37198 Federal Register 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant UNm 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, 
Wilson Hall, Duilding 1, 9000 Rockville 
Pike, Dcthesda, Maryland 20205, on 
September 19, 1983, from 9:00 a.m. to 
recess at approximately 5:00 p.m. This 
meeting will be open to the public from 
9:00 a.m. To approximately 4:00 p.m. to 
discuss: 
Report of Working Croup on President's 
Commission's report on social and ethical 
issues of genetic engineering with humans: 
Containment for oncogenes and retroviruses: 
Amendment of Guidelines: 
Proposed exemption for organisms that 
exchange genetic information; and 
Other matter requiring necessary action by 
the Committee. 
Attendance by the public will be 
limited to space available. 
In accordance with provisions set 
forth in Section 552b(c)(4), Title 5. U.S. 
Code and Section 10(d) of Pub. L 92-463, 
the meeting will be closed to the public 
for approximately one hour for the 
review, discussion, and evaluation of 
proposal(s) from a commercial 
concern(s) for field testing of 
recombinant organisms. It is anticipated 
that this will occur from approximately 
4:00 p.m. until adjournment. The 
proposal(s) and the discussion could 
reveal confidential trade secrets or 
commercial property such as patentable 
material. 
Dr. William J. Cartland, Jr., Executive 
Secretary, Recombinant DNA Advisory 
Committee, National Institutes of 
Health. Duilding 31, Room 3D10, 
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. 
Note. — OMD's "Mandatory Information 
Requirements for Federal Assistant Program 
Annoucemcnts" (45 FR 39592) requires a 
statement concerning the official government 
programs contained in the Catalogue of 
Federal Domestic Assistance. Normally NIH 
lists in its announcements the number and 
title of affected individual programs for the 
guidance of the public. Decause the guidance 
in this notice covers not only virtually every 
Nil I 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 
/ Vol. 48, No. 159 / Tuesday, August 16. 1983 / Notices 
require several additional pages. In addition. 
Nllt 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 lollow the Nltl Guidelines. In lieu of 
individual program listing. Nllt invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalogue of Federal 
Domestic Assistance are affected. 
Dated: August 4 . 1983. 
Betty J. Beveridge, 
Committee Management Officer. National 
Institutes of Health. 
|FR Doc. S3-22331 Filed S-1S-S3: MS am| 
BIUJHO CODE 4MO-01-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS, HHS. 
action: Notice of proposed actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth 
proposes 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 September 19, 1983, the 
Director of the National Institute of 
Allergy and Infectious Diseases will 
issue decisions on these proposals in 
accord with the Guidelines. 
DATE: Comments must be received by 
September 15. 1983. 
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. 
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. Report of Working Group of Ethical 
and Social Issues 
At its April 11. 1983 meeting, the 
Recombinant DNA Advisory Committee 
(RAC) endorsed a proposal to form a 
working group to comment and report to 
RAC on the “Report on the Social and 
Ethical Issue of Genetic Engineering 
with Human Beings," issued by the 
President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research. 
The President's Commission began its 
study in September 1980, in response to 
a request of the President's Science 
Advisor. Concern had been expressed 
earlier that year by the Nation's three 
major religious associations that no 
governmental body was "exercising 
adequate oversight or control, nor 
addressing the fundamental ethical 
questions in a major way." The 
Commission's report, issued in 
November 1982, concluded that 
continuing oversight of the Held is 
desirable, and suggested that one 
possible mechanism could be revising 
the responsibilities of the RAC. 
The RAC Working Group for 
Development of Response to President's 
Commission's Report on Ethical and 
Social Issues met at NIH on June 24. 
1983, and prepared a proposal for 
consideration by the full RAC on 
September 19, 1983. The Working Group 
requested that the document be 
published for comment. 
Proposal of RAC Working Group for 
Development of Response to President's 
Commission's Report on Ethical and Social 
Issues, June 24, 1983 
The Working Croup agrees that there is a 
need for ongoing consideration of the ethical 
and social implications of the application of 
genetic technology to humans. Within this 
context. RAC should be prepared to consider 
social and ethical issues related to the 
applications of recombinant DNA 
lechologies. For specific cases which come 
before the committee, RAC should consider 
explicitly issues such as those raised in the 
"Splicing Life" report of the President's 
Commission for the Study of Ethical Problems 
in Medicine and Biomedical and Behavioral 
Research. We. therefore, recommend that: 
(1) The membership of the RAC be 
modified to Include adequate representation 
to deal credibly with these issues. 
(2) Procedures should be developed for the 
coordinate consideration of experiments 
involving the use of recombinant DNA 
technology in humans by Institutional Review 
Boards, the Office of Protection from 
Research Risks, the Food and Drug 
Administration, Institutional Biosafety 
Committees, the Office of Recombinant DNA 
Activities, and the Recombinant DNA 
Advisory Committee. 
(3) The NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
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