39770 
Federal Register / Vol. 46, No. 149 / Tuesday, August 4, 1981 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Inatitutes of Health 
Recombinant DNA Advisory 
Committee; Notice of Meetings 
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 3lC. 9000 
Rockville Pike. Bethesda, Maryland 
20205. on September 10. 1981. from 9:00 
a.m. to recess at approximately 6:00 
p.m., and. if necessary, on September 11, 
1981. from 8:30 a.m. to 5:00 p.m. This 
meeting will be open to the public on 
September 10 from 9:00 a.m. to 
approximately 3:00 p.m., and on 
September 11 from 8:30 a.m. to 
adjournment to discuss: 
Proposed major revision of Guidelines 
Amendment of Guidelines 
E. coU K-12 host-vector systems 
Host-vector systems other than E. coli K-12 
Risk-assessment 
Review of protocols for required containment 
levels 
Requests for exceptions to prohibitions 
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 lOfd) of Pub. 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 September 10, from 
approximately 3KX) p.m. until 
adjournment. The proposal(s) and the 
discussion could reveal conridential 
trade secrets or commercial property 
such as patentable material. 
Dr. William ). Cartland, 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. 
In addition, notice is hereby given of a 
meeting of the Large Scale Review 
Working Croup sponsored by the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health. 
Conference Room 4, Building 31A. 9000 
Rockville Pike, Bethesda, Maryland 
20205, on September 9. 1981, from 2K)0 
p.m. to 5:00 p.m. The meeting will be 
open to the public. Attendance will be 
limited to space available. 
Further information may be obtained 
from Dr. Elizabeth Milewski. Executive 
Secretary, Large Scale Review Working 
Croup. NIAID, Building 31, Room 4A52, 
Bethesda. Maryland, telephone, (301) 
496-6051. 
July 27. 1981. 
Thomas E. Malone, Ph.O., 
Deputy Director, NIH. 
OMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements" (45 FR 39592) requires a 
statement concerning the ofTicial 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 inlemationaL have elected 
to follow the .NIH Guidelines. In lieu of the 
individual program listing. NIH invites 
readers to direct questions to the information 
addressed above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
NIH programs are not covered by 0MB 
Circular A-05 because they fit the description 
of "programs not considered appropriate” in 
Section B-(b)-(4) and (5) of that Cirtnilar. 
|F1t Doc SI-12141 FUod S-S-Sl. S45 •m| 
BIUJMO COOC 411»-0a-«l 
Recombirtant DNA Research; 
Proposed Actions Under Guidelines 
agency; National Institutes of Health, 
PHS, HHS. 
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 
September 10-11, 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 
September 3. 1981. 
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 CONTACr. 
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 Utilize Hemophilus 
Parainfluenzae to Clone Moloney 
Murine Leukemia Provirus. 
Dr. lames. W. Gautsch of Scripps 
Clinic and Research Foundation 
requests permission to clone Moloney 
MuLV provirus and cellular flanking 
regions in Hemophilus parainfluenzae. 
The provirus DNA and flanking regions 
will be ligated into vector pRK290, a 
plasmid with a broad host range in gram 
negative bacteria. The cloned plasmid 
DNA wdl subsequently be used to infect 
NIH 3T3 cells. 
2. Evaluation of a Proposal Using 
Conjugative Plasmids to Transfer DNA 
between E. Coli, Vibrio Cholera, and 
Vibrio Harveyi. 
Dr. ). W. Hastings of Harvard 
University requests permission to clone 
Vibrio Harveyi DNA in E. coli and 
Vibrio cholera. Conjugation proficient 
plasmids (e.g., pRK290 derivatives) will 
be used to transfer the cloned V. 
Harveyi DNA between E. coli, V. 
cholera, and V. Harveyi. 
3. Request to Include Streptococcus 
Lactis and Streptococcus Sanguis in a 
Sublist of Appendix A. 
Dr. Larry McKay of the University of 
Minnesota has requested permission for 
the one way transfer of Streptococcus 
lactis DNA into S. sanguis strain 
Challis, and that these strains be 
included under the exemption category 
of Appendix A on the basis that they 
exchange genetic information by known 
physiological processes. He also 
requests permission to transfer a 
recombinant plasmid from 5. faecalis to 
S. lactis. 
1177 ] 
