17672 
Federal Register / Vol. 49, No. 00 / Tuesday, April 24, 1984 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
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, 
Building 3lC, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20205, on June 1, 1984 from 9:00 a.m. to 
adjournment at approximately 5:00 p.m. 
This meeting will be open to the public 
on June 1 from 9:00 a.m. to 
approximately 3:30 p.m. to discuss: 
Report of the Working Group on 
Release into the Environment; 
Guidelines for submission of 
proposals to Plant Working Croup 
and RAC; 
Amendment of Guidelines; 
Consideration of experiments 
requiring review by RAC; and 
Other matters to be considered by the 
Committee. 
Attendance by the public in the open 
portion of the meeting will be limited to 
space available. Members of the public 
wishing to speak at the meeting may be 
given such opportunity at the discretion 
of the chairman. 
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 one hour and a half 
for the review, discussion, and 
evaluation of two proposals from 
commercial concerns for field testing of 
recombinant organisms. It is anticipated 
that this will occur from approximately 
3:30 p.m. to 5:00 p.m. on June 1. The 
proposals 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 3B10, 
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 late date. 
Dated: April 10. 1984. 
Betty J. Beveridge, 
Committee Management Officer. A'///. 
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 Fedeal 
Domestic Assistance- Normally N!H 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 whether individual programs 
listed in the Catalog of Federal Domestic 
Assistance are affected. 
|FR. Doc. S4-10600 Filed 4-23-84; 845 am) 
BILLING COOE 4140-01-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 
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 
meeting on June 1, 1984, the Director of 
the National Institute of Allergy and 
Infectious Diseases will issue decisions 
on these proposals in accord with the 
guidelines. 
DATE: Comments must be received by 
May 24, 1984. 
address: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 3B10, 
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. Comments received 
by close of business May 29, 1984, will 
be reproduced and distributed to the 
RAC for considerations at its June 1, 
1984, meeting. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from Drs. Stanley Barban and Elizabeth 
Milewski, Office of Recombinant DNA 
Activ ities, National Institutes of Health, 
Bethesda, Maryland 20205, (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following actions under the 
guidelines for research involving 
recombinant DNA molecules. 
I. Proposed Amendment of Procedures 
for Scale-Up of Organisms Listed in 
Appendix C 
In May 1983, Dr. Irving S. Johnson of 
Eli Lilly and Company proposed that 
prpeedures be modified for experiments 
involving more than 10 liters of culture 
of "exempt” organisms listed in 
Appendix C of the NIH guidelines for 
research involving recombinant DNA 
molecules. In September 1983, Dr. Max 
Marsh of Lilly Research Laboratories 
offered an alternate modification of 
Appendix C and requested it be referred 
to the RAC Large-Scale Review Working 
Group. The proposals were reviewed by 
the RAC at its September 19, 1983, 
meeting and referred to the Large-Scale 
Review Working Group. The RAC 
Large-Scale Review W'orking Group met 
on February 7, 1984. After evaluating 
data and discussing the issues, the 
Large-Scale Review Working Group 
proposed the following modifications to 
the guidelines: 
1. In Appendix K-II-D of Appendix K- 
II, PI-LS Level, the word "minimize” 
would be substituted for "prevent.” 
Appendix K-II-D would read as follows: 
Appendix K-II-D. Exhaust gases removed 
from a closed system or other primary 
containment shall be treated by filters which 
have efficiencies equivalent to HEPA filters 
or by other equivalent procedures (e.g., 
incineration) to minimize the release of 
viable organisms containing recombinant 
DNA molecules to the environment. 
2. The second paragraph of Appendix 
C-II, Experiments Involving E. coii K-12 
Host-Vector Systems; Appendix O— III, 
Experiments Involving Saccharomyces 
cerevisiae Host-Vector Systems; and 
Appendix C-IV, Experiments Involving 
Bacillus subtilis Host- Vector Systems; 
would be modified to read as follows: 
For these exempt laboratory experiments. 
PI physical containment conditions are 
recommended. 
3. A paragraph would be added 
following the second paragraph of 
Appendix C-II, Appendix C— III, and 
Appendix C-IV. That paragraph would 
read as follows: 
For large-scale fermentation experiments 
Pl-LS physical containment conditions are 
recommended. However, following review by 
the IBC of appropriate data for a particular 
host-vector system, some latitude in the 
application of Pl-LS requirements as outlined 
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