Federal Register / Vol. 50, No. 14 / Tuesday. January 22, 1985 / Notices 
2941 
Guidelines proposed by the working 
group and published in the January 5. 
1984, Federal Register be accepted. 
This recommendation was accepted 
by the Director, NIAID. in a notice 
published in the April 25. 1984, Federal 
Register (49 FR 17844). However, 
concerns were raised about the intended 
scope of the new Section III— A — 4; e.g., 
would this language be construed to 
cover feeding of bacteria containing 
recombinant DNA or the administration 
of vaccines containing recombinant 
DNA to human subjects. On checking 
with members of the Working Croup on 
Social and Ethical Issues, the Director, 
NIAID, verified that it was their intent 
to include under Section III— A — 4 only 
experiments in which the intent is to 
modify stably the genome of cells of a 
human subject and not experiments 
involving feeding of bacteria containing 
recombinant DNA or the administration 
of vaccines containing recombinant 
DNA. The following clarifying footnote 
was. therefore, added to Section III— A — 4: 
Section III— A— 4 only covers those 
experiments in which the intent is to modify 
stably the genome of cells of a human 
subject. Other experiments involving 
recombinant DNA in human subjects such as 
feeding of bacteria containing recombinant 
UNA or the administration of vaccines 
containing recombinant DNA are not covered 
in Section III— A — 4 of the Guidelines. 
In addition, appropriate clarifying 
language was added to the new footnote 
concerning Section III— B— 4 — b. 
The RAC Working Group on Human 
Gene Therapy held its first meeting 
(open to the public) on October 12, 1984. 
At the October 29, 1984. RAC meeting, 
the Chair of the working group 
presented a progress report and a draft 
outline of the Points to Consider in the 
Design and Submission of Human 
Somatic-Cell Gene Therapy Protocols. 
At a second meeting (open to the public) 
held on november 16, 1984, the working 
group further refined the document that 
follows. The draft that emerged from the 
November 10 meeting was circulated to 
all members of the RAC and the working 
group for comments, and numerous 
suggested changes were incorporated 
into the document. 
The Working Group on Human Gene 
Therapy is comprised of three 
laboratory scientists, three clinicians, 
three ethicists, three lawyers, two 
specialists in public policy, and a 
representative of the public. The group 
is assisted by an executive secretary, 
three liaison members, and a consultant. 
The names and Institutional affiliations 
of these persons follow: 
Recombinant DNA Advisory Committee 
Working Croup on Human Conn 
Therapy 
Chair 
Wallers, LeRoy, Ph.D. 
Center for Bioethics, Kennedy 
Institute of Ethics, Georgetown 
University, Washington, D.C. 20057 
202-625-2386 
ANDERSON W. French, M.D. 
laboratory of Molecular Hematology, 
National Heart, Lung, 4 Blood 
Institute, National Institutes of 
Health, 10/7D18, Bethesda, 
Maryland 20205, 301 496-5844 
AREEN, Judity, J.D. 
Georgetown University Law Center. 
600 New Jersey Avenue, NW„ 
Washington, D.C. 20001, 202 624- 
8203 
CAPRON, Alexander, LLB. 
The Law Center, University of 
Southern California. Los Angeles. 
California 90089-0071, 213 743-6473 
CHILDRESS. James F„ Ph.D. 
Wilson Center, 1000 Jefferson Drive, 
SW., Washington, D.C. 20560. 202 
357-2279 
GOROVITZ, Samuel Ph.D. 
Department of Philosophy, University 
of Maryland, 1131 Skinner Hall, 
College Park. Maryland 20742, 301 
454-2851 
GOTTESMAN. Susan K.. Ph.D. 
laboratory of Molecular Biology, 
National Cancer Institute, 37/4B09, 
National Institutes of Health, 
Bethesda, Maryland 20205, 301 496- 
3524 
GROBSTEIN, Clifford, Ph.D. 
Department of Science, Technology, 4 
Public Affairs, Mail Code Q060, 
University of California, San Diego, 
La Jolla, California 92093, 619 452- 
3352 
MAHONEY, Maruice J.. M.D. 
Department of Human Genetics, Yale 
University, 333 Cedar Street. 305 
WWW, New Haven, Connecticut 
06510, 203 785-2661 
MITCHELL, Robert E., LLB. (Ex-officio) 
Attorney at Law, 13915 San Antonio 
Drive, Norwalk, California 90650, 
213 863-8736 
MOTULSKY. Arno G.. M.D. 
Department of Medicine, University of 
Washington, Seattle, Washington 
98195, 206 543-3593 
MURRAY. Robert F.. M.D. 
Division of Medical Genetics, Howard 
University, Box 75, 520 W Street, 
NW„ Washington. D.C. 20059, 202 
636-6382 
RICH, Robert F„ Ph.D. 
School of Urban 4 Public Affairs. 
Carnegie-Mellon University, 
Pittsburgh, Pennsylvania 15213, 412 
578-8783 
VARMUS. Harold. Ph.D. 
Department of Microbiology. 
University of California, San 
Francisco, California 94143, 4t5 666- 
2824 
WITHERBY, Anne R.. B.S. 
2 Commonwealth Avenue, Boston, 
Massachusetts 02118, 617 247-0123 
Executive Secretary 
GARTLAND. William J.. Jr.. Ph.D. 
Office of Recombinant DNA 
Activities, National Institute of 
Allergy 4 Infectious Diseases, 
National Institutes of Health, 
Bethesda, Maryland 20205 301 496- 
6051 
Consultant 
TEMIN, Howard M.. Ph.D. 
Department of Oncology, McArdle 
Laboratory for Cancer Research, 
University of Wisconsin, Madison, 
Wisconsin 53706, 608 202-1209 
Liaison Representatives 
McCarthy, Charles Ph.D. 
Office of Protections from Research 
Risks, Office of the Director, 
National Institutes of Health, 31/ 
4B09, Bethesda, Maryland 20205, 301 
496-7005 
MILLER, Henry, I., M.D. 
Office of Biologies, Food and Drug 
Administration, HFN-823, 8800 
Rockville Pike, Bethesda, Maryland 
20205, 301 443-4864 
HARMISON, Lowell, Ph.D. 
Office of Assistant Secretary for 
Health, Room 1395, 5600 Fishers 
l,ane, Rockville, Maryland 20857, 
301 443-2050 
LEE, Bonnie M. 
Health Assessment Policy Stuff, 
Office of Health Affairs,. Food 4 
Drug Administration, HFY-20, 560Q 
Fishers Lane, Rockville. Maryland 
20857, 301 433-1382 
Points to Consider in the Design and 
Submission of Human Somatic-Cell 
Gene Therapy Protocols 
The following “Points to Consider" 
document prepared by the RAC 
Working Group on Human Gene 
Therapy is now published for public 
comment and is being sent to all 
Institutional Review Boards (IRB) for 
comment. Comments received will be 
circulated to all RAC and working group 
members. The working group will then 
meet to review the public comments. 
The "Points to Consider” document and 
the public comments received will be 
considered at the next RAC meeting. 
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