Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/) 
National Science Foundation (NSF) (http://www.nsf.gov/)
Department of Energy (DOE) (http://www.energy.gov/)
Department of Agriculture (USDA) (http://www.usda.gov/wps/portal/usdahome)

Components of Participating Organizations
Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov/)
National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov/)
National Institute on Mental Health (NIMH/NIH) (http://www.nimh.nih.gov/)
National Institute of General Medical Sciences (NIGMS/NIH) (http://www.nigms.nih.gov/) National Center for Complementary and Alternative Medicine (NCCAM/NIH) (http://nccam.nih.gov/)
Office of Dietary Supplements (ODS/NIH) (http://dietary-supplements.info.nih.gov/)
Directorate of Biosciences, National Science Foundation (http://www.nsf.gov/dir/index.jsp?org=BIO)
Office of Biological and Environmental Research, Department of Energy (http://www.science.doe.gov/ober)
Cooperative State Research, Education and Extension Service, Department of Agriculture (http://www.csrees.usda.gov/)

Title: International Cooperative Biodiversity Groups (ICBG)[U01]

Announcement Type
This is a reissue of RFA-TW-04-004  which was previously released October 26, 2004.  

Request For Applications (RFA) Number: RFA-TW-08-003

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.395, 93.242, 93.213, 47.074, 81.049, 10.206

Key Dates
Release Date:  September 5, 2007
Letters of Intent Receipt Date: November 6, 2007
Application Receipt Date: December 4, 2007
Peer Review Date: March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 5, 2007

Due Dates for E.O. 12372
 
Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institutes of Health, the National Science Foundation, the U.S. Department of Agriculture, and the U.S. Department of Energy (hereafter "the Government" or "the Participating Agencies") invite applications for the establishment or continuation of "International Cooperative Biodiversity Groups" to address the interdependence of biodiversity exploration for potential applications in health, agriculture and energy, with investments in research capacity that support sustainable use of these resources, the knowledge to conserve them and equitable partnership frameworks among research and development organizations in the U.S. and low and middle income countries.

This competition of the International Cooperative Biodiversity Groups program includes several changes from the previous RFAs, including an increased emphasis on microbial and marine organisms, some changes in target health areas, greater involvement of funded consortia with government contract resources, greater use of molecular and genomic tools, new data dissemination resources, and opportunity to integrate energy- or agriculture-related discovery research into projects. Information on the history of the ICBG program and previous competitions may be found at the following URL:  http://www.fic.nih.gov/programs/research_grants/icbg/index.htm

The Government plans to reissue this Request for Applications (RFA) next year, subject to the availability of funds.

1. Pertinent background that establishes the need for this research

We are dependent on biological diversity for therapeutics, biotechnological tools, new energy-relevant enzymes, and agricultural agents. Products originally identified from plants, animals and microorganisms are the basis for approximately 45% of the new chemical entities approved as drugs over the past 25 years.  Continued increases in consumer use of unregulated botanical therapies in the U.S., often based on traditional uses from other countries, further elevates our need to understand health applications of biodiversity.  Similarly, crop protection, domestic pest control, and animal health agents have drawn heavily from the world’s biological diversity over this same period.  Finally, we confront possibly dire consequences of global warming exacerbated by combustion of fossil fuels, and new biologically-based technologies are needed to develop alternative fuel sources and assimilate atmospheric CO2. 

However, advances in these areas are constrained, in part, by our reliance on less than 1% of the estimated 8-10 million species on the planet. Most of the structurally and pharmacologically diverse molecules we have developed are derived from compounds isolated from a few hundred species of plants and animals and microorganisms.  Systematic and phylogenetic studies suggest that while there is a great deal of redundancy in nature, there is likely an enormous undescribed set of biologically active molecules awaiting discovery in both known and as yet undescribed taxa.  

In the past 10 years, there have been many advances in the tools available to explore the planet’s extraordinary biological diversity, particularly that of the microbial world.  In parallel, we have made significant advances in the assay systems available to detect and characterize potentially useful biological activity, as well as in our technical ability to employ these molecules and biological processes to support health, agriculture and energy priority needs.

Ironically, we are today participating in one of the greatest mass extinction events the planet has undergone.  The International Union for the Conservation of Nature estimates that approximately one quarter of the world’s vertebrate species, half of the invertebrates, three quarters of the plants and an unknown but potentially very large portion of the world’s microorganisms are threatened with extinction. As a result of this trend, the biological base for an extraordinary wealth of health, energy and agricultural innovations is disappearing. 

The underlying causes of biodiversity loss are many and involve interwoven social, economic, technological and political elements.  In developing countries struggling to meet the most basic human needs, efforts to protect biological diversity will be most successful where we can enhance our ability to use it sustainably.  This includes both identifying new uses of diverse organisms and developing the local scientific capacity to study and take advantage of this diversity. Such investments provide both a practical and principled partnership framework to guide scientific research and will yield benefits to the global health, agriculture and energy communities as well as to local and national partners in collaborating countries.

At the nexus of these opportunities and threats there are urgent and simultaneous needs to explore and conserve the planet’s biological and biochemical resources.  The International Cooperative Biodiversity Groups program is an approach to these needs in an integrated model of collaborative international research and training.

2. Objectives of this research program

Each ICBG must develop a program to advance an integrated transdisciplinary scientific program that begins with exploration and characterization of biological diversity to:

2a) Discover and promote development of plants, animals, and micro-organisms and their molecular constituents toward i. health and ii. either energy or agricultural uses;

i. Health agents: Each ICBG will seek to discover potential therapeutic agents in a minimum of three disease areas; 1) Cancer, 2) Mental Health/CNS disorders and 3) a disease area of particular relevance to the host country and of global significance.  In this regard you may wish to review the current and projected global burden of diseases described under the Disease Control Priorities Project (http://www.dcp2.org/main/Home.html). HIV/AIDS, Tuberculosis, parasitic diseases, cardiovascular diseases, diabetes and other areas may be included, particularly if they satisfy the third criterion, but should not replace Cancer or Mental Health/CNS disorders.

Therapeutic research objectives will be mainly oriented to the discovery and development of bioactive small molecules and peptides, but analysis of botanicals, including ethnomedically-indicated botanicals and botanical drugs of public health significance, may also be a component of an integrated program.

Proposed bioassays and lead development strategies should have demonstrated disease relevance and include state of the art molecular, genetic, and biochemical approaches, as well as technologies appropriate to host country institutions.     

ii. In addition, each project will seek to develop potential organisms or agents in support of: a) biobased energy and climate goals of the DOE and/or b) sustainable agriculture goals of the USDA.

Energy/Climate goals:  Novel microorganisms with potential to degrade cellulosic materials, assimilate CO2 or generate biofuels are of great interest.  In this regard, microorganisms from environments with high carbon turnover or capacities to degrade cellulose, hemicellulose or lignins, such as may occur in tropical forest soils and on sea floors, are of particular interest. DNA sequencing carried out on isolated microbes or microbial communities is expected to be a significant component of this research and resources to support this activity through the DOE Joint Genome Institute are described below under Cooperative Agreement Terms and Conditions of Award.

Sustainable Agriculture goals:  You may choose to explore the discovery and development of new crop protection or animal health agents from natural products, as well as the production of biobased products, such as ethanol for bioenergy.

The search and collection of source organisms and materials should be guided by an explicit and formal analytical or theoretical framework based on phylogenetic, ecological and/or ethnomedical principles that maximize the potential for discovery of diverse and potentially useful organisms and/or molecular constituents. Further, the approach should provide a basis for post hoc review of the method’s productivity in this regard.   Applicants should provide a strong rationale for sample collections strategies, whether they are compound libraries or crude plants, animals, or micro-organisms.  

Focal organisms for exploration:

Microbial organisms (inclusive of prokaryotes, virus, fungi, algae and protists) from terrestrial or marine sources as well as marine invertebrates are of greatest interest to the participating agencies in this competition. While terrestrial flowering plants have been the principal organismal focus over the history of this program, they will be a much smaller component of any ICBG in the coming cycle, and may be used principally for research and development related to therapeutic botanicals, including development of new analytical methods, ethnomedical and taxonomic research.  Some targeted pharmaceutical or crop protection research with plants will be allowed where these organisms present extraordinary scientific opportunities and are highly cost effective.   Plant-associated microbes are of interest and carefully integrated exploration and analysis of these organisms in relation to their host plants may provide new scientific insights as well as potential new health, agriculture or energy related product candidates.  Finally, plants often have a significant role in the inventory, conservation and resource management objectives described under b) and therefore you may want to consider novel ways of integrating them into your planned activities.   Other classes of organisms may be considered if they are strongly justified as offering novel opportunities for discovery of bioactive molecules. Grantees are encouraged to consider extracting high quality DNA samples from collected organisms and substrates (“metagenome”) and storing these in the host country (and/or obtaining permission to use in the U.S. institution if resources are not present in the host country) for potential use in taxonomy, identification of associated organisms (such as microbial symbionts in terrestrial and marine plant and invertebrate collections), and genomic or metagenomic analysis of metabolic pathways from samples with interesting bioactivity.

2b) Undertake biodiversity inventory, and promote conservation and bioresource planning and policy in collaborating countries;

Inventories of biological diversity must be designed and conducted to meet international standards for documentation and deposition in national and international museums and/or databases.  Further, records of collections and identification information should be disseminated through appropriate internationally accessible internet sites, such as the Global Biodiversity Information Facility and the Encyclopedia of Life and those of internationally recognized museums. All taxonomic groups are relevant and those proposed for inventory do not necessarily have to be the same as those being analyzed for product oriented exploration as outlined above.  However, applicants should give careful thought to the potential synergies in expertise, data and cost-effectiveness if they overlap.  Similarly, the choice of organisms and areas to study should reflect not only scientific value but their relevance to conservation planning. 

Where possible and appropriate, bioinventory and the discovery/exploration research outlined above in objective 2a). should be integrated into a strategy that advances conservation and bioresource use planning, for example by engaging local government or non-governmental organizations in planning the creation of new protected areas or in strengthening the knowledge base for existing protected areas.  Alternatively, you may wish to help develop a scientifically based sustainable use technology relevant to the scope of this RFA that enables host countries and/or communities to derive income from their biological resources without damaging the resource base. 

2c) Train U.S. and developing country research scientists and transfer research tools related to the scope of the work of this RFA to collaborating research institutions in the developing world;

Examples of relevant areas of training could include systematics, geographic information science, ethnomedicine, natural products and medicinal chemistry, analytical chemistry, microbiology, pharmacology, genomic analysis, biotechnology, production methods, data management and quality control in botanical production, grant writing, and bioethics.  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 and analytical chemistry, database development, ecology and biodiversity analysis and 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.  Training may include, but is 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 one 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 application and in the application's budget request.

Physical infrastructure support could include assistance for museums and laboratories, the supply of necessary equipment in these facilities, and the enhancement of biodiscovery capacity in the host country.  Very 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 FIC.  USDA funds may not be used for renovation.

2d) Establish models for ethical and practical scientific collaboration with biogenetic resources;  

As international collaborations involving genetic resources have become increasingly regulated and politicized over the past 14 years since the United Nations (U.N.) Convention on Biological Diversity came into force, the global scientific community has struggled to find ways to work that are both scientifically productive and responsive to local, national and international expectations. 

The ICBGs have had a significant role in developing and testing new approaches to international collaborations among government, academic, industrial and not-for profit organizations, and local communities.  The diverse objectives and integrated structure of research and training partnerships, contractual agreements, procedures for obtaining access, and design of benefit-sharing plans of the ICBGs have often become, in and of themselves, subjects of both policy analyses and academic study.  The ICBGs have thus acquired a responsibility of experimenting with new approaches and disseminating their lessons for the global community.

All collaborative activities undertaken under this award should be governed by formal, mutually developed agreements, as described in more detail below.  Both the design and management of these “experiments” represent a significant investment of time in the politics of science and in policy formulation for ICBG investigators. Practical questions around the transaction costs associated with establishing a new partnership, measuring benefits that accrue to local and global interests, separating basic and commercial research for permit or contractual purposes, defining informed consent in a communal setting, and the impact of new regulations on host country scientists, research and public health, among others, pervade the international policy discussions but few lessons are available to inform these. ICBG investigators may wish to incorporate formal analysis and dissemination of their lessons, both successful and less so, to the academic and policy communities. 

Applications for funding as an ICBG should stress creative, synergistic and cost-effective approaches to the above described objectives: a) exploration/discovery, b) biodiversity inventory/conservation, c) training/capacity-building and d) partnership model development.  You are encouraged to contact the FIC Program Officials listed below to discuss how you may balance and integrate these complex objectives.  

3. Composition of an International Cooperative Biodiversity Group

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.

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.

While not mandatory, the active participation of the private sector is encouraged. Private sector partners may include companies, large and small, non-profit drug development organizations or a combination of these.

Groups should be multi-institutional in so far as multiple partners address the complex scientific objectives. Cost efficiencies through allocation of certain components of the work to private sector, U.S. Government and/or developing country institutions may be achievable.

Significant cost-savings should be achieved through careful and disciplined planning of research efforts as well as the size and nature of the participating team.  For example, scientific strategies that reduce isolation chemistry required to achieve novel discoveries are encouraged.  Furthermore, teams should be realistic in planning for the administrative burden of negotiating contractual agreements, communicating, developing reports and carrying out planning with large groups.

Applicants are encouraged to make explicit and potentially operational linkages to other projects funded by the participating agencies to maximize synergies and cost efficiencies.  Examples include NSF/USDA Microbial Observatories, Biotic Surveys and Inventories, NIH funded National Cooperative Drug Discovery Groups (NCDDGs), FIC research training grants, and NIH screening and drug development contracts (described in Section VI, under Cooperative Agreement Terms of Award).

a) The composition of an ICBG is envisioned as follows:

i)  A PI who is likely to also head an Associate Program.

ii)  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.  Developing country scientists must be substantially involved in the overall program design. Developing countries are defined as low or middle income countries in the World Bank list of economies (see :  http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS ).  

iii)  A U. S. Government Project Coordinator appointed by the FIC Program Official to provide assistance to the Group. The Project Coordinator does not have a fiduciary role in management of the grant, but rather provides technical advice and may facilitate access to other government resources, such as contract based screening, to the Group.

b)  The PI, in addition to providing scientific and administrative leadership, may head an Associate Program.  Associate Program Leaders will be directly responsible to the PI.  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 PI and the PI's institution in accordance with PHS policies.  The PI will also be responsible for maintaining an integrated relational database of all the significant research and capacity-building activities of the Group as outlined under SPECIAL REQUIREMENTS.

c)  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 PI 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 and capacity-building.  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 expertise.

d)  An individual scientist or a single institution may be proposed as a PI in only one application.  However, an individual scientist may be an Associate Program Leader in more than one application, or a PI and an Associate Program Leader on separate applications.  If a scientist appears on more than one application, it is the responsibility of the PI 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.  Federal scientists from the funding agencies 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 and include documentation in the application along with a letter of commitment, a current curriculum vitae.  The PI 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 Project Coordinator as described under "Terms and Conditions of Award."

e)  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.

f)  No prescribed number of Associate Programs per Group is stipulated.  However, the PI 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 budget resources and to minimize the burden of negotiating agreements and the management of data, the number of institutions collaborating in a Group should be considered carefully.

g)  In forming Groups, potential PIs 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. Regular telephone and internet based conferences can yield significant efficiencies in this regard.

h)  Under the provisions of assistance via a Cooperative Agreement, the U.S. Government Project Coordinator will assist the ICBG and participate in the Group in a manner specified in "Terms and Conditions of Award," and carry out the scientific responsibilities required.  The U.S. Government Project Coordinator will not conduct Associate Program activities. 

4.  Interests of Collaborating NIH Institutes and Centers and US Government Agencies

The Fogarty International Center (FIC) is dedicated to advancing Global Health through scientific research, training and partnerships with U.S. based and international organizations, and may support activities in any therapeutic or scientific area related to those goals.  To this end FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on low- and middle-income countries.  The ICBG program reflects the Center’s core principles: pioneering discovery and filling gaps, promoting international training and collaboration, advancing global health research at the NIH and encouraging science for diplomacy.

The Office of Dietary Supplements (ODS) has interests in regard to organism collection and analyses, focus on molecular diversity, area protection, support of indigenous population enterprises, and publications. ODS is particularly interest in supporting continued basic research on indigenous plants and animals and their traditional uses whose metabolic constituents have potential use as dietary supplements as well as the development, validation, and dissemination of analytical methods for the determination of these constituents. 

The National Institute of Mental Health (NIMH) has interest in supporting research on the discovery and exploration of CNS relevant compounds as potential novel therapeutic leads for mental disorders and would encourage the inclusion of assays for CNS-relevant targets, such as receptors, transporters, and ion channels, or of fundamental processes associated with CNS function.

The National Cancer Institute’s (NCI’s) Division of Cancer Treatment and Diagnosis (DCTD) is participating in this RFA.  As part of NCI’s overall mission to reduce the suffering and death due to cancer through the development of more effective interventions, the Developmental Therapeutics Program (DTP) within DCTD has played an intimate role in discovery or development of over 40 US-licensed chemotherapeutic agents, such as paclitaxel, a natural product drug.  The convergence of several fields, including proteomics, computational biology and nanotechnology, and the growing knowledge of cancer genetics and biology have led to new opportunities for discovering and developing more selective agents.  DTP’s unique experience in natural products sourcing and evaluation, together with its contracts-based resources, most of which are free, can help to overcome therapeutic development barriers by supporting high-risk projects through either service or collaborative processes.  DTP continues to serve as a vital resource in acquiring preclinical information and providing research materials, including web-accessible data and tools, plated compounds, tumor cell lines, animals, and GMP quality bulk drug for IND-directed studies.  For more information, see http://dtp.nci.nih.gov

The National Center for Complementary and Alternative Medicine (NCCAM) is interested in the exploration and definition of promising opportunities to advance health through ethnomedical research, in particular through identification and study of potentially valuable traditional/indigenous health care practices that are in danger of being lost.  In particular, NCCAM supports projects which (a) acquire a richer understanding of CAM whole medical systems and how they operate within their indigenous and dispersed settings; (b) advance understanding traditional/indigenous medical systems through international collaborative studies; and (c) contribute to the preservation of irreplaceable and valuable traditional/indigenous CAM knowledge and resources.  NCCAM also supports basic, preclinical and clinical investigation of complex natural products. It will support studies of isolated constituents from complex natural products when the intent is to: (a) characterize and standardize whole products (e.g., botanicals), (b) compare the actions of single constituents with the complex product from which they are derived, (c) identify mechanisms of action for the whole product, or (d) better understand or optimize the production of the whole product.

The mission of the National Institute of General Medical Sciences (NIGMS) is to support basic biomedical research that is not targeted to specific diseases.  NIGMS is interested in natural products research that contributes to an understanding of fundamental life processes and that creates a foundation for advances in disease diagnosis, treatment, and/or prevention. This could include the discovery of biological probes and/or drug leads where there is no effort to bias the discovery process toward a particular disease.

The National Science Foundation (NSF) supports basic research to promote discovery that advances the frontiers of knowledge, learning to sustain a broadly inclusive workforce, and research infrastructure through investments in instrumentation, facilities, and cyber infrastructure.  NSF is participating in this RFA to further the discovery, description, and inventory of global species diversity, and to organize that information in efficiently retrievable forms that best meet the needs of science and society.  NSF is interested in promoting new knowledge of biodiversity of plant, animal, and microbial diversity throughout the world, whether terrestrial, freshwater, or marine.  NSF is also interested in promoting the broader impacts of this new knowledge through: its integration with teaching and training; the participation of individuals from groups unrepresented in science; the creation of new partnerships among institutions and countries; the enhancement to biodiversity infrastructure such as well-vouchered natural history collections, or stocks and cultures including associated databases; and the dissemination of this knowledge to the benefit of society. 

The Department of Agriculture’s Cooperative State Research Education and Extension Service (USDA-CSREES) is interested in the discovery and development of new agents for the protection of crops or animal health, or new crops for the production of biobased products, such as ethanol for bioenergy.  The sustainable agricultural goals also should include the preservation of the environment and the long term profitability of farming.

The Department of Energy’s (DOE) Office of Biological and Environmental Research is interested in novel microorganisms with the potential to degrade cellulosic materials, assimilate CO2 or generate biofuels.  Microorganisms from environments with high carbon turnover or capacities to degrade cellulose, hemicellulose or lignins, such as may occur in tropical forest soils and on sea floors, are of particular interest.  Additionally, opportunities will exist to have DNA sequencing carried out on isolated microbes or microbial communities at the DOE Joint Genome Institute, following satisfactory scientific and technical reviews.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH U01 award mechanism(s).
For the purposes of this RFA, the National Science Foundation and the U.S. Department of Energy will transfer funds to the NIH to co-support awards, except in the case of a DOE Federally Funded Research and Development Center (FFRDC) where the DOE portion of an award will be made directly by DOE. A component project of a meritorious ICBG may be awarded directly by the USDA CSREES.  That component will be identified by CSREES in consultation with the other participating organizations after initial peer review of the entire ICBG proposal.  The Principal Investigator will be invited to reformat that component of their application for submission to the CSREES following that agency's guidelines and regulations (http://www.csrees.usda.gov/funding/rfas/biodiversity.html). The consortium ICBG project will be expected to function as an integrated project following the terms of this RFA, but with additional responsibilities for the CSREES awarded component. Decisions as to allocation of funds from different agencies in an ICBG award will be at the discretion of the Participating agencies. In all cases, the combined maximum allowable direct costs available from all participating U.S. government sponsors will not exceed $600,000/year.  

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans to continue this program after the initially awarded period of performance are indefinite at this time.

An NIH award will be made only to the PI's institution, which will subcontract with the other participating institutions.  All Group activities will be coordinated through the PI's institution.  Applicants must comply with PHS policies concerning allowable costs.  Note that foreign institutions, through subcontracts, are eligible for facilities and administrative (F&A) costs of up to eight percent.  Questions about allowable costs may be directed to Mr. Bruce Butrum, Grants Management Officer, FIC.

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 PI 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 under "Terms and Conditions of Award."

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. 

2. Funds Available

The participating IC(s) including FIC, NCI, NIMH, NIGMS, NCCAM, ODS and their agency partners NSF, USDA\CSREES, and DOE intend to commit approximately $3-4 million dollars in FY 08 to fund four to five
new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $600,000 per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, the Government intends to reissue this RFA in the next year to fund 1-2 more awards.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

For profit institutions, Non-domestic (non-U.S.) Entities (Foreign Organizations and Regional Organizations) are eligible to participate as members of a Group but are not eligible to be the principal applicant organization. 

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.

2. Cost Sharing or Matching

N/A

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

The NIH will review only one application from any one institution.  Therefore, you are encouraged to consult within your institution about other individuals who may be considering applying before developing one yourself.  

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

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. 4/2006) 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.  Furthermore, this RFA is operating under a pilot initiative to explore the value of shortened applications.  As such, applicants are asked to deviate from the PHS 398 application instructions in the composition of the Biosketches, Research Plan, and Appendices as outlined below.

The application will be reviewed as a whole and, in addition, each Associate Program will be evaluated for its individual merit.  Therefore, the application should contain separate sections for each Associate Program, preceded by a Group Plan section.  Note that the Group plan may not exceed 20 pages (i.e. PHS-398 Research plan items A-D). Each Associate Program research plan may not exceed 10 pages (i.e. items A-D).  Applications that exceed the page limit will be returned to the applicant unread.

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, and Research Plan; Checklist.  A 20-page limit applies to this Group Plan section individually and includes Items A-D as described in the PHS 398 form. This page limit does not apply to the literature cited section or the list of project publications achieved under a prior ICBG award.

Complete the FACE PAGE for the application as in a regular research grant application.

For the Group Plan section, KEY PERSONNEL should list the Associate Program Leaders and other key investigators for the whole Group.  Do not use the pilot Multiple P.I. format pages of the PHS 398. The TABLE OF CONTENTS should number pages for the entire application consecutively, with the FACE PAGE as page one.

The BUDGET page in this section (Form Page 5) 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 and travel to the annual ICBG meeting of all Groups at NIH.

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.

Biographical Sketches: All Biographical sketches should be compiled alphabetically in the Group Plan Section and should not be repeated elsewhere.  Individual biographical sketches may not exceed 4 pages.  Do not include publications submitted or in preparation.  For publicly available citations, URLs or PMC submission identification numbers may accompany the full reference.  Note copies of these publications are no longer accepted as appendix material.  Follow all other instructions on the Biographical Sketch Format Page (PHS 398 reissued 4/2006) with the following modifications:  Section B. Selected peer-reviewed publications are limited to 10 or fewer.  With respect to the proposal, these 10 citations should include; (a) the most relevant, (b) the most significant, and (c) the most recent publications.  Following each cited publication, the applicant should very briefly summarize the findings or achievements described in the publication that demonstrate relevance (familiarity with the field), and/or broad scientific impact, unless this is already apparent from the title.  Summaries should not exceed 60 words each.  Include Sections A and C as described in the Biographical Sketch Format Page

Incumbent Groups must describe, within the research plan, the progress they have attained toward the original goals of their program, including a summary description of publications, trainees, significant molecules or species, conservation achievements and any other accomplishments of the Group. A comprehensive list of publications from prior ICBG support should be placed in an appendix. 

Inasmuch as the PI 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 PI'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 how the data from the various associate programs involved in field and laboratory research will be integrated into a single relational database.  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. As the Research Plan in the Group Plan is limited to 20 pages, it should emphasize the potential Impact or Significance of the ICBG on the research objectives: a) exploration/discovery, b) biodiversity inventory/conservation, c) training/capacity building, and d) partnership/model development.

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 PI 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. 

The Group Plan Section must also include the following elements to be considered responsive to minimum requirements:

i.  A statement assuring compliance with the ICBG Program Principles for Access, Intellectual Property and Benefit-sharing detailed in this RFA.

ii.  A statement of acceptance of the provisions of “Terms and Conditions of Award," as described in that section of the RFA.

Finally, it is important that both the DESCRIPTION (project summary) and the relevant SPECIFIC AIMS in the Group Plan identify clearly all the therapeutic areas and other targets for the entire project.

b)  Associate Programs

Each Associate Program section should begin with its own TITLE PAGE.  The TITLE PAGE should state “International Cooperative Biodiversity Groups”, the overall project title, and the PI 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.

Each of the Associate Programs should be numbered consecutively (i.e., AP 1, AP 2).  Use Form PHS-398 for each Associate Program, but omit the FACE PAGE, TABLE OF CONTENTS, BIOSKETCHES and CHECKLIST for the individual AP. The remaining parts of the PHS-398 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.  There should be only one CHECKLIST included at the end of the entire application.

A 10 page limitation applies to each of the individual Associate Program’s Research Plans (items A-D).  It is important to focus attention on the potential Impact or Significance of the Associate Program in the 10 page Research Plan, while providing the essential methodological details and rationale for the approaches chosen. The Associate Program Training Plan, if relevant, should also be included within these 10 pages. The literature cited section is not included in this page limitation.

c)  Appendices

Appendices should not total more than 25 pages exclusive of completed or draft agreements among the group’s participating organizations and the list of prior publications for competing renewal applications, should be located at the end of the grant application, and should be listed individually in the Table of Contents.

i. If internal or external advisory groups will be used in addition to those specified in this RFA, list their membership and describe their roles.

ii. Include in one appendix all letters of support from Associate Program Leaders, Government officials, community leaders, as well as a list of documents or actions that will be required to fulfill local institutional and governmental regulations in order to carry out the proposed work.

iii. List in a separate table any and all consultants, both paid and unpaid.  Include a signed letter of agreement from each consultant.

iv. If completed or draft contracts are included they should be in a single appendix. These do not fall under the 25 page appendix limit. 

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 6, 2007
Application Receipt Date: December 4, 2007
Peer Review Date: March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent by email to:

Dr. Joshua Rosenthal (joshua_rosenthal@nih.gov)

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the FIC. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

All activities at the foreign site(s) will be restricted until cleared by the U.S. State Department.

All collections of biodiversity specimens at the foreign site(s) and associated research on collected material will be restricted until cleared by NIH staff following review of collection permits and other documents demonstrating achievement of prior informed consent and mutually agreed terms as outlined below in Section VI, 2 under Principles for Accessing Genetic Resources.  

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Direct your questions about financial or grants management matters to:

Bruce Butrum
Grants Management Officer
Bldg. 31, Room B2C29
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
FAX:  (301) 594-1211
Email: butrumb@mail.nih.gov

6. Other Submission Requirements

Special Requirements

1.  Award Monitoring and Evaluation

Progress of each funded Group will be monitored and evaluated using semi-annual technical progress reports prepared by the Group.  Detailed reporting instructions will be provided to grantees upon receipt of award or by request.  Part of this reporting process will rely on grantee cooperation with an ICBG Data Coordinating Center that will be supported under a contract from the Government.  Evaluation of productivity and accomplishments of Groups will utilize diverse criteria including scientific publications, new species, new lead compounds, new energy-related resources, new analytical or production methods, other new inventions or discoveries and appropriate intellectual property (e.g., patents), trainees, courses, local income-generating activities, institutional and policy changes and conservation or health policy impacts.

The U.S. Government Project Coordinator or the FIC Program Official, 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.  ICBG Global Data Center

To ensure the integrity of collaboration within groups and the ability of the Government to monitor and facilitate progress of the ICBGs, minimum data elements, formats and standards for a subset of data will be required from each Group.  Grantees will be required to maintain an integrated relational database for bioinventory (e.g. species name and collection site) and drug discovery (e.g. bioassay results and compounds isolated) and to provide a subset of these data on a regular basis to a Global Data Center serving all groups.  All grantee data will be treated as proprietary, confidential and the property of the grantees and their collaborators except where otherwise indicated by the grantees.  The Data Center will also serve a variety of data analysis, data management, literature access, outreach and training needs of the funded groups.  To facilitate coordination of data entry and to provide data access at multiple sites within a single ICBG, the Global Data Center can host a Group server and provide secure web-based functionality if requested by the PI. The Government will choose a software package to consolidate these data and will seek to use a system that Groups can easily use or with which Groups can integrate their own data management systems.  You are encouraged to discuss this issue with the FIC program managers. Allocation for a data manager to coordinate data entry and analysis and to interact with the Global Data Center should be included in the budget.

3.  Genetic Resources Access, Intellectual Property and Benefit-Sharing

Because the discovery of bioactive agents from natural sources is one objective of this effort, along with ensuring that an equitable economic benefit accrues to developing country organizations or communities associated with ICBG research, it is essential that applicants develop appropriate plans for access to genetic resources and contractual agreements for the treatment of benefits and any applicable intellectual property that may arise.  The importance of carefully planned and executed approaches to access and benefit-sharing is a function of both their integral relationships with the goals of this program and the rapidly changing regulatory environment in many countries as they respond to the U.N. Convention on Biological Diversity.  The development of these plans and agreements is frequently complex, challenging and time-consuming 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 prior informed consent, intellectual property and the sharing of benefits from ICBG-sponsored research, consistent with meeting the programmatic goals of this RFA.  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 ICBG "Principles for Access, Intellectual Property and Benefit-Sharing" detailed in this RFA (see Section VI.2.) Draft or completed contracts or permits (subject to the 50 page total page limit) may be included in appendices, as described above.

If these are not completed before the time of award, awardees will have one year from the date of their award to provide signed copies of locally appropriate evidence of prior informed consent and formal agreements specifying the rights and responsibilities of each Group member institution. Applications that represent continuation from previous ICBG awards must also provide updated, revised or new evidence of prior informed consent and agreements by the end of the first award year.  The above applies to all research carried out under this RFA, including any that may involve U.S. Government laboratories.   Failure to provide these documents may impact budget and constrain activities in subsequent years, or result in termination of the award.

Minimum Requirements for Application

Applications to the International Cooperative Biodiversity Groups must meet a set of 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 or as detailed below.

1.  Identify a single PI from a U.S. eligible 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 and led by a developing country institution that hosts the ICBG.

3.  Identify the PI’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 including data management.

4.  Present, for each Associate Program, research, technical approaches, and detailed budget requirements.

5.  Provide a description of the Group's plan for assuring legal and appropriate access to genetic resources, treatment of intellectual property and sharing of benefits that may result from US Government funding of the proposed work.  The application requires, at a minimum, an authoritative outline of the legal and policy requirements of the collaborating country and descriptions of the agreements to be developed among all Group members and their institutions, including local community organization representatives as appropriate.

6. Present letters of support for the project from: 1) the relevant host country Government agency(ies), acknowledging the multiple objectives of the program and its coincidence with national and local laws and policies; and 2) at least one representative investigator from each participating institution, indicating his or her ability to conduct the proposed research and training within the budgets and timeframes of the project and the intellectual property framework of the ICBG program and the proposed project.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants are expected to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of any submitted data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor such proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

Program considerations include geographic distribution, balance of program emphases and interests of funding partners, and special opportunities.  In addition, funding decisions will take into account the ability to comply with the terms and conditions of award, including the Principles of Access and Benefit-sharing described in Section VI.2, below.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Receive a second level of review by appropriate national advisory councils or boards of participating sponsors.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  What is the potential impact of the project on human health, biodiversity conservation and, where appropriate, agricultural crop protection and animal health or the development of new biobased products such as biofuels?  Will it measurably advance the scientific capacity of the host country(ies) and contribute to sustainable economic opportunities?

Approach: Is the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there likely to be strong multidisciplinary cooperation among associate programs and potential for synergy of activities toward the goals of the program?  Are the plans for intra-Group communication and data-sharing adequate to meet the objectives of this program and do they account for the special requirements of an international collaboration?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?  Do the PI and Associate Program leaders have a track record of success relevant to this RFA and demonstrated past support from NIH, NSF, USDA, DOE or other sponsors?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the proposed work take place in a country or region that is a priority for biodiversity conservation and economic development efforts, and does it take advantage of the unique biological and intellectual resources of that country or region? Would the genetic resource access and benefit-sharing policies and procedures of the host country facilitate development of the proposed project?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of any plan for sharing research resources.

The adequacy of such resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of such data and resource sharing plans with the awardee before recommending funding of an application. The final version of such data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of such resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

PRINCIPLES FOR ACCESSING GENETIC RESOURCES, THE TREATMENT OF INTELLECTUAL PROPERTY AND THE SHARING OF BENEFITS ASSOCIATED WITH ICBG-SPONSORED RESEARCH

In developing both research plans and appropriate 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. 

1.  Disclosure to and informed consent of host country stakeholders

a)  Plans to collect samples for drug discovery or for other potentially commercializable agents should be vetted with the national government authorities of the host country and with any other organizations they, you or your partners deem appropriate at the earliest stage of planning and once again, formally, before any collections take place.

b)  Where national governments do not have clear regulations to guide informed consent procedures, activities should follow a two phase approach to distinguish basic and commercial research.  Basic research intended primarily for publication, including collecting and analyzing biodiversity, including bioassay and chemistry work, may be considered "basic" research for the purposes of this program.  If, at any time, researchers intend to file a patent application based on this work or to send a sample for testing to an industrial partner, the research immediately enters the commercial realm for the purposes of this program and must follow all the requisite permit and contract standards of the host country.

c)  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.  Under best practices such arrangements develop as a partnership with early and ongoing full participation of community representatives in project design.

d) 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 or resources they provide, these concerns should be respected in the conduct of ICBG projects.

e)  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 mutual agreement and understanding of the Group’s goals and methods.  Presentations by scientists to host country stakeholders 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 or organizations.  Arrangements with individuals who cooperate or provide information should be based upon prior community-level agreements whenever possible or appropriate.

2.  Clear designation of the rights and responsibilities of all partners.

a)  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 U.S. research institutions, and indigenous and local peoples whose resources, biological or intellectual, are utilized in the research process.

b)  It is strongly recommended that all parties to agreements have separate, competent legal counsel to represent their interests.

c)  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.

d)  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 US Government retains "march-in" rights to require licensing if the inventing organization(s) fail to pursue development of the process or invention or discovery (e.g. process), as described in the “Terms and Conditions of Award.”

e)  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.

f)  Agreements should specify that the basic goals of the collaboration include biodiscovery for therapeutic, agricultural and/or energy-related agents, economic development, and the conservation and sustainable use of biological diversity.

g)  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.

3.  Protection of inventions using patents or other legal mechanisms.

a)  Non-profit organizations (including universities) and small business firms retain the rights to any inventions resulting from U.S. Government contracts, grants, or Cooperative Agreements consistent with the Bayh-Dole Act and its implementing regulations (35 USC 200-212; 37 CFR 401).  PL 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. 

b)  The specific intellectual property arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc., ., consistent with the Bayh-Dole Act.  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.  You are encouraged to develop an arrangement that best suits the particular circumstances of your Group.

4.  Sharing of benefits with the appropriate source country parties.

a) Benefits that emerge from an ICBG should be considered thoughtfully by the Group, and may include financial benefits from a commercial relationship or product, as well as training, targeted research to address local priorities, and the establishment of long-term partnerships, among other types.

b)  Equitable distribution of financial or other benefits that flow from a commercial relationship or product should accrue to all those who contribute to the relationship or product, whether they are members of the consortium or not, including research institutions and local or indigenous people who provide useful traditional knowledge.

c)  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.

d)  The selection of beneficiaries must be justified in terms of program goals, as well as local and international laws and customs.

e)  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. 

e)  Ideally, compensation begins flowing early in the collaboration through initial payments, training, equipment or services, to provide near-term conservation incentives.

5.  Information flow that balances proprietary, collaborative and public needs.

a)  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. While proprietary needs often require at least temporary confidentiality, you are strongly encouraged not to withhold research results beyond those which are likely to be commercialized or would harm the interests of project stakeholders in identifiable ways.

b)  Sharing of information among collaborating organizations should be an ongoing and regular process and should be as complete as possible to maximize efficiency of research and equity in partnerships while recognizing the proprietary concerns of those partners. Reporting back to collaborating communities, where relevant, on significant project developments should be a regular and expected component of the project.

6.  Respect for and compliance with relevant national and international laws, conventions and other standards.

a)  Relevant international conventions, such as the U.N. Convention on Biological Diversity and national laws regarding study, use and commercialization of chemical, genetic, biological and cultural resources, should be observed rigorously in the development of agreements and the conduct of research.

b)  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. In this regard you are encouraged to review the U.N. Biodiversity Convention’s Bonn Guidelines on Access and Benefit-sharing: http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award 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 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for planning, directing, and executing the proposed project and ensuring that the Group is responsive to the requirements and conditions set forth in the RFA.  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 exploration and discovery, biodiversity inventory and