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.)
Funding Opportunity Title	Human Heredity and Health in Africa (H3Africa): H3Africa Biorepository Grants. (UH2/UH3)
Activity Code	UH2/UH3 Phase Innovation Awards Cooperative Agreement
Announcement Type	Reissue of RFA-RM-12-003
Related Notices	June 27, 2018 - This RFA has been reissued as RFA-RM-18-020. NOT-RM-12-026 October 26, 2012 - See Notice NOT-OD-13-005. Notice of Change in Due Date.
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-008
Companion Funding Opportunity	RFA-RM-12-006, U54 Human Heredity and Health in Africa (H3Africa): Collaborative Centers Cooperative Agreements RFA-RM-12-007, U01 Human Heredity and Health in Africa (H3Africa) Research Projects Cooperative Agreements RFA-RM-11-010, U41 Human Heredity and Health in Africa (H3Africa): Bioinformatics Network Cooperative Agreements RFA-RM-12-005, U01 Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310, 93.172
Funding Opportunity 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 Institutions in African countries to develop an H3Africa Biorepository in order to provide an international site for the receipt, storage and distribution of samples from H3Africa research projects as well as other African research studies. The NIH is partnering with the Wellcome Trust to provide support for H3Africa, an initiative to enhance the development of sustainable research capacity in Africa that will use genomics as a part of a cutting-edge approach to promote health and combat disease. The purpose of this FOA is to call for applications for UH2/UH3 cooperative agreements that will provide funding to develop plans for an H3Africa Biorepository, building upon existing infrastructure. Applications should include plans for initial two-year UH2 Phase I studies (Phase I) as well as plans for an additional four years of support for implementing a full-scale H3Africa Biorepository (Phase II), beginning in 2014. The outcome of the UH2 Phase I studies will be fully developed plans for a full-scale H3Africa Biorepository, with evidence that the challenges enumerated below have been overcome. Feasibility testing/planning activities should include testing proposed logistical approaches, training, developing collaborations and otherwise assembling or planning for additional infrastructure that will be needed for a full-scale biorepository. The outcome of the Phase II scale-up period will be a fully operational biorepository that receives, processes, stores, and distributes samples for research in Africa, using state-of-the-art methods in accordance with international standards. Activities should include completion of infrastructure improvements, full-scale implementation of all study protocols and procedures for quality control/quality assurance, protection of human subjects and data/resource sharing, and collaboration with other H3Africa researchers.

Posted Date	August 22, 2012
Open Date (Earliest Submission Date)	September 28, 2012
Letter of Intent Due Date	September 28, 2012
Application Due Date(s)	(Extended to October 31, 2012 per NOT-OD-13-005), Originally October 29, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February/March, 2013
Advisory Council Review	May, 2013
Earliest Start Date(s)	August 1, 2013
Expiration Date	(Extended to November 1, 2012 per NOT-OD-13-005), Originally October 30, 2012
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.

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

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. As documented in a recent review of studies across the world, about 75% of the thousands of genetic studies completed to date 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/whitepaper.cfm) 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 first set of FOAs soliciting applications for H3Africa was published about one year ago (see Archive Funding Opportunities at https://commonfund.nih.gov/globalhealth/grants.aspx), and funding for the program will begin in the summer of 2012.

The research program described in this and previous FOAs 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 with national and international partners, particularly in other countries within Africa, but also in countries outside of the continent. The second is to support cutting-edge genomics/genetics 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 include a research component (RFA-RM-12-006 and RFA-RM-12-007), a bioinformatics network component (to be funded in Summer 2012), a biorepository component (this FOA) and a social issues component (RFA-RM-12-005). 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.

Scientific Scope

NIH is taking a two-stage, one-application approach to the development of biorepositories that will meet the H3Africa Research Consortium s sample storage and distribution needs. The first stage (Phase I) will provide up to two-year UH2 Phase I awards each funded at up to $125,000 total costs per year (depending on the number of awards made). During the UH2 period, the successful awardees will each: (a) create a plan for the organization and development of a full-scale repository, (b) formulate procedures and equipment needs, (c) train personnel, (d) identify and provide solutions for any logistical problems that can be foreseen and (e) within the limits of the Phase I budget, test and implement as many of the procedures as possible. The objective of the Phase I stage will be for the awardees to plan for and demonstrate their ability to fulfill the goal of implementing a full-scale biorepository in Phase II.

In the second stage (Phase II), the NIH plans to continue support to scale up two or three of the awards for a further four-year period. The Phase II stage will be funded at an increased level of up to $2 million total costs in FY15 and up to $1.7 million total costs per year in FY16-18, depending on the number of awards funded. In Stage II, the awardees will implement the plans they developed during Phase I to implement a full-scale biorepository. It is expected that each of the biorepositories will be operating at full scale by no later than the end of the second year of Phase II.

To meet the proposed schedule and to determine whether the questions of feasibility and capability have been adequately addressed, NIH will conduct an administrative review during the second year of the UH2 Phase I study period. Substantial progress will need to be demonstrated in order to be considered for scale-up to a Phase II award at the time of the administrative review that will be conducted by the H3Africa staff and NIH Advisory Councils, according to standard NIH processes for administrative reviews. The decisions about continued support for Phase II will be based on the accomplishments and progress made in Phase I, and the quality of the updated plans for fully implementing an international repository, which were developed in Phase I and incorporated into the year 2 progress report. Beyond attaining or exceeding the awardee’s stated milestones for the Phase I period, the successful Phase II continuations will be those that are judged to have produced data to demonstrate the feasibility of establishing and sustaining a biorepository at their site, have the most insight into and experience overcoming the challenges of sustaining a biorepository in Africa and have demonstrated a working relationship with the other H3 Africa Biorepository(ies) and H3Africa consortium projects.

While this FOA indicates that the UH2 Phase study will be followed by a UH3 Phase II scale-up after an administrative review, applicants should understand that the Phase II scale-up will occur only if the administrative review recommends that the Phase I effort has been successful and that the Phase II scale-up can proceed with relative confidence of success. The administrative review recommendations must be endorsed by an appropriate NIH Council before the Common Fund will release funds for the Phase II award.

Objectives

The purpose of this FOA is to solicit combined applications for the UH2 Phase I study and the UH3 Phase II scaled-up biorepository.

UH2 Phase I Study: The objectives of the H3Africa Biorepository initial two-year UH2 Phase I study are to develop a plan that will lay the foundation for establishing a biorepository to serve initially the H3Africa Consortium (see http://www.h3africa.org/) and to demonstrate the applicant’s ability to accomplish the activities that will be necessary for providing a full-scale H3Africa Biorepository in the UH3 Phase II.

The grant application should include a description of the following for UH2 Phase I:

• the vision for the full-scale (Phase II) biorepository, in terms of the services that will be provided and the infrastructure and capabilities that will be necessary to provide them, that the applicant will be working toward during Phase I;
• how the applicant plans to utilize and improve the existing infrastructure at the institution, in terms of facilities, equipment, software, personnel, and scientific networking, as well as institutional and national commitment to the biorepository;
• how the expertise for development of sample receipt, handling, storage and distribution to the investigators within the H3Africa Consortium will be accomplished;
• the problems and obstacles that are anticipated in order to meet the challenge of serving as a biorepository to multiple investigators from multiple institutions in multiple African nations within the H3Africa Consortium, and how the applicant will create or take advantage of forward-looking solutions to solve those problems and overcome those obstacles;
• the plan during the Phase I period to test or demonstrate the validity of the proposed approaches, e.g., receipt and distribution of samples within Africa, and;
• the training in biorepository management and sciences to meet the needs of the full-scale H3Africa Biorepository, and subsequently enhance the expertise of African scientists in the field of genomics and/or laboratory science.

UH3 Phase II Scale-up: For Phase II, the grant application should address how the implementation of the biorepository will build on the plan and data generated during Phase I; and how the services of the biorepository may eventually be expanded (although not necessarily within the six-year period of this award; see Sustainability section) beyond the H3Africa investigators to investigators elsewhere in Africa and abroad.

In summary:

This FOA calls for applications to propose a two-stage plan for an H3Africa Biorepository, including a two-year UH2 Phase I study to develop a plan that will lay the foundation of an H3Africa Biorepository, and a Phase II plan to implement a scaled-up biorepository that will serve the needs of the H3Africa Consortium. (see http://www.h3africa.org/).

The objectives of the Phase I and II H3Africa Biorepository application should describe:

• the plan for the full-scale biorepository that the applicant will be working toward;
• how the applicant plans to utilize and improve the existing infrastructure;
• the development of expert services for staffing the repository;
• solutions to anticipated problems and obstacles in order to build a repository in Africa;
• efforts during the UH2 study phase to test or demonstrate the validity of the proposed approaches;
• staff training in biorepository management and science to meet the needs of biorepository.

In the UH3 stage of the award, the successful project(s) will apply the proposed credible biorepository plan, approaches and tools from the UH2 Phase I to the UH3 Phase II scale up. The criteria that will be used to determine which of the Phase I projects will be continued into Phase II will include:

• Successful achievement of the defined milestones for the Phase I period of the project
• Potential for meeting the goals of the initiative to establish a large-scale H3Africa Biorepository
• Concrete and encouraging results and accomplishments of the feasibility activities in Phase I
• The availability of funds
• H3Africa program priorities and balance

The H3Africa Biorepository application must clearly describe the objectives and plans for both the two-year Phase I (supported by the UH2 mechanism, 12 page Research Strategy) and the four-year biorepository scale-up Phase II (supported by the continuation UH3 mechanism, 12 page Research Strategy).

Funding Instrument	Cooperative Agreement
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIH Common Fund intends to commit for the UH2 (Phase I) period an estimated total of $400,000 over two years for 1 to 2 UH2 grants. For the UH3 (Phase II), up to $16 million total costs for four years beyond the UH2 Phase I phase will be available to support up to three full-scale biorepositories. Funding per year will vary depending upon the number of biorepositories funded. .
Award Budget	Up to $125,000 total costs per year for the first two years, is allowed for Phase I. If only one Phase I grant is awarded, the award will be adjusted. For the Phase II period the budget is limited to $2 million total costs in FY15 and $1.7 million total costs in FY16-18. The Phase II budget should be for four years total. As in the Phase I grant, the amount per award per year will be adjusted depending on the number of Phase II applications awarded. A six year budget that includes both phase I and phase II is required for the application.
Award Project Period	The maximum period of funding for the entire UH/UH3 application is six years.

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

• Non-domestic (non-U.S.) Entities (Foreign Institutions). Specifically:
• African institutions are eligible for the awards:
• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

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.

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

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 4-6 weeks prior to the application due date.

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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.

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

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

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

The letter of intent should be sent to:

Louise Wideroff, Ph.D., MSPH
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Boulevard, MSC 9555
Bethesda, MD 20892-9555
Phone: 301 451 8663
Fax: 301 594 6043
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

NIH/NIDA/DBNBR
6001 Executive Boulevard, Room 4271, MSC 9555
Rockville, MD 20852

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

FedEx/UPS/Other Courier Delivery Address:

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

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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• The Research Strategy for the UH2 (Phase I) is limited to 12 pages.
• The Research Strategy for the UH3 (Phase II) is limited to 12 pages.

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

The H3Africa Biorepository UH2/UH3 application must be submitted as a single application and should be clearly organized into two phases: (UH2 (Phase I) and UH3 (Phase II)). To clearly distinguish between the two phases, applicants should specify separate UH2 and UH3 research strategies in the Research Plan of the PHS 398, which allows up to 12 separate pages for each phase.

In preparing the application, investigators should consider the fact that applications will be assigned a single impact/priority score for both UH2 and UH3 phases. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of milestones are critical. Milestones should be sufficiently scientifically rigorous to be valid for assessing progress in the UH2 phase, and will reflect the scientific judgment and experience of the applicant.

PHS 398 Research Plan: For applications submitted for this FOA, the following should be included:

Introduction (resubmissions only): The Research Plan must include an introduction to the Application for resubmitted applications only. The introduction is an opportunity for the PI who has revised and is resubmitting an application to address the comments from the initial review of the previous application. It is limited to one page. New applications should not include an introduction. For more information, see specific instructions in PHS 398.

Specific Aims: Applicants should address the scientific questions to be answered, what specifically will be done during the proposed funding periods, and how the proposed research is relevant to the mission of a participating NIH IC. Specific aims should be scientifically appropriate for the relevant phases of the project. 1 page is allowed for the specific aims.

The Research Strategy: For Phase I (first 12 pages), the Research Strategy Section should describe in detail how the applicant will use the initial two-year feasibility period to lay the foundation for a fully functional, scaled-up biorepository in the most useful, forward-looking way possible. For Phase II (second 12 pages), the Research Strategy Section must include description of how the biorepository will be further developed in Phase II based on the Phase I plan and feasibility data generated during Phase I.

The Research Strategy for the UH2 and UH3 should be broken down in to Significance, Innovation and Approach. The description of these three elements of the Research Strategy will differ in the UH2 and the UH3. Applicants should pay attention to how the information requested below applies to the pilot project (UH2) vs. the scaled up project (UH3).

Significance: This section should describe why building an international biorepository in Africa is important for improving African health. It can also note how the benefits will extend to improved health outcomes elsewhere in the world, particularly in the US. The PD/PI should discuss the barriers to success in both phases of the project, how this study will address the problems and what new improvements in African genomic research, health care, therapies or technical capabilities might be expected if the biorepository is successful.

Innovation: This section of the Research Strategy should address what innovative solutions are being proposed to meet the special challenges of establishing an international biorepository in Africa. Describe what novel concepts, approaches and technologies will be employed to meet the challenges of successfully establishing an African biorepository capable of receiving samples from other African nations and preparing and sending samples to other nations, both on the African continent and beyond. Importantly, the applicant should describe how success in this project will improve the African biorepository service in general and promote the field of genomics in Africa.

Approach: This section of the research should describe the overall strategy and methodologies that will be used to accomplish the specific aims of the project.

For Phase I, the application should describe in detail how the applicant will use the initial two-year feasibility period to lay the foundation for a fully functional, scaled-up biorepository in the most useful, forward-looking way possible. For Phase II, the application must describe how the biorepository will be further developed based on the Phase I plan and feasibility data generated during Phase I. In each section of the application, the following topics must be addressed for both phases. It is important to note that this list is not exhaustive, and applicants should identify and address any other topics that they think should be included in the UH2 Phase I study process, particularly potential barriers, in addition to those identified below, that they believe need to be addressed in order to establish a successful, sustainable biorepository in Africa.

Note: Helpful information about best practices for biorepositories can be found at http://www.isber.org/bp/index.cfm, and a set of industry standards that will help repository applicants evaluate their adherence to the best practices can be found here.

Infrastructure: The types of information that should be addressed include the plans for building on the institution’s existing infrastructure to establish adequate:

• Biorepository capacity. The H3Africa Biorepository(ies) that will be supported in Phase II are intended to meet the needs of the entire H3Africa Consortium, i.e. the research projects supported by both the NIH and Wellcome Trust partners, as well as any other partners that may join the Consortium during the project period. It is expected that the Phase II biorepository(ies) will deal with as many as 100,000 samples per year including blood and DNA in liquid, frozen or dry form. The applicant must provide a plan for how the biorepository will ramp up its abilities to receive, store and distribute samples during Phase II, based on the success of demonstrating this ability in Phase I;
• Biorepository infrastructure, including the following:
  • dedicated space;
  • room details, including size, ventilation, access, ambient temperature, and keeping the space free of outside dust, dirt, and living organisms;
  • maintenance, including heating, air conditioning, water purification systems and any other specialized electrical or mechanical services required;
  • electrical set-up, including voltage, surge-protection, and back-up requirements;
  • any specialized rooms, and;
  • routine pesticide use, if applicable;
  • equipment and software. The description of existing institutional infrastructure must be provided in the Resources section of the grant application;
  • capacity for storage, maintenance, quality control, and distribution of samples based upon the informed consent and policy of the H3Africa Consortium, which will be developed by the entire H3Africa Consortium;
  • equipment, including but not limited to, mechanical and nitrogen vapor freezers, liquid nitrogen tanks, laminar flow hoods, incubators, and specialized equipment needed to isolate or aliquot DNA;
  • computers, including up-to-date, appropriate software maintenance and service of equipment and computers, and;
  • back-up plans to ensure continued biorepository function at all times.

Infrastructure Improvement: As described, the Phase I UH2 portion of the application should focus on the plan to improve the institution’s existing biorepository capability to the level needed to meet the needs of the H3Africa Consortium. The Phase II part of the application should provide additional information as to how that plan will be put into practice to make additional improvements to the infrastructure so that within the first two years of Phase II, the repository will be fully functional. The applic ation may include requests to purchase new equipment within either phase of the award. Adequate justification should be provided for any requested equipment. Funds for new buildings are not permitted in this application. Note: Foreign grantees are limited to 500K or less in the Alterations & Renovations category: http://grants.nih.gov/grants/foreign/budgets.htm?print=yes&

Biorepository Operations:

Biospecimen processing and storage methods: The application should describe all of the operational aspects of an H3Africa Biorepository and how the plans for designing, testing, and carrying out the operations will become routine in Phase II. It should describe, which (if any) of those biorepository operations are already in place at the institution. This section should begin with a description of the overall flow of samples into and out from the repository. Additional details should be provided for:

• robust methods for sample receipt;
• robust methods for sample processing and storage;
• robust methods for sample distribution.

In each case, the applicant should discuss how the methods of choice will be determined, any innovations planned, and how the methods or new approaches will be tested (including any plans to test certain methods during the two-year Phase I period). The processing and storage methods must be consistent with the end use expected for the sample, for example DNA sequencing or genotyping. The applicant should describe how each method compares with industry standards (http://www.isber.org/bp/index.cfm). Methods may include, but are not limited to, separation of blood lymphocytes for making cell lines as needed, extraction of DNA from isolated blood cells or other tissue, aliquoting, cryopreservation, dry storage, etc. The applicant should describe how specimens will be aliquotted and/or formatted prior to storage or shipment. In addition, the applicant should comment on how the collection methods and pre-processing services at the collection site, if any, will be monitored to ensure that specimens reaching the H3Africa Biorepository are not compromised.

Sample transfer among African countries is an aspect of this effort that may be particularly challenging. A well thought-out plan and tests for specimen transfer should be described. Issues that should be discussed include standardization of collection and shipping procedures, shipping across international borders (including rules for samples entering the country where the biorepository is located, rules for samples entering countries where samples may be shipped, customs requirements and procedures, and any other issues identified by the applicant). How will timely and cost-effective shipping of biospecimens be assured to sites with varying requirements? How will biospecimens be packed shipped, received, and tracked to numerous individuals or centers? How will shipped samples be tracked and an audit trail documented?

The application should describe any experience that the applicant has in transferring materials to other countries, either in Africa or elsewhere, as well as any efforts that will be made during the UH2 Phase I study period to develop and test components of the shipping procedures and to demonstrate that the plans set forth for biospecimen transfer will actually work for samples sent to and received from other countries in Africa. Documentation of these should be provided.

Quality Control and Assurance: Quality control and assurance procedures will be critical for a biorepository to provide high quality services and to ensure the continuous integrity, authenticity, and sterility for each sample. Therefore, a critical part of the UH2 Phase I study process is to propose and test a robust quality control and assurance plan. A description of the following should be included in Phase I and II:

• plans to test and monitor the collection method and pre-processing services at the collection site (if any) to ensure that specimens reaching the H3Africa Biorepository are not compromised;
• plans for and tests of quality processing, storage and distribution methods;
• methods for rapid and accurate retrieval of samples;
• a plan as to how samples will be tested for end-process suitability;
• planned systems and tests for notifying staff of an equipment failure and corrective actions;
• plans as to how the biorepository will test and ensure the continuous integrity, authenticity, and sterility for each sample type needed for a world class Biorepository including but not limited to barcode labeling, DNA fingerprinting, etc.

Bioinformatics: An essential part of the biorepository plan will be the plans for software and database support for the biorepository. The current and planned bioinformatics capacity of the biorepository should be clearly described, both at the level of the overall program and at the level of each functioning component of the repository. Issues of data acquisition, data management, data storage, database security and analytical capability, both current and planned should be addressed. The choice of sample management database should be described and justified. The bioinformatics tools that will be used for each of these functions, and the applicant’s experience and plans to receive more training for the repository staff with these tools, if needed, should be described in the application. Additionally, current or planned backup systems for recovery in case of electrical failure should be discussed. Finally, the issues of communication and consistency with the H3Africa Bioinformatics Network should be discussed.

In phase II, NIH anticipates there will be a need for a common H3Africa Biorepository website to provide information about the H3Africa Biorepositories and to present a single catalog of available resources for users. While it is difficult to make specific plans for interacting with other biorepositories without knowledge of what those repositories are, the application should include ideas about the issues that will be faced in establishing a common H3Africa Biorepository website and the applicant s willingness to participate in its development. The applicant should describe his/her preference for a website design; a common design will be agreed to by the Phase II awardees if the Phase II funds are awarded. Individual biorepositories may also maintain their own individual websites if desired, but will not be required to do so once the existence of a common website has been established.

Human subjects protection: The application for the Phase I award should include a discussion of any issues involving human research participants that the biorepository will need to address, and how the biorepository will address those issues. See section V1 for further instructions on Protection of Human Subjects. Applicants should be sure to address the issue of consent for the samples that are received and data/sample securing procedures and procedures for data sharing.

Training: A key objective of the H3Africa program is to help support the ability of the next generation of African researchers to take advantage of genomic approaches to health research. Therefore, the application must include in both Phases I and II a component for training in biospecimen handling and processing and other biorepository skills, although smaller budgets in Phase I will limit training activities during that phase. The training elements can include:

Training in biorepository skills at all levels i.e., technical staff, research scientists, and database developers/ managers; and provision of opportunities for career and leadership development for biorepository personnel.

Collaborative and consistent procedures: As already noted, the NIH intends to fund up to four Phase I awards and, in phase II, up to three full-scale biorepositories. In Phase I, the funded biorepositories will be required to work together in pilot projects to harmonize their activities and their services so that users will have more than one world-class biorepository to work with in Africa, but will not encounter significantly different procedures and policies at each biorepository when they submit or request samples. The Phase I component of the application, therefore, must discuss the applicant’s willingness to participate in such a collaborative system and how the applicant will approach the objective of establishing such interactivity and harmonization such as collaborating on the development of Standard Operating Procedures for all H3Africa Biorepositories in Phase II. To this end, evidence of success in this kind of collaboration during the UH2 Phase I study phase will be considered at the administrative review.

Sustainability: One of the major goals of the H3Africa program is to establish world-class biorepositories in Africa that will in turn, help to enable African scientists to excel in their research. While it may be premature to expect that applicants will be able to develop concrete plans for sustaining the biorepository activity six years in advance (the two-year UH2 Phase I study period plus the four-year Phase II scale-up period), applicants should discuss the issue of future sustainability of the envisioned biorepository, its capacity to sustain itself on the continent beyond the H3Africa funding program, and if appropriate, the ability to eventually provide biorepository services beyond the H3Africa program. Sustainability should be discussed in the Plan section of the application along with the other topics listed here. The discussion of sustainability should be compatible with the letters of institutional and national commitments (see below) in providing an overview of the long-term prospects for a sustained biorepository activity. In addition to institutional commitment, sustainability issues that should be considered, include but are not limited to, potential future income from fee for services, availability of funds from other sources, equipment replacement/modernization, continuous access to space, essential supplies, services, and stability of the positions for trained personnel.

Data Sharing and Release plan: A plan for data and resource sharing and release is expected for all NIH applications (http://grants.nih.gov/grants/policy/data_sharing/), and an applicant must have submitted an acceptable Data and Resource Sharing and Release plan before it can be funded. Thus, in addition to a well thought-out plan for distributing the resources received at the biorepository, the application is expected to include a plan for widely sharing the data that accompany those resources. After all H3Africa awards have been made, the H3Africa Consortium (see below) will develop a unified policy for data and resource release, and the application must include a statement that the investigators will abide by the Consortium’s data and resource policy, consistent with the relevant NIH policies, laws and regulations. Examples of current data release guidelines under the H3Africa Initiative for NIH programs can be found at: http://www.h3africa.org/dataReleasePolicy.cfm.

Administration: The application for the UH2 Phase I study award must discuss the management plan for Phase I and how it will be scale up for Phase II, the administrative and management issues that the full-scale biorepository will face, and the proposed plan must include a strong management plan for Phase II. For example, the plan should include how the institution will manage the NIH funds, what administrative staff are needed to ensure smooth management of the grant expenditures and accountability and what experience or training the existing staff may have had for these duties.

H3Africa Consortium Meetings: The NIH and the Wellcome Trust plan to hold two H3Africa Consortium meetings per year, and applicants should request funds to travel to these meetings in their application. Most of the meetings will be held in Africa. However, in 2015 one of the Consortium meetings will be held in Bethesda, Maryland and in 2016 one meeting will be held in London, UK. The UH2 Phase I study application may include a request for funds to support the travel of up to two biorepository personnel to each of the meetings that will be held during both the Phase I and II periods. For the meeting in Bethesda, funds for the travel of the Program Director/Principal Investigator (PD/PI) and two trainees may be requested.

Monitoring and Evaluation Plan: Applications for the UH2 Phase I study award should include a discussion of how the funds and supported activities will be monitored and evaluated, specifically for the UH2 Phase I and more generally for the scaled-up Phase II biorepository. The application should include a well-defined set of milestones for every six months of Phase I as well as annual milestones for the four years of UH3 Phase II, although it is understood that any timelines and milestones for the full-scale biorepository that are proposed in the application will evolve as the awardee makes progress during the feasibility phase. A discussion of the implications of successful accomplishment of the Phase I goals for the proposed UH3 Phase II study should be included.

The milestones in the latter years must be clear and may be changed as the project proceeds. These milestones allow the NIH staff and its consultants to follow the grant’s progress. The milestones for the entire six years of support will be negotiated and finalized at the time of award, and will then be included in the Terms and Conditions of the award. The milestones will be subject to change only with the NIH Program Director’s agreement, but will be reconsidered on an annual basis to account for the project’s experience and progress. An example of the level of detail and specificity needed for milestones can be found in an example set of acceptable milestones from past genomics projects, posted at http://www.h3africa.org/genomicsProjectMilestones.cfm. The milestones for the latter years of Phase II should be more general than those given at this site.

Institutional and National Commitments: Applications should include letters from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent from the institution) stating its commitment to the proposed project and its sustainability. The institution should also indicate its commitment to overcoming any administrative obstacles to the implementation of the proposed UH2 Phase I study activities and the Phase II activities. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program. The letter should also briefly state its commitment to participate as a member of the H3Africa Bioinformatics Consortium (RFA-RM-11-010) and discuss the institution's plans for sustaining the Biorepository.

As the programmatic activities of this initiative will support an important international resource if the applicant is successful in competing for the full-scale repository, letters of support from the relevant national ministries, for example the Ministry of Science, Ministry of Health and/or Ministry of Education; Medical Council; or appropriate government official for the host country will be required. The letter should briefly describe the national policy concerning the development of national scientific resources 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). Letters should also describe their commitment toward sustaining this international resource. It is highly recommended that these letters of support be included with the application; if the letters are submitted later, this could affect and delay the review of the application. An award will not be made without receipt of these letters of support.

The overall H3Africa Biorepository application must describe Phase I and II plans for:

• Infrastructure
• Infrastructure improvement
• Operations
• Bioinformatics
• Human Subjects protection
• Training
• Collaborative and Consistent procedures
• Sustainability
• Data Sharing and Release
• Administration
• H3Africa Consortium meetings
• Monitoring and Evaluation
• International and National Commitments

Budget: Please note that a 6 year budget is required for the entire application; this is made up of the Phase I (UH2, 2 years) and Phase II (UH3, 4 years) budgets.

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:

• In addition to the proposal for distributing biospecimens that is presented in the application, applicants are also expected to include a plan for sharing the data that will have been submitted along with the biospecimens, consistent with achieving the goals of the H3Africa initiative. Such plans must be approved by H3Africa program staff before the application can be funded. See http://www.h3africa.org/dataReleasePolicy.cfm for examples of data sharing plans under the H3Africa Initiative for NIH programs. Subsequently, the final, uniform H3Africa policies for resource and data sharing will be determined by the Steering Committee (see below) once all the awards have been made. The applicant should also state his/her willingness to adhere to the final H3Africa Consortium policies on resource and data sharing, once they have been determined, consistent with NIH policies, laws and regulations.

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 (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.

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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be 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(s)/PI(s) 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 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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

• Letters of support from the relevant national ministries, for example the Ministry of Science, Ministry of Health and/or Ministry of Education; Medical Council; or appropriate government official for the host country should be submitted with the application but may also be submitted post application.

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.

For this particular announcement, note the following:

The H3Africa UH2/UH3 Biorepository program aims to support an initial UH2 phase I and a follow-on four-year UH3 scaled up biorepository phase. Accordingly, the reviewers will evaluate the likelihood that the application's plan and proposed activities for the UH2 phase I will build the necessary foundation to launch a full-scale biorepository in two years time.

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).

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? Specifically, will the proposed biorepository be an effective contribution to African investigators genomic research efforts across the entire continent?

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application propose forward looking and innovative ways to address the special challenges that a biorepository in Africa may face? Does the applicant propose creative networking solutions to solve problems that may face establishment of a biorepository network?

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?

Does the application propose, in the African context, plans, including alternative strategies when needed, that make it likely that the applicant can succeed in establishing a full-scale biorepository in the next phase? Are the proposed milestones adequate for measuring progress during the UH2 Phase I and are the high level UH3 Phase II scaled up biorepository milestones appropriate for the next phase of the project?

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? Do the existing infrastructure, personnel, and current standard procedures described support the likelihood that the UH2 Phase I grant will lead successfully to a UH3 Phase II scaled up repository?

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 and compatible with the H3Africa goal of fostering research within Africa?

Will the Center and/or its components be well-positioned to obtain the funding necessary for continued activity at the end of six years of support?

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines 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 or Board.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• The plan to demonstrate that sample flow into and out of the biorepository and host country is feasible.

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

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

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

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

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

Panel of Scientific Consultants (PSC):

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

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

• All aspects of the proposed activities, including any modification of Network design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.
• Awardees agree to the governance of the Consortium through the Steering Committee and recommendations from the Panel of Scientific Consultants.
• Awardee(s) will agree to accept close coordination, cooperation, and participation of NIH H3Africa staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Awardee(s) will provide goals and reports of progress toward those goals at regular intervals as requested by H3Africa staff and ensure that the data produced meet the quality standards agreed to at the beginning of the project by the H3Africa Consortium;
• Awardee(s) will ensure that the data are deposited in the appropriate public database (e.g., GenBank or other, as specified by H3Africa program staff), that resources developed as part of this project are made publicly available according to H3Africa policies, and that results are published in a timely manner;
• Awardee(s) will adhere to the H3Africa policies regarding intellectual property, data and resource release and other policies that might be established during the course of this activity that are consistent with applicable NIH policies, laws, and regulations;
• Awardee(s) will integrate with and connect to the H3Africa Bioinformatics Network (see FOA RFA-RM-11-010, U41) and deposit samples in the H3Africa Biorepository that is anticipated to be established;
• Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

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

Areas of Joint Responsibility include:

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

The Steering Committee will:

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

The Independent Experts Committee (IEC):

The IEC will make regular assessments and provide recommendations to the Directors of NIH funding components and the Director of DPCPSI about progress of the H3Africa components toward the goals of the H3Africa program and about continued support of the components of the H3Africa Consortium.

• The IEC will meet at least once a year. During part of this meeting, there will be a joint meeting with the H3Africa Steering Committee to allow the IEC members to interact directly with the awardees.
• Annually, the IECs will provide assessments regarding the progress of the H3Africa Consortium and of the individual components and, as necessary, will present recommendations regarding any changes that may be necessary in the H3AFrica program to the Directors of the NIH funding components.

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 awardees' right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

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

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

Jane L. Peterson, Ph.D.
National Human Genome Research Institute
National Institutes of Health
Phone: 301-496-7531
Fax: 301-480-2770
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

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

Dr. Rudy Pozzatti, Ph.D.
National Human Genome Research Institute
National Institutes of Health
Phone: 301-402-8739
Fax: 301-435-1580
Email: [email protected]

FedEx/UPS/Other Courier Delivery Address:

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

Ms. Victoria Bishton
National Human Genome Research Institute
National Institutes of Health
Phone: 301-451-7928
Email: [email protected]

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

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