Full Text TW-98-001
 
INTERNATIONAL COOPERATIVE BIODIVERSITY GROUPS
 
NIH Guide, Volume 26, Number 27, August 15, 1997
 
RFA:  TW-98-001
 
P.T.


Keywords: 

 
Fogarty International Center
National Cancer Institute
National Institute of Allergy and Infectious Diseases
National Institute of Mental Health
National Institute of Child Health and Human Development
Office of Alternative Medicine
National Heart, Lung and Blood Institute
National Science Foundation
Foreign Agricultural Service
 
Letter of Intent:  October 15, 1997
Application Receipt Date:  January 22, 1998
 
PURPOSE
 
The National Institutes of Health, the National Science Foundation
and the Foreign Agricultural Service (hereafter "the Government" or
"the Participating Agencies") invite applications for the
establishment or continuation of "International Cooperative
Biodiversity Groups" to address the interdependent issues of
biodiversity conservation, economic growth, and human health through
discovery of therapeutic agents for diseases of importance to
developed countries as well as those primarily important in
developing countries.  Particularly relevant disease areas and health
needs include cancer, HIV-AIDS and opportunistic infections (e.g.
tuberculosis), malaria, central nervous system disorders,
contraception and sexually transmitted diseases, and cardiovascular
and pulmonary diseases.  Applications that propose, in addition to
pharmaceutical drug discovery, research and training related to
phytomedicine analysis and natural product-based crop protection or
veterinary agents are also encouraged.
 
For the purposes of this joint biodiversity and drug development
program, the National Institutes of Health (NIH) will be allocated
funds from the National Science Foundation (NSF).  The Foreign
Agricultural Service (FAS) will review all applications that contain
agricultural components for possible co-funding in countries where
they have available resources.  Participating NIH components are the
Fogarty International Center, the National Cancer Institute, the
National Institute of Allergy and Infectious Diseases, the National
Institute of Mental Health, the National Institute of Child Health
and Human Development, the Office of Alternative Medicine and the
National Heart, Lung and Blood Institute.  It is possible that other
organizations may join the program at a later time.  The Fogarty
International Center (FIC) of the NIH will administer this program
under the authority and regulations of the Public Health Service
(PHS).
 
There are no plans to reissue this Request for Applications (RFA) at
this time.
 
HEALTHY PEOPLE 2000
 
The PHS is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a PHS-led national
activity for setting priority areas.  This RFA, INTERNATIONAL
COOPERATIVE BIODIVERSITY GROUPS, is related to the priority needs of
several diseases of interest to the National Institutes of Health.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report: Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington DC, 20402-9325
(telephone 202-512-1800).
 
SUMMARY
 
This RFA calls for the development of interdisciplinary programs
through the establishment of International Cooperative Biodiversity
Groups (ICBGs), with active and substantial participation by U.S. and
developing country scientists and institutions.  It is the intent of
this RFA to promote the conservation of biological diversity through
the discovery of bioactive agents from natural products, and to
ensure that equitable benefits from both the research process and any
discoveries accrue to the country of origin.  Benefits that accrue to
the country of origin may take a variety of forms but will include
economic benefits and enhancement of research capacity.  The RFA is
seeking proposals that will build institutional relationships with
developing countries that will continue to grow beyond the life of
the RFA and will serve as effective models for others to develop
similar relationships.
 
BACKGROUND
 
This RFA represents a recompetition of the International Cooperative
Biodiversity Groups program following its first five years of
funding. The unifying theme underlying this RFA is the concept that
the discovery and development of pharmaceutical and other useful
agents from natural products can, under appropriate circumstances,
promote sustained economic growth in developing countries while
conserving the biological resources from which these products are
derived.  This theme reflects the partnership between the National
Institutes of Health, the National Science Foundation and the U.S.
Agency for International Development that was the genesis for the
original ICBG program.
 
Natural products that hold promise for the development of
pharmaceutical agents, as well as those that form the basis for many
traditional herbal remedies and serve as leads for agricultural and
other uses, are often found in ecosystems that are seriously
threatened.  These include terrestrial ecosystems such as tropical
forests as well as marine ecosystems such as coral reefs, and
mangroves.  Predominantly found in developing countries of the
tropics, these ecosystems are rich in biological diversity.  Tropical
forests, for example, cover only seven percent of the earth's
surface, but they are thought to contain at least one-half of all
plant and animal species.  Deforestation is apparently proceeding at
a rate of 20 million hectares per year, resulting in the loss of
species at rates estimated to be 100 to 1000 times greater than
background extinction.  Cultural diversity is also seriously
threatened by habitat conversion and the loss of biological resources
on which many traditional societies depend.
 
Recent experience demonstrates that diverse plant, microbial and
animal resources, contain a wealth of potentially useful compounds.
For example, the demonstrated clinical utility of the Vinca
alkaloids, vinblastine and vincristine, of the camptothecin
analogues, and the effectiveness of taxol in treatment of ovarian and
breast cancers, have generated enthusiastic support for a thorough
exploration of natural products.  In addition to cancer, natural
products are proven and/or possible sources of drugs for malaria,
parasitic diseases, diarrheal disorders, AIDS and its opportunistic
infections,
cardiovascular diseases, respiratory diseases, hepatitis, central
nervous system disorders, and other serious illnesses prevalent in
developing countries.  Natural products have also been a valuable
source of crop protection agents such as pyrethrins and of veterinary
medicines such as ivermectin.
 
The terrible irony is that as advances in biology expand our ability
to use genetic diversity to combat these diseases, the raw material
is being lost to extinction. Perhaps even more urgent than the losses
of genetic and chemical diversity as sources of potential
pharmaceutical and agricultural protection agents, are the immediate
repercussions of biodiversity loss in many developing countries where
herbal remedies from diverse biota are a primary source of health
care.  Simultaneous with these biological losses to extinction are
accelerating losses of traditional knowledge associated with the
biota.  This knowledge of the identity and utility of specific
organisms for medicinal and other uses has intrinsic value as part of
our cultural patrimony, is currently important as a source of health
care for many people, and may offer important leads for future
treatments of numerous human ailments.
 
The underlying causes of biodiversity loss are many and complex, and
involve interwoven social, economic, and political elements.  It is
clear, however, that poverty, unemployment, and lack of economic
opportunities are significant contributing factors.  In developing
countries struggling to meet the most basic human needs, efforts to
protect biological diversity will succeed only if implemented in the
context of promoting sustained economic growth.  Likewise, to be
effective, efforts to protect biological diversity must include the
active participation of affected local communities, which ultimately
will determine the success or failure of those efforts.  Biological
resources must benefit local populations if the resources are to be
conserved.  Consequently, the sustainable economic potential of
biological resources, such as developing pharmaceuticals from natural
products, can be used to promote biodiversity conservation by
providing an economic return from sustainable use of the resources
while improving quality of life through better human health.
Experience suggests that the development of significant conservation
incentives is most likely when both near and long term benefits
accrue to stakeholders.
 
ELIGIBILITY REQUIREMENTS
 
Public and private non-profit institutions, for profit institutions,
Governments and their agencies, and foreign institutions are eligible
to participate as members of a Group.  However, the Group Leader must
be located in a public or private non-profit institution, Government
or Governmental agency of the United States.  Foreign and for-profit
institutions may participate in an ICBG as Associate Programs.
 
MECHANISM OF SUPPORT
 
1.  Awards will be made as Cooperative Agreements (U01).  Assistance
via Cooperative Agreement differs from grant awards in that
sponsoring Government components anticipate substantial programmatic
involvement in achieving the goals and objectives of the project.
The nature of the U.S. Government's assistance is described in
Section J, Part 3 of this RFA under "Terms and Conditions of Award."
There is no intent, real or implied, for Government staff to direct
Group activities or to limit the freedom or scientific creativity of
investigators.
 
2.  The estimated starting date for the initial year of award under
this RFA is August 1, 1998.  This RFA is a one-time solicitation.
However, should the Government determine that there is continuing
program need, the Government may issue a new RFA.
 
3.  An award will be made only to the Group Leader's institution,
which will subcontract with the other participating institutions.
All Group activities will be coordinated through the Group Leader's
institution. Applicants must comply with PHS policies concerning
allowable costs. Particularly pertinent to this RFA is the non-
allowability of indirect costs to organizations outside the U.S.  Any
questions about allowable costs may be directed to Ms. Silvia Mandes,
Grants Management Officer, FIC.
 
4.  Under the Cooperative Agreement, a relationship between the
awardee and the Government is established in which the Group is
responsive to the requirements and conditions set forth in the RFA.
Specifically, the Group Leader defines the details for the project in
response to the RFA, retains primary responsibility for the
performance of the Group, and agrees to coordinate with the
assistance of the Government in all aspects of scientific and
technical management of the project in accordance with the terms and
conditions outlined in Section J., Part 3. "Terms and Conditions of
Award."
 
5. Awards pursuant to this RFA are contingent upon availability of
funds.  Subsequent to receiving awards, the awardees may request
supplemental support from the Government to expand their activities.
Funding for such expansion must be provided from sources other than
the FIC, but should be administered through the FIC if they originate
from one of the agencies sponsoring this RFA.  In making such a
request the applicant must identify the source of the funds and
certify that the funds are committed prior to submission of the
supplemental request. Complementary funds could also be supplied, for
example, from a
non-governmental organization or a U.S. Governmental agency, not
currently participating in this RFA.  Applicants are encouraged to
apply for funds from corporate partners or non-profit foundations to
supplement conservation and development activities in the host
countries, perhaps utilizing trust funds in those countries for
management of such resources.  Regardless of the source, any
supplemental support for Group activities must be reported to FIC.
 
6.  All policies and requirements that govern the grant program of
the U.S. Public Health Service apply, in particular, PHS Grants
Policy Statement, DHHS Pub. No. (OASH) 90-50.000 (Rev), October 1,
1990.
 
FUNDS AVAILABLE
 
The Government anticipates making five awards (Cooperative
Agreements) for project periods of up to five years.  Approximately
$2.5 million (total costs) for the initial year's funding has been
set aside to cover direct and indirect costs of all awards.
Therefore, the cost
effectiveness of program design in relation to proposed budgets will
be a very important funding criteria, and the limits of overall
program funding should be kept in mind.
 
All currently funded Groups that wish to be eligible for funding
beyond their fifth year of support under their initial ICBG award
must apply under this RFA.
 
DEFINITIONS
 
COOPERATIVE AGREEMENT:  An assistance mechanism in which substantial
Government scientific and programmatic involvement with the recipient
is anticipated during performance of the planned activity.
 
INTERNATIONAL COOPERATIVE BIODIVERSITY GROUP:  A consortium of
Associate Programs, at least one of which is located in a developing
country institution, representing diverse scientific disciplines and
organizations which join together under guidance and direction of a
single Group Leader (Principal Investigator) and which function as a
unit with a common goal:  to promote, through multidisciplinary
approaches, drug development, biodiversity conservation, and
sustained economic growth.  In this RFA the terms International
Cooperative Biodiversity Group, ICBG, and "Group" are used
synonymously.
 
DEVELOPING COUNTRY:  It is the responsibility of the applicant to
demonstrate that the country (ies) that would host the proposed ICBG
qualifies as a developing country with significant biological
diversity. In addition, the proposed country must be one that
maintains diplomatic relations with the United States Government.
While no absolute
distinctions are made, it is unlikely that a country that has a per
capita gross domestic product greater than $9000 per year would
qualify. Applicants are encouraged to examine the data on their
proposed country in the statistical summary table, Economic
Development and Biodiversity, found on the FIC Biodiversity World
Wide Web site
(http://www.nih.gov/fic/res/countries.htm).  Applicants are also
strongly encouraged to consult with the FIC Biodiversity Program
Director regarding their proposed collaborating country.
 
ASSOCIATE PROGRAM:  A component of the overall Group, with a
separate, detailed program plan and budget, that brings to the Group
a unique resource, capability or expertise.
 
CENTRAL OPERATIONS OFFICE:  An administrative unit located at the
Group Leader's institution, which is responsible for coordinating
and/or providing administrative support for all Group activities
including budgets from the Group's associate programs.
 
NATURAL PRODUCT:  In the context of the ICBG, a term used broadly to
encompass any naturally occurring bioactive agent selected for
preclinical evaluation against a disease or for another medical,
agricultural, cosmetic or industrial need.  This, of course, excludes
materials which are synthesized de novo as well as any semi-synthetic
derivatives which do not require the collection of material from
nature.
 
GROUP LEADER:  The Principal Investigator identified in the
application who assembles the ICBG, submits the single application in
response to this RFA and who is responsible for the performance of
the Group as a whole and of each Associate Program Leader.  The Group
Leader will coordinate Group activities both scientifically and
administratively, and in addition, may lead one of the Associate
Programs of the Group. The Group Leader's institution is legally and
fiscally accountable for the disbursement of funds awarded. The Group
Leader's institution must be a not for profit institution in the
United States.
 
ASSOCIATE PROGRAM LEADER:  The director of one of the Associate
Programs of the ICBG.
 
TECHNICAL ADVISORY GROUP (TAG): A committee of advisors with relevant
expertise from the Participating Agencies and Institutes, including
the Director of the Fogarty International Center (FIC).  The TAG
reviews applications to make funding recommendations following the
initial peer review, and meets several times per year, as necessary,
to review developments in the ICBG program as a whole and progress of
individual Groups.
 
FIC BIODIVERSITY PROGRAM DIRECTOR:  A representative of the Fogarty
International Center, a member of the TAG, and the Government program
administrator for all funded Groups.  The Program Director has lead
responsibility for day to day funding and policy decisions in
coordination with the Director of the FIC and the Technical Advisory
Group.  In conjunction with the Government Scientific Coordinator for
each ICBG, the Program Director supports the activities of the Groups
where possible through policy and program functions.
 
U.S. GOVERNMENT SCIENTIFIC COORDINATOR:  A representative of the TAG
who assists a specific ICBG, attends Group meetings, interacts
scientifically with the Group, and facilitates the role of the
Government as a participant in the Group.  The U.S. Government
Scientific Coordinator serves as the chair of his or her respective
Advisory Committee.
 
ADVISORY COMMITTEE:  A subset of two or more U.S. Government
scientific advisers from the TAG to assist the work of the Group by
providing advice and assistance and through the Scientific
Coordinator (Committee Chair), to the Group.  The Advisory Committee
assists in such matters as reviewing the Group's progress reports and
suggesting mid-course corrections and future directions for the
Group.  The Advisory Committee assembled for each Group is determined
by the TAG.  Each committee, including the Scientific Coordinator,
attends Group meetings, where possible, meets separately at least
once per year, and maintains ongoing communication regarding Group
progress.
 
PATENTABLE INVENTION:  Any new and useful process, machine,
manufacture or composition of matter, or any new and useful
improvements thereof, as defined under the U.S. Patent Statute (35
USC 101).
 
CONTRACTUAL AGREEMENT:  Any formal written agreement negotiated among
participating institutions in an ICBG, or between the ICBG and other
organizations, that stipulates the rights and responsibilities of the
parties with respect to the research process, the treatment of
intellectual property and the sharing of benefits.
 
RESEARCH OBJECTIVES
 
1. The overall goals of the International Cooperative Biodiversity
Group Program are drug discovery, biodiversity conservation, and
economic development.  The following cross-cutting approaches should
guide the research and capacity-building efforts toward these goals:
a) assisting with the discovery of drugs that address priority health
needs of the United States and the participating developing country;
b) parallel assistance with research on other natural products-based
materials such as herbal medicines, crop protection agents,
veterinary medicines, or other useful products; c) developing
inventories of native species and indigenous knowledge; d) training,
targeted toward achieving the research goals of this RFA and meeting
the needs of the participating country; and, e) enhancing the
scientific infrastructure within the host country.  Specifically, the
program objectives are to:
 
a) Discover, isolate, and preclinically evaluate agents from natural
sources to treat or prevent diseases of importance to developed
countries as well as those primarily important in developing
countries. Particularly relevant disease areas and health needs
include cancer, HIV-AIDS and opportunistic infections (e.g.
tuberculosis), malaria, central nervous system disorders,
contraception and sexually transmitted diseases, and cardiovascular
and pulmonary diseases.  It should be noted that studies required for
the later stages of drug development (e.g. formulation development,
toxicology, etc.) and the conduct of clinical trials are beyond the
scope of this RFA.
 
b) Discover, isolate, and/or evaluate other natural-product based
entities such as phytomedicines, crop protection agents, animal
veterinary medicines, or other useful products with the potential to
provide near to medium term economic benefits to local communities
and other developing country partners through product earnings or
stimulation of local industries.  Such efforts should address local
health and development priorities.  It is probable that in many cases
research in these areas can  be carried out in parallel with drug
discovery work with minimal additional cost to Groups.   This may be
achieved by incorporating academic, governmental or commercial
partners with the appropriate scientific resources and by utilizing
the same or similar samples to those collected for drug discovery.
 
c) Undertake inventories of biological diversity and develop
collection practices compatible with conserving biodiversity, and
produce
documentation of all collected material in the form of museum
catalogues, published works, and/or databases, reporting specific
locality and all features of biology relevant to standard botanical
and zoological collections; assure accessibility of inventory
specimens to the public by housing them in public institutions (such
as universities and national museums), and accessibility to inventory
databases through publication on the Internet.
 
d) Support research training targeted to meet the needs of the
developing country  represented within the Group and related to the
scope of work of the RFA, and to augment field experience and
training of U.S. scientists in areas of knowledge unique to the
developing country. Support for local health needs would concentrate
on joint research and training, focusing on disease prevention and
control using locally available resources, and discovery of
appropriate therapeutics and other useful products.
 
Examples of relevant areas of training could include systematics,
information science, ethnomedicine, chemistry, cell biology,
biotechnology, or production methods, data management and quality
control in pharmaceutical development.  Incumbent Groups should plan
to advance the level of training of developing country scientists
beyond initial efforts to include advanced field and laboratory work
such as the development and conduct of locally appropriate bioassays,
isolation chemistry, database development, ecology and biodiversity
management techniques.
 
Research training supported through this award may take place in the
host country or in the United States and may be linked to degree-
earning programs.  Types of training may include, but are not limited
to:  i) practical and applied short-term courses or workshops for
professionals or technicians; ii) course work, laboratory, or field
training in essential research skills for technical assistants,
graduate degree candidates, or professionals; and iii) fellowships
for 1 or more years for degree candidates or post-doctoral trainees
to conduct research related to the goals of the Group. Training costs
and plans, must be specified in the text of the proposal and in the
proposal's budget request.
 
e) Assist in enhancing the scientific infrastructure within the
participating developing country(ies) where the biodiversity
resources are found.  Infrastructure support could include both
social and physical infrastructure. Social infrastructure might be
enhanced through strengthening of networks of scientists or local
healers.  Physical infrastructure support could include assistance
for herbaria, museums, and laboratories, the supply of necessary
equipment in these facilities, and the enhancement of collecting and
screening capabilities in the host country.  Limited renovation of
existing facilities, but not
construction of new facilities, is allowable under this RFA.  All
renovation of facilities must be strictly relevant to the research
objectives of the Group and requires prior approval of the
Government.
 
It is likely that some element of all five approaches (a-e) will be
included in successful applications.  Without a comprehensive and
multi-disciplinary approach, it would be difficult to meet the
requirement that drug discovery, biodiversity conservation, and
sustained economic growth be addressed.
 
2.  Applications for funding as an ICBG should stress creative,
synergistic approaches to biodiversity conservation, drug discovery,
and sustainable economic growth.  Experience has shown that synergy
among these goals is more likely when the varied activities of the
ICBG have significant geographical overlap than when they are widely
dispersed among different regions and countries.  However, legitimate
scientific or other considerations may lead to less geographically
localized programs.
 
I. COMPOSITION OF GROUPS
 
Groups should be multi-disciplinary, including individuals and
organizations with expertise in various relevant disciplines of the
biological and physical sciences, as well as areas such as economics
and sociology, and may include those who have not collaborated in
programs of this type in the past.
 
In addition to being multidisciplinary, it is expected that Groups
will be international in scope with participation of developing
country institutions to the greatest extent possible.  Since it is
unlikely that all of the required capabilities will be located within
one institution, Groups likely will be multi-institutional as well.
 
The active participation of the private sector is encouraged because
it: 1) will allow this segment of the scientific community to
contribute its considerable intellectual and material resources; 2)
will promote private sector participation in conservation; and 3)
will facilitate efforts to negotiate conditions for the equitable
distribution of profits and other benefits to all parties, including
developing country institutions involved in conservation and
sustainable resource use. Furthermore, the interaction of academic
and non-profit institutions with industry and Government will
encourage the creation of novel, interdisciplinary approaches which
may not otherwise develop.
 
1.  The composition of an ICBG is envisioned as follows:
 
a) A Group Leader who is likely to also head an associate program.
 
b) Associate Programs, each headed by an Associate Program Leader, in
diverse scientific disciplines, such as ecology, microbiology, cell
biology, ethnobiology, sociology, anthropology, botany, zoology,
entomology, pharmacology or chemistry, that may be appropriate to the
realization of Group objectives.  A predominance of developing
country and U.S. institutions composing the Associate Programs is
strongly encouraged. At least one of the Associate Programs must be
located in a developing country and directed by a scientist or
program administrator in a developing country institution.
 
c) The U. S. Government Coordinator (Advisory Committee Chairperson)
appointed by the Technical Advisory Group to provide assistance to
the Group.
 
A schematic diagram is available that represents possible
relationships among scientists, disciplines, and associate programs
that might form an International Cooperative Biodiversity Group.
Please refer to the FIC Biodiversity World Wide Web page for this
diagram
(http://www.nih.gov/fic/res/rfa.htm), or contact the Biodiversity
Program Director at FIC for more information.
 
2.  The Group Leader, in addition to providing scientific and
administrative leadership, may head an Associate Program.  Associate
Program Leaders will be directly responsible to the Group Leader.
The formation of the Group, submission of the application in response
to this RFA, the overall management of the Group, and the allocation
of funds to the various Associate Programs based on anticipated
needs, past performance and the overall Group needs at any given time
will be the responsibility of the Group Leader and the Group Leader's
institution in accordance with PHS policies.
 
3.  The composition of the Group and its Associate Programs should
depend on the talents required to accomplish its scientific and
technical objectives as perceived by the Group Leader and Associate
Program Leaders.  The major consideration in structuring an ICBG
should be the maximum utilization of intellectual, physical, and
financial resources to carry out the proposed research.  If the Group
includes more than one Associate Program on a specific topic, each
should be capable of contributing high quality, necessary, and non-
overlapping talents.
 
4. An individual scientist or a single institution may be proposed as
a Group Leader in only one application.  However, an individual
scientist may be an Associate Program Leader in more than one
application, or a Group Leader and an Associate Program Leader on
separate applications. If a scientist appears on more than one
application, it is the
responsibility of the Group Leader to demonstrate in their
applications that there are no scientific or budgetary overlaps or
proprietary conflicts with each individual's proposed activities.
Likewise, individuals currently receiving funding via contracts,
grants, gifts, commercial arrangements, or Cooperative Agreements may
be funded under this RFA providing that there is no scientific or
budgetary overlap or proprietary conflict in funded activities.
 
Any Associate Program Leader must complete their portion of the
overall application in detail even if no funds are requested for his
or her specific project.  NSF Staff or intramural scientists at the
NIH or the Department of Agriculture may participate in an ICBG as
collaborators or consultants, but may not submit a formal application
as an Associate Program Leader, assist in developing other portions
of the application, or receive funds from this program.  Such a
government scientist must obtain appropriate clearances prior to
submission, and in the
application, provide a letter of commitment, a current curriculum
vitae, and documentation of the required clearances.  The Group
Leader must incorporate into the application, in the usual grant
format, a full description of the project, including technical
details and methodology. The participation of an intramural scientist
is independent of and unrelated to the role of the Advisory Committee
or the U.S. Government Scientific Coordinator as described in Section
J, Part 3. "Terms and Conditions of Award."
 
5. More than one Associate Program of a Group might be derived from a
single institution.  However, the varied talents and technologies
required for the effective attainment of the objectives described in
this RFA are not likely to be present in an individual institution.
It is anticipated that the Associate Program Leaders within a Group
will therefore likely be derived from several institutions.
 
6. No prescribed number of Associate Programs per Group is
stipulated. However, the Group Leader could experience difficulty in
providing the desirable level of guidance, and Group members might
communicate and collaborate less efficiently, if the Group were to
contain more than five or six Associate Programs.  In addition, to
ensure the most effective use of resources, the number of
institutions collaborating in a Group should be considered carefully.
 
7. In forming Groups, potential Group Leaders should remain cognizant
of the need for communication, including regular meetings of members,
and transfer in a timely manner of data and materials to Group
members located in all the participating countries.  A plan for
communication and material transfer, including all permits and other
legal documents required to assure this transfer, must be supplied.
 
8. Under the provisions of assistance via a Cooperative Agreement,
the U.S. Government Scientific Coordinator will assist the ICBG and
participate in the Group in a manner specified in Section J. 3 "Terms
and Conditions of Award ", and carry out the scientific
responsibilities required.  The U.S. Government Scientific
Coordinator will not conduct Associate Program activities.
 
J. SPECIAL REQUIREMENTS
 
1. Award Monitoring and Evaluation
 
Progress of each funded Group will be monitored and evaluated using
regular technical progress and financial reports prepared by the
Group. Detailed reporting instructions are being developed in
response to ongoing program reviews, and may be available from the
Program Director following the deadline for receipt of a Letter of
Intent.
 
The U.S. Government Scientific Coordinator or the ICBG Program
Director, with advice from the Advisory Committee, may also elect to
conduct site visits or enlist the  technical assistance of external
consultants to review progress and work with investigators to suggest
mid-course changes or recommendations for non-competitive renewal of
awards.
 
2. Intellectual Property and Benefit-Sharing
 
Because the discovery of bioactive agents from natural products is
one objective of this effort, along with ensuring an equitable
economic benefit accrues to developing country organizations or
communities associated with ICBG research, it is essential that
applicants develop appropriate research plans and contractual
agreements for the treatment of intellectual property.  These plans
must ensure that inventions and the various intellectual and material
contributions that lead to their development are properly protected
and compensated.  Experience has shown that the development of these
plans and agreements is frequently complex and challenging because
multiple institutions and countries are involved, often with very
different objectives, perceptions and
expectations, and occasionally from very different legal
environments.
 
In the application each applicant Group must, therefore, provide a
detailed description of its approach to intellectual property and  to
the sharing of benefits from ICBG sponsored research.  Descriptions
should encompass both the conduct of collaborative research
activities and the nature of contractual agreements among the
collaborators.  The research plan and contractual agreements among
Group members must be designed such that they address the program
principles that are detailed in Appendix 1.
 
Prior to receiving an award formal agreements specifying the rights
and responsibilities of each Group member institution must be signed
and dated by the organizational official authorized to enter into
such arrangements, and must be on file at the Fogarty International
Center. (See Section M., "MINIMUM REQUIREMENTS FOR APPLICATION").
Proposals that represent continuation from previous ICBG awards must
also provide updated, revised or new agreements prior to receiving an
award.  The above applies to all research carried out under this RFA,
including any that may involve U.S. Government laboratories.
 
3. Terms and Conditions of Award
 
The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator (Group
Leader) at the time of award.  The "Terms and Conditions of Award"
described in this section are in addition to, and not in lieu of,
otherwise
applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH
grant administration policy statements.
 
a) Awardee Rights and Responsibilities
 
Assistance via Cooperative Agreements differs from that of grants in
that, in addition to programmatic and administrative stewardship
responsibilities, the U.S. Government in awarding the Cooperative
Agreement anticipates substantial scientific involvement during
performance of the project.  However, the Group must define its
objectives and its approaches to attain these objectives in accord
with its own interests, scientific creativity, capabilities and
perceptions. In this process, Groups are invited to use novel and
effective
approaches to the interdependent program areas of drug development,
biodiversity conservation and sustained economic growth.  The Group
must develop the details of the program design following the guidance
given in this RFA.  It is the primary responsibility of the Group
Leader to state clearly the objectives of the Group, to direct the
research and other activities stipulated in the proposal, and to
ensure that the results obtained are properly disseminated, and
published.  It is anticipated that decisions will be reached by
consensus of the Group under the leadership of the Group Leader and
that the U.S. Government Scientific Coordinator will have the
opportunity to offer input to this process.
 
The Group Leader is responsible for organizing meetings of all Group
members at least once per year to review progress, plan and design
research and technical activities, and establish priorities.
 
Each project is expected to contribute to the achievement of three
classes of benefits: health benefits through the discovery of natural
products which may lead to new pharmacologic and possibly
agricultural agents, benefits in the understanding and conservation
of biological diversity, and potential economic benefits.  The
following three sections describe responsibilities of the awardee
relating to the realization of these benefits.
 
i. Drug Discovery
 
One principal end product of the ICBG is the identification of
bioactive natural products with potential for biomedical use.  Other
possible end products include information toward the development of
phytomedicines of local importance as well as agricultural agents and
other natural product based materials.  Research toward these
products should utilize the important resources of indigenous
knowledge where relevant and acceptable to local participants.  The
awardee is responsible for developing strategies to insure that
profits derived from those agents or from the knowledge which
provides access to those agents are
equitably distributed to the appropriate participating organizations
and communities, as described in Principles for the Treatment of
Intellectual Property (Appendix 1).
 
The Government will retain the option to cross-file or independently
file an application for investigational clinical trial [e.g. an
Investigational New Drug Application (INDA) or an Investigational New
Device] to the United States Food and Drug Administration of any
invention resulting from these Government supported Cooperative
Agreements.  It is the responsibility of the Group Leader to submit
to the U.S. Government Scientific Coordinator upon request reports of
data generated by the Group or any of its members required for cross-
filing purposes.  Such reports will include background information,
methods, results, and conclusions.  They will be subject to approval
and revision by Government staff and may be augmented with test
results from other Government-sponsored projects prior to submission
to the appropriate regulatory agency.
 
The awardee will retain custody of and rights to the data, and timely
publication or dissemination of major findings by the Group members
is encouraged.  Publications or oral presentations of work done under
this agreement will require appropriate acknowledgment of joint
support from NIH and NSF, and FAS as applicable, under this RFA.  The
Government will have access to all data generated under this
Cooperative Agreement and may periodically review the data.  It is
the responsibility of the Group Leader to provide this data to the
FIC Program Director and the
Government Scientific Coordinator upon request.
 
ii. Biodiversity Conservation
 
The primary products of biodiversity conservation efforts should
include:
1) strengthened host country capabilities to implement sustainable
resource use policies and programs; 2) the establishment of biotic
inventories and collections of preserved or living specimens of
plants, animals and microbes; and 3) enhancement of the value of
biodiversity to communities affected by conservation efforts through
benefit-sharing activities, educational programs, sustainable use
income opportunities, or other approaches.  Additional end products
could include floral and faunal lists, identification keys, and
computerized databases.  These should be made available for use by
the host-country natural resource management authorities as soon as
possible.
 
Projects must comply with all national and international regulations
regarding collection and importation of organisms.  Assurance must be
provided that all requisite permits from the relevant governments
will be procured.  Requests to collect species that have been
declared threshold or endangered by the Convention on International
Trade in Endangered Species (CITES) must be especially well
justified, and all regulations regarding these species must be
scrupulously followed.
 
Collection of biological materials for inventories, assays, chemical
analyses or commercial development must be conducted with close
attention to the potential impact of collection on natural
populations of target or associated organisms.
 
Voucher specimens should be collected for all taxa.  These must be
preserved in a manner suitable to allow subsequent identification and
scientific analysis of the specimens.  Specimen collections must be
placed in appropriate depositories, such as natural history museums,
herbaria, and living organism stock collections.  It is especially
important to deposit specimens in the host country, and plans for the
eventual deposition of all collections made during the life of the
proposed ICBG should be included in the proposal.  Strengthening host
country capabilities in these areas is encouraged as a component of
any ICBG.
 
Floral and faunal lists and identification keys should be published
in English and in the major language(s) of the host country.  When
ethnobiological studies are involved, results should also be
published in the language(s) of the indigenous people(s) where
possible.
 
The development of biodiversity databases, such as computerized keys,
inventory lists, and geographic information systems, is strongly
encouraged.  Where possible, these databases should be located at the
host country institution where collections from ICBG activities are
deposited.  In any case, the institutions where collections are
housed must have ready access to the data, and where possible, the
biodiversity (biological inventory) database should be accessible via
the internet. If these databases are linked to drug discovery
databases with
proprietary information appropriate attention to security of those
data is expected.
 
iii. Economic Development
 
ICBG efforts must provide for both near and long term benefits to the
source country and communities from the research process and any
discoveries which emerge from it.
 
It is strongly recommended that Groups hold a public meeting or
workshop in the host country during the formative or very early
working stage of the project.  Experience has shown that such fora
involving individuals from from local communities as well as from
university, government, and private voluntary organizations are an
extremely valuable means of gaining early feedback on working plans
and broad-based support for future project efforts.
 
For projects that will have substantial interactions with indigenous
and local communities Groups are advised to consult social scientists
with local expertise, at a minimum during project planning and
periodically thereafter.
 
End products of special concern for economic development include
training targeted to the specific needs of the research program and
the participating country, enhancement of the scientific
infrastructure of the participating country, and identification of
new natural products suited for sustainable microenterprise
development and/or health promotion in the participating country.  In
respect to these products the following guidelines must be observed:
 
In the enhancement of scientific infrastructure, project managers
must specifically consult with participating country officials to
assure that the enhanced research capabilities can be sustained after
completion of the project, using locally available resources.  In so
far as possible and appropriate to the research needs of the program,
equipment procured will be of U.S. source and origin.   Major
equipment procurements which are not from U.S. sources or origins
must be justified in writing and are subject to U.S. Government
approval.
 
Where information is generated that would be useful to developing
countries in meeting development objectives, such as information
useful in establishing sustainable natural products-based industries
or novel and important approaches to partnership frameworks, such
information will be made available to the Government of the
developing country partners and to the U.S. Government.  Moreover,
within the Cooperative Agreement , a plan to disseminate this
information should be developed and implemented.  The dissemination
plan may include such elements as publication of results in
appropriate journals; presentations at conferences; the transfer of
relevant information to agricultural and industrial extension
services; and direct publication and extension efforts by the
collaborators.
 
In the licensing of a product for advanced development and/or
commercial production, the licensee must be required to use the
participating country and/or communities as the first source of raw
or processed material, subject to the negotiation of mutually
acceptable terms.
 
b)  Nature of U.S. Government Assistance
 
The U.S. Government shall assist in the activities of the ICBG
principally through the U.S. Government Scientific Coordinator and
the FIC Biodiversity Program Director.  The Program Director shall be
the primary Government contact with the Group Leader for issues
relating to program administration, funding and policy.
 
The Coordinator will be the primary Government contact with the Group
Leader for scientific and technical issues.  The Coordinator will be
appointed by the Government from one of the participating agencies.
During performance of the award, the Coordinator may provide
appropriate assistance in the design of activities; in the
identification of scientific resources; and in the collection of
materials or information. In all cases, the role of the Coordinator
will be to assist and
facilitate, and not to direct activities.
 
The U.S. Government Scientific Coordinator, as well as any other
Group member, may assist in research planning; may suggest studies
within the scope of the Group's objectives; may present to the Group
findings from published sources or from grant or contract projects in
support of these suggestions; may participate in the design of
project activities and experiments as agreed to by the Group; and may
participate in the analysis of results.
 
When appropriate and with prior knowledge of the Advisory Committee
to the Government Scientific Coordinator, U.S. Government
laboratories or contractor laboratories may be available for training
related to the specific research efforts of the ICBG.  Prior written
approval from the laboratory director must be obtained.  Funding for
this training must be within the ICBG's approved budget.
 
The in vitro human cancer cell line screen of the NCI will be
available for testing of all ICBG materials, including extracts,
either in the form of a primary screen or for confirmatory secondary
testing, as appropriate.
 
Upon recommendation of the U.S. Government Scientific Coordinator,
and with appropriate prior mutual agreement, other Institutes of the
NIH, including NIAID, NICHD, NIMH, may use their contract-based
resources in support of Group research activities.  The following is
a list of resources that may be available.  It cannot be assumed that
any specific resource will be made available, and accordingly they
should not be included as part of the application unless formally
agreed upon prior to submission, and documentation of such a
commitment is provided with the application.  All compounds and
information exchanged between awardee and the Government will be
governed by confidentiality agreements among the parties involved.
These resources include:
 
i. Reference compounds for standardization of test systems, as
analytical standards, and for related purposes.
 
ii. Needed resources such as test materials and research results and
other information that may not otherwise be available to the Group.
 
iii. Laboratory testing capacity, whenever appropriate and possible,
in the current contract-based preclinical therapy-related laboratory
testing program.  The Group is expected to provide sufficient test
material for such testing.
 
iv. Searches of computer files of materials, chemical structures and
biological activity, if requests for such searches are sufficiently
focused to avoid excessive costs.  Information given to an ICBG will
be restricted by any standard confidentiality agreements between the
Government and suppliers of test material to the Government.
 
v. Experimental animals and other biological resources (e.g. cell
cultures), if available, to Groups whose main research activities do
not require these materials on a regular basis, and if fully
justifiable. Note: in all cases Groups whose experimental approach
involves studies that require animals must 1) meet all PHS animal
protection requirements (see below) and 2) budget for anticipated
associated costs in their application.
 
vi. Computer processing and statistical evaluation if costs are not
excessive.
 
The Government will have access to data generated under this
cooperative agreement and may periodically review the data.
 
These "Terms and Conditions of Award" require that the U.S.
Government Scientific Coordinator approve the following:  reports
intended for inclusion in INDAs and Clinical Brochures;
redistribution, outside the ICBG, of biological and chemical
materials received from the U.S. Government; and dissemination of
research or project findings resulting from the use of such materials
to assure conformity to existing
confidentiality agreements with suppliers.
 
c) Collaborative Responsibilities
 
At least twice during the five year duration of awards under this RFA
representatives of all funded Groups and all available TAG members
will attend a joint meeting to share important information, to review
the overall progress of the program and establish future priorities.
 
d) Arbitration
 
Disagreements pertaining to approval by the U.S. Government
Scientific Coordinator on scientific and technical programmatic
matters will be arbitrated by a panel composed of one Group designee,
one Government designee assigned by the Government Scientific
Coordinator, and a third designee with expertise in the relevant area
chosen by the other two. This arbitration procedure in no way affects
the awardee's right to appeal an adverse action in accordance with
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at
45 CFR Part 16.
 
4. Inclusion of Women and Minorities in Research Involving Human
Subjects
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
K. LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 15, 1997, a
short letter of intent that includes a descriptive title of the
proposed project, a short (one paragraph) description of the intended
components, and to the extent known, names of members of the proposed
Group (Group Leader and Associate Programs) and their institutions.
The letter of intent is requested in order to provide an indication
of the number and scope of applications to be reviewed and to assist
in the formation of an initial peer review group.  The letter of
intent does not commit the sender to submit an application, nor is it
a requirement for submission of an application.  Letters of Intent
should be sent directly to:
 
Dr. Joshua Rosenthal
International Cooperative Biodiversity Groups Program
Fogarty International Center
National Institutes of Health
31 CENTER DRIVE  MSC 2220
BETHESDA, MD  20892-2220
 
L. APPLICATION PROCEDURES
 
1.  Receipt Date
 
The deadline for receipt of applications at the Division of Research
Grants is JANUARY 22, 1998.  APPLICATIONS RECEIVED AFTER THIS DATE
WILL BE CONSIDERED AS NOT RESPONSIVE TO THIS RFA AND WILL BE RETURNED
WITHOUT REVIEW.  Please note, the Division of Research Grants will
not accept any application to this RFA that is the same as one
currently being considered by any other review group or awarding unit
of the National Institutes of Health.
 
2.  General
 
a) The regular research grant application Form PHS-398 (Rev. 5/95)
must be used in applying.  General instructions for completing the
Form PHS-398 are contained in the application package.  Apply
additional instructions as outlined in this RFA.  The Form PHS-398 is
available through the NIH pages on the World Wide Web
(http://grants.nih.gov/grants/funding/phs398/phs398.html), from
sponsored projects offices at most institutions or from the Division
of Research Grants.  One completed original and five (5) copies
total, including appendices, are required.
 
Submit a signed, typewritten original of the application, including a
single Checklist, and three (3) signed, single sided photocopies in
one package to:
 
Division of Research Grants
National Institutes of Health
Suite 1040
6701 ROCKLEDGE DR MSC 7710
Bethesda, Maryland 20892-7710
 
To ensure that your application receives appropriate consideration,
it is essential to send the two (2) remaining copies of your
application with all appendices directly to:
 
Dr. Joshua Rosenthal
International Cooperative Biodiversity Groups Program
Fogarty International Center
National Institutes of Health
31 CENTER DRIVE  MSC 2220
BETHESDA, MD  20892-2220
 
b) To expedite the review of the application, and to assure its
identification with this RFA:
 
The application form should state "TW-98-001 International
Cooperative Biodiversity Groups" on line 2 of the face page of the
application form; personalized titles more fitting for your
application should be listed on line 1 and not on line 2.
 
The RFA label available in the application form PHS-398 (Rev. 5/95)
must be affixed to the bottom of the face page.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.
 
3.  Organization of Application and Suggested Modifications of Form
PHS-398 (Revised, 5/95)
 
This RFA requires the submission of a single application for each
proposed International Cooperative Biodiversity Group.  Applicants
should follow the instructions given in the Form PHS-398 (Rev. 5/95)
package unless otherwise indicated in this announcement or in
supplemental instructions.  Because of the multi-institutional nature
of an ICBG and the special requirements in this RFA, additional
instructions regarding format and some modifications are given to
guide the writing of a comprehensive application.
 
The application will be reviewed as a whole, and in addition each
Associate Program will receive an individual critique. Therefore, the
application  should contain separate sections for each Associate
Program, preceded by a Group Plan section.
 
a) Group Plan
 
This section should contain the following portions of the PHS-398:
Face Page; Description, Performance Sites, Key Personnel; Research
Grant Table of Contents; Budget for Entire Period of Proposed
Support; Research Plan; Checklist.   The 25 page limit described in
the PHS-398 applies to this Group Plan section individually.
 
Complete the FACE PAGE for the application as in a regular research
grant proposal.
 
For the Group Plan section, Key Personnel should list the Associate
Program Leaders for the whole Group.  The Table of Contents should
number pages for the entire application consecutively, with the FACE
PAGE as page 1.
 
The BUDGET page in this section (Form EE) should reflect the
consolidated TOTAL DIRECT COSTS, by category, of the entire proposed
ICBG.  A summary page of the TOTAL DIRECT COSTS, by Associate
Program, by year, must be included on a separate page. The Group Plan
section should also provide, from the applying institution, a
Detailed Budget for the First Twelve Month Period and a Budget for
the Entire Proposed Project Period for Direct Costs for the
management and coordination of Group activities through a Central
Operations Office and all travel including the cost of annual Group
meetings.
 
Often the various research tasks necessary to reach the Group's goals
may need to be phased in, at least in part, in sequential fashion.
For example, isolation chemistry will not likely begin until samples
have been collected and samples with biologically active constituents
have been identified and verified.  In such cases, the budgets for
the individual Associate Programs should, logically, reflect an
appropriate change in relative emphasis among tasks until an
operational steady state situation is attained.  Justification for
phase-in budgets also should be provided.
 
Inasmuch as the Group Leader may also function as an Associate
Program Leader for his/her Associate Program, detailed budget
information that duplicates information provided in the section
describing the Group Leader's Associate Program need not be included
in the Group Plan Section.
 
The RESEARCH PLAN in the GROUP PLAN section should summarize and
synthesize the associate programs to illustrate a coherent Group
effort, e.g., how the projects are mutually reinforcing and how
collectively they will further the goals of the proposed research.
This should include a description of the interrelationships among
members of the Group and organizational charts in accordance with
Sections H. and I. of this RFA.  It is important to discuss any prior
collaborative efforts among the investigators as evidence of the
ability to work together in multi-disciplinary and/or international
projects.
 
The Group Plan section should not repeat details that are provided in
the Associate Program sections, however, it should contain any
additional information about the proposed Group Leader or his/her
institution that is evidence of the capability to carry out the
scientific and administrative duties required in this RFA and the
functions of the Central Operations Office.
 
In addition, the Group Plan Section must include the following
elements to be considered responsive to minimum requirements.
 
i. A statement assuring compliance with the Program Principles for
the Treatment of Intellectual Property and assuring adequate patent
coverage of new inventions that may issue as a result of Government
funding in accordance with Appendix 1.
 
ii. A statement of acceptance of the provisions of "Terms and
Conditions of Award," as described in Section J, Part 3.
 
iii. A plan to assure maintenance of close collaboration and
effective communication among members of the Group in accordance with
Section I, Part 7.
 
b) Associate Programs
 
Each of the Associate Programs, including the Associate Program (if
any) of the proposed Group Leader, should be numbered consecutively
(AP 1, AP 2, ...).  Use Form PHS-398 for each Associate Program but
omit the checklist for the individual program. The 25 page limitation
stipulated in the PHS-398 application package applies to each of the
individual Associate Programs.
 
Each Associate Program section should begin with its own TITLE PAGE
(in front of the application FACE PAGE). The TITLE PAGE should state
"International Cooperative Biodiversity Groups", the overall project
title, and the Group Leader at the top of the page.  The Associate
Program Leader, the Associate Program number within the group, and
its general field(s) of study should be stated in the lower right
hand corner.
 
The "Title of Project" (line 1) on the FACE PAGE should list the
overall Group title and should be the same for all associate programs
in one Group application, but should end with the Associate Program
number (e.g., - AP 1).  The remainder of the FACE PAGE should be
completed as in a regular grant application.
 
The Table of Contents for these sections should be consistent with
the GROUP PLAN TABLE OF CONTENTS, and should be detailed enough to
enable reviewers to find specific information readily.
 
It is also suggested that the "Description" (grant application form
page BB) of each of the Associate Programs, in addition to describing
the work proposed, provide a statement of relevance to the overall
objectives of the proposed ICBG.
 
The remaining parts of the PHS-398, except the CHECKLIST for each
Associate Program section should be completed as in a normal grant
application, detailing the proposed work of the Associate Program,
and where relevant, the interactions with other Associate Programs
within the Group.
 
c) APPENDICES
 
i. Incumbent Groups must describe, in 10 pages or less, the progress
they have attained toward the original goals of their program,
including a list of publications, workshops and any other
accomplishments of the Group.
 
ii. If internal or external advisory groups will be used in addition
to those specified in this RFA, list their membership and describe
their roles.
 
iii. List in a separate table all consultants, both paid and unpaid.
Include a signed letter of agreement from each consultant.
 
iv. If the applicant has an approved assurance covering the research
(multiple project assurance for human subject/full assurance of
compliance for animal subjects), the applicant should provide with
the application, an indication of certification of institutional
review board (IRB) approval if humans are involved and verification
of the institutional animal care and use committee (IACUC) approval
if animals are involved in any Associate Program (domestic and
foreign).  These reviews and approvals should occur PRIOR TO
SUBMISSION OF the
applications for award and the certifications and verifications
should be SUBMITTED WITH the applications.  Failure to provide
required certifications and verifications within applications could
result in deferral of award or rejection of application.  If animals
or humans will be subjects of the research at PERFORMANCE SITES OTHER
THAN THE APPLICANT ORGANIZATION, the applicants must identify, with
the
application, the assurance status of each participant.  Failure to
provide this information within the applications could result in
deferral of award or rejection of application.  Questions concerning
use of human or animal subjects in research should be referred to the
Office of Protection from Research Risks, National Institutes of
Health, Bethesda, MD 20892 (Telephone:  (301) 496-8101 for Human
Subject Protections and (301) 496-7163 for Animal Welfare).
 
M. Minimum Requirements for Application
 
Applications to the International Cooperative Biodiversity Groups
must meet a set minimum requirements, listed below, in order to be
considered by the peer review panel.  These requirements are each
described elsewhere in this RFA and should be addressed in the
relevant portions of the application:
 
1. Identify a single Group Leader from a U.S. non-profit institution
who will be responsible for the application, for Group research and
technical activities, and for the disbursement of funds in support of
Group activities.
 
2. Structure the Group to include at least one Associate Program
located within a developing country institution.
 
3. Identify the Group Leader's institution that will assume legal and
financial responsibility and accountability for the use and
disposition of funds awarded on the basis of this RFA; show
availability of
personnel and facilities capable of performing and supporting the
administrative and scientific functions of this ICBG.
 
4. Present, for each Associate Program, research and technical
approaches, as specified in Sections H and J.3. of this RFA, and
detailed budget requirements.
 
5. Provide a description of the Group's plan for assuring adequate
protection of intellectual property and sharing of benefits that may
result from Government funding of the proposed work.  The application
requires an outline for the basic framework of an agreement or
agreements among all Group members and their institutions, including
local community organization representatives, signed and dated by the
organizational official authorized to enter such arrangements for
each Group member and member institution.  The outline or plan need
not list specific terms of agreements, but must indicate
correspondence of the basic plan with relevant national and
international laws and the program principles described in Appendix
1.  Finalized, signed agreements among all Group members must be
submitted to the FIC for review prior to award.
 
6. Provide a clear, concise plan in narrative and diagrammatic form
that depicts the interrelationships among the members of the Group
and the contribution of each to the fulfillment of Group objectives;
provide an organizational chart of the Group showing the name,
organization, and scientific discipline of the Group Leader and
Associate Program Leaders; provide an organizational chart for each
Associate Program within the Group showing relationships among the
key personnel.
 
7. Provide a plan to assure the maintenance of close collaboration
and effective communication among members of the Group and between
the Group and host country government and community leaders.  The
application must include letters of commitment to the plan by all
Associate Program Leaders.
 
8. The application should include a general letter of support for the
project from the relevant developing country Government agency(ies),
acknowledging the multiple goals of the program.  The application
must include a list of the documents that will ultimately be
necessary to satisfy local institutional and governmental
requirements, and a statement of commitment from the Group Leader to
provide these before an award is made.  Copies of all permits and
legal documents and
certifications of governmental authorizations required to assure
collaborations must be provided before an award is made.
 
9. Describe the ways in which the Group Leader and the Associate
Program Leaders possess the outstanding scientific and technical
skills and leadership qualities to conduct the proposed research
successfully, including relevant research programs, experience,
unique competencies, and pertinent publications, peer recognition or
other evidence of accomplishment.
 
10. Outline the capacity and plans to cooperate with and to provide
research training for developing country nationals (eg. scientists,
students).
 
11. Describe the competence of the Group Leader to manage
comprehensive research projects and to coordinate and integrate
research and project activities of diverse Associate Programs.
 
12. Describe how each component Associate Program is required for the
attainment of the Group's objectives and that each has available the
professional and technical personnel to permit efficient and
successful conduct of the proposed research; documentation should
include curricula vitae for all key professionals involved in the
Group.
 
13. Indicate that all key personnel have the time available for this
project and show for all key professional personnel: 1) title,
identifying number, percentage of effort devoted to the project,
direct costs, and project period of all awarded and pending grants,
contracts, Cooperative Agreements, and industrial commitments
regardless of source of funding; and 2) identify and explain areas of
potential scientific and/or budgetary overlap with active and pending
grants, contracts, and Cooperative Agreements and what support would
be relinquished if this Cooperative Agreement award is made.
 
14. Describe, for each component Associate Program and the Group as a
whole, the facilities available for conduct of the proposed research.
Funds will be provided for alteration or renovation only for
facilities in developing countries under this RFA.
 
15. Provide a plan for scheduling at least one Group meeting per year
with active participation of all Associate Program leaders, notifying
Group members, and disseminating Group meeting proceedings. Include
plans for information exchange and discussions among Group members
between Group meetings.
 
16. Provide a research training plan which includes types of
training, numbers of trainees, in-country courses and workshops, if
any, and letters of commitment from institutions where training will
take place. Costs associated with training activities must also be
specified in the Budget section of the application.
 
17. Submit an overall work scope and schedule for the specified time
frame of the application.
 
N. REVIEW CONSIDERATIONS
 
1. Review Procedures
 
Applications will be received by NIH Division of Research Grants
(DRG) and reviewed by the DRG and FIC for completeness.  Incomplete
applications will be rejected without further review and returned to
the applicant.
 
The FIC will evaluate proposals for their responsiveness to this RFA.
Applications will be analyzed to determine if they meet the goals and
objectives of the program as described in this RFA.  Applications
that are judged to be non-responsive will be administratively
withdrawn, and the proposed Group Leader and institutional official
will be notified.
 
The Government may conduct an initial peer review to eliminate
applications that are clearly not competitive for award.  The
Government will withdraw from further competition those applications
judged to be noncompetitive and notify the Group Leader and
institutional official.
 
Those applications judged to be both competitive and responsive will
be further evaluated, using the review criteria below, for scientific
and technical merit by a peer review group convened by the National
Institutes of Health.  The peer review group will consist of members
with the necessary scientific disciplines to evaluate the
applications received.  Secondary review will be provided by the FIC
Advisory Board. Based on recommendations from the peer review
process, the ICBG
Technical Advisory Group and Participating Agencies will recommend
funding levels and priorities.  The Agencies will critically examine
the submitted budget and will recommend an appropriate budget and
period of support for each approved application.  Final funding
decisions will be made by the Director, FIC, considering the outcome
of the above process.
 
2.  Review Criteria
 
Significance
 
a) Potential impact on human health, biodiversity conservation, and
sustainable economic development.
 
Approach
 
b) Technical merit of proposed methods in response to this RFA.
 
c) Degree of multidisciplinary cooperation among associate programs
and potential for synergy of activities toward the three goals of the
program.  Adequacy of plans for effective intra-Group communication
and for assuring Group cohesiveness, accounting for the special
requirements of an international collaboration.
 
d) Adequacy of plans to build capacity for biodiversity and
biomedical research, and applicability of those plans to local and
international scientific needs beyond the specific targets of the
proposed work.
 
e) Extent and level of developing country participation, and
documentation of local community involvement.
 
Innovation
 
f) Originality of proposed approaches in response to this RFA.
 
Investigators
 
g) Adequacy of the scientific disciplines and specific competencies
represented by the Group Leader and Associate Program Leaders;
experience, competence, commitment, and time availability of the
Group Leader, Associate Program Leaders, and other key personnel.
Previous success relevant to this RFA and demonstrated past support
from NIH, NSF or other sources.
 
h) Ability, as measured by previous success, to cooperate with and
train developing country nationals in the scientific and technical
disciplines considered critical to meeting the objectives of the
proposed programs.
 
i) Administrative experience and competence of Group Leader in the
development, implementation, and management of comprehensive research
programs and the demonstrated commitment of the applicant institution
to support these activities.
 
Environment
 
j) Extent to which the proposed work takes place in a country or
region that is a priority for biodiversity conservation and economic
development efforts, and takes advantage of the unique biological and
intellectual resources (including indigenous knowledge, where
appropriate) of that country or region.
 
k) Adequacy of existing physical facilities, research and training
resources available to the Group Leader and Associate Program
Leaders. Evidence of availability and competence of the applying
institutions to carry out all required legal, fiscal and policy
responsibilities.
 
Special Considerations
 
This RFA does not cover clinical trials or collection of samples of
human tissue.  However, research that involves obtaining data through
1) intervention or interaction with a living individual, or 2)
collecting private information that identifies a living individual,
shall be undertaken only in accord with Department of Health and
Human Services regulations for protection of human subjects (Title 45
Code of Federal Regulations Part 46).  Investigators proposing such
research should consult their local Institutional Review Boards or
the Office for Protection from Research Risks (OPRR), National
Institutes of Health, 6100 Executive Boulevard, MSC 7508, Rockville,
Maryland 20852-7508.  In this regard, applicants must be sure to meet
the requirements of obtaining single project assurances from OPRR for
all projects involving human subjects at foreign sites unless
otherwise covered by a multiple project assurance.
 
The involvement of informants in the collection of information on
traditional uses of biota for ethnomedical or other uses requires
strict adherence to the Principles for the Treatment of Intellectual
Property outlined in Appendix 1.
 
O. INQUIRIES
 
It is strongly advised that prospective applicants contact the FIC
early in their planning process to discuss their applications and to
obtain any clarifying information or instructions that may be
developed. Written or telephone inquiries concerning the objectives
and scope of this RFA or inquiries about whether or not specific
proposed research would be responsive to this RFA are encouraged and
should be addressed to:
 
Dr. Joshua Rosenthal
Director, Biodiversity Program
Fogarty International Center
National Institutes of Health
31 CENTER DRIVE  MSC 2220
BETHESDA, MD  20892-2220
Telephone: 301-496-2516
FAX:  301-402-2056
Email: joshua_rosenthal@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Silvia Mandes
Grants Management Officer
Fogarty International Center
National Institutes of Health
31 CENTER DRIVE  MSC 2220
BETHESDA, MD  20892-2220
Telephone: 301-496-1653
FAX: 301-402-0779
Email: mandess@ficod.fic.nih.gov
 
Direct inquires regarding peer review of applications to:
 
Dr. Kirt Vener
Chief, Review Logistics Branch
Division of Extramural Awards
National Cancer Institute
Executive Plaza North
Room 622B
BETHESDA, MD 20892
Telephone: 301-496-7173
FAX: 301-402-0275
Email to: kv5n@nih.gov
 
P. AUTHORITY AND REGULATIONS
 
Awards are made under authorization of the Public Health Service Act,
Title III, Part A, Sections 301 and 307, and Title IV, Part A,
section 482 (P.L. 78-410, as amended by P.L. 99-158, 42 USC 241,
242l, and 287b) and administered under PHS grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This program is
not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.  The participation by other agencies in
funding the program is authorized under the Economy Act (31 U.S.C.
1535).
 
Appendix 1
 
Principles for the treatment of intellectual property and the sharing
of benefits associated with ICBG sponsored research.
 
In developing both research plans and intellectual property
agreements it is important that all involved understand the
differences between patent coverage and benefit-sharing agreements.
While legal protection of the right to commercialize an invention is
generally accomplished through the patent system, agreements among
collaborators are generally required to designate the terms of
partnerships including, among other things, the licensing of an
invention and the sharing of any financial benefits that accrue from
it.
 
The conduct of ICBG sponsored research and the agreements among the
collaborators must address the following principles to be eligible
for funding.
 
a) Protection of inventions using patents or other legal mechanisms.
 
Non-profit organizations (including universities) and small business
firms retain the rights to any patents resulting from U.S. Government
contracts, grants, or Cooperative Agreements.  P.L. 96-517, through
regulation, extends to businesses of any size the first option to the
ownership of rights to inventions made in the performance of a
federally-funded contract, grant, or Cooperative Agreement.  All
group members, therefore, including businesses of any size, might be
full partners in the research of the Group and in rights to file
patents for any inventions resulting therefrom as specified in the
Group's research agreement.  This includes communities organized into
or represented by an appropriate legal entity.
 
The specific intellectual property arrangements among the
institutions may vary and could include joint patent ownership,
exclusive licensing arrangements, etc.  Valuable intellectual
resources that cannot or will not be patented, such as novel assays
or traditional medicinal
techniques, may require alternative protection methods such as trade
secrets. Applicants are encouraged to develop an arrangement that
best suits the particular circumstances of their Group.
 
b) Clear designation of the rights and responsibilities of all
partners.
 
i.  This is principally done through the design of adequate
contractual agreements. Agreements should be among all collaborating
organizations, whether or not they are recipients of government
funds.  These may include commercial drug developers, source country
and US research institutions, and indigenous and local peoples whose
resources,
biological or intellectual, are utilized in the research process. ii.
It is strongly recommended that all parties to agreements have
separate, competent legal counsel to represent their interests.
iii.  Useful contractual tools for the designation of rights and
responsibilities include material transfer agreements, research and
development agreements, license options agreements, know-how
licenses, benefit-sharing agreements, and structured trust funds.
iv.  Unless stipulated otherwise in agreements among source country
institutions and their collaborators, biological samples and
associated information collected under ICBG sponsored research is the
property of the source country institutions. The Government retains
"march-in" rights to require licensing if the inventing
organization(s) fail to pursue development of the process or
invention, as described in the "Terms and Conditions of Award".
v.  The ownership and compensation terms of first generation and
subsequent inventions based upon a lead discovered in ICBG work
should be clearly stipulated in agreements.
vi.  Agreements should specify that the basic goals of the
collaboration include the drug discovery, economic development, and
the conservation and sustainable use of biological diversity.
vii.  Agreements should also indicate how a sustainable source of
materials for follow-up analysis of a lead compound will be
developed, and should preferentially use the participating country
and/or
communities as the first source of raw or processed materials.
 
c) Sharing of benefits with the appropriate source country parties.
 
i.  Equitable distribution of benefits should accrue to all those who
contribute to a commercialized product, whether they are members of
the consortium or not, including research institutions and local or
indigenous people who provide useful traditional knowledge.
ii.  Benefits should flow back to the area in which the source plant,
animal or microorganism was found, in such a way that they at least
indirectly promote conservation of biological diversity.
iii.  The selection of beneficiaries must be justified in terms of
program goals, as well as local and international laws and customs.
iv.  Benefits should be structured such that they are appropriate to
the needs of the communities and the resources of the other
collaborators. For example, trust funds managed by a community or
community-project board may be more effective in support of
conservation and health or education services than cash payments to a
single individual or
authority. Note that direct cash compensation may even have injurious
effects on non-money economies.
v.  Ideally, compensation begins flowing early in the collaboration
through initial payments, training, equipment or services, to provide
near term conservation incentives.
 
d) Disclosure and consent of indigenous or other local stewards.
 
i.  Arrangements for the use of traditional knowledge or the
collection of samples from the lands of local peoples should be based
upon full disclosure and informed consent of those peoples.
ii.  Indigenous concepts of intellectual property should be
respected. If for instance, cooperating indigenous groups, on the
basis of
religious or other concerns, object to specific uses, widespread
dissemination or other treatments of the knowledge they provide,
these concerns should be respected in the conduct of ICBG projects.
iii.  The process of disclosure and informed consent should be as
inclusive and formal as is possible and culturally appropriate.   The
best practice is the development of written agreements with a
community following complete and formal presentation of the Group's
goals and methods.  Presentations should provide realistic
descriptions of the type, amounts and probabilities of benefits as
well as any costs or risks that may accrue to cooperating
communities.
iv.  Arrangements with individuals who cooperate or provide
information should be based upon prior community - level agreements
whenever possible or appropriate.
 
e) Information flow that balances proprietary, collaborative and
public needs.
 
i.  Agreements and research plans should anticipate the tension
between the traditional scientific ethic of public access to
information, including publication of results, and the understandable
desire of indigenous or commercial partners for confidentiality of
information with potential commercial value, pending protection
through patenting or other means.
ii.  Sharing of information among collaborating institutions should
be as complete as possible to maximize efficiency of research and
equity in partnerships while recognizing the proprietary concerns of
those partners.
 
f) Respect for and compliance with relevant national and
international laws,  conventions and other standards.
 
i.  Relevant international conventions such as the U.N. Convention on
Biological Diversity and national laws regarding study, use and
commercialization of chemical, biological and cultural resources
should be observed rigorously in the development of agreements and
the conduct of research.
ii.  An essential goal of this program is to develop models for
sustainable and equitable commercial use of biodiversity-rich
ecosystems.  As such ICBG research agreements and activities should,
wherever possible, go beyond the minimum legal standards regarding
international research collaborations, looking to codes of conduct
and other standards for guidance.
 
.

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