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Federal Register / Vol. 45, No. 22 / Thursday, January 31, 1980 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
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, 
Wilson Hall, Building 1, Bethesda, 
Maryland 20205, on March 6, 1980, from 
9:00 a.m. to recess at approximately 6:00 
p.m. and on March 7, 1980, from 8:30 
a.m. to 5:00 p.m. This meeting will be 
open to the public on March 6 from 9:00 
a.m. to recess at approximately 6:00 
p.m., and on March 7, from 8:30 a.m. to 
3:00 p.m., to discuss: 
Amendment of Guidelines. 
Containment practices appropriate for 
large-scale production. 
Exceptions to prohibitions. 
Exemptions for organisms that exchange 
genetic information. 
Procedures for lowering characterized 
clones. 
Review of large-scale experiments. 
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. 
Other matters requiring necessary action 
by the Committee. 
Attendance by the public will be 
limited to space available. 
In accordance with the 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 
on March 7 from 3:00 p.m. to 5:00 p.m. 
for the review, discussion and 
evaluation of proposal(s) from a 
commercial concem(s) for scale-up of 
recombinant DNA experiments. The 
proposal(s) and the discussions 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. 
Dated: January 25, 1980. 
Suzanne L. Fremeau, 
Committee Management Officer, National 
Institutes of Health. 
[FR Doc. 80-3040 Filed 1-30-80. 8:45 am) 
BILLING CODE 4110-08-11 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHEW. 
ACTION: Notice of proposed actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
SUMMARY: This notice sets forth 
proposcls for actions to be taken under 
the 1978 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
[Federal Register of December 22, 1978 
(43 FR 60108)]. 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 March 6-7, 1980, 
meeting, the Director of the National 
Institutes of Health will issue decision 
on these proposals in accord with the 
Guidelines. 
DATE: Comments must be received by 
March 3, 1980. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
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: 
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 (43 FR 60108), as well as 
actions under these Guidelines. 
1. Amendment of Section IV-D-2-a. 
As a comment on the Proposed Revised 
Guidelines for Research Involving 
Recombinant DNA Molecules published 
for comment in the Federal Register on 
November 30, 1979 (44 FR 69210), David 
Lester of Princeton, New Jersey, has 
proposed that Section IV-D-2-a, dealing 
with membership and procedures for the 
Institutional Biosafety Committee, be 
modified by adding as the penultimate 
sentence of IV-D-2-a the following: 
“Such nonaffiliated members shall be 
appointed by the governing body of the 
community in which the institution is 
situated." 
2. Amendment of Section Ill-O of the 
Proposed Revised Guidelines. Dr. Kent 
Wilcox of the Medical College of 
Wisconsin has suggested a clarification 
of the language of Section III-O, 
Classification of Experiments Using the 
E. coli K-12 Host-Vector Systems, of the 
proposed revised Guidelines published 
for comment in the Federal Register on 
November 30, 1979 (44 FR 69210). 
Section III-O is proposed to read, in 
part, as follows: 
* * * For these experiments no 
Memorandum of Understanding and 
Agreement (MUA) as described in Section 
IV-D-l-c need be submitted, nor is any 
registration with NIH necessary. However, 
for these experiments, prior to their initiation, 
investigators must submit to their 
Institutional Biosafety Committee (IBC) a 
registration document that contains a 
description of (a) the source(s) of DNA, (b) 
the nature of the inserted DNA sequences, 
and (c) the hosts and vectors to be used. This 
registration document must be dated and 
signed by the investigator and filed only with 
the local IBC. The IBC shall review all such 
proposals but such review is not required 
prior to initiation of experiments. An 
exception, however, which does require prior 
review and approval by the IBC is any 
experiment in which there is a deliberate 
attempt to have the E coli K-12 efficiently 
express any gene coding for a eukaryotic 
protein * * *. 
Dr. Wilcox suggests that the term 
"eukaryotic protein” is not well defined. 
He questions whether this term refers 
specifically to proteins encoded in the 
DNA of eukaryotic organisms and if so, 
whether animal viruses and viroids are 
considered to be eukaryotic organisms. 
Dr. Wilcox suggests that the last 
sentence of the above citation be 
modified to read as follows (modified 
text in italics): 
* * * An exception, however, which does 
require prior review and approval by the IBC 
is any experiment in which there is a 
deliberate attempt to have the E. coli K-12 
efficiently express as a protein product the 
information carried in any gene derived 
either from a eukaryotic organism or from 
any virus or viroid which infects a 
eukaryotic organism * * *. 
3. Amendment of Section III-O of the 
Proposed Revised Guidelines. Dr. Shlart 
Levy of Tufts University School of 
Medicine has recommended an 
amendment to Section III-O of the 
Proposed Revised Guidelines (44 FR 
69210). Dr. Levy notes that the plasmid 
studied in his risk-assessment studies 
was a nonconjugative poorly 
[30] 
