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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
Appendix I-II-B. Data To Be Submitted 
for Certification 
Appendix Host-Vector 1 
Systems Other than Escherichia coli K- 
12. The following types of data shall be 
submitted, modified as appropriate for 
the particular system under 
consideration: (i) a description of the 
organism and vector; the strain’s natural 
habitat and growth requirements; its 
physiological properties, particularly 
those related to its reproduction, 
survival, and the mechanisms by which 
it exchanges genetic information; the 
range of organisms with which this 
organism normally exchanges genetic 
information and the type of information 
is exchanged; and any relevant 
information about its pathogenicity or 
toxicity; (ii) a description of the history 
of the particular strains and vectors to 
be used, including data on any 
mutations which render this organism 
less able to survive or transmit genetic 
information; and (iii) a general 
description of the range of experiments 
contemplated with emphasis on the 
need for developing such an Host- 
Vector 1 system. 
Appendix I-lI-B-2. Host-Vector 2 
Systems. Investigators planning to 
request Host-Vector 2 systems 
certification may obtain instructions 
from NIH/ORDA concerning data to be 
submitted (see Appendices I-lIl-N and 
O). In general, the following types of 
data are required: (i) description of 
construction steps with indication of 
source, properties, and manner of 
introduction of glnetic traits; (ii) 
quantitative data on the stability of 
genetic traits that contribute to the 
containment of the system; (iii) data on 
the survival of the host-vector system 
under non-permissive laboratory 
conditions designed to represent the 
relevant natural enviromnent; (iv) data 
on transmissibility of the vector and/or 
a cloned DNA firagment under both 
permissive and non-permissive 
conditions; (v) data on all other 
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; and (vi) in some cases, 
the investigator may be asked to submit 
data on sm^val and vector 
transmissibility from experiments in 
which the host-vector is fed to 
laboratory animals or one or more 
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 shall be 
submitted 12 weeks prior to the RAC 
meeting at which such data will be 
considered by the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, room 
4B11, Bethesda, Maryland 20892, (301) 
496-9838. Investigators are encouraged 
to publish their data on the 
construction, properties, and testing of 
proposed Host Vector 2 systems prior to 
consideration of the system by the RAC 
and its subcommittee. Specific 
instructions concerning the submission 
of data for proposed Escherichia coli K- 
12 Host- Vector 2 system (EK2) involving 
either plasmids or bacteriophage in 
Escherichia coli K-12, are available 
from the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Building 31, room 4B11, Bethesda, 
Maryland 20892, (301) 496-9838. 
Appendix /-///. Footnotes and 
References of Appendix I 
Appendix 1-III-A. Hersfield, V., H.W. 
Boyer, C. Yanofsky, M.A. Lovett, and 
D.R. Helinski, Plasmid ColEl as a 
Molecular Vehicle for Cloning and 
Amplification of DNA. Proc. Nat. Acad. 
Sd., 1974, 71, pp. 3455-3459. 
Appendix I-III-B. Wensink, P.C., D.J. 
Finnegan, J.E. Donelson, and D.S. 
Hogness, A System for Mapping DNA 
Sequences in the Chromosomes of 
Drosophila Melanogaster. Cell, 1974, 3, 
pp. 315—335. 
Appendix I-IIl-C. Tanaka, T., and B. 
Weisblum, Construction of a Colidn El- 
R Factor Composite Plasmid in Vitro: 
Means for Amplification of 
Deoxyribonucleic Acid. J. Bacteriol., 
1975, 121, pp. 354-362. 
Appendix I-IIl-D. Armstrong, K.A., V. 
Hershfield, and D.R. Helinski, Gene 
Cloning and Containment Properties of 
Plasmid Col El and Its Derivatives, 
Science, 1977, 196, pp. 172-174. 
Appendix I-III-E. ^livar, F., R.L. 
Rodriguez, M.C. Betlack^ and H.W. 
Boyer, Construction and 
Characterization of New Cloning 
Vehicles: I. Arapicillin-Resistant, 
Derivative of PMB9, Gene, 1977, 2, pp. 
75-93. 
Appendix I-III-F. Cohen, S.N., 
A.C.W. Chang, H. Boyer, and R. Helling. 
Construction of Biologically Functional 
Bacterial Plasmids in Vitro. Proc. Natl. ‘ 
Acad, Sci., 1973, 70, pp. 3240-3244. 
Appendix I-III-G. Bolivar, F., R.L. 
Rodriguez, R.J. Greene, M.C. Batlack, 
H.L. Reyneker, H.W. Boyer, J.H. Cross, 
and S. Falkow, 1977, Construction and 
Characterization of New Cloning 
Vehicles II. A Multi-Piurpose Cloning 
System, Gene, 1977, 2, pp. 95-113. 
Appendix I-III-H. Tliomas, M., J.R. 
Cameron, and R.W. Davis (1974). Viable 
Molecular Hybrids of Bacteriophage 
Lambda and Eukaryotic DNA. Proc. Nat. 
Acad. Sci., 1974, 71, pp. 4579-4583. 
Appendix I-III-I. Murray, N.E., and K. 
Murray , Manipulation of Restriction 
Targets in Phage Lambda to Form 
Receptor Chromosomes for DNA 
Fragments. Nature, 1974, 51, pp. 476- 
481. 
Appendix I-III-J. Ramback, A., and P. 
Tiollais (1974). Bacteriophage Having 
EcoRI Endonuclease Sites Only in the 
Non-Essential Region of the Genome. 
Proc. Nat. Acad. Sci., 1974, 71, pp. 
3927-3820. 
Appendix I-III-K. Blattner, F.R., B.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, Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DNA Cloning, Science 1977, 196, pp. 
163-169. 
Appendix I-III-L. Donoghue, D.J., and 
P.A. Sharp, An Improved Lambda 
Vector: Construction of Model 
Recombinants Coding for Kanamycin 
Resistance, Gene, 1977, 1, pp. 209-227. 
Appendix I-III-M. Leder, P., D. 
Tieraeier and L. Enquist (1977), EK2 
Derivatives of Bacteriophage Lambda 
Useful in the Cloning of DNA from 
Higher Organisms: The kgt WES System, 
Science, 1977, 196, pp. 175-177. 
Appendix I-III-N. Skalka, A., Current 
Status of Coliphage AEK2 Vectors, 
Gene, 1978, 3, pp. 29-35. 
Appendix I-IIl-O. Szybalski, W., A. 
Skalka, S. Gottesman, A. Campbell, and 
D. Botstein, Standcudized Laboratory 
Tests for EK2 Certification, Gene, 1978, 
3, pp. 36-38. 
Appendix J. Biotechnology Research 
Su^ommittee 
The National Science and Technology 
Council’s Committee on Fundamental 
Science determined that a subcommittee 
should be continued to identify and 
coordinate Federal research efforts, 
identify research needs, stimulating 
international cooperation, and assess 
national and international policy issues 
concerning biotechnology sciences. The 
primary emphasis will be on scientific 
issues to increase the overall 
effectiveness and productivity of the 
Federal investment in biotechnology 
sciences, especially regarding issues 
which cut across agency boundaries. 
This subcommittee is called the 
Biotechnology Research Subcommittee. 
Membership of the Biotechnology 
Research Subcommittee wnll include 
Federal agencies that support 
biotechnology research. Agencies 
represented are: U.S. Department of 
Agricultmc, Department of Commerce, 
Department of Defense, Department of 
Energy, Department of Health and 
Human Services, Department of Interior. 
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