Attachment II - Page 51 
Federal Register / 
The Agency-Based Scientific Advisory 
Committees 
The scientific advisory committees 
will provide detailed scientific review oT 
individual applications or issues that 
have been submitted to them by federal 
agencies. Five agencies (EPA, FDA, 
USDA, NIH, NSF) will sponsor these 
committees, which will be composed 
principally of members of the scientific 
community who possess demonstrated, 
recognized expertises in disciplines 
related to biotechnology. The NIH RAC 
will continue to serve as the scientific 
advisory committee for biomedical 
research, operating under procedures 
specified by the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. The National Science 
Foundation will establish and operate a 
scientific advisory committee to 
examine the potential effects of 
environmentally related basic research 
in biotechnology. That committee will 
examine questions arising from projects 
supported by NSF and any other 
research sponsors requesting its 
assistance. The activities of the NSF 
committee will build on the strong 
ecology and ecosystems research 
program currently operated by NSF. The 
committees chartered by FDA. USDA. 
and EPA will address mainly 
commerical applications. 
Each agency will promptly send to its 
advisory committee a summary of each 
application relating to recombinant 
RNA, recombinant DNA, or cell fusion 
submitted to it for funding or 
administrative review, regardless of 
whether the agency is requesting a 
scientific review. The advisory 
committees may decline to receive 
summaries, or to review, an individual 
proposal or class of proposals; for 
example, the NIH RAC has established 
guidelines which exempt from review 
some classes of experiments involving 
recombinant DNA molecules. Any 
agency of the federal government may 
request one or more of the scientific 
advisory committees to review its 
applications. The parent Biotechnology 
Science Board may also request that an 
agency direct its scientific advisory 
committee to review an application. Any 
applicant may submit to the head of the 
appropriate agency a request that its 
advisory committee review an 
application. 
When a review is completed, the 
committee will submit its report to the 
agency that requested the review. It will 
also send a copy of the report, redacted 
to delete confidential business 
information and supplemented with 
such additional nonproprietary 
information as is necessary to 
Vol. 49, No. 252 / Monday, December 31. 1984 / Notices 50905 
appreciate the scientific significance of 
the report, to the parent board for 
review and comment. 
All applications and committee 
reports containing proprietary 
information will be protected for 
confidentiality in accordance with the 
procedures-of the individual agencies 
requesting scientific review. All 
procedures will be consistent with 
agency security procedures, conflict of 
interest and advisory committee rules, 
and time constraints. 
The Biotechnology Science Board 
The parent board will be chartered by 
the Department of Health and Human 
Services and will report to the Assistant 
Secretary for Health. The membership 
will include two members from each 
agency-based scientific advisory 
committee (described above). The board 
will: 
• Receive from each agency a summary of 
each application relating to recombinant 
RNA, recombinant DNA, or cell fusion 
which is submitted to one of the agency- 
based scientific advisory committees; and. 
may make a request to the submitting 
agency that another committee or the 
parent board itself undertake a review of a 
specific proposal or classes of proposals. 
• Review committee reports, redacted and 
supplemented as stated above. 
• Evaluate review procedures set by the 
agency-based scientific advisory 
committees. 
• Conduct analyses of broad scientific issues 
involving rRNA, rDNA, or cell fusion and 
other processes as needed. 
• Develop generic scientific guidelines that 
can be applied to similar, recurring 
applications. 
• Provide a forum for public concerns. 
The board will operate under the time 
and confidentiality constraints set by 
the individual agencies; all 
recommendations of the parent board 
will be advisor to the committee and/or 
agency requesting review; and its 
charter would be subject to renewal 
after two years. 
.Glossary of Terms 
These definitions are meant to assist 
the reader. They are not to be 
considered binding legally on any 
Federal agency or nonFederal 
organization. 
Animal: Multicellular organism 
composed of eukaryotic cells with 
ingestive nutrition and lacking rigid cell 
walls and photosynthetic ability; 
members include coelenterates. 
flatworms, molluscs, segmented worms, 
arthropods, echinoderms. and 
vertebrates. 
Antibody: A protein (immuinoglobin) 
produced by humans or higher animals 
in repsonse to exposure to a specific 
antigen and characterized by specific 
reactivity with its complementary 
antigen. (See also monoclonal 
antibodies.) 
Antigen: A substance, usually a 
protein or carbohydrate which, when 
introduced in the body of a human or 
higher animal, stimulates the production 
of an antibody that will react 
specifically with it. 
Antiserum: Blood serum containing 
antibodies from animals that have been 
innoculated with an antigen. When 
administered to other animals or 
humans, antiserum produces passive 
immunity. 
Artificial selection: Techniques 
imposed on populations of organisms to 
favor the growth or multiplication of a 
particular organism. 
Attenuated vaccine: Whole, 
pathogenic organisms that are treated 
with chemical, radioactive, or other 
means to render them incapable of 
producing infection. Attenuated 
vaccines are injected into the host 
which then produces protective 
antibodies against the pathogen to 
protect against disease. 
Bacteria: Any of a large group of 
microscopic or submicroscopic, 
prokaryotic organisms having round, 
rodlike, spiral or filamentous, unicellular 
or noncellular bodies that are often 
aggregated into colonies, are enclosed 
by a cell wall or membrane, and lack 
fully differentiated nuclei. Bacteria may 
exist as free living organisms in soil, 
water, organic matter, or as parasites in 
the live bodies of plants, animals and 
other microorganisms. 
Biological control agent: Any living 
organism supplied to or introduced into 
the environment to control the 
population or biological activities of 
another life form. 
Biological product: A virus, 
therapeutic serum, toxin, antitoxin, 
vaccine, blood, blood component or 
derivative, allergenic product, or 
analogous product used for the 
prevention, treatment or cure of 
diseases or injuries. (Same as biological 
drug.) (For FDA's regulatory definition, 
see 21 CFR 600.3(h): for USDA's. see 9 
CFR 101. 2(w).) 
Biological response modifier: Generic 
term for hormones, neuroactive 
compounds, and immunoactive 
compounds that act at the cellular level: 
many are possible targets for production 
with biotechnology. 
Biologies: Vaccines, therapeutic 
serums, toxoids, antitoxins, and 
analogous biological products used to 
induce immunity to infectious diseases 
or harmful substances of biological 
origin. 
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