Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

National Science Foundation (NSF)

Components of Participating Organizations

Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)
Directorate of Biosciences, National Science Foundation (NSF/Bio)

Funding Opportunity Title

Limited Competition: International Cooperative Biodiversity Groups (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-TW-08-010

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-TW-13-001

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.989 

Funding Opportunity Purpose

The National Institutes of Health and the National Science Foundation invite applications for the establishment or continuation of "International Cooperative Biodiversity Groups" (ICBG) to address the interdependence of biodiversity exploration for potential applications in health, with investments in research capacity that support sustainable use of these resources, the knowledge to conserve them, and equitable partnership frameworks among research organizations in the U.S. and low and middle income countries (LMICs). LMICs are defined as low or middle income countries in the World Bank list of economies (see: http://data.worldbank.org/about/country-classifications/country-and-lending-groups).   

Key Dates
Posted Date

July 26, 2013

Open Date (Earliest Submission Date)

October 20, 2013

Letter of Intent Due Date(s)

October 20, 2013

Application Due Date(s)

(Extended to December 11, 2013 per NOT-TW-14-001), Originally November 20, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

(Extended to December 12, 2013 per NOT-TW-14-001), Originally November 21, 2013

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The National Institutes of Health and the National Science Foundation (hereafter "the Government" or "the Participating Agencies") invite applications for the establishment or continuation of "International Cooperative Biodiversity Groups" (ICBG).  The program is built on the observation that natural products derived from organisms in nature remain the most productive source of new therapeutics, yet the biodiversity on which discovery of these drugs depends is rapidly disappearing around the world.  Consequently, the ICBG program supports international, public-private, interdisciplinary research teams in the exploration and discovery of novel compounds and extracts with potential for development as therapeutic agents for multiple disease targets, at the same time as it builds research capacity in partnering countries to support sustainable exploration and use of biodiversity and the knowledge to conserve it.  These goals are advanced through fair and equitable partnership frameworks among research organizations in the U.S. and in low and middle income countries (LMICs).

This competition of the International Cooperative Biodiversity Groups (ICBG) program continues several new emphases that began with the previous FOA, RFA-TW-08-010, including an emphasis on microbial and marine organisms, greater involvement of funded consortia with government contract resources, and greater use of molecular and genomic tools. This FOA also introduces some new features, including some new target health areas (neurological disorders and stroke, pain and inflammatory processes, and others, see Interests of NIH institutes and Centers, below) and an emphasis on supporting the scientific basis for integrated conservation and development efforts through research and research training rather than through direct implementation activities.

Information on the history of the ICBG program and previous competitions may be found at the following URLs:  http://www.fic.nih.gov/programs/research_grants/icbg/index.htm and http://www.icbg.org.

Pertinent background that establishes the need for this research

Biological diversity has been a rich source for therapeutics, biotechnological tools, and new agents in an array of fields from bioenergy and agriculture to materials science. 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.  Moreover, as key global pathogens become increasingly drug-resistant, many of the drugs that we have relied on for decades need to be replaced or supplemented with new frontline therapeutics. 

However, advances in these areas are constrained, in part, by our dependence 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, animals and microorganisms.  Systematic and phylogenetic studies suggest that while there is a great deal of redundancy in nature, there is likely an enormous unexplored 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, significant advances have been made both in the assay systems available to detect and characterize potentially useful biological activity, as well as in the technical capability to employ these molecules and biological processes to support health priority needs.

At the same time, the biological diversity on which new discoveries depend is disappearing at an accelerated rate. 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 innovations is disappearing. 

The underlying causes of biodiversity loss are many and involve interwoven social, economic, climactic, 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 to provide benefits to society. 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 community 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.

Objectives of this research program

Each ICBG must develop a collaborative consortium among institutions in the US and LMICs to advance an integrated interdisciplinary scientific program that begins with exploration and characterization of biological diversity to:

Discover and promote development of plants, animals, and micro-organisms and their molecular constituents toward human health therapeutic agents. 

Therapeutic targets:  Each ICBG will seek to discover potential therapeutic agents in: 1) disease areas of relevance to both U.S. and LMIC populations, and 2) disease areas of particular relevance to the host country of the proposed ICBG partnership.  At least three therapeutic areas (including one or more assays in each area) are required and the rationale for their inclusion in this natural products based program must be justified scientifically.  We encourage the inclusion of assays for neurological diseases, antibiotics (including MDR and latent TB), and neglected tropical diseases (http://www.who.int/neglected_diseases/diseases/en/) because of their significant health burden and inadequate therapeutic options, but all well-justified areas are acceptable. Note that malaria blood stage assays are not of interest unless they are well integrated with secondary screens for other stages of parasite development.  Assays carried out by industrial partners may expand or contribute to this core set. Therapeutic research objectives will be mainly oriented to the discovery and development of bioactive small molecules and peptides. 

Assays:  The rigor, creativity, and information content of the bioassays employed will be critical to the success of the biodiscovery program and will be a key review criterion for this FOA.  The proposed set of bioassays and lead development strategies should have demonstrated disease relevance and include state-of-the-art molecular, genetic, phenotypic, and biochemical approaches, as well as some assays that employ technologies appropriate to host country institutions. For screens to be carried out in academic laboratories, applicants should describe both primary and secondary screens, dereplication strategies (i.e. strategies to quickly determine if active extracts and compounds are novel and do not duplicate known and previously studied entities), the decision basis for advancing a hit and prioritizing follow-up chemistry efforts, and potential pre-clinical development options.  Teams should include experts in the assay areas proposed, either as members of the Associate Programs (Projects) or as consultants to the project. Investigators are encouraged to utilize a diversity of biological screens that provide information beyond basic toxicity to mammalian and microbial cells. In the screening of micro-organisms or their products, applicants should consider how to best elicit the microbe's signaling and defensive molecular repertoire that has evolved based on its normal ecological context. In that regard, assays should be linked to collection strategies where the linkage may provide a screening advantage.  For example, organisms that are highly defended against fungal pathogens may be a good source of anti-fungal compounds.

While not required, applicants are encouraged to develop novel or improved methodologies for sample collection, preparation, screening, and for rapid chemical dereplication and isolation that will increase the efficiency of discovery in natural products research. 

Collections:  Collections must be restricted to the biodiversity of the partnering LMICs. The collection of source organisms and materials should be guided by an explicit theoretical framework based on phylogenetic, genomic, ecological, and/or other principles that maximize the potential for discovery of diverse and potentially useful organisms and/or novel molecular constituents. The rationale for the utility of this approach in the context of the assays proposed should be outlined. 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. Groups who have had previous ICBG support should justify the choice of collection strategies based on prior research outcomes.

Another consideration in collection strategies and choice of organisms is the potential to contribute new knowledge to the biology and/or ecology of organisms or systems by focusing efforts more systematically or thematically.  While drug discovery is a high-risk venture, knowledge of biological and ecological systems can contribute information of general use, inform the selection of assays that might increase the potential for new chemical and therapeutic discovery, and contribute to conservation goals through insights into best management practices.

Collections from biodiversity are precious resources.  Where these will involve living organisms, such as micro-organisms, applicants should describe how these organisms will be stored, backed-up in redundant collections, and protected so that they provide a continuing resource at the conclusion of the award.  In addition, applicants should describe the proposed fate of remaining extracts and compounds derived from such collections when current assays are completed to ensure that they are as fully evaluated as possible and potentially available for future use. 

Focal organisms for exploration: Collections should emphasize microbial and marine source organisms. Microbial organisms include both marine and terrestrial microbial communities and, where appropriate, their host organisms, and might include plant endophytes, rhizosphere communities, and invertebrate symbionts among others. Other classes of organisms may be considered if they are strongly justified as offering opportunities for discovery of novel and useful bioactive molecules, or as continuing work on promising leads developed through prior ICBG support.

Grantees are encouraged to extract high-quality DNA samples from collected organisms and substrates and store these in the host country (and/or obtain 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 associated microbes), microbial diversity analysis (especially important as 99% of all microbes are currently unculturable), and genomic or metagenomic analysis of metabolic pathways from samples with interesting bioactivity.

Undertake biodiversity analysis, and promote conservation and bio-resource planning and policy in collaborating countries;

Analysis of biological diversity must be designed and conducted to meet international standards for documentation and deposition of specimens in national and international museums and/or databases and publication in peer reviewed journals.  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 or national databases. Inventory efforts should be substantially integrated with product-oriented discovery collections to take advantage of potential synergies in expertise, biological data, and collection logistics and to enhance cost-effectiveness. 

Where possible and appropriate, bioinventory, choice of target organisms for collections, geographic area, and the discovery research outlined above 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 scientific basis for management of existing protected areas.  Alternatively, as a component of a local Access and Benefit Sharing (ABS) agreement, collection and research activities of the ICBG project may be used to help host communities derive income from their biological resources without damaging the resource base.  Except in the context of an ABS agreement and/or as well integrated with the other activities of the ICBG, direct conservation-development projects should not be a major component of the proposed ICBG project and are best achieved by collaboration with and leveraging investments of other organizations.   

Train U.S. and LMIC research scientists and transfer research tools related to the scope of the work of this FOA to collaborating research institutions in the partner host countries;

Examples of relevant areas of training could include systematics, geographic information science, natural products and medicinal chemistry, microbiology, ecology, pharmacology, screening development and methodologies, genomic analysis, bioinformatics, biotechnology, production methods, data management, 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, advanced data mining and 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 the enhancement of biodiscovery capacity in the host country and high priority equipment for Associate Program institutions.  Very limited renovation of existing facilities, but no construction of new facilities, is allowable under this FOA.  All significant equipment purchases and any proposed renovation of facilities must be strictly relevant to the research objectives of the Group and requires prior approval by FIC. 

Establish models for ethical and practical scientific collaboration focused on non-human genetic resources; 

As international collaborations involving genetic resources have become increasingly regulated and politicized over the past 20 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, as well as 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 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 for therapeutic agents, b) biodiversity inventory/conservation, c) training/capacity-building, and d) partnership model development.  However, among these objectives, exploration/discovery of human health therapeutics is the leading edge of any successful ICBG and excellence in this area will be a key consideration in application review. You are strongly encouraged to contact the FIC Program Official listed below to discuss how you may balance and integrate these complex objectives. 

Composition of an International Cooperative Biodiversity Group

A. Core components of an ICBG:

i) A Program Director/Principal Investigator (PD/PI) who is likely to also head an Associate Program.  Multiple PD/PIs (MPIs) are allowed where appropriate, but given the complex nature of an ICBG, applicants should weigh the advantage of having a single overall leader to guide and help integrate the various components of the project.

ii) Associate Programs, each headed by an Associate Program Leader, in diverse scientific disciplines or organized around integrated themes such as ecology, microbiology, therapeutic discovery, chemistry, or taxonomy and collections that are appropriate to the realization of Group objectives.  At least one of the Associate Programs must be located in a LMIC and directed by a scientist or program administrator in an LMIC institution.  LMIC scientists must be substantially involved in the overall program design. LMICs are defined as low or middle income countries in the World Bank list of economies (see: http://data.worldbank.org/about/country-classifications/country-and-lending-groups).

iii) Central Operations Core (optional), which will coordinate legal agreements, contracts, and permits for the Associate program activities, coordinate communications and material transfers among the members of the consortium, and have responsibility for reporting and database maintenance.  Groups may instead choose to incorporate these activities into one of the Associate Programs.

iv) 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.  This component is added post-award and is not considered at the application stage.

B. The PD(s)/PI(s), in addition to providing scientific and administrative leadership, may head an Associate Program.  Associate Program Leaders will be directly responsible to the PD/PI.  The formation of the Group, submission of the application in response to this FOA, 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 PD/PI and the PD’s/PI's institution in accordance with PHS policies.  The PD/PI will also be responsible for maintaining an integrated relational database of significant research activities of the Group as outlined under SPECIAL REQUIREMENTS. The PD/PI must incorporate into the application, in the usual grant format, a full description of the project, including technical details and methodology. 

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 PD/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. Associate Program Leaders must complete their portion of the overall application in detail even if no funds are requested for his or her specific project.

D. While not mandatory, the active participation of the private sector is encouraged, either as an early-stage discovery partner or toward development of a promising lead molecule. Private sector partners may include companies, large and small, and non-profit drug development organizations. While for-profit companies may not receive funds from this award, they benefit from the collaborative legal framework and access to materials and expertise provided by the ICBG. 

E.  Who may participate: An individual scientist may be proposed as a PD/PI and/or an AP leader in only one application.  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 and current biosketch.  The participation of a U.S. government intramural scientist is independent of and unrelated to the role of the Advisory Committee or the U.S. Government Project Coordinator as described under "Cooperative Agreement Terms and Conditions of Award."

F.  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 FOA are not likely to be present in an individual institution.  Moreover, at least one U.S. and one LMIC institution must be involved.  Therefore, it is anticipated that the Associate Program Leaders within a Group will be derived from several institutions.

G. The number of Associate Programs per Group should not exceed eight (exclusive of a Central Operations Office).  However, the PD/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 four to 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.

H.  In forming Groups, potential PDs/PIs should remain cognizant of the need for meeting legal requirements and 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. Teams should be realistic in planning for the administrative burden of negotiating contractual agreements, communicating, developing reports, maintaining one or more databases, and carrying out planning with large groups.  Budget for these activities should be proposed in a Central Operations Core or as a component of an Associate Program.

I. 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.

J.  Significant cost-savings may 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.  Cost efficiencies through allocation of certain components of the work to private sector, U.S. Government and/or LMIC institutions may be achievable. In this regard, 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 Dimensions of Biodiversity; FIC research training grants; NIGMS and NCCAM Genomes to Natural Products Initiative and other research grants; NINDS and NCI Translational R21 and U01 grant mechanisms; and NIH screening and drug development contracts (described in Section VI.2.A.2).

Interests of Collaborating NIH Institutes and Centers and U.S. Government Agencies

The Fogarty International Center (FIC) is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC 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, and advancing global health research at the NIH and around the world.

The National Cancer Institute’s (NCI’s) Division of Cancer Treatment and Diagnosis (DCTD) is participating in this FOA. 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 analytical tools, plated compounds, tumor cell lines, animals, and GMP quality bulk drug for IND-directed studies.  For more information on DTP-provided resources, see http://dtp.nci.nih.gov/.  In addition, NCI makes available its drug discovery and development resources through the NExT program, a competitive program which encourages the submission of applications for a partnership with the NCI to facilitate oncology drug discovery and development.   NCI is committed to moving high-priority discovery and development projects through proof-of-concept clinical trials, especially in areas of unmet needs not adequately addressed by the private sector.  For more information, see http://next.cancer.gov/ .

The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care. Although a wide range of research topics is of interest to NCCAM, studies focusing on modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness are strongly recommended. With respect to this ICBG initiative, NCCAM is interested in projects examining the pharmacological utility of natural products isolated from bacterial and/or fungal endophytes. Projects that incorporate the use of state-of-the-art high content screens, new methods and technologies, and the capacity to elucidate basic mechanisms of activity are encouraged.

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.  NIGMS is also interested in expanding known chemical space through the identification of new chemical entities and new chemical classes of natural products as well as the development of state-of-the-art methodologies in natural products research.

The mission of the National Institute of Neurological Disorders and Stroke (NINDS) is to reduce the burden of neurological disease. As part of NINDS's overall mission, the Office of Translational Research facilitates the preclinical discovery and development of new therapeutic interventions for neurological disorders. Signaling pathways and networks in the microbial and pathogen-host interactions represent the evolutionary precursors or adaptations to neuronal signaling. Furthermore, recent discoveries have begun to highlight the interplay of the immune and nervous systems in humans and immunomodulatory therapies are being developed with the express intent of treating neurological disorders. Natural products derived from the sources mentioned above represent the potential to enrich for a collection of modulators of signaling mechanisms that have been selected by evolutionary pressure for complex yet specific intra- and intercellular communication. These might include functional modulators of ion channels, membrane receptors, or a variety of intracellular messengers. For these reasons, NINDS is interested in exploring the arena of natural products as a potential source for compounds of relevance as starting points for developing therapies with the potential to ameliorate neurological disorders or as probes for neuroscience research relevant to the NINDS mission.

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 FOA 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.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Issuing agencies and partner components intend to commit an estimated total of $3.3 mil for Fiscal Year 2014, corresponding to an estimate of 3-4 awards. The number of awards is contingent upon NIH appropriations and funds availability as well as the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

An applicant may request a budget for direct costs up to $700,000 per year.

Award Project Period

An applicant may request a project period of up to five years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

To be eligible, the applicant must include partnerships with institutions in LMICs where collections and other scientific activities will take place. LMICs are defined as low or middle income countries in the World Bank list of economies; see:  http://data.worldbank.org/about/country-classifications/country-and-lending-groups.  

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

 Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.  
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

While each institution may only submit one application as the applicant institution, an institution may be both the applicant organization on one application and a sub-award or associate program on additional applications.  

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent electronically to:

Flora Katz, Ph.D.
Fogarty International Center, NIH
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-402-9591
Email: flora.katz@nih.gov

Page Limitations


Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Associate Program

12

Central Operations

6


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component (Group Plan)

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Group Plan)

Complete entire form.

PHS 398 Cover Page Supplement  (Group Plan)

Follow all instructions in the SF 424 (R&R) Application Guide.

Research & Related Other Project Information (Group Plan)

Follow standard instructions. In the Project Summary/Abstract, in addition to a summary of overall goals and proposed activities, clearly identify all the therapeutic areas and other targets for the entire program.

Other Attachments: Include here as relevant and available:

Project/Performance Site Location(s) (Group Plan)

Enter primary site only. This should be the site of the applicant organization.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Group Plan)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Group Plan)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Group Plan)

Specific Aims: List the major goals of the overall program.

Research Strategy: The Research Strategy should summarize and synthesize the integrated approach the ICBG will use to meet the diverse goals of the overall program.  The plan should describe the organization and relationships of 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.  Discuss any prior collaborative efforts among the investigators as evidence of the ability to work together in multi-disciplinary and/or international projects. 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. If internal or external advisory groups will be used in addition to those specified in this FOA, describe the roles such a group would play and the areas of expertise to be included, but do not name the members of the group.

Incumbent Groups must describe the progress attained toward the original goals of their program, including highlights of publications, electronic or other tools created, trainees, significant molecules, new species, assay or processing innovations, conservation achievements and any other accomplishments of the Group.

Because the discovery of bioactive agents from natural sources is one objective of this effort, along with ensuring that an equitable 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 and, more recently, the Nagoya Protocol.  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, either in this section or under the appropriate Associate Program or Central Operations Core, each applicant Group is expected, therefore, to 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 FOA.  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 FOA. Draft or completed contracts or permits may be included in attachments, as described above.

The Group Plan section should not repeat details that are provided in the Associate Program or Central Operations Core sections.

Progress Report Publication List:  Attach a list of publications from prior ICBG funding.

Letters of Support: The application should include letters of agreement from all Associate Program Leaders, collaborators, and consultants, both paid and unpaid and in the public and private sectors, who will play a significant role in the activities of the proposed project. Letters should also be included, as relevant, from Government officials, community leaders or others whose authority is relevant to the objectives outlined but who may not be considered research participants or collaborators. Letters pertaining to the entire project should be placed here.  Letters specific to Associate programs should be placed in the Associate Program section.  If letters are relevant to more than one Associate Program they should only be included once in the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

It is recognized that some data generated in an international drug discovery program must remain confidential and proprietary.  However, Groups should plan to make data available to the extent possible and compatible with national guidelines in the U.S. and participating ICBG countries and with written MOUs and other agreements.  Groups should plan to submit the major part of their biodiversity /bioinventory data to national or international public databases by the conclusion of the award period.  Chemical structures, genomic sequences, and associated information that do not constitute materials that will be further explored for development towards therapeutic agents should be disseminated through publications and/or by contribution to public databases such as PubChem, GenBank, or comparable U.S. or host country public resources. Electronic tools, e.g., for analysis of genomic sequence or chemical structure data, developed through support from this award, might also be made publicly available. 

Micro-organism strains and natural product materials should also be shared to the extent possible and consistent with the legal agreements governing the ICBG. This may include contributing micro-organisms to national or international repositories such as national Biological Resource Centers or ATTC (http://www.atcc.org/ ) or contributing compounds or extracts to host country, U.S., or NIH collections such as the NIH molecular libraries small molecule repository (http://mli.nih.gov/mli/secondary-menu/mlscn/ml-small-molecule-repository/ ) or the NCI Natural Products Repository (http://dtp.nci.nih.gov/branches/npb/repository.html ). 

Resource Sharing Plans specific to individual Associate Programs should be included in those sections.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Appendices should be listed individually in the Table of Contents.

Appendices may include important reprints that are not readily available to reviewers.

Associate Program

When preparing your application in ASSIST, use Component Type ‘Associate Program.’

Each Associate Program should be submitted as an distinct component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Associate Program)

Complete only the following fields:

PHS 398 Cover Page Supplement (Associate Program)

 Follow all instructions in the SF 424 (R&R) Application Guide.

Research & Related Other Project Information (Associate Program)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Associate Program)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Associate Program)

Budget (Associate Program)

Budget forms appropriate for the specific component will be included in the application package.

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 likely not 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.

Physical infrastructure support could include the enhancement of biodiscovery capacity in the host country and high priority equipment for Associate Program institutions.  Very limited renovation of existing facilities, but no construction of new facilities, is allowable under this FOA.  All significant equipment purchases and any proposed renovation of facilities must be strictly relevant to the research objectives of the Group and require prior approval by FIC. 

If you are not using the Central Operations Core option, include under the appropriate Associate Program all expenses for the administration and coordination of the operations of the ICBG (see instructions for Central Operations Core for details).  At least one Associate Program or the Central Operations Core must budget for a data manager who will be responsible for integrating data across all the Associate Programs, providing the specified data fields to the ICBG Global Data Center, and interacting with that Center.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Associate Program)

Specific Aims:  List the major goals of the associate program.

Research Strategy: Describe the proposed work of the Associate Program and how it will integrate and interact with other Associate Programs to fulfill the overall goals of the project. 

It is important to focus attention on the potential Impact or Significance of the Associate Program, while providing the essential methodological details and rationale for the approaches chosen. In addition, this section should summarize the expertise that will be available to realize the specific aims of the Associate Program. Applicants should be realistic regarding challenges, such as proposed numbers of collections, capacity for extractions or microbial isolations, and any barriers (policy or otherwise) to sample exchange among the components of the Group and suggest how such challenges will be addressed. The Associate Program Training Plan, if relevant, should also be included within each section. 

If a Central Operations Core will be incorporated into one of the Associate Programs or distributed among Associate Programs, describe the details under the appropriate AP descriptions (see Central Operations Core, below).

Letters of Support: Include any letters of support that are specific to the Associate Program and are not included under the Group Plan or Central Operations.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Central Operations Core

When preparing your application in ASSIST, use Component Type ‘Central Operations.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Central Operations Core)

Complete only the following fields:

Research & Related Other Project Information (Central Operations Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Central Operations Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Central Operations Core)

Budget (Central Operations Core)

Budget forms appropriate for the specific component will be included in the application package.

Include all costs for communications, transfer of materials, negotiation of permits and agreements, reporting, and other core functions not otherwise included in the AP budgets to allow the administration of the ICBG program. The budget should allocate funds for purposes not specific to one Associate Program, such as the cost of annual meetings of the entire Group, and PD/PI and Associate Program Leader travel to the annual ICBG network meeting of all Groups at NIH, and support for a data manager to integrate data across the projects.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Central Operations Core)

Specific Aims:  List the key functions and goals of the Central Operations Core.

Research Strategy: Describe how this component will be organized and its functions, which may include, among other activities, coordination of legal agreements, contracts, and permits for the Associate program activities, coordination of communications and material transfers among the members of the consortium, outreach activities, and responsibility for reporting and database integration and maintenance.

Letters of Support: Include any letters of support that are specific to the Central Operations Core and are not included under the Group Plan or Associate Programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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.B. under "Principles for Accessing Genetic Resources".

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed and will be administratively withdrawn by the NIH.  

Special Requirements

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 submitted to the government specifically for this database will be treated as confidential and the property of the grantees and their collaborators except where otherwise indicated by the grantees.  However, while the government will not make this data public, grantees are advised to work with their collaborators and program officials to ensure that the broadest possible use is made of data and samples from their projects (see "Research Sharing Plan" under Group Plan, Section IV.2.).  The Data Center will also serve a variety of data analysis, data management, literature summary, 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 may host a Group server and provide secure web-based functionality if requested by the PD/PI. The Government will choose a data system and contractor to serve these functions. If Groups maintain their own data systems, the Data Center will help them extract and upload the required fields to meet the government's requirement. Applicants 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.

Summary of Minimum Requirements for Application

Applications to the ICBG 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 FOA and should be addressed in the relevant sections of the application or as detailed below.

1.  Identify a PD/PI (or the contact PD/PI if using MPI) from a U.S. eligible institution who will be responsible for the application, for interacting with the Government concerning 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 LMIC institution that hosts the ICBG.

3. Identify the (contact) PD’s/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 FOA; show availability of personnel and facilities capable of performing and supporting the administrative and scientific functions of this ICBG, including data management.

4. For each Associate Program, describe 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 U.S. 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: a) 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 b) 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.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The Associate Programs ("Projects") in an ICBG are highly interdependent and each contributes to the overall goals of the ICBG proposal.  Consequently, applications will be reviewed as a whole and scored under "Overall".  Reference to the merit of individual components (Associate programs and the optional Central Operations Core) may be made, as appropriate, under each review criterion. 

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project present a thoughtful and powerful approach to the exploration of biodiversity for novel drug discovery? Will it measurably advance the scientific capacity of the host country(ies) to make use of and manage their biodiversity resources?    

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the Group have the ability and commitment, as measured by previous success, to collaborate with and train LMIC nationals in the scientific and technical disciplines considered critical to meeting the objectives of the proposed programs?

Do the PDs/PIs have administrative experience and competence in the development, implementation, and management of multi-component, international, and/or multidisciplinary research programs?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Is the framework for integration of collections, drug discovery, biodiversity conservation, capacity building, and collaborative agreements innovative? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

For incumbent Groups, have they demonstrated sufficient accomplishments from prior support, as evidenced by publications, compounds, contributions to biodiversity management, capacity building and other areas to justify a continuation of their program?

Is there a rigorous and well-developed plan to discover and analyze health therapeutic agents from biodiversity? 

Collections: Have the applicants provided a compelling justification for their choice of organisms, and for their collection and material processing strategies? Are there plans to adequately preserve their strains and chemistry materials? 

Assays: Are bioassay approaches adequately described, well-justified with respect to need, high-quality, and in sufficient number and variety to obtain adequate exposure of collected materials? 

Do they include both well-thought-out state-of-the-art and/or novel primary and secondary screens, as well as informative assays appropriate for the LMIC partnering laboratories?  Does the Group have appropriate expertise in the assay areas chosen? 

Chemistry: Have the applicants considered how to most efficiently minimize the recovery of known compounds and maximize the discovery of novel chemistries or activities?

Biodiversity inventory/conservation: Have they developed an integrated plan to promote biodiversity conservation and contribute to the knowledge base for effective conservation policy and/or management?

Capacity Building: Is the plan for building scientific capacity for biomedical and biodiversity research, such as through training, technology transfer, inter-institutional exchanges, and others, adequate and appropriate to local and international scientific needs beyond the specific targets of the proposed work? 

Framework for Scientific Collaboration, including Access and Benefit-Sharing related to genetic resources: Do the applicants 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 the U.S. Government funding of the proposed work? Is their approach likely to meet the objectives of the program, as outlined in this FOA?

Are the other goals of the ICBG integrated conceptually and operationally with the therapeutic research? 

Are the extent and level of LMIC participation appropriate and sufficient to achieve the project's objectives?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the proposed work take place in a country or region that is a priority for biodiversity conservation 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 or benefit from this example?

Is there sufficient evidence of the availability and competence of the institutions involved to carry out all required legal, fiscal and policy responsibilities, such as by evidence of prior international support?  Have the participating institutions demonstrated commitment to support these activities?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable  

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS) In addition, Reviewers may comment on whether there are plans for the collections resulting from the activities of this grant, and the extracts and compounds derived from those collections, to be made available for use by the investigators or research community in the LMIC and/or globally at the conclusion of the project.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the the FIC Advisory Board and possibly the Councils of participating NIH components. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, 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.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) 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 FOA.  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 conservation, training and capacity-building, and partnership model development.  The Group must develop the details of the program design following the guidance given in this FOA.  It is the primary responsibility of the PD/PI to state clearly the objectives of the Group, to direct the research and other activities stipulated in the application, 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 PD/PI and that the U.S. Government Project Coordinator will have the opportunity to offer input to this process.

Each project is expected to contribute to the achievement of three classes of benefits:  1) health benefits through the exploration of chemical and genetic properties of biodiversity; 2) benefits in the understanding and conservation of biological diversity; and 3) enhanced scientific capacity of the host country.  The following three sections describe responsibilities of the awardee relating to the realization of these benefits.

Projects must comply with all national and international regulations regarding collection, import/export and use of biological specimens.  All requisite permits for inventory collections and for product- oriented research collections from the relevant government organizations will be procured in advance of collection activities and copies must be provided to the FIC Program Official.  Requests to collect species that have been declared threatened or endangered by the Convention on International Trade in Endangered Species (CITES) must be particularly well-justified, and all regulations regarding these species must be scrupulously followed.

Awardees will have up to one year to provide evidence of prior informed consent and completed, signed agreements specifying the rights and responsibilities of each Group member institution sufficient to conduct the research activities proposed in the application. Extensions or exceptions will be few and may only be granted by the FIC Program Official, in writing. 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 FOA, 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.

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.

For projects that will have substantial interactions with indigenous and local communities, Groups are advised to develop formal, well-documented consultations with indigenous community leaders and respected local Non-Governmental Organizations during project planning and periodically thereafter.  Seeking the advice or participation of social scientists and development organizations with local expertise is also advisable during this process.

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 agreed terms.  

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.  Equipment procured will be of U.S. source and origin where possible.  Major equipment procurements that are not from U.S. sources or origins must be justified in writing and are subject to U.S. Government approval.

Awardees will retain custody of and have primary rights to the data and software developed under this award, subject to current Government policies regarding rights of access. Molecular discovery data shared with the U.S. Government and its contractors will be presumed to be confidential until otherwise indicated or agreed upon. However, in this context grantees will work with their collaborators and program officials to ensure that the broadest possible use is made of data and samples from their project.  The majority of bioinventory data must be deposited in a public database by the conclusion of the project, vouchers should be publically available, and data should be disseminated to the greatest extent possible consistent with the goals and legal agreements of the program. Significant findings emerging from ICBG-funded research must be published in a timely fashion in peer-reviewed scientific journals except in cases in which clear proprietary concerns are present.  Publications or oral presentations of work done under this agreement will require appropriate acknowledgment of joint support from the NIH and the NSF under this FOA. Groups are encouraged to submit published chemical and extract data, or non-published data as desirable, to the PubChem public database maintained by the NIH (http://pubchem.ncbi.nlm.nih.gov/deposit/deposit.cgi).

Grantee organizations and their domestic and foreign partners retain custody and rights to all proprietary data and intellectual property that emerge and develop from their research, as outlined in the section, "Principles for Access, Intellectual Property and Benefit-sharing." 

The US 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 U. S. Food and Drug Administration of any invention resulting from these U.S. Government-supported cooperative agreements.  It is the responsibility of the PI to submit to the U.S. Government Project Coordinator and FIC Program Official, and the ICBG Global Data Center upon request, data and reports 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.

NIH and NSF staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A U.S. Government Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additionally, an FIC Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The U.S. Government shall assist in the activities of the ICBG principally through the U.S. Government Project Coordinator and the FIC Program Official.  The FIC Program Official shall be the primary Government contact with the PI for issues relating to program administration, funding and policy.

The U.S. Government Project Coordinator will be the primary Government contact with the PI for scientific and technical issues.  The Project Coordinator will be appointed by the Government.  During performance of the award, the Project Coordinator may provide appropriate assistance in the design of activities and in the identification of and access to NIH and other scientific resources.  In all cases, the role of the Project Coordinator will be to assist and facilitate, and not to direct, activities. 

The U.S. Government Project 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 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 Project 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.  Except in special circumstances, such as database training provided by the ICBG Global Data Center, funding for this training must be within the ICBG's approved budget.

The Project Coordinators for all ICBGs will participate in the Technical Advisory Group (TAG) for the ICBG Program.  The FIC Program Official chairs the TAG and will make all final programmatic and budgetary determinations on behalf of the U.S. Government. 

The Group is encouraged to make full use of NIH contract-based resources in drug discovery and development to facilitate screening and development of important lead compounds discovered from the funded ICBGs.  These resources should not be considered a substitute for the development of screens within the Associate Programs of the ICBG, but used as a supplemental source for the screening of extracts and compounds and lead development. The intent is to broaden the scope of discovery, which may be limited within one Group's technical capabilities and budgetary constraints, and maximize the chance of success in lead development.  For example, the NCI's Developmental Therapeutics Program has available contract resources in screening, in vivo testing, formulation, pharmacology and toxicology (http://dtp.nci.nih.gov/). NINDS has an Anticonvulsant Screening Program (http://www.ninds.nih.gov/research/asp/index.htm ).  Similar resources are available through the other components of the NIH not listed on this FOA, such as NIMH's Psychoactive Drug Screening Program (http://pdsp.med.unc.edu/), NIAID's Microbiology and Infectious Diseases Resources (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/Pages/prodspecialists.aspx) and other NIAID Resources for Researchers (http://www.niaid.nih.gov/labsAndResources/pages/default.aspx?wt.ac=tnLabs ).

All samples transferred to the U.S. Government resources for evaluation should have a completed Material Transfer Agreement with sample originator retaining the intellectual property.  The Groups should contact ICBG Technical Advisory Group representative(s) from participating agencies and institutes or the FIC Program Official regarding potential use of this support.  The Groups are also encouraged to make full use of the resources at Molecular Libraries Centers originally established through the NIH Roadmap Programs for compound testing and evaluation.  In addition, all Groups are encouraged to establish workable sample and other resource sharing agreements to facilitate the maximum exposure of samples to additional disease areas not covered in one Group's research plans if these efforts may advance the goals of the overall ICBG.

These "Terms and Conditions of Award" require that the U.S. Government Project 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.

The U.S. Government will have access to all data generated under this Cooperative Agreement and will periodically review the data for program management purposes.  The U.S. Government may elect, following consultation with grantees, to publish summary results from program activities to fulfill its responsibility to disseminate lessons learned from the program. 

Areas of Joint Responsibility include:

The PD/PI 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. The FIC Program Official, Project Coordinator, and members of the Technical Advisory Group (TAG) will attend these meetings, when possible. You should attempt to coordinate the timing of these meetings with the Governments' representatives.

In addition, the PDs/PIs from each ICBG will meet periodically at the NIH Campus to share findings and lessons with each other and the ICBG TAG. At least two of the network meetings during the five-year duration of awards under this FOA should include Associate Program Leaders from each Group. Applicants should budget for these meetings from grant funds.

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 monetary and non-monetary 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 appropriate 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, bioassay and chemistry work, may be considered "basic" research for the purposes of this program.  However if, at any time, researchers indicate an intent to commercialize, the research will be deemed to immediately be entering the commercial realm for the purposes of this program and must follow all the requisite permit and contract standards of the host country.  This would probably not apply to the patenting of an invention, or sending a sample to an ICBG industrial partner for routine screening, but might be triggered by the licensing of that material.

c)  Arrangements for the use of traditional knowledge or the collection of samples from the lands of indigenous and local communities should be based upon full disclosure and informed consent of those communities.  Under best practices such arrangements develop as a partnership with early and ongoing full participation of community representatives in project design.

d) Indigenous and local communities' customary laws, community protocols and procedures, and concepts of intellectual property should be respected.  If, for instance, on the basis of religious or other concerns, cooperating indigenous and local communities 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. However, ICBG's should consider carefully whether to enter into these relationships in regard to balancing the expectations of data-sharing in NIH-funded projects with the value of the information obtained for the goals of the project.  In addition, ICBG projects should not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities.

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 communities 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. LMIC institutions that do not have access to appropriate counsel may consider contacting Public Interest Intellectual Property Advisors (PIIPA: http://www.piipa.org/ ) for assistance. 

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.  For those discoveries subject to 35 USC 200-212 (Bayh-Dole Act), inventorship and ownership will be consistent with applicable laws, and the U.S. 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, above.

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, consistent with applicable laws.

f)  Agreements should specify that the basic goals of the collaboration include discovery from biodiversity for therapeutic agents, scientific capacity building, 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 (PL 96-517) and its implementing regulations (35 USC 200-212; 37 CFR 401).  PL 96-517, through regulation as well as applicable Executive Order, 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, consistent with applicable laws.  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 may not be patentable, such as traditional medicinal techniques, may require alternative protection methods.  You are encouraged to develop an arrangement that best suits the particular circumstances of your Group.

4.  Fair and equitable 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 non-monetary benefits such as training, institutional capacity building, targeted research to address local priorities, and the establishment of long-term partnerships, among other types, consistent with applicable laws.

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 associated with genetic resources, consistent with applicable laws.

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 and the sustainable use of its components.

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. 

f)  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 potential 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, research results should not be withheld which would unduly compromise the goals of the program, e.g., beyond those results concerning materials 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. All manuscripts should be shared with all Associate Programs before submission for publication.  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, the Nagoya Protocol (where partnering countries are signatories), and national laws regarding access, study, use, benefit-sharing, 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.

Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee (if a Steering Committee exists; otherwise by mutual consent of the relevant stakeholders) chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. These special dispute resolution procedures in no way affect 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Award Monitoring and Evaluation

Progress of each funded Group will be monitored and evaluated using semi-annual and annual technical progress reports prepared by the Group.  Detailed reporting instructions will be provided to grantees upon receipt of award or by request and will include tabular data using table formats provided by the sponsoring agencies.  A CD of each semi-annual and annual report should be sent to the FIC Program Official. We anticipate that part of this reporting process will rely on grantee cooperation with an ICBG Data Support 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 analytical or production methods, fundamental scientific discovery in integrated areas such as ecology or microbiology, new inventions or discoveries and appropriate intellectual property (e.g., patents), trainees, courses, positive institutional and policy changes, and conservation or health policy impacts.

The U.S. Government Project Coordinator and/or the FIC Program Official, with advice from the Technical Advisory Group, 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.  

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post-submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)

Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources) Telephone: 301-435-0714 TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

FIC:

Flora Katz, Ph.D.
FIC Program Director, ICBG
Deputy Director, Division of International Training and Research
Fogarty International Center (FIC)
Telephone: 301-402-9591
Email:  flora.katz@nih.gov

NCI:

Yali Fu, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5924
Email:  fuyali@mail.nih.gov

NCCAM:

John Williamson, Ph.D.
Program Director
National Center for Alternative and Complementary Medicine (NCCAM)
Telephone: 301-496-2583    
Email:  williamsonjs@mail.nih.gov

NIGMS:

Barbara Gerratana, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone:  301-594-3827
Email: gerratanab@mail.nih.gov

NINDS:

Rajesh Ranganathan, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1751
Email: rajesh.ranganathan@nih.gov

NSF:

Samuel M. Scheiner, Ph.D.
National Science Foundation
Telephone:  703-292-7175
Email:  sscheine@nsf.gov

Peer Review Contact(s)

Mike Radtke
Center for Scientific Review
Telephone: 301-435-1728
Email:  radtkem@mail.nih.gov

Financial/Grants Management Contact(s)

FIC:

Elizabeth C. Whittington
Fogarty International Center (FIC)
Telephone: 301-451-6830
Email: clevelande@mail.nih.gov

NCI:

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

NCCAM:

George A. Tucker, M.B.A., CGMS
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: tuckerg@mail.nih.gov

NIGMS:

Lisa A. Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@mail.nih.gov

NINDS

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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