Department of Health and Human Services

Part 1. Overview Information
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://genome.gov) on behalf of the NIH.

Participating Institutes:

National Human Genome Research Institute (NHGRI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
Office of AIDs Research (OAR)  
Fogarty International Center (FIC)
Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

Human Heredity and Health in Africa (H3Africa): Collaborative Centers (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • August 22, 2012 - This RFA has been reissued as RFA-RM-12-006.
  • June 13, 2012 - See Issuance of RFA-RM-12-005: Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program (U01).
  • May 25, 2012 - See Notice NOT-RM-12-024. Notice of Intent to Publish Human Heredity and Health in Africa (H3Africa): Collaborative Centers FOA.
  • November 16, 2011 - See Notice NOT-RM-12-006. Notice of Total Costs allowed.
  • October 14, 2011 - See Notice NOT-RM-12-002. The purpose of this Notice is to revise the wording of the following passages; Section IV, 2. Page Limitations, Section IV, 2. Administration and Management, Section IV, 2. Under Collaborations and Section I, Part 2.
  • 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-11-008

Companion FOA

RFA-RM-11-009, Human Heredity and Health in Africa (H3Africa): Research Grants (U01)
RFA-RM-11-010, Human Heredity and Health in Africa (H3Africa): Bioinformatics Network (U41)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.310, 93.172, 93.279, 93.853, 93.989 93.865

FOA Purpose

This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund (Common Fund) and participating NIH Institute(s) and Center(s), invites applications from foreign Institutions in African countries who wish to develop the study of genomic/genetic/environmental contributors of human health and disease within Africa, using cutting edge research tools to understand health and diseases affecting African populations more completely and increase capacity for biomedical research, in terms of building infrastructure (including data and research resources), genomic proficiency of researchers and numbers of trainees.  In partnership with the Wellcome Trust, the H3Africa initiative is focused on supporting these efforts as part of an effort to promote sustainable research in Africa that will promote health and combat disease.

The purpose of this FOA is to call for applications for research centers called H3Africa Collaborative Centers.  Awards will focus on supporting research on the genetic/environmental contributors to health and disease in Africa that fall within the mission of the NIH, which is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

Key Dates
Posted Date

August 23, 2011

Letter of Intent Due Date

September 30, 2011

Application Due Date(s)

December 2, 2011

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

February/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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

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 that accompany it. 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 is 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 are 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 (and a similar call for proposals from the Wellcome Trust http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm ) 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 interrelated, interdependent objectives.  The first is to increase the human resources for conducting cutting-edge genomics-based research in Africa through training 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 for research training and for the improvement of the research capacity of African laboratories where the research is carried out.  The third is to support the improvement of specific types of infrastructure, i.e., bioinformatics and biorepository capacity, which are needed to do genomics-based and environmental research.  To achieve these objectives, the H3Africa program at NIH will comprise the following:  Infrastructure improvement will be addressed by support for an H3Africa Bioinformatics Network (see companion FOA, RFA-RM-11-010) and for up to four planning grants for biorepositories in Africa (see companion FOA, RFA-RM-11-011).  It is anticipated that one or more full-scale H3Africa Biorepositories will be established in Africa after the planning grant/feasibility phase.  A companion FOA to this document (RFA-RM-11-009), “Human Heredity and Health in Africa (H3Africa): Research Projects” calls for genomic/genetic research applications from individual investigators who wish to add a genomics component to an existing disease-based research effort.  The current FOA calls for applications for the H3Africa Collaborative Centers, which should include opportunities for genomics/genetics /environmental research, research training, administrative training, and career support in a multi-institution collaboration .  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.

Research Objectives:

A. Scientific scope

The objective of this FOA is to solicit applications to establish H3Africa Collaborative Centers (H3ACC) to implement research projects that will apply genomic approaches to understand the genetic and environmental contributors to chronic and infectious diseases and health in Africa.  Each H3ACC will be composed of multiple projects that collaborate to provide the complete capacity needed to carry out a genomics-based research project on a disease or condition important to Africa.  The Centers will have a strong training and career development component and clear organizational and management structures. 

The scientific focus of applications responsive to this FOA will broadly be within the scope of human genetic/environmental contributors to disease and other health-related traits in Africa.  The following list provides examples of the types of topics that may be addressed.  It is important to note, however, that this list is meant only to provide guidance; it is not exhaustive and appropriate topics are not limited to the examples given here. 

While applications submitted in response to this FOA may propose research in any disease or health area that falls within the broad areas of genetic/environmental contributors to disease or health research, there are also specific areas of interest to the NIH components that are participating in H3Africa.  These include: 

Neurological disorders and stroke: Research in neurological projects that address the H3 goals are of interest.  Study designs may include a broad range of disciplines, such as molecular genetics, pharmacogenomics, epidemiology, stigma research, and intervention research.  Quality phenotyping is essential for genetic research; therefore, collection and analysis of genetic material from individuals participating in well characterized, neurological-based cohorts materials is of high interest, particularly in the the areas of stroke and stroke risk factors, epilepsy, and susceptibility to peripheral neuropathy due to infection or inflammation, as well as other neurological diseases and disorders.   Applications that enhance the NIH-funded Medical Education Partnership Initiative (MEPI) training experience are encouraged (http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-MEPI.aspx). Applications that use technologies such as mobile technologies that enhance health, knowledge, or care delivery of neurological disorders are also of interest.

B. Implementation of the objectives of H3Africa.

As noted in the Background section, there are several specific objectives that the H3Africa Program is trying to achieve.  Applications submitted in response to this FOA must address the following:

If the data are to be generated by the center itself, the applicant’s experience with the necessary technologies, the costs of generating the data, and the anticipated uses should be addressed.  The availability of samples and supplies should be discussed, as should any issues of long-term maintenance and servicing of the necessary equipment. 

Alternatively, the applicant may choose to send the samples elsewhere for data generation, for example to other research centers or to service providers.  Such an approach could be taken, for example, for genotyping, microarray analysis or sequencing. In either case, the data generator may be in Africa or overseas.  In describing this approach, the applicant should describe how the samples will be prepared for shipment to the data generator, the type of data expected, and how the data will be returned to the center for analysis.

The applicant should describe how the resultant data, whether produced in-house or obtained externally, will be analyzed, including a discussion of the applicant’s experience with the relevant analytical technologies and methods.

Sample collection and Human Subjects Issues.  The research plan must include a detailed plan for sample acquisition (where applicable), storage, preparation of material needed etc.   In particular, investigators are urged to obtain consent for the wide sharing of samples and data; justification should be provided if samples and data will not be shared or only shared in a limited manner.  A document entitled "Essential Elements of Informed Consent for H3Africa Research Projects" may be helpful to applicants in writing their informed consent documents; this can be found at http://www.h3africa.org/informedConsent.cfm.  A timeline for developing and implementing an informed consent process, including obtaining IRB approval, must be included in the application. 

H3Africa anticipates establishing a biorepository in Africa starting in 2014.  All samples (blood, DNA or cell lines) are expected to be deposited in the H3Africa Biorepository where they can be distributed and shared for further research consistent with achieving the goals of this funding initiative.  Sample deposition must occur expeditiously, no later than the date of the first publication that describes the samples or by the end of the project, whichever comes first.  A statement of commitment from the applicant institution to send samples to the H3Africa Biorepository must be included in the application, consistent with achieving the goals of the H3Africa initiative.  This should include a description of the host country’s policies for sending samples out of the country.

Collaboration.   Most of the collaborations in which African biomedical research scientists have been involved have been with scientists from abroad, rather than with other Africans. One of the goals of the H3Africa Initiative is to foster collaborations between and among investigators within Africa in order to build a larger African scientific community that will lead to more training opportunities and cutting-edge science on the continent.  Such collaborations will also contribute to sustainability of African genomics programs.  Therefore, applications submitted in response to this FOA will be required to be structured around significant collaborations with scientists at other institutions within the applicant’s home country or with scientists in other African counties.  One example of an acceptable collaboration would be one in which each aspect of the overall research program, such as sample acquisition, phenotyping, genomic data generation, data analysis, is done by a separate component.  Another example would be one in which a full genomic analysis is done at each collaborating component on a different sample population and the results combined for a comparative analysis.  These examples are only intended to be illustrative; the organization of the collaborative activities will be determined by the investigators involved and the applicants should propose the set of collaborations that would best achieve the proposed research objectives.  While international collaborations with scientists outside of Africa may be included, the majority of the collaborative activity should be within Africa.

All applications must include a description of the overall set of proposed collaborations, how each collaborative component will contribute to the functioning of the Collaborative Center, how the collaborating groups will communicate, and how the overall Collaborative Center will be managed with collaborations that are not on site.   If appropriate, one of the collaborating components can be a management core.

Training and Career Building. Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a critical objective of the H3Africa program. Therefore, the applications must include a component which may address either training, or career development, or both.

A well thought-out plan for the training and career building program, its applicability to the research and its long term contributions to the goals of H3Africa should be included.  Long-term sustainability and institutional/governmental commitments to the training program and the independent career positions established through the Centers should also be discussed. Applicants should note that the Medical Education Partnership Initiative (MEPI) is a sister initiative to H3Africa within the Common Fund's overall Global Health Program.  H3Africa applicants are encouraged to collaborate with MEPI grantees as part of their training program where possible, in order to take advantage of the training infrastructure and opportunities available through MEPI.

Bioinformatics.   The bioinformatics capacity of the Collaborative Center should be clearly described, both at the level of the overall center and at the level of each of the collaborating components.  Issues of data acquisition, data management, data storage, and analytical capability should be addressed.  The bioinformatics tools that will be used for each of those functions, and the applicant’s experience should be described in the application. These bioinformatics activities may be embedded within the individual research components or may appear as a separate bioinformatics core in the Center.  Additionally, a bioinformatics research component, for example new computational tool development, may be included within the research application as one of the collaborative aspects.

Please note the H3Africa Program will fund a separate H3Africa Bioinformatics Network (see companion FOA, RFA-RM-11-010) to provide connectivity among the H3Africa participants, and eventually beyond H3Africa.  The H3Africa Bioinformatics Network will also have the ability to develop new bioinformatics tools for genomics research in Africa.  The Collaborative Centers and any other H3Africa-funded activity will be required to interact with H3Africa Bioinformatics Network.  Therefore, applicants for a Collaborative Center award must include a statement from the applicant institution committing it to collaborating and sharing data with the H3Africa Bioinformatics Network consistent with achieving the goals of H3Africa.

A Collaborative Center and its host institution must have an effective administrative infrastructure.  It must also have the ability to provide effective administrative management and careful oversight of the award and, more generally, of the conduct and support of research.  Funds (up to $35,000 direct costs) must be requested within the Collaborative Center application to support a program of training in the NIH grant process. The funds will be used for a training program that will be administered in conjunction with the National Institute of Child Health and Development's International Extramural Associates Research Development Award program (see http://nichd.nih.gov/about/org/dsp).   The training component will support the following for a single individual from the applicant institution:  an initial orientation implemented through a distance learning component, and a two-week training curriculum on-site at the NIH (in Bethesda, MD, USA) for a single research administrator to learn about grants management, NIH policies and procedures, fiscal accountability and research.  Upon return to his or her home institution, that individual will be responsible for designing and implementing an Infrastructure Development Plan. The institution will be equally responsible for approving and carrying out the plan and for providing sustainable support for it as an ongoing institutional component.  The research administrator will use the funds set aside for this purpose from the Collaborative Center grant during the period of the grant to improve and reinforce the institution’s research capacity and research administration infrastructure (through the Office of Research or Office of Sponsored Projects), as outlined in the final, approved version of the Infrastructure Development Plan. 

If the institution’s administrative staff have already received such training or believe they have enough experience that they do not need this initial training, the application should provide information about the staff’s level of experience and previous training received, and should propose an administrative training program that is appropriate to their level of experience.  See Additional Instructions below for information about what must be included in the IEARD program request.

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.

In Summary: This FOA calls for applications for H3Africa Collaborative Centers to carry out the research goals of H3Africa, which include:

The scientific scope of the H3Africa Collaborative Centers is broad, and may address:

It is strongly suggested that applications will address the following:

Section II. Award Information
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

This initiative is supported by NIH Common Fund, Institute(s) and Center(s) and Offices of the NIH who have signed on to support the H3Africa initiative.  The amount of funding and the number of awards will rely upon the outcome of peer review, the interests of the NIH institutes, and the availability of funds.

The total amount of funds available for these awards is approximately $3.75 million per year for FY12-16, contingent upon receiving scientifically meritorious applications. Up to 3 awards are anticipated from this solicitation.

Award Budget

Applications are limited to $920,000 direct costs which includes salaries, supplies, training, equipment, travel, and other allowed expenses for research grants.  In order to address H3Africa's goals to build infrastructure each applicant may request up to an additonal $250,000 for equipment.  The request for equipment must be very well justified.  In subsequent years the research plan budget may not exceed $920,000 direct cots.  $35,000 direct costs/year must also be set aside for participation in the International Extramural Administrative Research Development Program component (see above) under Implementation of H3Africa Objectives section..

Award Project Period

Scope of the proposed project should determine the 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Specifically:

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 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.

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.

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/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 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).

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

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.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

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 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: Jane_Peterson@nih.gov

FedEx/UPS/Other Courier Delivery Address:

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

Application Submission

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, 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: rudy.pozzatti@nih.hhs.gov

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9306
Rockville, MD 20852

Page Limitations

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:

The research Strategy section for each component of the scientific of the collaborative center is limited to 12 pages in length.  If there is an administrave core, it is limited to 6 pages in length. 

Research Plan

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

The application must include a detailed research plan that is responsive to the objectives of the H3Africa program, as set forth in this FOA (see Research Objectives).  An H3Africa Collaborative Center must comprise at least three collaborating components that together address one or more of research areas, examples of which are given in the Research Scope section of this FOA.  At least one of the collaborating components must be outside of the applicant institution; bi- or multi-national collaborations are encouraged. 

The Adminstration and Management section should also include a description of the applicant institution's current capacity for administration of research grants, including information about the placement of the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) within the institution and its line of authority, the institutional provision of resources such as office space, administrator salary, office equipment and other in-kind activities, and the applicant institution's plans to support and sustain the research office. The application should also describe any plans the institution has for further development of its research administration program.  

The H3Africa Collaborative Center award will include $35,000 in funds per year to support such further development at the applicant institution.   It is expected that by the end of year -01 of the Collaborative Center award, one or more research administrators will have received training equivalent to that provided by the NICHD International Extramural Research Administration Development Award (IEARDA) program.  The purpose of the IEARDA program is to increase the knowledge and/or experience of research administrators with funding opportunities, grant applications, research program and project oversight, data management, fiscal accountability, and scientific reporting requirements of the NIH and other international research funding agencies, all of which will be important in the adminstration of the Collaborative Center award.  If at least one individual at the applicant institution who will have significant responsibility for the management of the Collaborative Center award has participated in the NICHD program, the application should document that and then describe the applicant institution's plans to use the specified funds to enhance and further strengthen its research administration activities.  If no individual at the applicant institution has yet received such training, the specified funds should be used to support an individual to participate in this program at the earliest possible offering after an award is made (the NICHD has agreed to accept one person from each awarded Collaborative Center into its training program).  NICHD will review the qualification of the person nominated before accepting him or her in the IEARDA program The application should thus identify the person or persons who will be responsible for administering the Collaborative Center award and a Biosketch should be provided for each.  The application should also include a brief, one to two page, description of the Center's and applicant institution's plans for the administration of the award (equivalent to the Institutional Development Plan of the IEARDA program).  Finally, the application should include a statement of support from the applicant institution that provides approval of the nominee’s IEARD training periods at home through the distance learning component and at the NIH for the NIH residency, and provides the release time for these periods and any financial support needed for training.  This statement of institutional support may be included in the required Letter of Institutional Support described in the Implementation of the Objectives of H3Africa section above.   More about this program can be found at http://www.H3Africa.org/IAERDinfo.cfm.

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:

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 Institutions

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

3. Submission Dates and Times

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.

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.

6. Other Submission Requirements and Information

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 responsiveness by components of participating organizations, 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  proposal writing and grants management 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 H3Africa_meeting@mail.nih.gov .  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 H3Africa_meeting@nih.mail.gov .  This will enable NIH to provide you with any updates or additional logistics about the meeting. 

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.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Collaborative Center (CC) 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 center proposed).

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 Collaborative Center  that by its nature is not innovative may be essential to advance a field.

Significance

Does the propsed Collaborative Center address an important problem or a critical barrier to progress in the field? If the aims of the Colllaborative Center 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? How will the goals of the proposed Collaborative Center address the goals of H3Africa? How will collaborations with other institutions both within and outside the country contribute to the success and sustainability of the program?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Collaborative Center? 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?  

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? How does the program promote and support “innovation” that will strengthen and sustain genomics research in Africa?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Collaborative Center? 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 Collaborative Center 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? Will the training program proposed be effective in addressing the training goals of H3Africa? Will the Center support the career building objectives of H3Africa? Are the bioinformatics data handling and analysis plans adequate to address the needs of the Center?   Is the proposed collaborative nature of the Center conducive to achieve the Center's goals?  Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project?  Has the issue of future sustainability been adequately addressed?

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 Center take advantage of resources available at the collaborating institutions?  Does the proposal identify and plan to take advantage of other resources at the participants' institutions, countries or other countries where necessary?   

Additional Review Criteria - Overall

As applicable for the Collaborative Center  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.

Center as an Integrated Effort – Overall Impact

Sustainability

Is the Center's plan for sustainability feasible? Will the Center 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 institutions suggest viable long-term 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 center 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

Additional Review Considerations - Overall

As applicable for the center 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:  Does the proposed data release plan constitute a good basis for negotiating a final data release plan?  Does the applicant indicate a willingness to accept the H3Africa's consensus Data Release policy?; 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.

2. Review and Selection Process

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:

Applications will be assigned to the appropriate NIH Institute or Center and 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. The following will be considered in making funding decisions:

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

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, CCR 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 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 recipient’s activities by involvement in and otherwise working jointly with the award recipient 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 awardee(s) for the project as a whole, although specific tasks and activities may be shared among the awardee(s) and the NIH as defined below.

Definitions

Steering Committee (SC):

The Steering Committee is the primary governing body of the Consortium.  PI(s)/PD(s) 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.  The PSC will be responsible for monitoring and assessing 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:

Awardee(s) will integrate with and connect to the H3Africa Bioinformatics Network (see FOA RFA-RM-11-010 and deposit samples in the H3Africa Biorepository that is anticipated to be [t1] established;

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

Areas of Joint Responsibility include:

Steering Committee participation.  A Steering Committee (H3ASC)will serve as the main governing board of the H3Africa Consortium.  The Steering Committee membership will include the NIH Project Scientist(s) and the P.I. of each awarded cooperative agreement.  The Steering Committee Chair will not be an NIH staff member but will be appointed by NIH 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 as a result of this FOA and of other H3Africa FOAs, it is possible that NIH H3Africa staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees funded as a result of a specific FOA.  

The Steering Committee will:

Each full member (limited to one person per awarded center, in the case of multiple PIs 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 make regular assessments and provide recommendations to the Directors of NIH funding components about progress of the H3Africa components toward the goals of the H3Africa program and about continued support of the components of the H3Africa Consortium.

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.

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

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: commons@od.nih.gov

Scientific/Research Contact(s)

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: Jane_Peterson@nih.gov

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: jrutter@nida.nih.gov

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: waddysp@mail.nih.gov

Peer Review Contact(s)

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: rudy.pozzatti@nih.hhs.gov

FedEx/UPS/Other Courier Delivery Address:

NIH/NHGRI/DER
5635 Fishers Lane, Suite 4076, MSC 9306
Rockville, MD 20852

Financial/Grants Management Contact(s)

Victoria Bishton
National Human Genome Research Institute
Telephone: 301.451.7928
Email: bishtonv@mail.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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