41924 
Federal Register / Vol. 47, No. 184 / Wednesday. September 22, 1982 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meetings 
Pursuant to Pub. L. 92-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at Wilson Hall, Building 1, National 
Institutes of Health, 9000 Rockville Pike, 
Belhesda, Maryland 20205, on October 
25, 1982, from 9:00 a.m. to adjournment 
at approximately 6.00 p.m. This meeting 
will be open to the public to discuss: 
CDC/NIOSH report on medical 
surveillance 
Classification of microorganisms for 
purposes of Guidelines 
Review of protocols for required 
containment levels 
Containment levels for cloning toxin 
genes 
Amendment of Guidelines 
Proposed exemptions to Guidelines 
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 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 Group sponsored by the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health, 
Wilson Hall, Building 1, 9000 Rockville 
Pike, Bethesda, Maryland 20205, on 
October 26, 1982, from 9:00 a.m. to 12:00 
noon. The meeting will be open to the 
public to discuss: 
CDC/NIOSH report on medical 
surveillance 
Proposed revision of the Physical 
Containment Recommendations for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules 
Attendance will be limited to space 
available. 
Further information may be obtained 
from Dr. Elizabeth Milewski, Executive 
Secretary, Large-Scale Review Working 
Group, NIAID, Building 31, Room 4A52, 
Bethesda, Maryland, telephone (301) 
496-6051. 
Dated: September 15, 1982. 
Betty J. Beveridge, 
NIH Committee Management Officer. 
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 readers to 
direct questions to the information 
address above about whether individual 
programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
NIH programs are not covered by 
OMB Circular A-95 because they fit the 
description of “programs not considered 
appropriate" in Section 8— (b)— (4) and (5) 
of that Circular. 
[FR Doc. 82-28009 Filed 0-21-82; 8:45 am) 
BILLING CODE 4 1 *0-0 t-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. October 25, 1982, 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 
October 22. 1982. 
AOORESS: 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 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. Request for Permission To Clone a 
Hybrid Gene Involving the Gene 
Encoding Diphtheria Toxin 
Dr. John Murphy of Harvard Medical 
School requests permission to construct 
a hybrid molecule in which the gene 
coding for the melanocyte stimulating 
hormone (MSH) is joined to a segment 
of the gene encoding diphtheria toxin. 
The diphtheria toxin gene segment 
would encode the A subunit and 
portions of the B subunit. The segment 
would be devoid of the diphtheria toxin 
binding domain. The MSH gene would 
be a synthetic oligonucleotide. The 
MSH-diphtheria toxin hybrid gene 
would be introduced into poorly 
mobilizable plasmids such as pBR322, 
PUC9, or PUC8, and cloned in E. coli 
EKl host-vector systems. Dr. Murphy 
proposes that work leading up to the 
gene fusion would be conducted under 
Pl + EKl containment. Pl+EKl 
containment would be appropriate for 
cloning the diphtheria toxin segment, as 
without a binding domain the 
polypeptide has very low toxicity. Dr. 
Murphy proposes that propagation of 
the hybrid gene in E. coli K-12 be 
conducted in the high containment 
Building 550 at the Frederick Cancer 
Research Facility (FCRF), since the 
specific toxicity of the hybrid gene 
product is unknown. Laboratory 
practices and containment equipment 
are to be specified by the IBC. 
II. Request for Permission To Clone a 
Toxin Structural Gene From E. Coli 
Drs. Alison O'Brien and Randall 
Holmes of the Uniformed Services 
University of the Health Sciences 
request permission to clone the 
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