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Federal Register / Vol. 50, No. GO / Thursday, March 28, 1985 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Pub. L. 92-4G3, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health, 
Building 31C, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20205, on May 3, 1985, 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 Group on Release 
into the Environment; 
Report of the Working Group on Human 
Gene Therapy; 
Proposed coordinated framework for 
regulation of biotechnology; 
Proposed working group on biological 
weapons; 
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, 
substantive program information. A 
summary of the meeting will be 
available at a later date. 
Dated: March 8, 1985. 
Betty ). Beveridge, 
Committee Management Officer. Niff. 
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 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 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, NTH 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. 
[FR Doc. 85-7063 Filed 3-27-85; 8:45 am) 
BILLING CODE 4140-01-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 
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 May 3, 1985, 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 
April 29. 1985. 
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 April 26, 1985, will 
be reproduced and distributed to the 
RAC for consideration at its May 3, 
1985, 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 Points to Consider for 
Environmental Testing of 
Microorganisms 
Deliberate release into the 
environment of any organism containing 
recambinant DNA. except certain plants 
as described in Appendix L, falls under 
Section III— A of the NIH Guidelines. 
Experiments in this category cannot be 
initiated without submission of relevant 
information on the proposed 
experiments to NIH, review by the RAC 
after publication for public comment, 
and specific approval by NIH. 
The RAC Working Group on Release 
Into the Environment has prepared draft 
submission guidelines for individuals 
preparing proposals involving testing in 
the environment of microoganisms 
derived by recombinant DNA 
techniques. The proposed guidance 
follows: 
Points To Consider for Submissions 
Involving Testing in the Environment of 
Microorganisms Derived by 
Recombinant DNA Techniques 
Experiments in this category require 
specific review by the Recombinant 
DNA Advisory Committee (RAC) and 
approvals by the National Institutes of 
Health (NIH) and the Institutional 
Biosafety Committee (IBC) before 
initiation. The IBC is expected to make 
an independent evaluation although this 
evaluation need not occur before 
consideration of an experiment by the 
RAC. Relevant information on the 
proposed experiments should be 
submitted to the Office of Recombinant 
DNA Activities (ORDA). The objective 
of this review procedure is to evaluate 
the potential environmental effects of 
testing of microorganisms that have 
been modified by recombinant DNA 
techniques. 
These following points to consider 
have been developed by the RAC 
Working Group on Release into the 
Environment as a suggested list for 
scientists preparing proposals on 
environmental testing of 
microorganisms, including viruses, that 
have been modified using recombinant 
DNA techniques. The review of 
proposals for environmental testing of 
modified organisms is being done on a 
case-by-case basis because the range of 
possible organisms, applications, and 
environments indicate that no standard 
set of procedures is likely to be 
appropriate in all circumstances. 
However, some common considerations 
allow the construction of points to 
consider such as those below. 
Information on all these points will not 
be necessary in all cases but will 
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