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Federal Registex / Vol. 47. No. 102 / Wednesday. May 26, 1982 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institiitea of Health 
Recombinant DNA Adviaofy 
Committee; Meeting 
Pursuant to Pub. L 92-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Conunittee 
at Wilson Hall. Building, 1, National 
Institutes of Health, 9000 Rockville Pike, 
Bethesda, Maryland 20205, on June 28. 
1962, from 9:00 a.m. to adjournment at 
approximately 6:00 p.m. This meeting 
will be open to the public to discuss: 
Proposed major revision of the 
Guidelines 
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. 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, 
Wilson Hall, Building 1, 9000 Rockville 
Pike. Bethesda. Maryland 20205. on June 
29. 1982. from 9:00 a.m. to 12:00 noon. 
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. 
Dated: May 19. 1982. 
Batty |. Bavaridge. 
National Institutes of Health Committee 
Management Officer. 
Nota. — OMB'i "Mandatory Information 
Requirement! 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 eBecUve or in 
the public interest to attempt to Rst 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 0MB 
Circular A-95 because they Ht the description 
of "programs not considered appropriate" in 
Section 8-(b)-{4) and (5) of that Circular. 
|HI Doc si- 14374 nUd S-lS-aZ S4S un| 
WUJNQ COOC 4140.41-M 
Recombinant DNA Research: 
Propoaed Actlona Under Guldellnea 
AQENCY: National Institutes of Health. 
PHS. HHS. 
ACTION: Notice of proposed revisions of 
NIH guidelines for research involving 
recombinant DNA molecules. 
•ummary: This notice sets forth 
proposed revisions of 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 28-29. 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 
June 25. 1982. 
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 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 Institfites of Health will 
consider the following proposed 
revisions of the Guidelines for Research 
Involving Recombinant DNA Molecules. 
I. Proposed Revision of Appendix A. 
Sublist F 
Dr. Gary M. Dunny of the New York 
State College of Veterinary Medicine 
requests that Streptococcus agalactiae 
be added to Appendix A, Sublist F, on 
the basis that it exchanges genetic 
Information with other Streptococcus 
species in Sublist F. 
II. Proposed Prohibition 
Dr. Richard Novick of the Public 
Health Research Institute of City of New 
York and Dr. Richard Goldstein of 
Harvard Medical School have proposed 
that a prohibition against the 
construction of biological weapons by 
molecular cloning be added to the 
Guidelines. The rationale for this 
proposal is outlined in a letter to ORDA. 
III. Proposal for Revision of the 
Guidelines 
A. Introduction 
The Recombinant DNA Advisory 
Committee (RAC) at its February 8-9, 
1962 meeting, recommended that the 
National Institutes of Health (NIH) 
accept a proposed modification (46 FR 
59734) of the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. In supporting this 
modification, the RAC recommended 
that a working group be formed to 
simplify further and modify the 
document. On April 21. 1982. the NIH 
promulgated the revised Guidelines (47 
FR 17180). 
An ad hoc Working Group on 
Revision of the Guidelines was formed 
and convened for a meeting on April 19, 
1962. The committee addressed several 
issues at this meeting. The first topic 
was an attempt to improve the 
"presentation" of the Guidelines. It was 
felt that most of Section II, which 
describes physical and biological 
containment standards, as well as 
shipping, should be moved to three 
separate new Appendices (G, H, and I). 
In addition, the section describing 
shipment (currently II-C) should be 
expanded to include further information 
on packaging and labeling. It was noted 
that the current Guidelines provide little 
concrete guidance for shipping 
materials; rather, they refer the reader to 
other sources. 
Language describing "General 
Applicability" and "General 
Definitions" should be removed from 
Section IV and placed in Section I. 
The working group discussed the 
question of whether the language of 
Section lII-A-1 and Appendix F which 
refers to "toxins" also applies to other 
pharmacologically active molecules. A 
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