G96 
Federal Register / Vol. 49, No. 3 / Thursday, January 5, 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 February 6, 1984, from 9:00 
a.m. to recess at approximately 5:00 
p.m., and on February 7, 1984, from 9:00 
a.m. to adjournment at approximately 
12:00 noon. This meeting will be open to 
the public on February 6 from 9:00 a.m. 
to approximately 11:00 a.m. and again 
from 1:00 p.m. to recess, and on 
February 7 from 9:00 a.m. to 
adjournment to discuss: 
Report of the Working Group on Social and 
Ethical Issues: 
Amendment of Guidelines; and 
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 one hour and a half 
for the review, discussion, and 
evaluation of proposal(s) from a 
commercial concern(s) for field testing 
of recombinant organisms. It is 
anticipated that this will occur from 
approximately 11:00 a.m. to 12:30 p.m. on 
February 6. 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, Nutional 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 later date. 
In addition, notice is hereby given of a 
meeting of the Large-Scale Review 
Working Group sponsored by the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health, 
Building 31C, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20205, on February 7, 1983. The call to 
order will be dependent upon the 
adjournment of the Recombinant DNA 
Advisory Committee. If the RAC has no 
business to conduct on February 7, 1983, 
the Large-Scale Review Working Group 
will meet from 9:00 a.m. to 
approximately 12:00 noon. If the RAC 
meets on February 7, the Large-Scale 
Review Working Croup will meet from 
1:00 p.m. to approximately 4:00 p.m. The 
meeting will be open to the public. 
Attendance will be limited to space 
available. 
The Large-Scale Review Working 
Group is soliciting data or other 
technical information concerning (1) 
viability of E. coli K-12, Bacillus 
subti/is, and Saccharomyces cerevisiae 
in aerosols, and (2) containment systems 
for fermentors, e.g„ exhaust air 
treatment data. 
Further information may be obtained 
from Dr. Elizabeth Milewski, Executive 
Secretary, Large-Scale Review Working 
Group, NIAID, Building 31, Room 3B10, 
Bethesda, Maryland, telephone (301) 
496-6051. 
Dated: December 8, 1983. 
Betty J. Beveridge, 
Committee Management Officer. 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 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 pubiic interest to attempt to list these 
programs. Such a list would hkely 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. 
|FK Dm: 84-4 Filed 1-4-84. 8:45 4m| 
BILLING COO€ 4 140-01 -Id 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
action: Notice of proposed actions 
under NTH 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 February G-7, 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 
February 6, 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. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from Drs. Stanley Barban and 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 actions under the 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
I. Proposed Amendments of the NIH 
Guidelines and Comments by the 
Director, NIAID. 
A. Amendments Proposed by Messrs. 
Jeremy Rif kin and Edward Rogers 
Messrs. Jeremy Rifkin and Edward 
Lee Rogers, on behalf of the Foundation 
on Economic Trends, Michael W. Fox, 
Environmental Action, Inc., and 
Environmental Task Force, in a letter 
dated November 7, 1983, propose the 
following amendments to the NIFI 
Guidelines. 
1. Amendment of the Section III. The 
title of Section III of the Guidelines 
would be changed from "Containment 
Guidelines for Covered Experiments" to 
"Guidelines for Covered Experiments." 
Messrs. Rifkin and Rogers argue that 
the current title of Section III reflects an 
orientation towards experiments 
contained within a laboratory. However, 
the RAC is reviewing experiments 
involving the deliberate release into the 
environment of certain organisms 
containing recombinant DNA. Messrs. 
Rifkin and Rogers state that: 
Accordingly, the focus should no longer be 
on the concept of containment alone, but 
rather on guidelines to assure safety for all 
experiments, whether through containment 
procedures or other techniques. 
[239] 
