28904 
Federal Register / Vol. 45, No. 85 / Wednesday, April 30, 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. 
Conference Room 6, Building 31 C, 
Bethesda, Maryland 20205, on June 5, 
1980, from 9:00 a.m. to recess at 
approximately 6:00 p.m„ and on June 6, 
1980, from 8:30 a.m. to 5:00 p.m. This 
meeting will be open to the public on 
June 5 from 9:00 a.m. to recess at 
approximately 6:00 p.m., and on June 6 
from 8:30 a.m. to approximately 3:00 p.m. 
to discuss: 
Amendment of Guidelines 
Containment practices appropriate for large- 
scale production 
Voluntary compliance with Guidelines 
Institutional Biosafety Committees 
Exceptions to prohibitions 
Exemptions for organisms that exchange 
gene, tic information 
.Procedures for lowering containment for 
characterized clones and purified DNA 
Review of large-scale proposals 
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 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 two 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 June 6, 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. 
Dated: April 22, 1980. 
Suzanne L. Fremeau, 
Committee Management Officer, National 
Institutes of Health. 
[FR Doc. 80-13046 Filed 4-28-80: 3:49 am] 
BILLING CODE 4110-08-M 
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 
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 6724)]. 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 June 5-6, 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 
May 30, 198a 
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 
am. and 5:00 pm. 
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 (45 FR 6724), as well as 
actions under these Guidelines. 
1. Proposal to Amend Section lll-O of 
the Guidelines to Permit Use ofFf 
Phages. The National Institutes of 
Health (NIH) promulgated revised 
Guidelines in January 1980 (45 FR 6724). 
The revised Guidelines include a new 
Section, ffl-O, "Classification of 
Experiments Using the E- coli K-12 
Host-Vector Systems,” which, in part, 
reads as follows: 
“* * * experiments using E. coli K-12 shall 
use PI physical containment hnd * * * an 
EK1 host-vector system [i.e. (a) the hoBt shall 
not contain conjugation-proficient plasmids 
or generalized transducing phages and (b) 
lambda or lambdoid bacteriophages or 
nonconjugative plasmids shall be used as 
vectors].* * *” 
Section ffl-O, which was promulgated 
on the recommendation of the RAC, did 
not include reference to use of Ff 
bacteriophages (filamentous single- 
strand male-specific bacteriophages 
such as M13 and fd). Consequently, 
when the revised Guidelines were 
promulgated in January 1980, 
investigators were informed that Ff 
bacteriophages may continue to be used 
as a component of EKl systems at the 
containment levels specified by the 1978 
Guidelines. (A complete discussion of 
this issue appears in the Decision 
Document that accompanied the 
November 30, 1979 proposed revised 
Guidelines (44 FR 69244-69245) and the 
Decision Document that accompanied 
the final revised Guiidelines (45 FR 
8721)). 
In December 1979, the RAC was asked 
to consider how E. coli K-12 host-vector 
systems employing Ff phages should be 
treated under the 1980 Guidelines. In 
response to thiB NIH- request, the Host- 
Phage Subcommittee drafted a 
recommendation which was presented 
to the full RAC at the March 6-7, 1980 
meeting. 
The RAC agreed that the following 
proposed amendment to Section IH-O 
should be published in the Federal 
Register for a thirty-day comment period 
(amended text in italics): 
"* ’ * experiments using E. coli K-12 shall 
use PI physical containment and, * * * an 
EKl host-vector system [i.e. (a) the host shall 
not contain conjugation-proficient plasmids 
or generalized transducing phages and (b) 
lambda or lambdoid or Ff bacteriophages or 
non-con juga five plasmids shall be used as 
vectors].* * *" 
Background documentation is available 
from ORDA. 
2. Proposed Changes to Allow 
Recombinant DNA Experiments with 
Class 3 Organisms and Certain Plant 
Pathogens. The National Institute of 
Allergy and Infectious Diseases (NIAID) 
requested that the NIH consider 
whether, and under what conditions, 
recombinant DNA technology might be 
used to study CDC Class 3 etiological 
agents. Experiments employing these 
agents are currently prohibited by 
Section I-D-l of the Guidelines which 
states as not to be initiated: 
“I-D-l. Formation of recombinant DNMAs 
derived from the pathogenic organisms 
classified [1] as Class 3, 4 or 5 ]2] or the cells 
[91] 
