Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov) on behalf of the NIH
Funding Opportunity Title	Human Heredity and Health in Africa (H3Africa): Bioinformatics Network (U41)
Activity Code	U41 Biotechnology Resource Cooperative Agreement
Announcement Type	New
Related Notices	August 9, 2016 - This RFA has been reissued as RFA-RM-16-011. NOT-RM-11-014 August 22, 2012 - See Issuance of RFA-RM-12-006, Human Heredity and Health in Africa (H3Africa): Collaborative Centers (U54) . October 14, 2011 - See Notice NOT-RM-12-004. The purpose of this Notice is to provide additional information to those applicants who plan to include an advisory committee. September 14, 2011 - See Companion RFA-RM-11-011, Human Heredity and Health in Africa (H3Africa): H3Africa Biorepository Grants (UH2/UH3).
Funding Opportunity Announcement (FOA) Number	RFA-RM-11-010
Companion FOA	RFA-RM-11-008, U54 Human Heredity and Health in Africa (H3Africa) Collaborative Centers RFA-RM-11-009, U01 Human Heredity and Health in Africa (H3Africa) Research Grants
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.172, 93.310
FOA Purpose	The purpose of this FOA is to call for applications to develop an H3Africa Bioinformatics Network by implementing innovative, cost-effective approaches to improving the connectivity among, and overall bioinformatics infrastructure in, all of the components of the H3Africa Consortium, including the H3Africa Collaborative Centers, research projects, and biorepository(ies); to fostering connectivity, interaction and coordination among African research groups working in genomics-based research on human disease and health across the continent; to promoting pan-H3Africa communication; to providing bioinformatics training of several types; to providing services and support to build bioinformatics capacity at African research institutions; to promoting computational skills among African researchers; and to developing new computational tools for genomics research in the African setting.

Posted Date	August 23, 2011
Letter of Intent Due Date	November 2, 2011
Application Due Date(s)	December 2, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	January-March, 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	December 3, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Part 1. Overview Information
Part 2. Full Text of 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

Purpose/Research Objectives. Low- and middle-income nations suffer over ninety percent of the world’s burden of premature mortality, as measured in lost years of life. These countries, constituting three-quarters of the world’s population, now must deal with a triple burden: the persistent cluster of infectious diseases, malnutrition, and a growing incidence of chronic disease and disabilities due to increased life spans and new risk exposures. The NIH has a long-standing commitment to address both communicable and non-communicable diseases around the world through health research and training, and one of NIH’s stated priorities is enhancing efforts in global health. Genomics and other large-scale biological studies provide cutting-edge approaches to research on the genetic and environmental contributors to health and disease, the understanding of which will lead to unimagined advances in medical science and powerful new ways for improving human health. To maximize the impact on the health of people globally, advances in the fields of genetics/genomics/environmental studies must be integrated into the research conducted in developing countries, as well as into their medical education and health services. Notably, however, African researchers and populations are substantially underrepresented in genomics and environmental research endeavors. For example, it has been found, as documented in a recent review, that, worldwide, the majority of the thousands of genetic studies completed to date (about 75%) were conducted exclusively in populations of European descent and only a fraction of the studies done with non-European populations came from Africa (Rosenberg NA, Huang L, et al. (2010). Nat Rev Genet 11(5):356-366). The paradox of limited genomics research conducted in Africa and the centrality of contemporary African populations for our understanding of human evolution and population genetics has been widely noted.

While there are pockets of research excellence in genetics and environmental studies on the African continent done by African and other scientists, a limited number of individuals have the expertise to engage in this work compared to the overall population size and burden of disease there. It is the objective of the H3Africa Initiative to enhance the capability of African scientists and research institutions to use genomics and other powerful new approaches to address problems of African health and disease. Increasing African research capacity by building infrastructure, expanding the genomic proficiency of researchers, and increasing the number of well-trained individuals are essential to promote sustainable efforts to address the challenges to advancing health and combating disease in Africa. While focused on benefitting the people of Africa, such research may also be relevant to the health of individuals in the U.S. and other countries worldwide, particularly those of African descent. For example, many scientists believe that different environmental exposures for a population whose genetic architecture evolved in environments with a scarcity of available resources may be an underlying contributor to disease in the U.S.

H3Africa is a partnership among the National Institutes of Health (NIH, USA), the Wellcome Trust (WT, UK), and the African Society of Human Genetics (AfSHG). A set of recommendations for H3Africa was developed by a pair of working groups, composed primarily of African scientific experts, who addressed the major scientific, ethical and practical issues in the development of a large-scale genomics research program in Africa. The working groups formulated a detailed proposal (which can be found in a white paper at www.h3africa.org) to address the goal of creating and sustaining a network of African Centers that could carry out training and research based on state-of-the-art genomics approaches. Through support for infrastructure development, training, and specific research projects, the working group recommendations were designed to catalyze genomics and environmental research concerning human diversity, health, and disease biology of particular relevance and benefit to African populations and societies. The proposal was discussed at a public meeting held in Cape Town, South Africa in March 2011 and the attendees ratified the white paper’s recommendations.

The research program described in this FOA is a response to the disparities in research capacity noted above and is based, in significant part, on the recommendations of the H3Africa white paper and from discussions at the Cape Town meeting. The H3Africa Initiative aims to contribute to the establishment of a viable, productive, and eventually sustainable, African research infrastructure to study the genetic and environmental contributors to disease and health. It aims to do so through a combination of the leveraging of existing capacity, expertise and infrastructure with investment in new research, infrastructure-building and training efforts.

H3Africa has three specific interrelated, interdependent objectives. The first is to increase the human resources for conducting cutting-edge genomics-based research in Africa through training, career development and enhanced collaborations within Africa and with the African scientific diaspora. The second is to support cutting-edge research that will not only generate important findings and discoveries, but will serve as a vehicle both for research training and for the improvement of the African laboratories where the research is carried out. The third is to support the improvement of specific types of infrastructure, i.e., biorepository capacity and bioinformatics, which are needed to do genomics-based research. To achieve these objectives, the H3Africa program at NIH will comprise several components. Infrastructure improvement will be addressed by support for an H3Africa Bioinformatics Network (this FOA) and for biorepositories in Africa (see NOT-RM-11-015). It is anticipated that one or more full-scale H3Africa Biorepositories will be established in Africa. Research activities will be supported through both Collaborative Centers (see companion FOA, RFA-RM-11-008 U54) and individual research projects (see companion FOA, RFA-RM-11-009 U01; also see a similar call for proposals from the Wellcome Trust at http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm). Finally, there will be a small grant program that will be funded in FY13, to support research on the societal implications of genomics in Africa. All awards under the NIH H3Africa program will be made to African Institutions and the majority of the awarded funds must be spent in Africa. All awardees will participate in the H3Africa Consortium to further enhance the collaborative nature of this Initiative.

H3Africa is funded, in part, through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. Updates on all NIH Common Fund Global Health initiatives can be found at http://commonfund.nih.gov/globalhealth/grants.aspx. The H3Africa website (http://h3africa.org ) will also have ongoing updates on H3Africa activities and information about upcoming H3Africa meetings.

The current FOA calls for applications for a cooperative agreement to support the H3Africa Bioinformatics Network.

Research Objectives. As the capacity for using genomics-based approaches for biomedical research in Africa grows, a similar increase is required in the bioinformatics efforts to handle, store and analyze the genomic and other relevant data that will be generated. Interest in bioinformatics is gaining momentum in Africa, and there are now several research-specific, country-based, or regional bioinformatics networks in place on the continent. A network-based approach is highly relevant to the African context, and thus the H3Africa Initiative will include an H3Africa Bioinformatics Network as a key component that will incorporate some of the existing infrastructure.

Within H3Africa, bioinformatics activities are envisioned to take place at several levels, with different purposes. Each of the individual projects within the Collaborative Centers (U54s) and each of the individual cooperative agreement research projects (U01s) will have to provide the bioinformatics capability it needs for data generation, storage, submission to public data resources, and for initial analysis. The Collaborative Centers (U54s) will also need to be connected with one another to meet the integrated bioinformatics needs of the larger research projects that they will be undertaking. At a higher level yet, the H3Africa Bioinformatics Network is being established to provide connectivity among all of the H3Africa research sites (including those funded by the Wellcome Trust), to provide the training in bioinformatics that is critically needed in Africa, and to conduct bioinformatics research, particularly research that will lead to the development of new computational tools customized to address the specific issues of genomic research in African populations. Planning discussions to date have imagined that the H3Africa Bioinformatics Network will be organized as a central administrative site and associated bioinformatics nodes, or as a hub and spokes model. However, applicants are free to propose any type of organization that they wish that will meet the scientific objectives described in this FOA.

Scientific scope. The purpose of this FOA is to solicit applications to establish an H3Africa Bioinformatics Network that will serve the H3Africa Research Network’s research and training needs. The objectives of the H3Africa Bioinformatics Network are to:

• Provide a foundation to establish a high level of bioinformatics capability across all parts of Africa;
• Implement innovative, cost-effective means of providing an overall bioinformatics infrastructure for H3Africa, taking advantage wherever possible of existing bioinformatics capability and infrastructure;
• Foster connectivity and interactivity among the H3Africa research groups to enhance translational research and bioinformatics across the continent, including support for collaborations, by establishing the necessary links at the level of research groups and, as possible, research institutions; by promoting cross-network communication through, for example, teleconferences, webinars, virtual courses, social media, distributed coding projects, and an on-line helpdesk; and by providing services and support to build continental and local bioinformatics capacity;
• Provide bioinformatics training and promote computational skills among African researchers, through:
  • Training at all levels for research scientists, bioinformaticians, and computational support staff participating in H3Africa;
  • Providing opportunities for career and leadership development for bioinformatics researchers;
  • Establishing multiple approaches to training in bioinformatics, including on-site, in-person training and both synchronous and asynchronous on-line education, including providing supporting infrastructure;
  • Supporting the development of skills needed to develop and maintain bioinformatics infrastructure, including identifying the needs, challenges, and solutions related to both equipment and the Internet;
  • Develop the skills and orientation to create or take advantage of forward-looking solutions to the emerging obstacles posed by the large amounts of data now being generated in genomics-based research, for example but not limited to, the use of cloud computing for storage, analysis, and data transfer;
  • Facilitate and consult on data submission by H3Africa research sites to international repositories, as well as access to data; provide guidance for data management and storage, and data sharing;
  • Engage in bioinformatics research and development of computational tools optimized for use in genomics-based research in Africa.

Overall Vision. The application must provide an overall vision for the H3Africa Bioinformatics Network, including how it will achieve the objectives listed above, why the proposed organizational model was chosen, how that model is optimal to achieve the goals of the H3Africa Initiative, and what is innovative about the model in the African context.

The Network. The H3Africa Bioinformatics Network will be expected to work with the H3Africa research projects that are funded by both the NIH and the Wellcome Trust, as well as with the biorepository projects. As a guideline, the companion FOAs state that the NIH will fund up to three Collaborative Centers, up to four research projects, and biorepositories. In addition, the Wellcome Trust intends to make two to four awards, and these projects will be included in the H3Africa Consortium (see http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm ). The funding agencies anticipate that the H3Africa Consortium may be expanded as other funders contribute, so the application should discuss how provision will be made for the addition of participants in the H3Africa Research Network.

It is anticipated that there will be two types of sites with which the H3Africa Bioinformatics Network will be involved:

• Research sites: One of the remits of the Network is to link the research sites participating in H3Africa. As noted above, the H3Africa research projects themselves are expected to have or to build the local bioinformatics, computational, and analysis capabilities needed for the conduct of the research they propose; the H3Africa Bioinformatics Network is not responsible for building such infrastructure and foundation for them. However, the Network should play a consultative role, by providing advice to the research projects and trainees on identifying and meeting their remaining needs, as well as keeping them abreast of new analysis tools and other innovations that will help them to build upon what is being supported by their own research funding.

The application should describe how the Network will interact with the initially funded research sites and what services and benefits will be offered to them. The application should also discuss what capacity in terms of research sites it could handle beyond the initial H3Africa sites, as well as any plans it may have for encouraging growth by adding new Network participants. A fee-for-membership model may be considered for non-H3Africa research sites, if needed, but the objective should be to encourage membership.

• Bioinformatics sites: While a site in the H3Africa Bioinformatics Network may be at the same institution as one of the research sites that will be competitively selected, it is recognized that there are also existing sites in Africa that have strong bioinformatics capabilities and track records, significant bioinformatics skills and infrastructure, but which may not have all of the genomics-based research capability to be competitively selected as a research project. Yet other sites may not be as well-developed but are interested in building up their existing bioinformatics capabilities and infrastructure. Applicants for the H3Africa Bioinformatics Network are encouraged to consider including either or both of these types of sites in their proposed Network, to the extent that doing so will facilitate meeting the objectives of the H3Africa Initiative.

The application should provide information about all of the proposed participating bioinformatics sites, including their existing infrastructure, skills and needs; the role(s) that they will play in outreach to the expanding African genomics community; and how the sites will contribute to the synergy of the Network. The application should also specifically discuss the following:

Training and Career Building. As discussed above, one of the most important remits of the H3Africa Bioinformatics Network is training. The application should describe in detail an innovative and forward-thinking training program, which may take place at both the Network research sites and the Network bioinformatics sites. The application should discuss the applicant’s vision for bioinformatics training in Africa and his/her experience in bioinformatics training; how the training opportunities will be made widely available to H3Africa sites across the continent; how the trainees will be identified: whether and how additional training will be provided to the staff of the Network’s training sites themselves; how the training provided will be promulgated to benefit others who may not be direct members of the Network; and how the Network’s several training activities will be coordinated.

Data repositories. H3Africa research projects will be instructed to submit their data to international databases, such as those at NCBI, EBI and DDBJ. Therefore it is not anticipated that the H3Africa Bioinformatics Network will have a need to establish a large database to archive sequence or other molecular data, or phenotypic data. Rather than proposing to create new archives, the application should discuss plans for how the Network will work with users to help them to better be able to deposit to, and access data from, the international databases.

Bioinformatics research. The H3Africa Bioinformatics Network application may include a bioinformatics research component. Examples of the types of research that would be appropriate include the development of software or algorithms for data processing, data mining, genomic data visualization, analysis, or other bioinformatics and computational research tools useful for genomics research, particularly the unique aspects of genomics research in Africa. While database resources may in some cases be necessary as part of the Network, the major focus of a research component is intended to be in the areas of data processing, analysis, and interpretation for biological discovery, not in database construction or services. The research component should be a minority of the H3Africa Bioinformatics Network activities. As a guide, it would be reasonable to consider devoting up to 10% of the requested funds to such research, although a larger percentage of the budget may be requested with appropriate justification.

Other Network activities. There are many other activities that could be provided by an H3Africa Bioinformatics Network to benefit the expanding African genomics-based and bioinformatics research communities. Applicants are encouraged to describe creative plans, in addition to what is called for above, for using up-to-date tools and strategies to provide a robust and state-of-the-art approach to the use of bioinformatics and computation for providing maximum progress toward achieving the goals of H3Africa.

Several additional topics should be addressed in the application:

Sustainability. One of the major goals of the H3Africa program is to enable African scientists to demonstrate their world-class skills through the establishment of cutting-edge research programs that will lead to more publications and other evidence of productivity, thereby increasing their opportunities for future funding through competitive grant processes, as well as through increased investment in research by national governments and private sources. Applicants should discuss the issue of future sustainability of bioinformatics infrastructure and capacity on the continent beyond the H3Africa program and how the specific H3Bioinformatics Network will, during its lifetime, contribute to the on-going future of cutting-edge research efforts in Africa. This section of the application should be compatible with the letters of Institutional and National commitments (see below) to provide an overview of the long-term prospects for sustained bioinformatics structure, capacity and research.

Data Sharing and Release plan. A plan for data and resource sharing and release is expected for all NIH applications (http://grants.nih.gov/grants/policy/data_sharing/). Applicants are expected to provide a well thought-out plan for widely sharing data, tools and other resources generated by the Bioinformatics Network to further the H3Africa goal of encouraging more genomics-based research on health and disease by African scientists. An application must have an acceptable Data and Resource Sharing and Release plan before it can be funded, consistent with the goals of the H3Africa initiative. After the awards have been made, the H3Africa Consortium (see below) will develop a unified plan for data and resource release, and the application must include a statement that the investigators in the Bioinformatics Network will abide by the Consortium's data and resource policy. Examples of current data release guidelines for NIH programs can be found at: http://www.h3africa.org/dataReleasePolicy.cfm

H3Africa Research Network Meetings: The NIH and the Wellcome Trust plan to hold two H3Africa Consortium meetings per year, and applicants should request funds to travel to these meetings in their applications. Most of the meetings will be held in Africa. However, in the first year, one of the Research Network meetings will be held in London, U.K., and in year three, one will be held in Bethesda, MD in the U.S. For the meetings in Africa, travel for up to 2 people from the grantee institution and up to a total of 6 from the other bioinformatics sites combined will be allowed. For the meetings in London and Bethesda, travel for the PD/PI and up to two will be allowed. Adequate travel funds for these meetings must be requested in the application. Additional people will be allowed to participate in the meetings if funding for travel can be obtained from other sources.

Monitoring and Evaluation Plan: The application must contain a plan for how the project's progress, as well as funds and supported activities, will be monitored and evaluated. The plan should discuss how the Bioinformatics Network project will be assessed and how the applicant will define, identify, and determine impact. The plan should also discuss how any necessary modifications indicated as a result of the assessments will be effected. To facilitate the monitoring and evaluation, the application should include a well-defined set of yearly milestones for the research and training activities proposed. The milestones will be negotiated and finalized at the time of award. The milestones will be reconsidered on an annual basis to account for the Center s experience and progress, but will be subject to change only with the NIH Program Director’s agreement. An example of the level of detail and specificity needed for the milestones can be found in an example set of acceptable milestones from past genomics projects, posted at http://www.h3africa.org/genomicsProjectMilestones.cfm.

Institutional Commitment: The application should include a letter from an appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from each of the participating institutions, which substantiates the institution’s commitment to the proposed project. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, positions and resources that can contribute to the planned program. The institution should state its commitment to overcoming any administrative obstacles to the implementation of the application, such as accommodation for participation by multiple Schools at the university or collaboration with other institutions within or outside of the applicant’s country. The letter should also briefly discuss the institution's plans for sustaining an active program of scientific research.

As the programmatic activities of this initiative will support national and international collaborations, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component will be required. The letter should briefly describe the national policy concerning the development of a national scientific research program and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development (R&D). It is highly recommended that these letters of support be included with the application. If these are submitted later, this could impact and delay the review of the application. An award will not be made without receipt of these letters of support.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount of funds available for the Bioinformatics Network is approximately $3.1M total cost for FY2012 and $2.2M total cost per year for FY13-16, contingent upon receiving scientifically meritorious applications. One award is anticipated from this solicitation.
Award Budget	As only one award will be made, the total cost of the budget may not exceed the total costs given above.
Award Project Period	The maximum period is 5 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.

• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Specifically:

• African institutions are eligible for the awards:
• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

The PD/PI should be an established leader in the academic and scientific area in which the application is targeted, and be capable of providing administrative, clinical, and scientific leadership to the development and implementation of the proposed program.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Jane L. Peterson, Ph.D.
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: 301 496 7531
Fax: 301 480 2770
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9305
Rockville, MD 20852

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

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

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Dr. Rudy Pozzatti, Ph.D.
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: 301 482 0838
Fax: 301 435 1580
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9305
Rockville, MD 20852

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Research Plan section is limited to 30 pages.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The sections listed below are all part of the 30 pages of the Research Strategy.

Overview. The narrative portion of the application should begin with an overview that addresses the following: the rationale and vision for the proposed H3Africa Bioinformatics Network, a brief description of the network to be developed, community support for the proposed network, and the anticipated overall impact of the network on genomics research in Africa. The overview should also include a summary description of the project's components. The overview should include preliminary data that support the technological approach planned to establish the network, if appropriate. The vision for the long-term sustainability of the H3Africa bioinformatics network must be discussed.

Project Description. Development of the Bioinformatics Network

The central focus of the project should be the development of the H3Africa Bioinformatics Network using established, state-of-the-art technologies. This section should describe in detail the specific aims, methods, expected outcomes, metrics for success and quality control, yearly milestones for each component of the project, and facilities available to conduct the project. The investigators who will be responsible overall for the H3Bioinformatics Network and for each sub-project (node) should be identified, their expertise and experience briefly described and their roles in the H3Africa Bioinformatics Network outlined.

Description of subcomponents. In the H3Africa Bioinformatics network, the applicant is expected to propose other sites of bioinformatics activity that will constitute the network and work collaboratively with the primary site to support and facilitate the research of the H3Africa research projects, and to achieve the other goals of H3Africa. The activities that will take place at each site must be described well, and the way in which each site will contribute to the function of the H3Africa Bioinformatics site must be discussed. The application should also address any plans that the proposed Network has to enhance some or each of the participating sites so that bioinformatics capabilities become more wide-spread throughout Africa.

User support. The H3Africa Bioinformatics Network will be expected to provide consultation services and technical assistance to the H3Africa research projects. Applicants should describe their experience in providing user support, evidence of the quality of that service, and their plans to implement these service plans for the H3Africa Consortium.

H3Africa data submission and access. Data generated by H3Africa research projects must be submitted to international databases according to the data release policy that the Consortium adopts. Also, genomics data should be easily accessible by the H3Africa research community. The application should provide information about the applicant’s experience with, and plans for, helping researchers both submit and then access genomic data.

Training. Training activities are a critical component of the H3Africa Bioinformatics Network. The application must describe a well-considered training plan and allocate sufficient resources for training both specialists and non-specialists. Training sites may be at the applicant institution, at other project sites, at an H3Africa research site, and/or by distance. Examples include presentations, short courses, or symposia offered independently or in conjunction with society meetings attended by the user community; web-based tutorials; and user manuals and training guides.

Access and Dissemination. Applicants should include a well-described plan for dissemination of resources to network participants (bioinformatics "nodes" and H3Africa grantees) as well as a description of how that community will access resources through the Bioinformatics Network, consistent with achieving the goals of this program. Any web-based dissemination activities must emphasize user-centric design.

In the long run, it will be expected that the bioinformatics network will have a website presence, initially for the H3Africa grantees and eventually for the public. If appropriate, the web site should provide information about:

(1) the project’s focus and capabilities, including research objectives if appropriate;

(2) how to interact with the network and provide feedback;

(3) contact information;

(4) current newsworthy items about the network;

(5) links to online tutorials, if appropriate;

(6) the availability of software, reagents, and other resources such as FAQs, as applicable; and

(7) links to related NIH-funded resources.

Administration and management. The organizational and administrative structure of the project should be described. This section should separately address organizational structure, including how the PD/PI and the project staff at both the central site and remote sites will be organized with respect to the project activities, the administrative and managerial experience of the staff who will develop and run the resource development activities, and the distribution of effort across their areas of responsibility. Other issues that should be discussed in this section include internal decision-making processes, priority setting mechanisms, administrative aspects of communication among collaborating components, administrative staff responsibilities, and progress reporting.

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 PHS398 Application Guide, with the following modifications:

• H3Africa resource and Data sharing plans will be agreed to by the entire network once all the applications are funded. However, applicants must provide a plan in the application that must be approved by H3Africa program staff before the application can be funded, consistent with the goals of the H3Africa initiative.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and for responsiveness by The National Human Genome Research Institute, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicant Information Meeting, September 21-22, 2011

The H3Africa staff will host a meeting for applicants to discuss the NIH Funding Opportunity Announcements (FOAs) regarding H3Africa. The FOAs call for applications for H3Africa research projects, bioinformatics networks, collaborative research centers and Biorepository planning grants. The meeting will be held on the 21st and 22nd of September 2011 at the Windsor Golf Hotel and Country Club in Nairobi, Kenya.

On the 21st of September staff will discuss each FOA, be available to answer questions and hold application writing, grants management and review workshops specific to the NIH application process. On the evening of the 21st and the day of the 22nd of September NIH staff will be available to meet with applicants individually with the understanding that the general questions they ask and answers given by staff will be posted on a website.

Applicants interested in meeting separately with staff should schedule an appointment by sending an email to [email protected] . A teleconference link will be provided for individuals unable to attend the first day of the conference. The agenda, information regarding accommodation and the details of the teleconference can be found here. While registration for the meeting, except for the teleconference, is not required please inform H3Africa staff of your intent to attend by sending an email to [email protected] . This will enable NIH to provide you with any updates or additional logistics about the meeting.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115. Letters of support from institutions may be submitted after the application has been submitted.

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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed H3Africa Bioinformatics Network to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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 proposed project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed H3Africa Bioinformatics Network address an important problem or a critical barrier to progress in the field? If the aims of the proposed H3Africa Bioinformatics Network 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? Will the proposed H3Africa Bioinformatics Network further the goals of the H3Africa Initiative? Will it make a significant difference in doing genomic-based research in Africa?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the proposed H3Africa Bioinformatics Network 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? Do the PD/PIs have the experience to coordinate a collaborative network of the type proposed?

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? Does the application propose creative ways to implement and sustain an H3Africa Bioinformatics Network?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed H3Africa Bioinformatics Network? 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?

If the application involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the plans for interaction, communication and connectivity among the components of the proposed H3Africa Bioinformatics Network satisfactory? Will they help to achieve the aims of this FOA? Is the overall management structure sound?

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?

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/priority score, but will not give separate scores for these items.

Will the proposed Bioinformatics Network contribute to the future success of genomics-based and other cutting edge approaches to research in Africa? Will it contribute significantly to the development of a useful and productive bioinformatics research community in Africa?

Is the applicant's plan for sustainability feasible? Will the network and/or its components be well-positioned to apply for continued funding at the end of the project period?

Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained research enterprise?

Do the collaborations among the network participants suggest viable partnerships?

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

Not Applicable

Revisions

Not Applicable

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Human Genome Research Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Receive a second level of review by the appropriate National Advisory Council or Board
• Will receive a written critique.

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 appropriate National Advisory Council.l The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Ability of the proposed project to address the infrastructure development goals of the H3Africa Initiative
• Strength of the Institutional and National commitment to the project.

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

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.

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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, 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 Terms and Conditions for the Bioinformatics Network indicate that progress on the project will be reported to the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director as well as many Institutes, even though the funds used to support this FOA do not come from all of the Institutes. These terms apply to the Research Network as a whole, not just the Bioinformatics Network. The latter will be a member of a larger Research Network.

Definitions

Steering Committee (SC): The Steering Committee is the primary governing body of the H3Africa Consortium. PI(s)/PD(s) of each of the cooperative agreements, and NIH Program Directors serve on the committee. See further details about the Steering Committee under "Joint Responsibilities".

Panel of Scientific Consultants (PSC): The PSC will be composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the H3Africa Consortium. It will be responsible for reviewing and evaluating the progress of the H3Africa Consortium. See more about the PSC below under this topic.

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

• All aspects of the proposed activities, including overall management of the network, any modification of Network design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.
• Awardees agree to the governance of the Consortium through the Steering Committee and recommendations from the Panel of Scientific Consultants.
• Awardee(s) will agree to accept close coordination, cooperation, and participation of NIH H3Africa staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Awardee(s) will provide goals and reports of progress toward those goals at regular intervals as requested by H3Africa staff and ensure that the data produced meet the quality standards agreed to at the beginning of the project by the H3Africa Consortium;
• Awardee(s) will ensure that the data are deposited in the appropriate public database (e.g., GenBank or other, as specified by H3Africa program staff), that resources developed as part of this project are made publicly available according to H3Africa policies, and that results are published in a timely manner;
• Awardee(s) will adhere to the H3Africa policies regarding intellectual property, data and resource release and other policies that might be established during the course of this activity that are consistent with applicable NIH policies, laws, and regulations;
• Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• One H3Africa Project Scientist from each participating Institute will serve on the Steering Committee and have one vote; the number of NIH votes may not exceed the number of PI votes on the SC. They and other H3Africa project team scientists may serve on other study committees, when appropriate. The H3Africa Project Scientists may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., data sharing, data release, quality control, core establishment.
• The Project Scientists will participate (with the other Steering Committee members) in the group process of deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
• The Project Scientists will negotiate goals with the awardees as necessary, serve as a liaison between the awardees and the Panel of Scientific Consultants, the appropriate NIH Institute and Center National Advisory Councils, the NIH H3Africa Working Group made up of program staff that collectively manage the program, and the larger international scientific community, attend all Steering Committee meetings as voting members and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
• The Project Scientists will periodically report progress to the Director of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), of which the Office of Strategic Coordination that manages the NIH Common Fund is part of as well as OAR, and to the Directors of NHGRI, FIC, NINDS, and NIDA.
• The Office of Strategic Coordination (OSC), NHGRI, NIDA, NINDS and OAR reserve the right to withhold funding or curtail the study (or an individual award) in the event of (a) substantive changes in the agreed-upon work scope with which OSC, NHGRI , NIDA, NINDS and OAR cannot concur, (b) human subject ethical issues that may dictate a premature termination.
• Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH.
• Additionally, an agency program official or NIH program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

• Participate in the Steering Committee. A Steering Committee will serve as the main governing board of the H3Africa Consortium. The Steering Committee membership will include the NHGRI, NIDA, NINDS Project Scientist(s) and the P.I. of each awarded cooperative agreement in the H3Africa Initiative. The Steering Committee Chair will not be an NIH staff member but will be appointed by H3Africa staff. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. Because the Consortium will include investigators funded by this FOA and other FOA's for H3Africa, it is possible that H3Africa staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees under a specific FOA.

The Steering Committee will:

• Discuss progress in meeting the goals of the several H3Africa Consortium member projects;
• Develop recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, for example for data quality measures and assessment, conventions for data deposition;
• Schedule the time for, and prepare concise (3 to 4 pages) summaries of, the Steering Committee meetings, which will be delivered to members of the group within 30 days after each meeting. The SC will meet twice a year with intermittent conference calls.
• Each full member (limited to one person per awarded center, in the case of multiple PI’s per center) will have one vote.
• Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The Panel of Scientific Consultants (PSC). The PSC will provide recommendations to the Directors of the DPCPSI, NHGRI, FIC, NIDA, NINDS about continued support of each of the components of the H3Africa Consortium.

• The PSC will meet at least once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the PSC members to interact directly with the awardees.
• Annually, the PSCs will make recommendations regarding progress of the H3Africa Consortium and present recommendations regarding changes, if any, that may be necessary in the H3Africa Consortium program to the Directors of the DPCPSI, NHGRI, FIC, NIDA and NINDS.

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 composed of three members will be convened. The three members will be: a designee of the Steering Committee 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. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jane L. Peterson, Ph.D.
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: 301 496 7531
Fax: 301 480 2770
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9305
Rockville, MD 20852

Joni L. Rutter, PhD
Acting Director
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd, Rm 4282
Bethesda MD 20892-9555
Ph: 301.435.0298
Email: [email protected]

Salina Waddy, MD
Program Director
National Institute of Neurological Disorders and Stroke, NIH
Office of Clinical Research
6001 Executive Blvd, NSC, Suite 2153
Bethesda, MD 20892-9525
Rockville, MD 20852 (for Express/Courier Service)
Telephone: (301) 496-9135
FAX: (301) 402-1501
Email: [email protected]

Dr. Rudy Pozzatti, PhD
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Phone: 301-402-0838
Fax: 301 435 1580
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9306

Victoria Bishton
National Human Genome Research Institute
Telephone: 301.451.7928
Email: [email protected]

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.

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.