463, 
notice is hereby given of a meeting of 
the Recombinant DNA Advisory 
Committee on December 1-2, 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 on December 1, 1994, at 
approximately 9 a.m., and will recess at 
approximately 6 p.m. The meeting will 
reconvene on December 2, 1994, at 
approximately 8:30 a.m. and will 
adjourn at approximately 5 p.m. The 
meeting will be open to the public to 
discuss Proposed Actions under the N1H 
Guidelines for Research Involving 
Recombinant DNA Molecules (59 FR 
34496) 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, Suite 
323, National Institutes of Health, 6006 
Executive Boulevard, MSC 7052, 
Bethesda, Maryland 20892-7052, 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 26. 199-t. 
Susan K. Feldman, 
Committee Management Officer. NIH. 
(FR Doc. 94-27574 Filed 11-7-94; 8:45 ami 
BILLING COOC 4141-01-P-M 
Recombinant DNA Research: 
Proposed Actions Under the 
Guidelines 
AGENCY: National Institutes of Health 
(NIH), PHS, DHHS. 
ACTION: Notice of Proposed Actions 
Under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(59 FR 34496). 
SUMMARY: This notice sets forth 
proposed actions to be taken under the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules (59 FR 
34496). Interested parties are invited to 
submit comments concerning these 
proposals. These proposals will be 
considered by the Recombinant DNA 
Advisory Committee at its meeting on 
December 1-2, 1994. After 
consideration of these proposals and 
comments by the Recombinant DNA 
Advisory Committee, the Director of the 
National Institutes of Health will issue 
decisions in accordance with the NIH 
Guidelines. 
DATES: Comments received by 
November 22, 1994, will be reproduced 
and distributed to the Recombinant 
DNA Advisory Committee for 
consideration at its December 1-2, 1994, 
meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, Suite 
323, 6006 Executive Boulevard, MSC 
7052, Bethesda, Maryland 20892-7052, 
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, Suite 323, 6006 Executive 
Boulevard, MSC 7052, Bethesda, 
Maryland 20892-7052, Phone 301-496- 
9839, FAX to 301-496-9839. 
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. Venook and 
Warren 
In a letter dated October 3, 1994, Drs. 
Alan Venook and Robert Warren of the 
University of California, San Francisco, 
San Francisco, California, submitted a 
human gene transfer protocol entitled: 
Gene Therapy of Primary and Metastatic 
Malignant Tumors of the Liver Using 
ACN53 Via Hepatic Artery Infusion: A 
Phase I Study to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Gluckman 
In a letter dated October 6, 1994, Dr. 
Jack Gluckman of the University of 
Cincinnati Medical Center, Cincinnati, 
Ohio, submitted a human gene transfer 
protocol entitled: Intratumoral Injection 
of Herpes Simplex Thymidine Kinase 
Vector Producer Cells (PA31 7/ 
Gl TklSvNa.7) and Intravenous 
Ganciclovir for the Treatment of Locally 
Recurrent or Persistent Head and Neck 
Cancer to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
HI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Hersh, et. al. 
In a letter dated September 16, 1994, 
Drs. Evan Hersh, Emmanuel Akporiaye, 
David Harris, Alison Stopeck, Evan 
Unger, James Wameke, of the Arizona 
Cancer Center, Tucson, Arizona, 
submitted a human gene transfer 
protocol entitled: Phase I Trial of 
Interleukin-2 Plasmid DNA/DMRIE/ 
DOPE Lipid Complex as ah 
Immunotherapeutic Agent in Solid 
Malignant Tumors or Lymphomas by 
Direct Gene Transfer to the 
Recombinant DNA Advisory Committee 
for formal review and approval. 
Recombinant DNA Research, Volume 20 
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