Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 1986 / Notices 
16981 
information on yields of phage or 
plasmid molecules, ease of DMA 
isolation, and ease of transfection or 
transformation: and (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 arc 
available from ORDA. 
Apocndix l-IIl — Footnotes and 
References of Appendix / 
1. Hersfield. V., H.W. Boyer. C. Yanofsky. 
M..Y Lovett, and D.R. Heiinski (1974). 
Plasmid Co, 'El as a Molecular Vehicle for 
Cloning and Amplification of DXA. Proc. Nat. 
Acad. Sci. USA 71. 3455-3459. 
2. Wensink. P.C., D.J. Finnegan. J.E. 
Uonelson. and D.S. Hogness (1974). A System 
for Mapping DXA Sequences in the 
Chromosomes of Drosophila Me'.anczaster. 
Cell 3. 315-335. 
3. Tanaka. T.. and B Weisblum (1975). 
Construction of a Co'.icin El-R Factor 
Composite Plasmid In Vitro: Means for 
Amplification of Deoxyribonucleic Acid. ]. 
Bacteriol. 121. 354-362. 
4. Armstrong. K.A.. V. Hershfield. and D.R. 
Heiinski (1977). Cene Cloning and 
Containment Properties of Plasmid Co! El 
and Its Derivatives. Science 196. 172-174. 
5. Bolivar. F.. R.L Rodriguez. M.C. Betlach. 
and H.W. Boyer (1977). Construction end 
Characterization of Xew Cloning Vehicles : 1. 
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 Bacterid Plasmids in 
Vitro. Proc. Nall. Acad. Sci. USA 70. 3240- 
3244. 
7. Bolivar. F.. R.L. Rodriguez. R.J. Greene, 
M.C. Butlach. H.L Reyneker. H.W. Boyer. J.H. 
Cross and S. Falkow (1977). Construction 
and Characterization of New Cloning 
Vehicles: II A Multi-Purpose Cloning 
System. Cene 2. 95-113. 
8. Thomas. M.. ).R. Cameron, and R.W. 
Davis (1974). Viable Molecular Hybrids of 
Bacteriophage Lambda and Eukaryotic DXA 
Proc Nat. Acad. Sci. USA 71. 4579-4583. 
9. Murray, N.E.. and K. Murray (1974). 
Manipulation of Restriction Targets in Phage 
Lambda to Form Receptor Chromosomes for 
DXA Fragments. Nature 251. 476-481. 
10. Ramback. A., and P. Tiollais (1974). 
Bacteriophage Having EcoR! Endonuclease 
Sites Only in the Non-Essential Region of tht 
Genome. Proce. Nat. Acad. Sci.. USA 71. 
3927-3930. 
11. Blattner. FJL B.C. Williams. A.E. 
Bleche. K. Denr.is’.on-Thompson. H.E. Faber. 
LA. Furlong. D J. Gunwald. D.O. Kiefer. D O. 
Moore. J.W. Shumm. E.L Sheldon, and O. 
Smithies (1977). Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DXA Cloning. Science 196. 163-169. 
12. Donoghue. D.J.. ar.d PA. Sharp (1977). 
An Improved Lambda Vector Construction of 
Model Recombinants Coding for Konamycin 
Resistance. Cene 1 . 209-227. _ 
13. Leder. P.. D. Tiemeier and L Enquist 
(1977). EK2 Derivatives of Bacteriophage 
Lcmbda Useful in the Cloning of DXA from 
Higher Organisms: The \gt ,VES System. 
Science 196. 175-177. 
14. Skalka. A. (1978). Current Status of 
Coliphage X EK2 Vectors. Cene 3. 29-35. 
15. Szybalski. W . A Skalka. S. Cottcsman. 
A. Campbell, and D. Botstcin (1978). 
Standardized Laboratory Tests for EK2 
Certification. Cene 3. 36-38. 
Appendix J — Biotechnology Science 
Coordinating Committee 
The following excerpts from its 
charter (signed October 30. 1985) 
describe the Biotechnology Science 
Coordinating Committee: 
Purpose 
The Domestic Policy Working Group 
on Biotechnology has determined that in 
the area of biotechnology with its rapid 
growth of scientific discovery, scientific 
issues of interagency concern will arise 
frequently and need to be 
communicated among the various 
agencies involved with reviews of 
biotechnology applications. The Federal 
Coordinating Council for Science. 
Engineering, and Technology (FCCSET) 
established by 42 U.S.C. 6651 is an 
interagency science committee chaired 
by the Director of the Office of Science - 
and Technology Policy with the mission 
of coordinating science activities 
affecting more than one agency. 
Committees may be established under 
FCCSET for addressing particular 
science issues. Thus, the Biotechnology 
Science Coordinating Committee (BSCC, 
is established to provide formally an 
opportunity for interagency science 
policy coordination and guidance and 
for the exchange of information 
regarding the scientific aspects of 
biotechnology applications submitted to 
federal research and regulatory agencies 
for approval. 
Functions 
The BSCC will coordinate interagency 
review of scientific issues related to the 
assessments and approval of 
biotechnology research applications and 
biotechnology product applications and 
postmarketing surveillance when they 
involve the use of recombinant RNA. 
recombinant DNA. cell fusion or similar 
techniques. 
The BSCC will: 
(a) Serve as a coordinating forum for 
addresssing scientific problems, sharing 
information, and developing consensus: 
(b) Promote consistency in the 
development of Federal agencies’ 
review procedures and assessments; 
(c) Facilitate continuing cooperation 
among Federal agencies on emerging 
scientific issues; and 
(d) Identify gaps in scientific 
knowledge 
Authority 
To accomplish these functions the 
BSCC is authorized to: 
(a) Receive documentation from 
agencies necessary for the performance 
of its function; 
(b) Conduct analyses of broad 
scientific issues that extend beyond 
those of any one agency; 
(c) Develop generic scientific 
recommendations that can be applied to 
similar, recurring applications; 
(d) Convene workshops, symposia, 
and generic research projects related to 
scientific issues in biotechnology; and 
(e) Hold periodic public meetings. 
Members and Chairman 
The BSCC includes the following 
initial members: 
Department of Agriculture 
Assistant Secretary for Marketing and 
Inspection Services 
Assistant Secretary for Science and 
Education 
Department of Health and Human 
Services 
Commissioner. Food and Drug 
Administration 
Director, National Institutes of Health 
Environmental Protection Agency 
Assistant Administrator for Pesticides 
and Toxic Substances 
Assistant Administrator fer Research 
and Development 
National Science Foundation 
Assistant Director of Biological. 
Behavorial & Social Sciences 
The BSCC is chaired by the Assistant 
Director for Biological, Behavioral and 
Social Sciences of the National Science 
Foundation and the Director of the 
National Institutes of Health on a 
rotating basis. 
Administrative Provisions 
(a) The BSCC will report tc, the 
FCCSET through the Chair. 
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