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2
THE WHITE HOUSE
WASHINGTON
Date: 10/11/90
TO: Ede Holiday
FROM:
STEPHEN I. DANZANSKY
Deputy Assistant to the President
and Director of Cabinet Affairs
This Bromley memo may provide some
background and light on the FCCSET
mandate and relationship with the
DPC & EPC.
It may be useful later if we get
into future "turf" battles on
jurisdiction.
Steve w
THE WHITE HOUSE
WASHINGTON
DQB has seen
February 16, 1990
2/17
MEMORANDUM FOR DAVID Q. BATES
FROM:
D. ALLAN BROMLEY Ama
SUBJECT:
FEDERAL COORDINATING COUNCIL FOR SCIENCE,
ENGINEERING AND TECHNOLOGY
Your memorandum of February 5, 1990 concerning the structure and operations of
the Federal Coordinating Council for Science, Engineering and Technology (FCCSET)
is greatly appreciated. Ken Yale's participation in the first FCCSET meeting on
January 24, and his subsequent conversations with Tom Ratchford on a variety of
issues related to FCCSET have also been immensely helpful. Clearly, it will be a
significant challenge to develop and coordinate truly national research programs from
various components in several agencies. However, the success of the FCCSET
Committee on Earth Sciences in the area of global change does, I believe, point the
way for other areas of research and development.
Although the primary responsibility of the FCCSET is to coordinate R&D among the
federal agencies, and the overwhelming fraction of the efforts of its committees will be
directed toward accomplishment of this mainly technical task, the FCCSET should
play a constructive policy role with respect to the Cabinet Councils. Below are some
preliminary thoughts on how this might be structured; I would be pleased to discuss
the issue with you in more detail, at your convenience.
The major policy role of FCCSET would be to provide expertise and analyses to the
DPC, EPC, NSC, as well as the Space and Competitiveness Councils. Typically the
issues would be very broad, with science and technology playing an important but
subsidiary role. In many - perhaps most - cases, the FCCSET could be tasked by the
appropriate council to provide analysis of a particular issue. In some cases,
alternative options might be analyzed by the appropriate FCCSET committee, in
response to specific requests by a council. In other cases - probably not very many -
a broad issue with mainly scientific and technological content might evolve to the
point of deserving consideration by a council.
What we need are effective ways for the councils to identify policy issues to be sent to
the FCCSET. With some thought and planning, I believe this can be done in an
operationally satisfactory manner.
2
Somewhat easier to conceptualize, is the process by which policy issues might
originate in FCCSET and be fed into the appropriate council. As FCCSET chairman,
and a member of EPC and DPC, it would be my responsibility to propose these
council agenda items.
The above discussion has focussed on what I call science and technology for policy:
i.e., making sure that the best science and technology (from the FCCSET) is made
available in a timely, "user friendly" manner to the policy fora (Cabinet Councils).
An example of this is the input of the FCCSET Committee on Earth Sciences to the
DPC Climate Change Working Group.
In addition to science and technology for policy, there is also a need, in some cases,
to provide policy for science and technology. This class of issues typically is not
important enough - on the national scale - to earn attention from a Cabinet Council,
and could be resolved directly by the FCCSET. An example of this class of issues is
the setting of priority among and within areas of basic research.
I am convinced that FCCSET, properly organized and functioning smoothly, will make
a significant difference in the coordination and priority setting within federal science
and technology programs. This is the primary responsibility of OSTP and of
FCCSET as set forth in our founding legislation. FCCSET can also be a useful
adjunct to the primary policy fora, and we look forward to working with you to see
that this is done in the most effective manner possible.
Document No.
CA
OFFICE OF CABINET AFFAIRS STAFFING MEMORANDUM
Date:
4-18-90
Due by: --
FCCSET Formation -- File memo update
Subject:
Ken Yale
From:
ACTION CONCUR FYI
ACTION CONCUR FYI
BATES
JACKSON
DANZANSKY
MCBEE
ADAIR
SCHALL
BUCHHOLZ
WETHINGTON
\
D'ANDREA
WILLIAMSON
DEWITT
YALE
DUGGAN
EVANS
FARRAR
HEIMBACH
Comments:
OliN-
Presessemo on thir
the
THE WHITE HOUSE
WASHINGTON
April 18, 1990
MEMORANDUM FOR THE FILES
SUBJECT:
FCCSET Formation
BOTTOM LINE: The Federal Coordinating Council on Science,
Engineering and Technology is in the process of completing the
formation of its committee structure. Actions need to be taken now
to ensure appropriate coordination with the new structure.
BACKGROUND: You will recall that, at the last FCCSET meeting
(March 14), Dr. Bromley asked for the names of suggested
chairpersons for each committee. Since then, the membership and
structure of 7 committees have been created (see attached list).
Charters are being prepared for all the committees, and they
will be sent to Dr. Bromley by the end of the week. There will be
a meeting on April 24 (Tuesday) of all the committee chairmen to
discuss the charters and make any necessary changes. The charters
will then be tabled at a meeting of the full FCCSET on April 30 for
final approval. It is then planned that the charters will be
published in the Federal Register, possibly with the names of the
members.
Staff of FCCSET have stated that the charters will not be made
available for review until the FCCSET meeting. Of course, at that
time there may be no way to make appropriate changes. In addition,
it is difficult to determine whether the activities contemplated
by the FCCSET Committees will overlap or conflict with other
interagency working group activities. Finally, absent any movement
to form or convene the Cabinet Council Science and Technology
Working Group, there may be a natural tendency for the FCCSET
committees to take up the issues more appropriate to the Working
Group.
RECOMMENDATION: The Science and Technology Working Group charter
should be prepared, Dr. Bromley could announce formation of the
Working Group in the FCCSET and other meetings, and meetings of the
Working Group should be started as soon as possible, to show there
is a viable process for taking issues to the Cabinet Councils. In
addition, The EPC and DPC executive secretaries should be able to
participate in the April 24 meeting to ensure adequate coordination
on issues with FCCSET. We should also request copies of the
charters, to ensure they do not inadvertently conflict with DPC and
EPC charters and activities.
SENT BY:Xerox Telecopier 7021 ; 4-11-90 ; 3:12PM ;
2023953462-
CABINET AFFAIRS.# 0
FEDERAL COORDINATING COUNCIL
FOR SCIENCE, ENGINEERING & TECHNOLOGY
COMMITTEES
MARCH 1990
Earth and Environmental Sciences
Chairman: Dallas Peck, Director, US Geological Survey, Department of the
Interior
Vice Chairmen: Erich Bretthauer, Assistant Administrator for Research,
Environmental Protection Agency
Lennard Fisk, Associate Administrator for Space Science and
Applications, National Aeronautics and
Space Administration
OSTP Liaison Member: James B. Wyngaarden, Associate Director for Life
Sciences
Education and Human Resources
Vice Chairmen: Ted Sanders, Deputy Secretary, Department of Education
Chairman: Adm. James Watkins (Ret.), Secretary, Department of Energy
Luther Williams, Senior Science Advisor, National Science
OSTP Liaison Member: J. Thomas Ratchford, Foundation Associate Director for Policy
and International Affairs
Food, Agriculture and Forest Research
Chairman: Charles Hess, Assistant Secretary for Science and Education,
Vice Chairmen: David O'Neil, Assistant Secretary for Land and Minerals
Department of Agriculture
Management, Department of the
Interior
James Benson, Acting Commissioner, Food and Drug
Administration, Department of Health
and Human Services
OSTP Liaison Member: James B. Wyngaarden, Associate Director for Life
Sciences
REVISED 4/4/90
SENT
International Science and Engineering
Chairman: Reginald Bartholomew, Under Secretary for Security Assistance,
Science and Technology, Department of
State
Vice Chairmen: Fred Bernthal, Deputy Director, National Science Foundation
Philip Schambra, Director, Fogarty International Center,
National Institutes of Health,
Department of Health and Human
Services
OSTP Liaison Member: J. Thomas Ratchford, Associate Director for Policy
Life Sciences and Health
and International Affairs
Chairman: James O. Mason, Assistant Secretary, Department of Health and
Human Services
Vice Chairman: David Galas, Associate Director for Health and Environmental
Research, Office of Energy Research,
OSTP Liaison Member: James B. Wyngaarden, Associate Director for Life
Department of Energy
Sciences
Physical, Mathematical and Engineering Sciences
Chairman: Erich Bloch, Director, National Science Foundation
Vice Chairman: Charles Herzfeld, Director Defense Research and Engineering,
Department of Defense
OSTP Liaison Member: Eugene Wong, Associate Director (designate) for
Technology and Industry
Physical Sciences and Engineering
Chairman: Thomas Murrin, Deputy Secretary, Department of Commerce
Vice Chairman: J.R. Thompson, Deputy Administrator, National Aeronautics
and Space Administration
OSTP Liaison Member: William D. Phillips, Associate Director (designate) for
Industrial Technology
SET
THE WHITE HOUSE
WASHINGTON
Date: 3-12-90
TO:
KEN YALE
FROM:
STEPHEN I. DANZANSKY
Deputy Assistant to the President
and Director of Cabinet Affairs
I have forwarded to Olin for
a look at the tax policy aspects.
By focusing on S&T working groups
on the broader aspects of small
S&T entrepreneurs, we can preempt
the bio-tech field.
CC: Olin Wethington
THE WHITE HOUSE
WASHINGTON
March 9, 1990
MEMORANDUM FOR THE BIOTECHNOLOGY WORKING GROUP of the
COUNCIL ON COMPETITIVENESS
FROM:
LARRY LINDSEY, Chairman, Finance Subgroup
SUBJECT:
Preliminary Report
To date we have elicited the views of biotechnology experts
from two very different firms. Jim Sherblom, Chief Executive
Officer of Transgenic, expressed the views of a small firm which
concentrates uniquely on biotechnology products. The other, Bob
Fraley, Director, Plant Science Technology, Monsanto Agriculture
Company, reflected the views of a large, diversified firm in
which biotechnology plays a minor, albeit significant, part.
We found many of the problems faced by these two firms to be
similar. However, there were significant differences in their
views on a number of key policy issues. Our analysis therefore
focusses on this dichotomy: general problems of the industry and
unique problems of small firms. A key effect of any policy
decision will be the structure of the biotechnology industry.
We consider several possibilities in the conclusion.
Industry Wide Challenges
Public Acceptance and Demand for Biotechnology Products. It
goes without saying that all of the incentives and regulatory
relief in the world will not help an industry whose product does
not enjoy widespread public acceptance. At present, the
biotechnology industry faces widespread public resistance, based
primarily on ignorance, but fanned by some anti-technology
extremists. Furthermore, the problem of public acceptance is
international in scope. We can draw several conclusions from the
evidence presented on this problem.
Federal regulatory policy has failed in its mission.
Ideally, regulation should both protect and reassure
the public. There is evidence that the existing
regulatory apparatus goes to great lengths to protect
the public. Yet, the public does not believe that
approved products are safe and effective. Public
acceptance of a regulated technology is inherently an
economic "public good". The federal government
therefore has an obligation to take positive steps to
increase public acceptance of biotechnology.
Public acceptance is likely to grow, but the next few
years are critical. Young people are now being exposed
to the concept and practice of biotechnology early in
their educations. High school biology experiments now
include cloning a gene from yeast. But, international
competition is such that an unfavorable economic and
regulatory environment in this country is likely to
cause America to lose its technological edge in this
key industry.
The issue of public acceptance can be manipulated as a
trade policy tool. The recent example of the EC
banning U.S. beef is an example of what can happen to
biotechnology products. Other nations can ban or
create informal barriers such as labelling and
inspection requirements which limit access to American
biotechnology products. In the meantime, their
domestic biotechnology industries can develop. These
restrictions can then be removed when their domestic
industries are able to withstand U.S. competition. Our
trade representatives should be aware of this strategy
and take aggressive action to protect foreign markets
for U.S. products.
Intellectual Resources. The need for increased funding for
the training of our future biologists is clear, and was
recognized in the President's budget. Emphasis is also needed on
adequately training students at the elementary and secondary
levels. President Bush and the nation's Governors have jointly
established goals, one of which is to make American high school
graduates number one in math and science by the end of the
century. In addition, we face a potential problem in that a
significant percentage of the graduate students and professors in
the biological sciences are citizens of other nations.
O
The government should continue the commitment evidenced
in the President's budget to encourage excellence in
America's scientific education. It is incumbent upon
the Congress to enact the President's Education
Excellence bill, proposed last year. Furthermore,
states must continue to emphasize quality and
accountability of students, teachers, parents, and
local school officials.
Federal immigration policies should consider the need
to retain our competitive edge in biotechnology.
America has always had an open door policy to students
wishing to study in American universities. Our
universities continue to be a major "export earner" by
attracting individuals from all over the world. Many
of these people stay in America and contribute to
American industry. While little can or should be done
to restrict the return of those who want to go back to
their native lands, American immigration policy should
allow those who can make a major contribution in this
important field to stay here if they wish.
Adequate Protection for Intellectual Property. Improvement
is clearly needed both in our own patent office, but particularly
abroad. The Administration is committed to pursuing the
protection of intellectual property in the current GATT
negotiations in Uruguay as a top priority.
Improvements at the U.S. Patent Office Should Be
Continued. The adequacy of personnel at the Patent
Office has been questioned. Clearly, increased
resources will be needed in the biotechnology field
as the industry continues to grow.
International cooperation in patenting should be
considered. It is difficult and expensive to obtain
patents in every country. Efforts should be made to
harmonize patent rules and testing requirements.
Ideally, patents granted by one major country (the U.S.
or Japan) should be accepted internationally.
Specific Challenge Facing Small Biotechnology Companies
Discriminatory Tax Rules. The Tax Reform Act of 1986
specifically "tilted the playing field" against small start up
ventures. Biotechnology firms were particularly adversely
affected by these changes. Some are being addressed by the
Administration. Other changes should be considered.
Capital Gains. Jim Sherblom of Transgenic said that, A
principal aid to the biotechnology industry, and small
firms in particular, would be the passage of a capital
gains tax rate reduction. Investors in start up
biotechnology firms are high-risk investors who must
tie up their funds for an extended period of time. He
noted that his fellow entrepreneurs were all
enthusiastic about the Administration's proposed
capital gains tax rate reduction at their last meeting
with investors. Large firms are less reliant on
informal investors and on equity generally and
therefore will tend to benefit less from a capital
gains tax rate reduction.
Stock Options. Risk accrues not only to suppliers of
capital, but also to entrepreneurs and managers.
Compensation for this extra risk is important.
Biotechnology firms use Stock Options as a form of
compensation for many, if not most, of their employees.
These options take on added value if the capital gains
tax rate is reduced. This helps small biotechnology
companies attract talented personnel. Some changes now
being considered in Congress would make these less
attractive. Stock options are also used by small firms
to attract people from larger firms. Therefore, larger
firms tend to less than enthusiastic about this as a
device.
Asymmetric Treatment of Profits and Losses. Losses may
be carried forward for up to 7 years. But, the average
development time for a new biotechnology product is
often longer than this. In addition, even if the firm
becomes profitable before the end of the 7 year period,
the time value of the tax loss is substantially reduced
in the interim. This is much less of a problem for
large, integrated firms who often have highly
profitable divisions which can offset their losses in
developing biotechnology products.
Limits on the Research and Experimentation Credit. The
credit, like losses, may be carried forward for only 7
years. The firm can only use this credit if it has tax
liability. So, the credit can only become applicable
if the firm is profitable after it has exhausted any
existing loss carryforwards. Thus, many biotechnology
firms lose their credits entirely. Others which may
receive the credit receive it only at a sharply reduced
present value. Again, large firms with profitable
divisions can receive the benefit of the credit
immediately.
Transfers of Assets. These problems are exacerbated
when a biotechnology firm is sold, or even goes to
market with a new equity offering. The Tax Reform Act
of 1986 limited the transferability of tax loss carry
forwards if more than 50 percent of the equity in a
firm changes hands. Thus, rapidly growing
biotechnology firms might lose this tax advantage.
Good Will. Biotechnology firms are also penalized by
the contrasting IRS and FASB treatments of good will.
Most of the value of a biotechnology firm is intangible
-- the human capital of the employees. FASB rules
require that this be depreciated, thus lowering the
apparent earnings of the firm. IRS allow no deduction
for this depreciation. Therefore, biotechnology firms
face the twin problem of lower apparent earnings and
higher taxes.
Public Policy and Industry Structure
Large integrated firms have inherent advantages at bringing
new products to market. These include access to capital and
expertise in manufacturing and marketing. On the other hand, a
good case can be made that small biotechnology firms have an
inherent advantage at developing new products and new ideas.
Their advantages include an increased effort by employees who
feel part of a small team and who benefit greatly from their
success as well as a less bureaucratic and more entrepreneurial
company ethos. This leads to a number of observations.
1. Ideally, the market structure of the industry should include
both small and large firms. Small firms can be the
industry's inventors and innovators while larger firms will
bring these inventions and innovations to market.
2. We should expect corporate buyouts in the industry. When a
small firm has developed a product, it is natural for the
firm to be acquired by a larger firm with expertise in
manufacturing and marketing. A free market for corporate
control is therefore probably beneficial to the
competitiveness of the industry.
3. Public policy should not tilt in favor of either small firms
or large firms. On the one hand, aggressive and myopic anti
trust enforcement is totally inappropriate. It will be
natural for monopolization to occur in narrowly defined
market niches as the industry grows. Joint production and
research ventures should be encouraged as a way of
minimizing capital costs and risks.
On the other hand, the current tax law bias against small
firms may cause an overconcentration in the industry and an
excessive reliance on large, diversified manufacturers.
These larger firms may not place sufficient emphasis on
their biotechnology divisions. We should consider tax law
changes to help level the playing field between large and
small firms in this area.
3/9/90
SCIENCE AND TECHNOLOGY TASK FORCE
OF THE WORKING GROUP ON BIOTECHNOLOGY
OF THE COUNCIL ON COMPETITIVENESS
A number of recommendations were made by the Task Force to strengthen the
fundamental research that supports the new biotechnology as well as the more
distal scale-up steps, all of which are depicted in Fig. I. Particular
emphasis was directed to research and training needs that will be essential
to support this field from discovery to marketplace. A key element in the
plan is enhanced cooperation among academia, government and industry in
multidisciplinary and multi-institution research and training, coupled with
sufficient support to enable investigators and trainees to have adequate
equipment required to be competitive in sustaining and enlarging our expertise
in this field.
A.
Molecular Biology and Cloning
Problem: Funding basic research on merit, the United States was the pioneer
in the development of rDNA technology that fostered the new biotechnology.
However, after a period during which NIH was funding approximately 40% of
approved grants, the funding of approved grants for basic biomedical sciences
decreased to approximately 24% in FY 90. One implication of this shortfall
is that a substantial amount of pre-commercial research is going unfunded and
unperformed in the United States. In meeting these needs, it is important
that Federal Government funds are leveraged with appropriate monies from
academe, industry, and state governments. Remedies for these problems would
enable us to expend resources on the development of model systems for cloning
of genes; expression of newly acquired genetic information; characterization
and sequencing of DNA, RNA and proteins; genetic research on physiological
processes such as post-translational secretion, intracellular transport
mechanisms, and processing events; and biocomputation and information
management systems to store and analyze large amounts of sequence information.
Similar deficiencies in training programs and shortages of practicing
scientists exist in biotechnology-related scientific fields, according to
surveys by NSF and the Industrial Biotechnology Association [the former is
shown in Appendix 1].
Solutions:
o
Enhance the support of molecular genetics, molecular biology, physical
chemistry, immunobiology, and information management. Particular
emphasis should be directed towards the development of multidisciplinary
research efforts, particularly the integration of the biological,
engineering and physical sciences. Specifically, areas of emphasis
should include: studies of model organisms used as hosts for expression
of cloned gene products and mechanisms of their post-translational
03:41 PM *PHS EXEC SEC
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2
modification, transport, and secretion; protein engineering; protein
folding/chemistry, and analyses of three-dimensional structure; ligand-
receptor interactions; biocomputation, informatics, and computer
modeling of complex structures and processes, including intercellular
communication.
o
To ensure a sufficient supply of broadly educated trainees, the
Government should enhance the training of scientists in the biomedical,
bioengineering, and agricultural fields in an interdisciplinary fashion.
As exemplified by the integration of molecular biology into many of the
other scientific fields constituting "biotechnology," the boundaries are
disappearing between the various fields in the biological sciences, and
it is now time to integrate the engineering and physical chemistry
disciplines with the biological sciences that are at the core of
biotechnology. Existing USG responses to this need include NIH/NIGMS
interdisciplinary predoctoral and postdoctoral research training
programs in biotechnology and NSF interdisciplinary predoctoral
programs. These should be expanded within NIH and NSF and instituted
in other funding agencies (USDA, DOE). Moreover, additional
multidisciplinary centers should be established in universities that
combine these different fields and wherever possible, different
institutions as well. These would build on the models of the existing
NSF programs of engineering research centers and science and technology
centers [Appendix 21. Particular attention should be directed to the
melding of the biological, physical, engineering and information
management sectors.
o
Improve quality of equipment in university laboratories -- state-of-
the-art computers, bioreactors, computer-assisted separation systems,
sequencers, polymerase chain reactor devices, and DNA synthesizers.
This could be accomplished in part by the expansion of highly cost-
effective shared equipment grants.
Problem: Specific gaps exist in our understanding of model systems that can
be used generically to augment the knowledge base required for the first, pre-
competitive stages of product development.
Solutions:
o
Improved understanding of gene expression in a number of model systems
likely to be used in scale-up is essential, and these systems should be
a focus for increased resources. These should include (but not be
limited to) Escherichia coli, Saccharomyces cerevisiae, Bacillus
subtilis, Agrobacterium tumifaciens, Rhizobium species, RNA
retroviruses, Arabidopsis, hybridomas and plant protoplasts, and
established mammalian and Lepidopteran cell lines.
o
Fundamental research on factors that affect the technical aspects of
scale-up; 8.8., factors affecting cellular growth and gene expression
in liquid phase and solid/liquid phases of cell growth.
03. 08. 90 03:41 PM *PHS EXEC SEC
P04
3
o
Fundamental research in structural biology, including protein structure-
function relationships; and analysis of metabolic pathways that
influence expression of newly acquired genetic information.
B.
Scale up from the Laboratory to the Marketplace
Problem: Insufficient research on large scale development, including protein
engineering, separation sciences, stability/purification/recovery of proteins,
bioprocess and biochemical engineering, and bioreactor design.
Solutions:
o
Fundamental model system work on parameters that influence scale-up,
such as cellular shear, regulation of gene expression, and mechanical
requirements for growth. This would inspire innovative ways to produce
cells in solid matrices or in aggregates, and general principles to
optimize product secretion or crystallization. Much of the technology,
particularly in human and animal cells, is more than 30 years old,
cumbersome and inefficient; for example, roller bottles and spinner
flasks are still used in the commercial-scale production of
biotechnology products from cultured mammalian cells. It 18 important
to undertake research on new methods for growing cells that can be
applied to other systems. Progress in the development of superior
bioreactor systems could enable rapid increases in cost-efficiency.
This is especially important in the production of amino acids, enzymes,
solvents and pharmaceuticals.
o
Downstream purification is extremely important in obtaining high quality
products from fermentation. Fundamental research that will complement
that in the private sector may be required for improvements in the
purification of proteins, glycoproteins and other macromolecules.
Consideration should be given to developing new procedures in
purification, such as the use of immunological reagents, absorption to
complex matrices, and large-scale fractionation. Such research merges
the physical, engineering and biological sciences.
o
State-of-the-art instrumentation, including robotics, biosensors, and
automated analytic, sequencing, and synthesis technologies is essential
throughout the spectrum from laboratory to marketplace; it must be made
available to investigators and updated periodically.
o
Development of multidisciplinary training centers in biomechanical
engineering in universities to catalyze interaction among the physical,
engineering, and biomedical sciences. Particular emphasis should be
given to the provision of adequate equipment that will enable both
faculty and students to model research on the processes involved from
laboratory scale to intermediate scale fermenters (500 liters) and where
03. 08. 90 03:41 PM *PHS EXEC SEC
500
4
appropriate, to larger scale fermenters. These large multidisciplinary
training grants should, wherever possible, have joint funding from
academia, government and industry to leverage governmental investment
and to foster intermingling of personnel among the various sectors.
Training should be encouraged beyond geographic and university
boundaries.
C. Non-scientific factors influencing innovation in and commercialization
of biotechnology
Problem: Incipient regulations on conflict of interest are on a potential
collision course with the technology transfer policy of the USG. Because
conflict of interest policy will involve university, industry and government
scientists, it is imperative that it receive careful analysis by the working
group.
Solution: The Federal Technology Transfer Act, enacted in 1986, encouraged
closer interaction between government-supported and governmental scientific
investigators and industry. While there has been a marked increase in the
frequency of interaction between these scientists and industry, few problems
have been identified. One issue of concern is developmental research that
leads to commercial applications such as clinical trials for pharmaceuticals
and devices and field testing for agrochemicals; this pre-commercial testing
could emerge from joint ventures or collaborations. Because there is
continuity of ressearch between discovery and patent, it is recommended that
disclosure be limited to situations in which patents are pending or have been
issued such as pharmaceutical agents used in clinical trials. This would not
effect the basic research phases of discovery and development.
Problem: Developments that could discourage the necessary use of animals in
research.
Solution: Guidelines should be developed for the ethical use of animals that
include substantial penalties for the disruption or destruction of laboratory
facilities or research.
Problem: Critics of the Small Business Innovation Grant program have
suggested that the Government's passive administration of this program may
have led to substantial underutilization of its resources.
Solution: While examples of successful biotechnology SBIR grants shown in
Appendix 3 indicate that this mechanism works, its efficiency should be
evaluated to determine whether the funds can be utilized more effectively to
bridge the gap between innovation and production in the field of
biotechnology. This reutilisation could be directed at some of the solutions
enumerated in this document.
03. 08. 90 03:41 PM *PHS EXEC SEC
FUD
5
D. Federal Technology Management
Problem: The Federal Technology Transfer Act (FTTA) mandated the facilitation
of technology transfers between federal laboratories and the private sector.
This was intended to enhance the return to taxpayers from the investment in
federal research programs. Concerns have been expressed about the level of
use and effectiveness of the new programs developed under the Act.
Solution: Implementation of the FTTA should be reviewed and coordinated to
enhance the efficiency of information exchange and technology transfer.
APPENDIX I
Table A-1. Occupational Employment in Dedicated Biotechnology
Companies, 1989
Planned
Total Shortage Hires
Total
Employed as % of as % of
Occupation
Employed
Ph.D.s Employed Employed
BIOTECHNOLOGY SPECIALTIES
Molecular Genetics
724
340
2.7%
13.8%
Classical Genetics
42
20
5.1%
15.3%
Industrial Microbiology
311
72
9.8%
29.3%
General Microbiology
665
248
1.2%
10.1%
Human/Animal Cell Biology
471
198
3.0%
10.1%
Plant Cell Biology
86
45
4.5%
13.4%
Human/Animal Molecular Biology
508
309
9.7%
21.7%
Plant Molecular Biology
90
55
3.7%
11.0%
Human/Animal Biology
246
87
3.4%
11.5%
Plant Biology
42
25
4.0%
15.8%
Pharmacology
209
93
11.9%
25.9%
Toxicology
73
17
17.8%
29.7%
Enzymology
81
59
11.9%
27.2%
Immunology
532
216
7.9%
20.8%
other piology
154
39
2.5%
15.3%
Analytical Biochemistry
377
156
3.9%
20.5%
General Biochemistry
1042
498
6.0%
17.7%
Other Chemistry
1397
644
5.0%
21.7%
Other Biotechnology Specialties
369
163
3.7%
43.0%
TOTAL
7420
3282
5.4%
19.4%
OTHER SCIENTISTS
Medical Science, MD
66
0
0.0%
0.0%
Medical Science, non MD
104
18
0.0%
65.8%
Health Physics
3
0
0.0%
0.0%
Agricultural Sciences
73
27
3.8%
3.8%
Other Physical Sciences
191
43
11.5%
16.1%
Behavioral/Social Sciences
310
67
3.0%
3.0%
Computer Sciences
655
59
1.7%
1.7%
Mathematics
115
31
22.7%
16.2%
11.4%
TOTAL
1517
246
6.5%
TOTAL SCIENTISTS
8937
3527
5.5%
18.8%
ENGINEERS
Biocnemical Engineer
170
0
9.1%
30.6%
Bioengineer
279
0
14.6%
25.6%
Bioprocess Engineer
115
0
3.7%
50.0%
Other Engineers
2337
0
2.0%
12.4%
TOTAL ENGINEERS
2901
0
3.7%
16.4%
TOTAL TECHNICIANS
5597
0
3.6%
19.4%
OTHER EMPLOYMENT
36550
TOTAL EMPLOYMENT
53985
NOTE: Shortages and new nires for engineers and tecnnicians are
computed on total employment; for scientists the base is Ph.D.
employment. Shortages are defined as unfilled vacancies for 90
days or longer.
SOURCE: NSF Survey of Dedicated Biotechnology Companies, 1989.
100
APPENDIX II
Industry University Cooperative Research Centers
-
University of Maryland-life cycle engineering
-
University of North Carolina/Duke University-monoclonal
lymphocyte technology
-
University of Texas Health Sciences Center-cell
regulation;
Biological Research Center
-
Johns Hopkins University-biophysical studies on
macromolecular assemblies;
Plant Science Center
-
Cornell University-experimental analysis and transfer
of plant genes.
Science and Technology Centers
-
California Institute of Technology-Center for
Development of an Integrated Protein and Nucleic Acid
Biotechnology-a collaboration between the Caltech and
industry for the development of the most advanced
techniques for genetic engineering, protein
engineering, protein chemistry, and data analysis in
order to speed research in protein and gene regulation.
-
Michigan State University-Center for Microbial Ecology-
a university-industry research program devoted to
understanding of microorganisms and their function in
their natural and man-made habitats by focusing on gene
pool accessibility, population diversity, community
diversity, novel organisms, physicochemical environment
as related to improvement in groundwater quality,
hazardous waste disposal, plant pest control, recycling
of nutrients, fermentation, and other industrial
processes, the development of safe genetically
engineered organisms.
Engineering Research Centers
-
Duke University and other North Carolina institutions
and industries-Center for Emerging Cardiovascular
- 2 -
Technologies-a university, biotechnology, industry,
state of North Carolina, and NSF and NIH funded Center
devoted to creation of the knowledge needed to design
and produce a new generation of advanced biomedical
systems, devices, and instruments for cardiac
intervention systems and cardiovascular imaging
systems,
-
Massachusetts Institute of Technology and biotechnology
industries-Biotechnology Process Engineering Center-a
Center focusing on integrating the life sciences and
bioprocess engineering with the goal of producing
advanced manufacturing technologies. Research thrusts
are:
(a) genetics, molecular biology, and biochemical
principles in protein production;
(b) engineering principles in protein production;
(c) downstream processing in biotechnology.
- Montana State University-Center for Interfacial Microbial
Process Engineering-a collaboration between the
university, relevant industry, and the Department of
Energy's Idaho National Engineering Laboratory addressing
microbial phenomena related to degradation of hazardous
substances and microbial processes in fouling and
corrosion.
For these centers organized to address complex problems requiring
scale, duration, facilities , and collaborative relationships
that best accommodate the overall research objectives, there is,
nonetheless, an explicit education and human resource development
component.
APPENDIX III
Representative Cooperative Research and Development Agreements
(CRADS) of NIH
As
A successful collaboration between NIH intramural scientists
and Integrated Genetics, Inc. resulted in the first report
of the production of a biologically active human therapeutic
protein in the milk of laboratory mice.
An American Pharmaceutical company is collaborating with
National Cancer Institute investigators on studies to
produce large amounts of recombinant uromodulin, an
immunosuppressive protein shown to have a role in regulating
the circulating levels of biological response modifiers
(interleukin-1, tumor necrosis factor), via recombinant DNA
technology, for subsequent evaluation of its clinical
usefulness.
Several pharmaceutical companies and NIH scientists are
collaborating in studies of the autocrine motility factor, a
protein produced by certain cancer cells and found to play
an important role in the process by which cancer cells
invade distant sites in the body, with the goal of
identifying therapeutic agents that inhibit this motility
factor; thereby facilitating the localization of metastases
and allowing predictions of the aggressiveness of a
particular cancer in an individual patient.
NIH investigators and those of several biotechnology
companies are focusing on the production of immunotoxins
(i.e., a monoclonal antibody attached to a toxin) for: (a)
preliminary treatment of adult T-cell leukemia; (b)
inhibition of ovarian cancer cells; and
(c) the construction of modified immunotoxins with increased
effectiveness in cancer treatment.
In another NIH-industry collaboration, biotechnological
studies have resulted in the identification of the gene
encoding for the membrane protein responsible for the
selective transport of drug often used in cancer
chemotherapy. It is now possible to develop molecular (DNA)
probes that will detect the presence of this gene and
thereby allow the development of a new generation of
chemotherapeutic agents (drugs) that are not affected by the
membrane transport protein, thus leading to the absence of
drug resistance.
NIH scientists cooperating with researchers at Genentech
- 2 -
have produced large quantities of osteogenic, a protein bone
growth factor presumed to be important in effective
regeneration of bony tissues of the head and face, for much
needed medical applications.
O
In a landmark achievement in hematologic research,
NIH-sponsored scientists collaborated with AMGEN, to clone
the gene for erythropoietin, the major hormonal regulator of
red blood cell production. Currently, large scale
production of the commercially available biotechnology
product had made provisions for effective treatment of
chronic anemia.
O
NIH scientists played major roles in developing of an
experimental HIV vaccine, which is being developed by a
biotechnology firm.
DRAFT
REPORT ON
REGULATORY ISSUES
Regulatory Task Force
Working Group on Biotechnology
Background
Where private markets fail to provide adequate incentives to
avoid unreasonable risks, appropriate levels of regulation can
protect public health and environmental welfare, enhancing safety
and increasing public confidence in these new technologies. In
these circumstances, regulation can shield the industry from
avoidable incidents that could tarnish its image and impair its
development. In 1986, a coordinated Federal effort set out the
groundwork for achieving the delicate balance between encouraging
innovation in biotechnology while protecting public health and
the environment from unreasonable risk. 1
The Coordinated Framework established a roadmap for Federal
regulation of biotechnology, and incorporated the principle that
1 "Coordinated Framework for Regulation of Biotechnology;
Announcement of Policy and Notice for Public Comment,"
51 FR 23302.
-2-
regulation should focus on the characteristics and risks of an
organism, not the process used to produce it. Based on the
principles outlined in the Coordinated Framework, the Food and
Drug Administration (FDA) announced that it did not need to
establish any new procedures for genetically-engineered products.
FDA's review of products is based on case-by-case review of risks
and use. However, the other two major regulatory agencies -- the
Environmental Protection Agency (EPA) and the Department of
Agriculture (USDA) -- announced that they would need to develop
additional rules. USDA proposed to develop new rules in some
areas for reviewing genetically-engineered organisms and products
that could pose high risks (e.g., plant pests, viruses, etc.).
EPA also proposed to develop new regulations for the review of
microorganisms that are likely to pose risks. Figure I
illustrates the intervention points for likely Federal regulatory
review in the course of research and development of biotech
products.
Regulatory Barriers to Innovation in Biotechnology
In serving as "gatekeepers" for the development and use of new
biotechnology products, however, regulatory agencies may create
substantial regulatory uncertainty associated with both the
potential for delay in regulatory approval and the possible
imposition of extensive restrictions or outright disapproval of
new biotech products. Both delay and regulatory uncertainty can
serve to discourage new research in regulated areas as well as
curtail the development of new products. Industry
-3-
representatives reported to the Task Force, for example, that
corporate strategies are increasingly based on avoiding rDNA
approaches because of both the direct regulatory costs and the
uncertainty associated with regulatory review of products using
these techniques. 2 These indirect "costs" of regulatory agency
review can substantially outweigh the direct costs associated
with the testing and paperwork requirements for regulatory agency
approval and the regulatory restrictions placed on development,
manufacture, and use of products.
The effects of regulatory delay can be particularly devastating
to small firms because, as relatively high-risk investments, they
face very high costs for obtaining capital investment. But even
larger, well-established corporations require substantially
larger expected future profits to pursue research in areas where
there are burdensome regulatory requirements and the criteria for
review are open-ended. As a result, the level of regulatory
review necessary to consider properly the potential risks must be
carefully constructed and monitored to avoid excessive
2
Dr. Nanette Newell, Synertech. There are similar reports in the
press; for example, a Vice President of Biotechnica International
Inc., reported that because of regulatory delay in approval of
field testing the company has turned away from experimenting
with altered genes and is working instead with less stringently
regulated mutant genes, thus, sacrificing scientific accuracy to
reduce bureaucratic delay." Wall Street Journal, January 30,
1989.
-4-
restrictions that curtail the benefits to society of
biotechnology.
Principles of Regulatory Review
1. Federal government regulatory oversight should focus on the
characteristics and risks of the biotech product -- not the
process by which it is created.
-- Where biotech products pose little or no risk,
appropriate exemptions from regulatory review should be
made for both testing and commercialization. A focus on
specific products (or classes of products) that may pose
risks concentrates regulatory oversight on areas of
concern and leaves relatively unfettered those
biotechnology products posing little or no risk.
2. Where products require review, regulatory review should be
designed to minimize regulatory delay while assuring
protection of public health and welfare. Lengthy and
cumbersome review procedures can result in an impenetrable
regulatory process that stifles innovation.
-- Where possible, expedited review procedures should be
adopted for products likely to pose lesser risk.
Tailoring the review process to the level of risk posed
by the product assures protection of public health and
the environment while minimizing regulatory delay.
-5-
-- The jurisdiction of the several regulatory agencies
should be clarified to avoid unnecessary confusion and
delay.
3. Regulatory programs should be designed to accommodate the
rapid advances in biotechnology.
-- Regulatory procedures should provide flexibility to
accommodate a rapidly changing science base in
biotechnology. Performance-based standards are generally
preferred over design standards. A performance standard
sets the ends or goals to be achieved, rather than
specifying the means to achieve it (e.g., through a
design standard). This provides firms with flexibility
3
in choosing the best means of compliance.
-- In addition, properly defined performance criteria can
more readily adapt to advances in the science and
accommodate changes in regulatory scope with the
accumulation of experience in biotechnology. The
adoption of performance criteria in the regulatory
process reduces the need to rely on a lengthy and
contentious regulatory process to revise regulations.
3 A performance-based standard for containment, for example, would
provide a far more flexible approach that would allow biological
approaches for assuring containment in place of a design-based
standard requiring, for instance, specific physical barriers.
-6-
Such unwieldy regulatory processes inevitably inhibit the
changes in regulatory structure needed to accommodate
advances in the science base.
4. Regulation in other areas should rely on performance goals or
standards, rather than mandating rigid controls or specific
designs for compliance. Performance standards create
opportunities for innovative solutions which could involve
new biotechnology products.
-- Performance standards in other (traditional) regulatory
programs would reduce the barriers to biotechnology
products in competing with traditional technologies. For
example, current statutory criteria and regulatory
requirements for the disposal of hazardous waste that are
based on the use of incineration discourage the
development and use of other techniques. These
"design-based" criteria and requirements may preclude
bioremediation techniques even though the biotech
application may be both less costly and more effective.
Initiatives to Reduce Regulatory Barriers to Biotechnology
1. Improve interagency coordination to reduce regulatory delays
and jurisdictional uncertainties.
2. Review FDA drug approval process: improve design of small
scale human trials (Phase II) and eliminate large scale
-7-
trials (Phase III), where possible. [Scale-up]
3. Develop a risk-based approach for field tests; implement this
approach in ABRAC guidelines and the proposed rule for FIFRA.
[Scale-up]
4. Revise the NIH guidelines to reflect current perspectives
that regulation should focus on the characteristics and risks
of the product, rather than on the process used. [Scale-up]
Establish
5. Examine sunset or other mechanisms to provide the regulatory
flexibility needed to respond to rapid advances in the
science base.
6. Improving Intellectual Property Rights
The uncertainties in intellectual property rights for
innovations in the biotechnology area continue to hamper the
industry. Two changes in U.S. law have been suggested as a
way of improving patent protection.
-- Determine the appropriate way to correct a recent PTO
interpretation of a court case (In re Durden) that
suggests use of a novel starting material in combination
with a known chemical process is not eligible for a
process patent. The application of Durden in the
biotechnology area could deny protection to innovations
-8-
that can only be protected through process patents.
-- Amend the Tariff Act of 1930 to provide the International
Trade Commission with jurisdiction to exclude imported
products produced by using biotechnological materials
covered by a U.S. patent.
In addition, improvement of patent laws in other countries would
provide U.S. biotechnology firms with better protection from
patent infringement by foreign companies. Some of these issues
are already under discussion in current GATT negotiations
(Uruguay round).
Finally, backlogs in approval of patent applications can
discourage both investment in biotechnology research and the
development of new products. To address this problem, the
Administration's 1991 budget includes hiring 100 new patent
examiners over the next five years and improving training for
examiners. In addition, the Patent Office is setting up an
information system that will establish a comprehensive data base
of patent information, substantially facilitating the review of
patent applications.
7. Address problems with State and local laws.
Some States and local governments have adopted regulatory
requirements (and even the prohibition of biotech activities)
that are specifically directed to biotechnology research and
-9-
development. These are typically process-based regulations.
Some have suggested that if other States adopt similar
legislation, or more importantly, place limits on the
commercial use of biotechnology products, there may be a need
for Federal intervention. Under current law, USDA and EPA do
not have the authority to preempt State law.
THE WHITE HOUSE
WASHINGTON
March 5, 1990
MEMORANDUM FOR OLIN WETHINGTON
KEN YALE
FROM:
STEPHEN I. DANZANSKY
SUBJECT:
Science and Technology Working Groups
In light of David and my conversations with Allan Bromley and
Larry Lindsey on the subject of S&T Turf, the following
assignments should be pursued:
O
Bromley would like our comments and changes to the
FCCSET charter and working documents communicated by
memorandum to his office by Friday, March 9. He has
agreed to accept almost all of these, but insists upon
his right to call together the heads of departments to
FCCSET organizational and status reporting meetings in
order to keep high-level attention on the coordinating
role of FCCSET. He has agreed to accept the
chairmanship of the DPC and EPC S&T Working Groups as
the policy channels through which the relevant councils
would percolate decisions to the President.
Both of you will need to review the FCCSET documents,
get White House Counsel legal guidance, and prepare a
memo to Bromley for David's signature into our Staff
Ops system by Friday morning.
The next step will be to get the EPC and DPC charters
drafted or redrafted to take into consideration the
following:
a. complimentary jurisdictions of EPC and DPC over S&T
issues; each Council's charter must reflect the
separation of domestic and economic issues.
b. the EPC charter as redrafted should except from
consideration those issues which the Competitiveness Council
will take up. Since the President's speech called for the
CC working group to "find ways that American industry can
better translate new ideas and technologies into marketable
products,' Olin will need to meet with Larry Lindsey to work
out what that means in terms of issues and jurisdiction and
redraft the EPC charter accordingly.
O
The new charters would be submitted through Staff OPS
to the Chairmen Pro Temp. Once signed, an announcement
could be made of the new Bromley chairmanships.
We would like to see this whole business completed by the end of
next week so that the Cabinet can be notified. I'm happy to
consult and counsel with you on any of this if you run into
problems.
Thanks for following up.
CC: David Q. Bates
THE WHITE HOUSE
WASHINGTON
March 12, 1990
MEMORANDUM FOR TOM RACHFORD
FROM:
STEPHEN I. DANZANSKY
Deputy Assistant to the President and
Director of Cabinet Affairs
SUBJECT:
FCCSET CHARTER
Thank you for giving us the opportunity to review and comment on
the charter of your Federal Coordinating Council on Science,
Engineering and Technology (FCCSET).
Forgive our perpetual lateness on these matters, but as between
our two policy Councils, the Competitiveness Council, White House
Counsel's Office, and a few last minute cross checks and double
takes, it literally could not be turned around sooner. My staff
will attest to the fact that I was in the office all weekend, in
part to resolve this S&T business.
Enclosed is our mark-up of your FCCSET charter, altered to
reflect its original statutory mission. Such a pruning, in our
opinion, will answer both the legal and cross-policy questions
raised with you and Allan in David's office last week.
Substituted therefore is a draft charter for a joint EPC/DPC
Working Group on Science and Technology which we would want Allan
to chair, and under which several task forces could be formed to
focus upon micro-policy questions (e.g., tax incentives for
research and experimentation). I see this Working Group
meeting at Cabinet or subcabinet level.
What this reconfiguration does, I believe, is place Allan in the
middle of the switchboard of S&T policy much as Bill Bennett is
at the center of drug policy: the S&T Czar. Working with us,
Allan can decide which policy issues go where and also keep
control of the agenda insofar as the Competitiveness Council
wishes to target on specific S&T issues like biotechnology.
We have to do more talking about the composite picture, but I
believe that this configuration will serve both of our objectives
well; and most important, those of the President.
Thanks for working with us and for your patience.
CC: David Bates
THE WHITE HOUSE
WASHINGTON
February 3, 1990
MEMORANDUM FOR DAVID Q. BATES
FROM:
KENNETH P. YALE Ky
SUBJECT:
Federal Coordinating Council on Science,
Engineering and Technology (FCCSET)
BOTTOM LINE: The Office of Science and Technology Policy is
revitalizing their FCCSET organization. Unless we have full
coordination with OSTP staff, FCCSET could duplicate existing
processes in the Cabinet Councils and create confusion.
BACKGROUND: A FCCSET meeting was held on January 24, 1990 to
discuss: 1) the structure and function of FCCSET, 2) the
structure of FCCSET Committees, and 3) financing and support
personnel for FCCSET (see attached briefing book).
An elaborate FCCSET structure was envisioned, basically a
scientific Cabinet Council, chaired by Dr. Bromley. It would
have interagency committees with representatives at the assistant
secretary level or above. Although there was some mention of
taking issues to the appropriate Cabinet Councils for review, it
was also stated that the FCCSET would resolve science and
technology policy issues.
Unless there is very close coordination with DPC and EPC,
FCCSET could encourage forum shopping and circumvent the DPC and
EPC processes. Instead of career level scientists preparing
background reports on science issues and acting as a
clearinghouse for information (eg., the CES), it appears the
proposed FCCSET formulation could consist of political level
people (ie. Assistant Secretary) developing policy -- a very
different function. You will recall that the original DPC and
EPC charters stated they would formulate, coordinate and
implement policy and "serve as the primary channels for advising
the President on policy."
RECOMMENDATION: We should be actively involved in the
development and operations of FCCEST, to avoid forum shopping and
confusing signals to the agencies. The value of FCCSET
committees composed of knowledgeable, career level scientists --
developing reports and acting as information clearinghouses for
agencies and DPC/EPC working groups -- should be emphasized.
Regular meetings between OSTP Associate Directors and Cabinet
Council Executive Secretaries would be appropriate.
THE WHITE HOUSE
WASHINGTON
February 5, 1990
MEMORANDUM FOR D. ALLAN BROMLEY
FROM:
DAVID Q. BATES
SUBJECT:
Federal Coordinating Council on Science,
Engineering and Technology
Thank you for including us in the development of your
Federal Coordinating Council on Science, Engineering and
Technology (FCCSET). I am responding to the request for comments
on the FCCSET structure. You may contact Ken Yale for more
specific comments and recommendations.
We would like to work closely with you as your FCCSET
committees get up and running. The scientific expertise which
your Committee on Earth Sciences brings to the DPC Global Change
Working Group has been very beneficial. There is much value in
assembling scientific staff from the agencies to investigate the
underpinnings of the issues faced by the Administration.
My staff and I look forward to working with you as your
FCCSET Committees develop. Our Cabinet Counsels and associated
working groups are at your service. You may find them a valuable
resource as the FCCSET Committees develop reports and background
papers.
As the "primary channels to advise the President on policy"
-- and without agency, statutory or advisory status -- both the
DPC and EPC are fully protected by executive privilege. As a
result, they are not subject to many of the statutory
restrictions that make it difficult for political appointees to
have a full and frank discussion. Thus, you may want to consider
close coordination with the DPC and EPC in order to develop a
process for full and adequate vetting of issues that are
Presidential in nature or require Presidential or Cabinet
attention or decisions.
Again, I thank you for allowing us to participate. Should
you have any questions, do feel free to contact myself, or the
Executive Secretaries of the Councils: Lehmann Li and Ken Yale.
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20506
February 12, 1990
Dear David:
As you know, on January 24 I chaired the first meeting of the Federal Coordinating
Council for Science, Engineering and Technology. I was pleased to have Ken Yale
from your staff there to represent the Office of Cabinet Affairs. I believe that we are
off to a good start on putting together a clearly much-needed structure to address
and coordinate cross-cutting science and technology issues within the Administration.
I would like to take this opportunity to fill you in on the outcome of our meeting and
to extend a personal invitation to you to participate in succeeding meetings. I would
greatly appreciate your support and input in these initial months as we develop the
charter, committee structure, and staffing arrangements.
Several issues were raised during the course of our discussion on the 24th, some of
which are fairly easy to resolve while others will require the careful consideration of
all FCCSET members. First, I think there was a general consensus that we need to
define in more detail the functions and activities of the FCCSET. There were
concerns expressed, for example, about the FCCSET's role vis-a-vis the President's
Council of Advisors on Science and Technology (PCAST), the types of issues the
FCCSET would address, FCCSET's role in the budget process, possible duplication of
the functions of other policy coordinating bodies such as the Domestic Policy Council
and the Economic Policy Council, frequency of meetings, etc.
In general terms, we have agreed that the future success of FCCSET and of its
committees depends crucially upon the participation of very senior policy level
representatives of the member agencies both in the FCCSET and in its committees.
We have also agreed that inasmuch as I chair both FCCSET and PCAST, I shall
accept the responsibility for insuring communication between the private sector
PCAST panels and the FCCSET committees and working groups that may be
established to consider parallel issues.
You will find attached a draft charter for the FCCSET which I believe addresses
these and other issues concerning the role, structure and functions of the FCCSET. I
request that you give this draft careful consideration and let me know your thoughts
on how it might be modified or improved.
Mr. Bates
Page 2
Second, at our meeting on the 24th, we discussed possible changes in the list of
FCCSET committees. There was general consensus that we should keep the number
of committees down but no agreement on how to accomplish that objective. There
are, I think you would agree, two types of committees. First, there are those that are
designed to oversee functional areas of R&D, such as health and life sciences or
mathematical and physical sciences. These committees would be responsible for
coordinating cross-cutting activities within their field of responsibility and reporting
on emerging issues and policy concerns. (I have attached a draft sample charter for
this type of committee.)
There are also those committees that are designed to address cross-cutting concerns
that affect the scientific well-being of this country but go beyond the confines of any
one functional area. They have a policy focus or enabling character that cuts across
all of the functional areas. Examples are: education, industrial technology, and
international science and technology.
Each of these two types of committees has validity within the FCCSET structure and
I would suggest that we find a way to keep both when needed. I have attached a.
revised committee structure which incorporates many of the suggestions from our
meeting. In addition, I have suggested some cross-cutting issues that may be included
in the mandate of these committees. I encourage you to review this suggested
structure in detail and let me know whether or not it meets the needs of your agency.
I am also interested in your ideas on critical cross-cutting issues which require
FCCSET attention and your suggestions as to which committee they might be
assigned. I encourage you to be as creative as possible and not necessarily restrained
by the committee structure suggested, because, it is by the development of a variety of
cross-cutting issues, that we will be able to test the validity of the suggested
framework.
A third issue coming out of our meeting on the 24th was the need for a FCCSET
executive secretariat. I am in the process of developing a list of candidates to serve
in this capacity. I am inclined to identify one senior, and one mid-level professional
staff person, together with support staff, to serve in the executive secretariat to the
FCCSET. The executive secretariat would be responsible for coordinating our
activities as well as overseeing the FCCSET committee structure. I would be
interested in any thoughts you have on this structure as well as any candidates you
believe merit consideration. One of the first tasks I will assign the executive
Mr. Bates
Page 3
secretariat is to work with the Department of Education to develop the necessary
language to amend PL 94-282 to incorporate the Department of Education as a
permanent member of the FCCSET.
I am anxious to move rapidly on all of these issues. As you know, there are a
number of urgent concerns that require FCCSET attention, and I would like us to get
to work on these posthaste. Therefore, I have asked my staff to try to arrange the
next meeting of the FCCSET as soon as possible. They will be contacting your office
to find a mutually convenient time. I hope that during the course of the meeting we
can reach agreement on the charter and the committee structure. I want to try and
have the executive secretariat established by that time. Therefore, if you have
candidates in mind for these positions, please let me know by February 14 so that I
can give them fair consideration.
Again, let me thank you for your continued support, and I look forward to seeing you
at our next meeting.
Sincerely yours,
Alan
D. Allan Bromley
Director
Attachments:
Tab A
Draft FCCSET Charter
Tab B
Suggested Committee Structure
Tab C
Sample FCCSET Committee Charter
Tab D
FCCSET Membership List
Tab E
Attendees at January 24 FCCSET Meeting
The Honorable David Q. Bates, Jr.
Assistant to the President
and Secretary to the Cabinet
The White House
Washington, D.C. 20500
cc: Kenneth P. Yale
February 6, 1990
DRAFT CHARTER
Federal Coordinating Council
For Science, Engineering and Technology
LEGISLATIVE MANDATE
The Federal Coordinating Council for Science Engineering and
Technology (FCCSET) was established in 1976 pursuant to Public
Law 94-282, Title V of the "National Science and Technology
Policy Organization and Priorities Act of 1976" to consider
cross-cutting science, engineering and technology issues. the
law states that:
"The Council shall consider problems and developments in the
fields of science, engineering, and technology and related
activities affecting more than one Federal agency, and shall
recommend policies and other measures designed to:
(1) provide more effective planning and administration
of Federal scientific, engineering, and technological
programs,
(2) identify research needs including areas requiring
additional emphasis,
(3) achieve more effective utilization of the
scientific, engineering, and technological resources
and facilities of Federal agencies, including the
elimination of unwarranted duplication, and
(4) further international cooperation in science,
engineering, and technology."
OBJECTIVES
In fulfilling this mandate, the FCCSET's two major objectives
are:
O
to provide authoritative scientific and technological
expertise and advice to policy discussions and
decisions to other cabinet-level councils including the
National Security Council, the Economic Policy Council,
the Domestic Policy Council, the Space Council and the
Competitiveness Council.
to coordinate science and technology efforts affecting
more than one Federal agency and surface and resolve
S&T policy issues.
FUNCTIONS
To accomplish these two objectives the FCCSET will:
O
serve as a central coordinating forum for addressing
problems and issues affecting more than one Federal
agency, sharing information, reviewing national and
international policy objectives and developing
consensus;
identify priority research and development needs;
facilitate continuing cooperation in planning
coordination and communication among Federal agencies
on science and technology issues;
issue reports, studies and assessments of current S&T
capabilities in fields of research and development of
concern to the Administration;
information
provide reviews, analyses, advice and recommendations
on science and technology matters to other policy
coordinating bodies within the White House including
the National Security Council, the Economic Policy
Council, the Domestic Policy Council, the Space
Council, and the Competitiveness Council;
seek to inform other policy making bodies of reviews,
studies and analyses underway, and coordinate
activities so as not to duplicate functions with these
bodies;
identify science and technology issues and concerns of
importance to the nation and bring policy
recommendations to the attention of the President
through appropriate policy bodies;
with the close cooperation of the Office of Management
and Budget, develop, and review annual and long-range
Federal budget plans in selected cross-cutting areas of
science and technology;
improve planning, coordination and communication among
Federal agencies engaged in science and technology.
ADMINISTRATIVE PROVISIONS
To accomplish these functions the FCCSET is authorized to:
detail employees to the Council to perform such
functions, consistent with the purposes of the FCCSET,
as the Chairman may assign to them;
establish committees for the purposes of conducting
studies, making reports, coordinating Federal science
and technology activities that involve more than one
Federal agency, and making recommendations to the
FCCSET;
develop, and review on an annual basis, charters for
committees, and assign high priority agenda items as
necessary;
Council meetings shall be called by the Chairman as
deemed appropriate and each agency member shall attend
at a senior policy level;
Council proceedings, studies, and reports, either
preliminary or final, shall be printed and distributed
only with the Chairman's authorization.
MEMBERSHIP
The Council shall be chaired by of the Director of the Office of
Science and Technology Policy and shall be composed of one policy
level representative of each of the following Federal Agencies:
Department of Agriculture
Department of Commerce
Department of Defense
Department of Energy
Department of Health and Human Services
Department of Housing and Urban Development
Department of the Interior
Department of State
Department of Transportation
Department of Veteran's Administration
National Aeronautics and Space Administration
National Science Foundation
Environmental Protection Agency
Other Agencies may be requested to participate in meetings of the
Council concerned with matters of substantial interest to such
agency.
Treasury, Education
DETERMINATION
I hereby approve and adopt this Charter which is determined to be
consistent with PL 94-282 which establishes the FCCSET.
Approved:
D. Allan Bromley
Date
Chairman, Federal Coordinating
Council for Science, Engineering
and Technology
FEDERAL COORDINATING COUNCIL
FOR SCIENCE, ENGINEERING AND TECHNOLOGY
SUGGESTED COMMITTEE STRUCTURE
WITH CROSS-CUTTING/SUBSIDIARY ISSUES
Committees:
Health and Life Sciences
Physical, Mathematical and Engineering Sciences
Earth and Environmental Sciences
Food Agriculture and Forestry Research*
Education and Human Resources
Technology and Industry
International Science, Engineering and Technology
Sample Cross-cutting/Subsidiary Issues:
Bioethics
Biotechnology
Global Change
High Performance Computing
Human Genome Research
Intellectual Property Rights
Manufacturing
Materials
Math and Science Education
S&T Initatives in Eastern Europe
S&T Information Collection, Utilization and Dissemination
Social and Behavioral Sciences
Technology Transfer
*Established by PL 94-282; legislative relief required if
abolished or merged
February 6, 1990
DRAFT
SAMPLE FCCSET COMMITTEE CHARTER
The Committee on
is hereby established by action of
the Federal Coordinating Council for Science, Engineering, and
Technology (FCCSET). FCCSET derives its authority from PL 94-
282.
Purpose
The purpose of the Committee on
is to increase
the overall effectiveness and productivity of Federal R&D efforts
in [fields related to the committee's jurisdiction]. The
Committee will address significant national policy matters which
cut across agency boundaries and shall provide a formal mechanism
for interagency science policy coordination and exchanges of
information regarding the scientific aspects of [field of
jurisdiction].
Functions
The Committee on
will:
review national and international Federal R&D programs,
including budgets, in [the field of committee
jurisdiction];
facilitate planning, coordination, and communication
among Federal agencies engaged in [the field of
committee jurisdiction];
identify and define Federal R&D needs in [the field of
committee jurisdiction] ;
develop and update long-range plans, including funding
levels, for overall Federal R&D efforts in [the field
of committee jurisdiction]
address specific programmatic and operational issues
and problems which affect two or more Federal agencies;
provide reviews, analyses, advice, and recommendations
to the FCCSET on Federal policies and programs
concerned with [the field of committee jurisdiction].
Structure
The Chairman of the Committee on
is appointed by the
Chairman of the FCCSET.
Responsibilities of the Chairman:
hold regular meetings of the Committee (no fewer than
six per year) and approve agendas;
submit an annual report to the Chairman of the FCCSET
for review by the full Council;
approve the establishment, continuation or termination
of subcommittees, task forces and working groups as
necessary to achieve the Committee's purpose;
meet regularly (bimonthly) with the Chairman of the
FCCSET and other Committee chairmen to evaluate
progress, discuss policy coordination, receive new
instructions from the FCCSET and report on ongoing
activities.
The following departments and agencies are represented on this
Committee at the Assistant Secretary level or above:
[All FCCSET members and any other agency or department not on the
FCCSET but with S&T activities in the committee's field of
jurisdiction].
Membership on subcommittees, task forces, and working groups is
not restricted to Committee members and is established as the
Committee Chairman may determine appropriate.
Committee activities will be coordinated by an Executive
Secretary, designated by the Committee Chairman. Additional
staff and funding assistance, consistent with the functions of
this charter, will be provided by member agencies as required by
the Committee chairman.
Private Sector Interface
The Committee will recommend to the Chairman of the FCCSET the
nature of private sector advice needed to accomplish its mission.
The Chairman of the FCCSET will take necessary steps to ensure
appropriate interaction between the President's Council of
Advisors on Science and Technology (PCAST) and the Committee.
The Committee may also seek ad hoc advice from various private
sector groups as consistent with the Federal Advisory Act.
Compensation
All members are full-time Federal employees who are allowed
reimbursement for travel expenses by their agencies plus per diem
or subsistence while away from their duty stations and in
accordance with standard government travel regulations.
Documentation
Agendas and records of actions of Committee meetings are prepared
and disseminated to members by the Executive Secretary. Records
of actions are submitted to members for approval. Complete
records of all Committee activities, including those of task
forces and working groups, are maintained in the office of the
Chairman. The Committee prepares a report for the Chairman of
the FCCSET not later than 60 days after the end of each fiscal
year. The report contains, as a minimum, the Committee's
functions; a list of members; a list of subcommittees, task
forces and working groups and their charters; the dates, places
and agendas for all meetings; and a summary of the Committee's
activities and recommendations during the year.
Termination Date
Unless renewed by the Chairman of FCCSET prior to its expiration,
the Committee on
shall terminate not later than
March 31, 1991.
Determination
I hereby determine that the formation of the Committee on
is in the public interest in connection with
the performance of duties imposed on the Executive Branch by law
and that such duties can best be performed through the advice and
counsel of such a group.
Approved:
Chairman, FCCSET
Date
MEMBERSHIP LIST
FEDERAL COORDINATING COUNCIL
FOR SCIENCE, ENGINEERING AND TECHNOLOGY
Chairman
The Honorable D. Allan Bromley
Assistant to the President
for Science and Technology
and Director
Office of Science and Technology Policy
358 Old Executive Office Building
Washington, D.C. 20506
Members
The Honorable Manuel Lujan, Jr.
Secretary of the Interior
18th and C Streets, N.W.
Washington, D.C. 20240
The Honorable Clayton Yeutter
Secretary of Agriculture
12th Street and Jefferson Drive, S.W.
Washington, D.C. 20250
The Honorable Louis W. Sullivan
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20585
The Honorable Jack Kemp
Secretary of Housing and Urban Development
451 7th Street, S.W.
Washington, D.C. 20410
The Honorable James D. Watkins
Secretary of Energy
1000 Independence Avenue, S.W.
Washington, D.C. 20585
The Honorable Donald J. Atwood, Jr.
Deputy Secretary of Defense
The Pentagon
Washington, D.C. 20301
The Honorable William K. Reilly
Administrator
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
The Honorable Richard H. Truly
Administrator
National Aeronautics and Space Administration
400 Maryland Avenue, S.W.
Washington, D.C. 20546
The Honorable Erich Bloch
Director
National Science Foundation
1800 G Street, N.W.
Washington, D.C. 20550
The Honorable Thomas J. Murrin
Deputy Secretary
Department of Commerce
14th and Constitution Avenue, N.W.
Washington, D.C. 20230
The Honorable Elaine Chao
Deputy Secretary
Department of Transportation
400 7th Street, S.W.
Washington, D.C. 20590
The Honorable Anthony J. Principi
Deputy Secretary
Department of Veterans Affairs
810 Vermont Avenue, N.W.
Washington, D.C. 20420
The Honorable Richard T. McCormack
Under Secretary for Economic Affairs
Department of State
2201 C Street, N.W.
Washington, D.C. 20520
Non-statutory Members
The Honorable Elizabeth Dole
Secretary of Labor
200 Constitution Avenue, N.W.
Washington, D.C. 20210
The Honorable Lauro F. Cavazos
Secretary of Education
400 Maryland Avenue, S.W.
Washington, D.C. 20202
Attendees
FCCSET Meeting
Wednesday, January 24, 1990
Agency
Principal
Staff
HHS
Louis W. Sullivan
Dr. William E. Bennett
Special Assistant to
Secretary Sullivan
Dr. William F. Raub
Acting Director, NIH
DOE
James D. Watkins
Dr. James F. Decker
Acting Director
Office of Energy Research
DOEd
Lauro F. Cavazos
John T. (Ted) Sanders
Under Secretary
EPA
William K. Reilly
Erich Bretthauer
(Acting) Assistant
Administrator for R&D
DOC
Thomas J. Murrin
Deborah Wince-Smith
Assistant Secretary for
Technology Policy
VA
Anthony J. Principi
Richard J. Greene, M.D.
Assistant Chief Medical
Director for R&D
NASA
Richard H. Truly
Kenneth S. Pedersen
Associate Administrator
for External Relations
NSF
Erich Bloch
Dr. Luther Williams
Senior Science Adviser
DOS
Richard T. McCormack
Frederick M. Bernthal
Assistant Secretary
OES
DOD
George P. Millburn
Craig I. Fields
Director, DARPA
DOA
Charles E. Hess
HUD
DOI
Dallas L. Peck
Dr. Harlan L. Watson
Science Adviser to the
Secretary of the Interior
DOL
Jennifer Dorn
Mr. Gary Reed
Assistant Secretary
Office Director, Office
for Policy
of Program Economics
DOT
Travis P. Dungan
Joseph Canny
Administrator
Deputy Assistant
Research and Special
Secretary for Policy
Programs Administration
OMB
Robert Grady
NSC
Eric D.K. Melby
Director for International Economic Affairs
DPC
Ken Yale
Executive Secretary, DPC
OSTP
Dr. J. Thomas Ratchford, Associate Director for Policy
and International Affairs
Dr. Karl A. Erb, Assistant Director for Physical
Sciences and Engineering
Ms. Sara Bowden
Dr. Mary Harley Kruter
Ms. Rachel Levinson
THE WHITE HOUSE
WASHINGTON
February 26, 1990
MEMORANDUM FOR ALLAN BROMLEY
FROM:
DAVID Q. BATES
SUBJECT:
FCCSET and Science and Technology Policy
Thanks for your thoughtful letter of February 12 concerning the
functions and activities of FCCSET and its draft charter. I have
reviewed the materials with interest. You have properly
identified several potential problems of coordination and
possible duplication of functions with existing policy bodies,
two of which the Office of Cabinet Affairs has direct
responsibility for administering.
As you well know Allan, the President in signing the charter for
the DPC and EPC clearly designated those two Cabinet Councils as
the "primary channels for advising the President on policy."
Early in the Reagan Administration there were six Cabinet
Councils, each with a separate area of expertise and
jurisdiction. That was changed in the summer of 1985 when it was
discovered that the proliferation of policy bodies, all reporting
to the President, invited Cabinet officers to "forum shop" their
issues between and among the councils which would likely give
them the best result. Thereafter all Cabinet-level policy
formulation was to be done in one of three fora: the National
Security Council, the Economic Policy Council and the Domestic
Policy Council.
With the addition of the Space Council and recently the
Competitiveness Council, there is growing concern that despite
the President's early directive, we are in danger of repeating
the mistakes of the past and undermining the positive benefit of
the 1985 consolidation. That is why I am expressing some reserve
in ratcheting up yet another "policy" body, albeit limited in
scope to matters of science and technology. The fact that
Congress has passed law establishing the FCCSET as a coordinating
mechanism, does not mean that it can tell the President how to
run his Administration.
I would recommend, therefore, some careful thought and
deliberation before proceeding apace with a new charter for
FCCSET. In fact, the EPC last year established a Working Group
on Science and Technology with a broad mandate to examine federal
policy in this area with an eye on U.S. competitiveness and sound
economic policymaking. Unfortunately, that group has somewhat
ground to a halt and just last week we spoke with Hollis
McLaughlin (Nick Brady's Counsellor) about revitalizing that
effort under your leadership. I believe that Steve Danzansky
mentioned this possibility to you. Treasury was most
enthusiastic.
In that light, I have asked our staff to work with White House
Counsel's office on how best to incorporate the work of FCCSET
with the EPC/DPC process without jeopardizing executive privilege
or subjecting ourselves to FOIA requests or congressional
oversight. They are now looking into the matter and should have
some answers within the next few days.
I would therefore counsel further consultation on the FCCSET
question. Right now I would be leaning toward establishing an
S&T Working Group in both the EPC and DPC under your leadership,
with the former policy council looking at economic interface
(e.g. competitiveness and industrial policy) and the latter
focusing upon controversial domestic policy considerations (e.g.
fetal research, medical experimentation, biotechnology, etc. )
Perhaps the FCCSET effort could then be limited to an advisory or
informational and coordinative role to protect the President from
congressional intrusiveness.
I promise to be back with you shortly on these important
questions and thank you for consulting with me in advance of
proceeding.