79386 
Federal Register / Vol. 45, No. 231 / Friday, November 28, 1980 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Public Law 92-463, notice 
is hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health, 
Conference Room 10, Building 31C, 9000 
Rockville Pike, Bethesda, Maryland 
20205, on January 8, 1981, from 9:00 a.m. 
to recess at approximately 6:00 p.m., 
and, if necessary, on January 9, 1981, 
from 8:30 a.m. to 5:00 p.m. This meeting 
will be open to the public on January 8 
from 9:00 a.m. to approximately 3:00 
p.m., and on January 9 from 8:30 a.m. to 
adjournment to discuss: 
Amendment of Guidelines 
Procedures for review of minor modifications 
of large-scale recombinant DNA 
experiments 
Exemptions for organisms that exchange 
genetic information 
E. coli K-12 host-vector systems 
Host-vector systems other than E. coli K-12 
NIH risk-assessment plan 
Review of protocols for required containment 
levels 
Review of meeting of Institutional Biosafety 
Committee chairmen 
Review of proposed evaluation of 
Institutional Biosafety Committees 
Other matters requiring necessary action by 
the Conunittee 
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 P.L. 92-463, 
the meeting will be closed to the public 
for approximately three hours for the 
review, discussion and evaluation of 
proposal(s) from a commercial 
concem(s) for scale-up of recombinant 
DNA experiments. It is anticipated that 
this will occur on January 8, from 
approximately 3:00 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. Gartland, Jr., Executive 
Secretary, Recombinant DNA Advisory 
Committee, National Institutes of 
Health, Building 31, Room 4A52, 
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. — 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, 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. 
NIH programs are not covered by OMB 
Circular A-95 because they fit the description 
of "programs not considered appropriate” in 
Section 8(b)(4) and (5) of that Circular. 
Dated: November 20, 1980. 
Suzanne L. Fremeau, 
Committee Management Officer, National 
Institutes of Health. 
[FR Doc. 80-37013 Filed 11-28-80: 8:45 am] 
BILUNQ CODE 4110-08-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS,DHHS. 
ACTION: Notice of 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 
January 8-9, 1981 meeting, 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 
December 29, 1980. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office of Recdmbinant 
DNA Activities, Building 31, RoOm 4A52, 
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 or 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 changes and 
amendments under the Guidelines for 
Research Involving Recombinant DNA 
Molecules, as well as actions under 
these Guidelines. 
1. Request to Include Streptococcus 
Faecalis and Streptococcus Sanguis in 
Appendix A. 
Dr. Donald Clewell of the University 
of Michigan has requested that 
Streptococcus faecalis and 
Streptococcus sanguis be included in a 
sublist of Appendix A of the Guidelines 
on the basis that they exchange genetic 
information by l^nown physiological 
processes. Dr. Clewell has provided 
information on these species in a letter 
to ORDA. 
2. Proposed Containment for 
Experiments Involving Non-Pathogens. 
Dr. Winston Brill, RAC member, has 
proposed that the Guidelines be 
amended to permit recombinant DNA 
experiments involving non-pathogenic 
prokaryotes and lower eukaryotes under 
Pi containment conditions. 
A. A new Section, III-0-2, would be 
added to the Guidelines, as follows: 
“HI-O-2. Experiments Involving Non- 
Pathogenic Prokaryotes and Lower 
Eukaryotes. Recombinant DNA 
experiments involving prokaryotes and 
lower eukaryotes, nonpathogenic [2AJ 
for man, animals, or plants, can be 
conducted under PI containment. 
B. A new paragraph would be added 
just before Section III-O begins, as 
follows: 
"When the reader finds that the 
containment level given for the same 
experiment is different in two different 
sections within Part III, he may choose 
which of the two levels he wishes to use 
for the experiment." 
C. The second paragraph of Section 
III-B-3 would be deleted. Revised 
Section III-B-3 would read as follows: 
"III-B-3. Non-HVl Systems. 
Containment levels for other classes of 
experiments involving non-HVl systems 
may be approved by the Director, NIH 
(See Sections IV-E-l-b-(l)-(b), IV-E-1- 
b-(2)-(c), and IV-E-l-b-(3)-(b)). 
D. Section IV-E-l-b-2-(f) would be 
deleted. This Section currently reads as 
follows: 
"IV-E-l-b-(2)-(f). Assigning 
containment levels for experiments in 
whicji both donor and recipient are non- 
[24] 
