55924 
Federal Register / Vol. 45, No. 164 / Thursday, August 21, 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 Linden Hill Hotel, Linden Room, 
5400 Pooks Hill Road, Bethesda, 
Maryland 20014, on September 25 1980, 
from 9:00 a.m. to recess at 
approximately 0:00 p.m., and on 
September 26, 1980, from 8:30 a.m. to 
5:00 p.m. This meeting will be open to 
the public on September 25 from 9:00 
a.m. to recess at approximately 6:00 
p.m., and on September 26 from 8:30 a.m. 
to approximately 3:00 p.m. to discuss: 
Amendment of Guidelines 
Procedures for review of proposals for large- 
scale production 
Voluntary compliance with guidelines 
Institutional Biosafety Committees 
Exceptions to prohibitions 
Exemptions for organism that exchange 
genetic information 
Review of large-scale proposals 
E. coli K-12 host-vector systems 
Host-vector systems other than E. coli K-12 
JvIIH 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 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 two hours for the 
review, discussion and evaluation of 
proposal(s) from a commerical 
concem(s) for scale-up of recombinant 
DNA experiments. It is anticipated that 
this will occur on September 26, from 
approximately 3:00 p.m. until 
adjournment. The proposal(s) and the 
discussion could reveal confidential 
trade secrets or commerical 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 committees members and 
substantive program information. A 
summary of the meeting will be 
available at a later date. 
Dated: August 14, 1980. 
Donald S. Fredrickson, M.D., 
Director. NIH. 
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 announcement 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. 
[FR Doc. 80-25288 Filed 8-20-80; 8:45 am] 
BILLING CODE 4110-08-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
AGENCY: National Institutes of Health), 
PHS, DHHS. 
ACTION: Notice of proposed actions 
.under NIH guidelines for research 
involving recombinant DNA molecules. 
SUMMARY: This notice sets forth 
proposals for actions to be taken under 
the 1980 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
[Federal Register of January 29, 1980 (45 
FR 6724JJ. 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 September 25-26, 1980, 
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 
September 22, 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: 
Background documentation and 
additional information can be obtained 
from Drs. Stanley Barban or Elizabeth 
Milewski, Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bqthesda, Maryland 20205, (301) 498- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following changes and 
amendments under the Guidelines for 
Research Involving Recombinant DNA 
Molecules (45 FR 6724), as well as 
actions under these Guidelines. 
1. Requests forpermission to 
transform chlamydomonas reinhardi 
with E. colisaccharomyces cerevisiae 
plasmids. Dr. John Carbon of the 
University of California, Santa Barbara, 
and Dr. Stephen Howell, University of 
California, San Diego, request 
permission to introduce Escherichia 
coli-Saccharomyces cerevisiae hybrid 
plasmids containing defined segments of 
DNA into the unicellular flagellate 
Chlamydomonas reinhardi under P2 
physical containment conditions. 
2. Request for permission to transform 
Candida albicans with E. Coli-S. 
Cerevisiae plasmids. Dr. P. T. Magee of 
Michigan State University, and Dr. W. 
Lajean Chaffin of Texas Tech 
University, have requested 
consideration of the appropriate 
containment level for the return of 
Candida albicans DNA to the host of 
origin. The Candida albicans DNA will 
be cloned in E. coli K-12 or in 
Saccharomyces cerevisiae employing a 
hybrid plasmid vector derived from E. 
coli K-12-S. cerevisiae or the yeast 2 
micron plasmid. 
3. Proposal to introduce genes cloned 
in E. Coli K-12 into Arabidopsis plants 
through the use of Agrobacterium 
tumefaciens carrying an E. Coli/Ti 
hybrid plasmid vector. Employing the 
following protocol, Dr. Donald J. Merlo 
of the University of Missouri-Columbia, 
requests permission to introduce genes 
into Arabidopsis thaliana: 
(a) A hybrid plasmid vector, 
constructed from the E. coli plasmid 
pBR325 and the origin of replication and 
transfer genes of Agrobacterium 
tumefaciens plasmid Ti, will be cloned 
in E. coli K-12. 
(b) Arabidopsis DNA will be 
introduced into the E. coli I Ti hybrid 
plasmid and cloned in E. coli K-12. 
(c) The thiamine gene of E. coli will be 
introduced into the E. coli / Ti vector 
[150] 
