NOTICES 
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tensive Department and Interagency 
Committee review, it was agreed that, 
at least for the present, recombinant 
DNA research inventions developed 
under HEW/NIH support should con- 
tinue to be administered within cur- 
rent HEW patent agreements. Each 
agreement, however, would require 
that licenses could be granted only if 
the licensee provides assurance of 
compliance with the physical and bio- 
logical containment standards set 
forth in the Guidelines. My decision 
and analysis on this were released in 
March 1978. A copy is available from 
the Office of Recombinant DNA Activ- 
ities, NIH. Bethesda, Md. 20014. Thus, 
I do not believe that a restriction of 
patents in this research area is war- 
ranted. 
A commentator urged that a system 
of fines be spelled out. NIH has no au- 
thority to impose fines in the absence 
of new legislation. However, NIH will 
suspend, limit, or terminate a grant or 
contract for noncompliance with the 
Guidelines. A commentator urged that 
penalty procedures be specified. 
Should it be necessary to suspend, 
limit, or terminate a grant, appropri- 
ate HEW procedures will be followed. 
In sum. Part IV of the Guidelines on 
Roles and Responsibilities has been 
substantially revised in response to 
the suggestions from many commenta- 
tors. The Guidelines now provide even 
more opportunity for advice from the 
local to the national level. The spirit 
of cooperation and effective oversight 
■will be enhanced by the revised Guide- 
lines both at the local level between 
the research community and the 
public and at the national level with 
Federal agencies, the scientific com- 
munity, and private sectors. 
Donald S. Fredrickson. 
Director, 
National Institutes of Health. 
Recombinant DNA Research— Re- 
vised Guidelines Proposed by the 
Director, NIH 
July 1978. 
Table of Contents 
I. Scope of Guidelines. 
I-A. Purpose. 
I-B. Definition of Recombinant DNA 
Molecules. 
I-C. General Applicability. 
I-D. Prohibitions. 
I-E. Exemptions. 
I- F. General Definitions. 
II. Containment. 
II- A. Standard Practices and Train- 
ing. 
II-B. Physical Containment Levels. 
II-B-1. PI Level. 
II-B-l-a. Laboratory Practices. 
II-B-l-b. Containment Equip- 
ment. 
II-B-l-c. Special Laboratory 
Design. 
II-B-2. P2 Level. 
II-B-2-a. Laboratory Practices. 
II-B-2-b. Containment Equip- 
ment. 
II-B-2-c. Special Laboratory 
Design. 
II-B-3. P3 Level. 
II-B-3-a. Laboratory Practices. 
II-B-3-b. Containment Equip- 
ment. 
II-B-3-c. Special Laboratory 
Design. 
II-B-4. P4 Level. 
II-B-4-a. Laboratory Practices. 
II-B-4-b. Containment Equip- 
* ment. 
II-B-4 -c. Special Laboratory 
Design. 
II-C. Shipment. 
II-D. Biological Containment. 
II-D-1. Levels of Biological Con- 
tainment. 
II-D-l-a. HV1. 
II-D-l-b. HV2. 
II-D-l-c. HV3 
II-D-2. Certification of Host- 
Vector Systems. 
II-D-3. Distribution of Certi- 
fied Host-Vectors. 
III. Containment Guidelines for cov- 
ered Experiments. 
III-A. Classification Of Experiments 
Using the E. coli K-12 Host-Vector 
Systems. 
III-A- 1. Shotgun Experiments. 
III-A-l-a. Eukaryotic DNA Re- 
Primates. 
Other Mammals. 
Birds. 
Cold-Blooded Ver- 
combinants. 
III-A-l-a(l). 
III-A-l-a(2). 
III-A-l-a(3). 
III-A-l-a(4). 
tebrates. 
III-A-l-a(5). Other Cold-Blood- 
ed Animals and Lower Eukaryotes. 
III-A-l-a(6). Plants. 
III-A-l-b. Prokaryotic DNA Re- 
combinants. 
III-A-2. Plasmids. Bacterio- 
phages, and Other Viruses. 
III-A-2-a. Viruses of Eukar- 
yotes. 
III-A-2-a(l). DNA Viruses. 
III-A-2-a(2). DNA Transcripts 
of RNA Viruses. 
III-A-2-a<3). Intracellular Viral 
DNA. 
III-A-2-b. Eukaryotic Organelle 
DNAs. 
III-A-2-c. PTokaryotic Plasmid 
and Phage DNAs. 
III-A-3. Lowering of Contain- 
ment Levels for Characterized or Pu- 
rified DNA preparations and Clones. 
III-B. Experiments with Other Pro- 
karyotic Host-Vectors. 
III-C. Experiments with Eukaryotic 
Host-Vectors. 
III-C-1. Vertebrate Host-Vector 
Systems. 
III-C-2. Invertebrate Host-Vector 
Systems in Which Insect Viruses Are 
Used to Propagate Other DNA Seg- 
ments. 
III-C-3. Plant Viral Host-Vector 
Systems. 
III-C-4. Plant Host-Vector Sys- 
tems Other than Viruses. 
III- C-5. Fungal or Similar Lower 
Eukaryotic Host-Vector Systems. 
III-D. Complimentary DNAs. 
III-E. Synthetic DNAs. 
IV. Roles and Responsibilities. 
IV-A. Responsibilities of the insti- 
tution. 
IV- A-1. Institition. 
IV-A-2. Institutional Biosafety 
Committee. 
IV-A-3. Biological Safety Officer. 
IV-A-4. Principal Investigator. 
IV-B. Responsibilities of the NIH. 
IV-B-1. Office of the Director, 
NIH. 
IV-B-2. NIH Recombinant DNA 
Advisory Committee. 
IV-B-3. NIH Components. 
IV -C. Registration. 
IV-C-2. Voluntary Registration 
and Certification. 
IV-C-3. Disclosure of Informa- 
tion. 
IV-D. Compliance. 
IV-D-I. Policy on Noncompli- 
ance. 
V. Footnotes and References. 
I. Scope of the Guidelines 
I-A. Purpose. The purpose of these 
guidelines is to specify practices for 
constructing and handling (i) recom- 
binant DNA molecules and (ii) organ- 
isms and viruses containing recombin- 
ant DNA molecules. 
I-B. Definition of Recombinant DNA 
Molecules. In the context of these 
guidelines, recombinant DNA mole- 
cules are defined as either (i) mole- 
cules which are constructed outside 
living cells by joining natural or syn- 
thetic DNA segments to DNA mole- 
cules that can replicate in a living cell, 
or (ii) DNA molecules that result from 
the replication of those described in (i) 
above. 
I-C. General Applicability. The 
guidelines are applicable to all recom- 
binant DNA research within the 
United States or its territories con- 
ducted at or sponsored by an institu- 
tion that receives any support for re- 
combinant DNA research from NIH. 
This includes research performed di- 
rectly by NIH. 
Any individual receiving support 
must be associated with or sponsored 
by an institution which can and does 
assume responsibilities described in 
these guidelines. 
Once approved at the local level, re- 
search may proceed but shall be modi- 
fied in accordance with the recommen- 
dations of the NIH if found not to 
FEDERAL REGISTER, VOL 43, NO. 144— FRIDAY, JULY 28, 1978 
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