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Federal Register / Vol. 49, No. 184 / Thursday, September 20, 1984 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Pub. L. 92-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health. 
Building 3lC, Conference Room 10, 9000 
Rockville Pike, Bethesda, Maryland 
20205, on October 29, 1984, from 9:00 
a.m. to adjournment at approximately 
5:00 p.m. This meeting will be open to 
the public to discuss: 
Report of the Working Croup on Release 
into the Environment: 
Report of the Working Group on Human 
Gene Therapy: 
Amendment of Guidelines; and 
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 the 
meeting may be given such opportunity 
at the discretion of the chair. 
Dr. William J. Gartland, Jr., Executive 
Secretary, Recombinant DNA Advisory 
Committee, National Institutes of 
Health. Building 31, Room 3B10, 
telephone (301) 496-6051, will provide 
materials to be discussed at the meeting, 
rosters of committee members, and 
substantive program information. 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) 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 forthe 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 to be not 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: September 12. 1964. 
Betty |. Beveridge, 
Committee Management Officer. NIH. 
|FR Doc. S4-Z4904 Filed 9-18-M. »:«S em| 
BILLING coot 41 40-01 -M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS, DHHS. 
action: Notice of Proposed Actions 
Under NTH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth 
proposed actions to be taken under the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
After consideration of these proposals 
and comments by the NIH Recombinant 
DNA Advisory Committee (RAC) at its 
meeting on October 29, 1984, the 
Director of the National Institutes of 
Health will issue decisions on these 
proposals in accord with the Guidelines. 
date: Comments must be received by 
October 22, 1984. 
address: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 3B10, 
National Institutes of Health, Bethesda, 
Maryland 20205. 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 5:00 p.m. Comments received 
by close of business October 24, 1984, 
will be reproduced and distributed to 
the RAC for consideration at its October 
29, 1984, meeting. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from Drs. Stanley Barban and Elizabeth 
Milewski, Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bethesda, Maryland 20205, (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following actions under the 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
I. Proposed Amendment of Section III— D 
of the Guidelines. 
In a letter dated August 21, 1984, Mr. 
C. Searle Wadley and Dr. John H. Keene 
of Abbott Laboratories, North Chicago, 
Illinois, propose that the following 
sentence be added to Section III— D of 
the Guidelines: 
Although these experiments are exempt, it 
is recommended that they be performed at 
the appropriate biosafety level for the host or 
recombinant organism (for biosafety levels 
see "Biosafety in Microbiological and 
Biomedical Laboratories"). 
In support of their proposal, Mr. 
Wadley and Dr. Keene state that it 
would be advisable to recommend that 
appropriate biosafety levels be 
considered for those recombinant 
experiments that are exempt from the 
Guidelines. 
II. Proposed Addition of Prohibited 
Experiments to the Guidelines. 
Mr. Jeremy Rifkin of the Foundation 
on Economic Trends, Washington, D.C., 
submitted the following letter, dated 
August 21, 1984, to NIH: 
I am formally requesting that the following 
item be placed on the agenda for the October 
29, 1984 meeting of the Recombinant DNA 
Advisory Committee of the National 
Institutes of Health. 
It has come to our attention that the 
National Institutes of Health and the National 
Science Foundation are helping to fund 
specific experiments by Dr. Ralph Brinster of 
the University of Pennsylvania in which 
human genes regulating growth hormone is 
being injected in to sheep and pig embryos 
with the express purpose of incorporating 
these human genes permanently into the germ 
line of these other mammalian species. These 
experiments are currently being conducted, in 
part, with the assistance and cooperation of 
the USDA at its agricultural experimental 
station at Beltsville. Maryland. 
If successful, these experiments would 
represent the second time in history that a 
segment of the genetic make-up of homo- 
sapiens has been permanently transferred 
into the genetic make-up of another species. 
The Brinster team has already successfully 
transferred the human growth hormone gene 
into the germ line of mice. Thus, a dramatic 
new technological threshold has been 
crossed, making it imperative that the Federal 
Government act immediately and 
expeditiously to establish a policy in regard 
to such experimentation. 
Therefore. I am proposing the following 
amendment to the NIH guidelines for 
recombinant DNA experimentation: 
The NIH prohibits any experimentation 
involving the transfer of a genetic trait from 
one mammalian species into the germ line of 
another unrelated mammalian species. 
"Unrelated" shall be defined as any two 
species that cannot male and produce one 
generation of offspring either in the wild or 
under pre-existing domestic breeding 
programs. 
This NIH guideline shall encompass all 
mammalian species, including homo-sapiens. 
Upon adoption of this guideline by the NIH. 
said agency shall immediately discontinue 
funding any current experimental research 
involving the transfer of genetric traits from 
one mammalian species into the germ line of 
another unrelated mammalian species and 
shall instruct all institutions receiving NIH 
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