Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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 Health and Heredity in Africa (H3Africa): Research Grants (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • December 21, 2011 - This RFA has been reissued as RFA-RM-12-004.
  • October 14, 2011 - See Notice NOT-RM-12-003. The purpose of this Notice is to revise the wording of two passages; Part 2, Section I, Purpose and Part 2, Section I, Research Objectives.
  • 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-11-009

Companion FOA

RFA-RM-11-008, U54  Human Heredity and Health in Africa (H3Africa) Collaborative Centers
RFA-RM-11-010, U41 Human Health and Heredity in Africa (H3Africa) Bioinformatics Network

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

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 projects.  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

Open Date (Earliest Submission Date)

November 2, 2011

Letter of Intent Due Date

November 2, 2011

Application Due Date(s)

December 2, 2011, by 5:00 PM local time of applicant organization.

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 SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 applications from the Wellcome Trust) 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, career development, and through 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 http://grants.nih.gov/grants/guide/notice-files/NOT-RM-11-014.html ) and for biorepositories in Africa (see: http://grants.nih.gov/grants/guide/notice-files/NOT-RM-11-015.html).   It is anticipated that one or more full-scale H3Africa Biorepositories will be established in Africa after the planning grant/feasibility phase.   The current FOA is a call for applications from new or established genomicists who propose to establish a collaboration between their independently funded H3Africa genomics/genetics project and an ongoing, funded project that does not currently have a genomics focus. The ongoing project may be an NIH or other US government funded grant, cooperative agreement or contract, for example from the CDC, or may be an award from non-US government entities such as the Wellcome Trust, Doris Duke Charitable Foundation, The Bill and Melinda Gates, Foundation and others.  A companion FOA to this document (RFA-RM-11-008) calls for H3Africa Collaborative Centers for genomic/genetic research (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 also be a small grant program to support research on the societal implications of genomics in Africa; this program will be funded in FY13.  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 independent H3Africa Research Projects that will collaborate with ongoing grants, cooperative agreements, contracts, or awards from the U.S. government (USG) (e.g. CDC, DOD, HRSA, NIH, USAID, and others) or non-USG funders (e.g., Wellcome Trust, Doris Duke Charitable Foundation, The Bill & Melinda Gates Foundation, and others) to add a genomics-based approach to the study of a chronic or infectious disease to an on-going funded study that does not currently have a genetics component.  Applications must include a description of the currently funded project and should clearly describe how the proposed genomics research will complement the research already being done in that project.

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 certain specific areas of interest to the NIH components that have contributed funding to 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 are of high interest, particularly in 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 research project 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 a research center 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 research site 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.

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.  This should include a description of the host country’s policies for sending samples out of the country.

Bioinformatics.   The bioinformatics capacity of the research project should be clearly described.  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.

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 research projects and any other H3Africa-funded activity will be required to interact with H3Africa Bioinformatics Network.  Therefore, applicants for a research projects funded under this FOA 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.

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 research projects to carry out the research goals of H3Africa, which include:

The scientific scope of the H3Africa research projects is broad, and may address:

Applications should address the following:

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) 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) 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 $1.25 million per year for FY12-16 contingent upon receiving scientifically meritorious applications. Up to 4 awards are anticipated from this solicitation..

Award Budget

Applications are limited to $275,000 direct costs per year which includes salaries, supplies, training, equipment, travel, and other allowed expenses for research grants. 

Award Project Period

The 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:

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 SF 424 (R&R) 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 SF 424 (R&R) Application Guide.

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 may have recently completed postdoctoral training or may be an established investigator. In either case, the PD/PI must have established him/herself as an expert 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. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIIH 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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

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

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at {nakamurk@mail.nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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 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.  Updated information can also be found at http://H3Africa.org .

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

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project 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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the goals of the proposed research project address the goals of H3Africa?  Is the collaboration with the funded grants, cooperative agreements, contracts, or awards from the U.S. government (USG) (e.g. CDC, DOD, HRSA, NIH, USAID, and others) or non - USG funders (e.g. Wellcome Trust, Doris Duke Charitable Foundation, The Bill & Melinda Gates Foundation, and others) appropriate and will it further our knowledge on the larger research questions being addressed by both the funded project and the H3Africa-funded project?  

Investigator(s)    

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

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 project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project 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 evaluation plans, milestones and timelines proposed appropriate and adequate for the project?   How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

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 project take advantage of resources available within the associated funded project?  Do the letters of collaboration and institutional support show strong commitment to the project, and for new investigators, to the PD/PI?

Additional Review Criteria

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.

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 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

Additional Review Considerations

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 Africa 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by a Scientific Review Group(s) assembled by the NHGRI Review Office, 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. 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. 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 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.

Definitions

Steering Committee (SC):

The Steering Committee is the primary governing body of the H3 Africa Research Network.  PI(s)/PD(s) of grants, 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 Research Network. It will be responsible for reviewing and evaluating the progress of the H3Africa Research Network.  See more about the PSC below under this topic.

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

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:

The Steering Committee will:

The Panel of Scientific Consultants:

The NIH will convene an expert committee, termed the Panel of Scientific Consultants (PSC), to provide advice to the Directors of DPCPSI, NHGRI, FIC, NINDS, NIDA, and NICHD about the progress and achievements of the H3Africa Research Program.  The PSC members will be experts in genomics-based research and research in Africa, who are not associated with any of the funded H3Africa projects.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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

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, Ph.D.
Acting Director
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd, Room 4282
Bethesda MD  20892-9555
Ph: 301.435.0298
Email: jrutter@nida.nih.gov

Salina Waddy, M.D
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)

Rudy Pozzatti, Ph.D.
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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