9436 
Federal Register / Vol. 48, No. 44 / Friday, March 4, 1983 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
National Institute of Allergy and 
Infectious Diseases; 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 April 11, 1983, from 9 a.m. to 
approximately 6 p.m. The meeting will 
be open to the public to discuss: 
Report on the Social and Ethical 
Issues of Cenetic Engineering with 
Human Beings; 
Report of Working Group on Revision 
of the Guidelines; 
Proposed update of risk-assessment 
plan; 
Amendment of Guidelines; 
Revision of large-scale physical 
containment recommendations; 
Classification of microorganisms for 
purposes of Guidelines; 
Review of protocols for required 
containment levels; and 
Other matters requiring necessary 
action by the Committee. 
Attendance by the public will be 
limited to space available. 
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 later date. 
There will be no meeting of the Large- 
Scale Review Working Group in 
conjunction with this meeting. 
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 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 
renders to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: February 18. 1983. 
Betty J. Beveridge, 
Committee Management Officer. NIH. 
[FR Doc. 83-5330 filed 3-3-83: 0 45 am| 
BILLING CODE 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 April 11, 1983, 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 
April 4. 1983. 
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. 
[. Proposed Modification of Appendix 
G-II-D-2-c (P4 Containment) 
The RAC Working Group on Revision 
of the Guidelines, at its January 21, 1983, 
meeting, discussed modifying the 
language of Appendix G-II-D-2-a of the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules (47 FR 
38048, August 27, 1982). That Appendix 
currently reads: 
Appendix G-II-D-2-a. Experimental 
procedures involving organisms that require 
P4 level physical containment shall be 
conducted either in (i) a Class III cabinet 
system or in (ii) Class I or Class II cabinets 
that are located In a specially designed area 
in which all personnel are required to wear 
one-piece positive pressure isolation suits. 
During the January 21, 1983, 
discussion, it was noted that the 
specification requiring use of the Class 
III glove box is to protect the 
investigator from infection acquired 
through aerosol exposure. The Class III 
glove box, however, does not afford 
protection when infection by the 
organism being studied does not occur 
through the respiratory route. Members 
of the working group pointed out that 
automatic assignment of all procedures 
to the Class III glove box, as specified in 
Appendix G-II-D-2-a, is not desirable 
since manipulations are more difficult to 
perform in the glove box. This slows 
research while not necessarily 
protecting the investigator. The working 
group suggested that authority to set 
containment for certain experiments 
within the P4 facility might be delegated 
to the local IBC in situations in which 
colonization or infection does not 
ordinarily result from aerosol exposure. 
On the recommendation of the 
working group, NIH staff has proposed 
the following modification of Appendix 
NG-II-D-2-c, which is considered the 
more appropriate section to modify: 
Appendix G-II-D-2-c. Alternative 
Selection of Containment Equipment. 
Experimental procedures Involving a host- 
vector system that provides a one-step higher 
level of biological containment than that 
specified can be conducted in the P4 facility 
using containment equipment requirements 
specified for the P3 level of physical 
containment. Alternative combinations of 
containment safeguards are shown in Table 
II. In those cases where the host is an 
organism which does not cause infection by 
the respiratory route (e g., use of E. coli K-12 
or S. cerevisiae host-vector systems), the 
local IBC may set appropriate containment 
for procedures within the P4 facility. 
II. Proposed Modification of Section III- 
B-5 
The RAC Large-Scale Review 
Working Group, which met on October 
26, 1982, has forwarded to RAC without 
comment a proposal by Dr. Allan Vyaitz 
of DNAX Corporation (a wholly owned 
subsidiary of Schering-Plough 
Corporation) to amend Section III-B-5 of 
the NIH Guidelines. Section III-B-5 
currently reads: 
[7R1 
