Federal Register / Vol. 48, No. 108 / Wednesday, ]une 1, 1983 / Notices 
24577 
properties of the system which affect 
containment and utility, including 
information on yields of phage or 
plasmid molecules, ease of DNA 
isolation, and ease of transfection or 
transformation, (vi) In some cases, the 
investigator may be asked to submit 
data on survival and vector 
transmissibility from experiments in 
which the host-vector is fed to 
laboratory animals and human subjects. 
Such in vivo data may be required to 
confirm the validity of predicting in vivo 
survival on the basis of in vitro 
experiments. 
Data must be submitted in writing to 
ORDA. Ten to twelve weeks are 
normally required for review and 
circulation of the data prior to the 
meeting at which such data can be 
considered by the RAC. Investigators 
are encouraged to publish their data on 
the construction, properties, and testing 
of proposed HV2 systems prior to 
consideration of the system by the RAC 
and its subcommittee. More specific 
instructions concerning the type of data 
to be submitted to NIH for proposed EK2 
systems involving either plasmids or 
bacteriophage in E. coli K-12 are 
available from ORDA. 
Appendix I— III. Footnotes and 
References of Appendix I. 
1. Hershfield, V., H. W. Boyer, C. Yanofsky, 
M. A. Lovett, and D. R. Helinski (1974). 
Plasmid Co I El as a Molecular Vehicle for 
Cloning and Amplification of DNA. Proc. Nat. 
Acad. Sci. USA 71. 3455-3459. 
2. Wensink, P. C.. D. J. Finnegan. J. E. 
Donelson, and D. S. Hogness (1974). A System 
fur Mapping DNA Sequences in the 
Chromosomes of Drosophila Melanogaster. 
Cell 3. 315-335. 
3. Tanaka, T., and B. Weisblum (1975). 
Construction of a Colicin El-R Factor 
Composite Plasmid In Vitro: Means for 
Amplification of Deoxyribonucleic Acid. j. 
Bacteriol. 121. 354-362. 
4. Armstrong. K. A., V. Hershfield, and D. 
R. Helinski (1977). Cene Cloning and 
Containment Properties of Plasmid Col El 
and Its Derivatives. Science 196. 172-174. 
5. Bolivar, F., R. L. Rodriguez, M. C. Betlach, 
and H. W. Boyer (1977). Construction and 
Characterization of New Cloning Vehicles: I. 
Ampicillin-Resistant Derivative of pMB9. 
Cene 2. 75-93. 
6. Cohen, S. N„ A. C. W. Chang, H. Boyer, 
and R. Helling (1973). Construction of 
Biologically Functional Bacterial Plasmids in 
Vitro. Proc. Natl. Acad. Sci. USA 70. 3240- 
3244. 
7. Bolivar. F„ R. L. Rodriguez. R. ). Greene, 
M. C. Batlach, H. L. Reyneker, H. W. Boyer. ). 
H. Crosa. and S. Falkow (1977). Construction 
and Characterization of New Cloning 
Vehicles: II. A Multi-Purpose Cloning 
System. Gene 2, 95-113. 
8. Thomas. M.. J. R. Cameron, and R. W. 
Davis (1974). Viable Molecular Hybrids of 
Bacteriophage Lambda and Eukaryotic DNA. 
Pioc. Nut. Acad. Sci. USA 71. 4 5 75MJ5B3. 
9. Murray, N. F,., and K. Murray (1974). 
Manipulation of Restriction Pargets in Phage 
Lambda to Form Receptor Chromosomes for 
DNA Fragments. Nature 251. 476-481. 
10. Rambach. A„ and P. Tiollais (1974). 
Bacteriophage Having EcoRI Endonuclease 
Sites Only in the Non-Essential Region of the 
Genome. Proc. Nat. Acad. Sci.. USA 71. 3927- 
3930. 
11. Blattner. F. R.. G. G. Williams, A. E. 
Bleche. K. Denniston-Thompson. H. E. Faber, 
L. A. Furlong, D. J. Gunwald, D. O. Kiefer, D. 
D. Moore, J. W. Shumm, E. L Sheldon, and O. 
Smithies (1977). Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DNA Cloning. Science 196. 163-169. 
12. Donoghue, D. J., and P. A. Sharp (1077). 
An Improved Lambda Vector: Construction of 
Model Recombinants Coding for Kanamycin 
Resistance, Gene 1. 209-227. 
13. Leder, P., D. Tiemeier and L. Enquist 
(1977). EK2 Derivatives of Bacteriopghage 
Lambda Useful in the Cloning of DNA from 
Higher Organisms: The gt WES System. 
Science 196, 175-177. 
14. Skalka, A. (1978). Current Status of 
Coliphage EK2 Vectors. Gene 3. 29-35. 
15. Szybalski, W.. A. Skalka, S. Gottesman, 
A. Campbell, and D. Botstein (1978). 
Standardized Laboratory Tests for EK2 
Certification. Gene 3, 36-38. 
Appendix J — Federal Interagency 
Advisory Committee on Recombinant 
DNA Research 
Appendix J— I. Federal Interagency 
Advisory Committee. The Federal 
Interagency Advisory Committee on 
Recombinant DNA Research advises the 
Secretary of the Department of Health 
and Human Services, the Assistant 
Secretary for Health, and the Director, 
National Institutes of Health, on the 
coordination of those aspects of all 
Federal programs and activities relating 
to recombinant DNA research. The 
Committee provides for communication 
and exchange of information necessary 
to maintain adequate coordination of 
such programs and activities. The 
Committee is responsible for facilitating 
compliance with a uniform form set of 
guidelines in the conduct of this 
research in the public and private 
sectors and, where warranted, to 
sugges’t administrative or legislative 
proposals. 
The Director of the NIH. or his 
designee, serves as Chairman, and the 
Committee includes representation from 
all Departments and Agencies whose 
programs involve health functions or 
responsibilities as determined by the 
Secretary. 
Departments and Agencies which 
have representation on this Committee, 
as of December 1980, are 
Department of Agriculture 
Department of Commerce 
Department of Defense 
Department of Energy 
Environmental Protection Agency 
Executive Office of the President 
Department of Health and Human Servic es 
Office of the Assistant Secretary for 
Health. Centers for Disease Control. Food 
and Drug Administration. Nation; I 
Institutes of I lealth 
Department of the Interior 
Department of Justice 
Department of Labor 
National Aeronautics and Space 
Administration 
National Science Foundation 
Nuclear Regulatory Commission 
Department of State 
Department of Transportation 
Arms Control and Disarmament Agency 
Veterans Administration 
At the second meeting of the 
Committee on November 23. 1976. all of 
the Federal agencies endorsed the NIH 
Guidelines, and Departments which 
support or conduct recombinant DNA 
research agreed to abide by the NIH 
Guidelines [1]. 
Appendix J— II. Footnote of Appendix J. 
1. Minutes of the first eight meetings of the 
Federal Interagency Advisory Committee on 
Recombinant DNA Research are reproduced 
in Recombinant DNA Research. Volume 2. 
Documents Relating to "NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules." June 1976-November 1977. 
Appendix K — Physical Containment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules 
This part of the NIH Guidelines 
specifies physical containment 
guidelines for large-scale (greater than 
10 liters of culture) research or 
production involving viable organisms 
containing recombinant DNA molecules. 
It shall apply to large-scale research or 
production activities as specified in 
Section III— B— 5 of the NIH Guidelines. 
All provisions of the NIH Guidelines 
shall apply to large-scale research or 
production activities with the following 
modifications: 
• Appendix K shall replace Appendix 
G when quantities in excess of 10 liters 
of culture are involved in research or 
production. 
• The institution shall appoint a 
biological safety officer if it engages in 
large-scale research or production 
activities involving viable organisms 
containing recombinant DNA molecules. 
The duties of the biological safety 
officer shall include those specified in 
Section IV-B-4 of the Guidelines. 
• The institution shall establish and 
maintain a health surveillance program 
for personnel engaged in large-scale 
research or production activities 
involving viable organisms containing 
recombinant DNA molecules which 
require P3 containment at the laboratory 
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