Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is a Common Fund initiative ( through the NIH Office of the Director, Office of Strategic Coordination ( All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by National Human Genome Research Institute (NHGRI) ( on behalf of the NIH.

Funding Opportunity Title
Limited Competition: Human Heredity and Health in Africa Consortium Biorepository (U24 Clinical Trial Not Allowed)
Activity Code
U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type
Reissue of RFA-RM-12-008
Related Notices
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose

The purpose of this FOA is to call for U24 cooperative agreement applications that will request funding to further develop and sustain up to three H3Africa Biorepositories, building upon existing infrastructure. The H3Africa Biorepositories will continue to have the responsibility of maintaining state of the art methods and technologies for DNA collection, processing, quality control, handling, management, and storage and of providing support services needed for bio-specimen collection and dissemination in Africa. They may also propose collection and handling of specimen types including but not limited to PBMCs, plasma, serum etc. Biorepositories will coordinate closely with H3Africa research projects and the H3Africa Bioinformatics network (H3ABioNet) to ensure responsible stewardship of high quality biological specimens linked to well-curated phenotypic and genomic data.

Key Dates

Posted Date
June 27, 2018
Open Date (Earliest Submission Date)
September 3, 2018
Letter of Intent Due Date(s)
30 days prior to the application due date.
Application Due Date(s)
October 3, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review
December 2018
Advisory Council Review
January 2019
Earliest Start Date

July 2019

Expiration Date
October 4, 2018
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description


In 2012, the NIH in partnership with the Wellcome Trust, and with advice from the African Society of Human Genetics, initiated the Human Heredity and Health in Africa Program (H3Africa). At the NIH, H3Africa is a component of the NIH Common Fund’s Global Health Initiative, and several Institutes and Centers have joined the Common Fund to support it. Recognizing that African researchers and populations have been, and still are, substantially underrepresented in genomics and environmental research and disproportionately affected by some environmental exposures, H3Africa is designed to provide new opportunities to African scientists to lead research on the genetic and environmental contributors to health and disease issues of importance to Africa through the use of genomics and other cutting-edge approaches. In this document, the term genomics and other cutting-edge approaches is used broadly and is intended to include approaches such as genetic epidemiology, phenotyping, biomarker development, pre-clinical research including the use of model organisms, and research on clinical utility, among others. The term "environmental contributors" is also used broadly and includes physical, chemical, biological, behavioral, and social environmental factors, among others. For further background on the origin and development of H3Africa, see the article Research Capacity: Enabling the Genomic Revolution in Africa Science (2014) 344: 1346-1348, and the H3Africa web site

In order to enhance the capacity for genomics and environmental health research, in Africa by African scientists, and to understand the genetic and environmental factors that determine disease susceptibility, H3Africa has three interrelated, interdependent objectives:

  • To support human genomics and genetics research that will not only generate important findings and discoveries relevant to human health, but will also serve as a vehicle to improve the research capacity of African laboratories and provide research opportunities for young scientists at the institutions where the research is carried out.
  • To expand expertise and experience in genomics-based biomedical research and environmental epidemiology in Africa through research experience, skills development, and enhanced collaborations with regional, national, and international partners.
  • To improve infrastructure including bioinformatics and biorepository capacity needed to support genomics-based and environmental research and associated data and sample sharing.

The H3Africa program is an initiative of the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. Investigators are invited to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. Common Fund programs are limited to a maximum of 10 (ten) years in length. The NIH H3Africa program will end in 2021; therefore, activities proposed in applications submitted in response to this FOA should (a) be framed in terms of what can realistically be accomplished in the remaining three years of the program (2019 2021) and (b) discuss how activities will be sustained after 2021, when Common Fund support for the program ends.

Investigators funded by the H3Africa program operate as a highly collaborative Research Consortium. The Research Consortium meets regularly in person and by teleconference. The H3Africa Consortium has developed a number of overall policies and guidelines (see These policies will be referred to at appropriate places in this document and all applicants are expected to recognize and adopt these policies (or else provide justification why a particular policy cannot be followed).

Purpose and Objectives

This Funding Opportunity Announcement (FOA) is soliciting applications for continued operations and capacity building of currently funded biobanks that are part of the H3Africa Biorepository Program (U24). It is expected that applicants will leverage and build upon their existing infrastructure to support multiple aspects of the scientific research outlined above. The H3Africa Biorepositories will continue to maintain state of the art methods and technologies for DNA and other specimen collection. They will provide processing, quality control, handling, management, storage, and support services needed for bio-specimen collection and dissemination in Africa. They must also coordinate closely with H3Africa research projects and the H3Africa Bioinformatics network (H3ABioNet) to ensure responsible stewardship of high quality biological specimens linked to well curated phenotypic and genomic data. The applicants should propose plans to establish new partnerships and capabilities, expand to serve entities beyond H3Africa, and transition to a self-sustaining model of operations by the end of the three-year period of funding provided by this FOA.

Applicants should propose a plan that clearly outlines how they will address:

1. The DNA sample storage and dissemination needs of the H3Africa consortium.

2. Capacity for other sample processing, storage and dissemination.

3. Shipping, storage, and quality control.

4. Responsible stewardship of additional samples types including samples for both genomic and environmental measures.

5. The biorepository needs of the local scientific community.

6. The specific challenges facing biobanking in Africa.

7. A business plan for continued operation beyond H3Africa support including the monitoring of local and regional research priorities and potential for development of services and capacity to support them.

Specific Areas of Research Interest

Responsible stewardship, tracking, and storage of samples are the primary responsibility of all Biorepositories and all practices and procedures of the H3Africa Biorepositories must meet International Society for Biological and Environmental Repositories (ISBER) standards. While all H3Africa Biorepositories are required to have and maintain expertise in the storage and handling of DNA samples, successful long-term planning will include moving beyond DNA storage. Biorepositories may propose to establish additional nucleic acid capabilities including extraction, genotyping, handling and storage of RNA, etc. H3Africa Biorepositories should also consider expanding to include storage of additional samples types such as blood or blood spots, serum, and urine; in storage of these types of samples, consideration should be given to downstream applications including analyses of environmental exposures. Finally, repositories should describe any specialized services they plan to offer. These could include, but are not limited to, plans to support:

  • Additional genomic analyses (DNA from blood spots, RNA, etc.)
  • Microbiome analyses (vaginal, nasal, fecal swabs, etc.)
  • HIV or other infectious disease research (PBMC processing, viral loads, viral sequencing, CD4/CD8 counts, immunological assays, etc.)
  • Biomarker analyses (from blood, serum, urine, etc.)
  • Appropriate storage for measures of environmental exposures (tobacco smoke, toxic metals, metalloids, and mineral nutrients, metabolites of pesticides, toxins from mold, polycyclic aromatic hydrocarbon metabolites, volatile organic compounds, etc.)

In all cases, applications to expand capacity should engage co-funders interested in that area of work. All applicants are encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed work with the goals of this FOA, with the H3Africa Consortium, and with NIH Institutes and Centers.

Additional Objectives of H3Africa

As noted in the Purpose section, there are several specific objectives that the H3Africa Program is trying to achieve. Successful applicants will become members of the H3Africa Consortium, and will be expected to adhere to these policies, unless adequate justification can be provided.

H3Africa Consortium Participation: H3Africa is organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The H3Africa Consortium includes all participants of research and infrastructure projects funded through H3Africa, as well as responsible Wellcome Trust and NIH staff. Groups funded under this initiative will be expected to participate in the H3Africa Research Consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. H3Africa Biorepositories are full consortium members, and are expected to work with H3Africa research projects and centers, with the H3Africa Bioinformatics Network, and with each other. Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium (a list of H3Africa Working Groups can be found at Each project is expected to comply with applicable consortium policies and procedures (found at In addition, the PD/PI(s) will be active members of the H3Africa Steering Committee, which meets regularly by teleconference. The H3Africa Consortium generally holds two meetings per year, usually in Africa.

H3Africa Data Sharing Policies: Data sharing is an increasingly important aspect of contemporary biomedical research, and the Consortium has developed a Data Sharing, Access, and Release Policy ( One of the roles of the H3Africa Informatics Network (currently: is to facilitate data sharing, by providing a data repository in Africa for all genetic and genomic data, as well as selected associated phenotypes. Members of the H3Africa Consortium submit data to the Informatics Network according to that policy, and thereby facilitate transfer of those data to the European Genome-Phenome Archive (EGA). An H3Africa Biorepository is expected to share data in the agreed-upon format with the H3Africa Bioinformatics Network and work together to establish a consortium-wide catalog of linked samples and data.

H3Africa Sample Sharing Policies: H3Africa funds a Biorepository Program consisting of three Biorepositories, located in Eastern, Western, and Southern Africa. All DNA samples must be deposited in one of the H3Africa Biorepositories according to H3Africa policies ( so that they can be distributed and shared for further research consistent with achieving the goals of this funding initiative. Other biological samples may also be banked for future use. H3Africa Biorepositories are expected to work with each other, and with H3Africa research projects and centers, to ensure integrity of sample quality and responsible stewardship of biological materials.

Community Engagement: H3Africa recognizes ongoing community engagement and the building of trust and strong relationships with research participants as an essential feature of ethical biomedical and population-based genomics research involving human subjects ( Community engagement can include a variety of activities, such as broad consent for sharing of samples and data, re-contact of research participants, return of results to individual participants, or other relevant topics. H3Africa should consider participating in Community Engagement activities as appropriate.

Collaborations: One of the major goals of the H3Africa Initiative is to facilitate opportunities for collaboration between and among investigators within Africa, to help build a larger African scientific community, which will in turn lead to more research opportunities and cutting-edge science on the continent. Intra-continental collaborations will also contribute to sustainability of African genomics programs. H3Africa Biorepositories are expected to collaborate with each other and with the Consortium and may also propose additional collaborations that will strengthen their capacity and potential for sustainability.

Providing the next generation of African researchers with opportunities in genomics: Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a primary objective of the H3Africa program. Operation of an H3Africa Biorepository should provide a variety of career enhancement opportunities to students, postdoctoral researchers, and young investigators, such as training in laboratory techniques, writing policies and SOPs, attending appropriate scientific meetings, and giving presentations to disseminate research findings. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the H3Africa program.
See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

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

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit up to a total of $2,200,000 and NHGRI $300,000 in FY 2019 contingent upon receiving scientifically meritorious applications.

The Common Fund and NHGRI intend to commit an estimated total of $6,900,000 over 3 years to fund up to three awards.
Award Budget
Application budgets need to reflect the actual needs of the proposed project and are limited to a total of $2.5M over three years with no more than $1M in any one year.
Award Project Period
3 years
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)


  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
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 not eligible to apply.

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

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Applicants must have an active DUNS number and SAM registration in order to complete the registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

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

The PD/PI should be an established investigator in their field and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have research experience in Africa, particularly in the country where the proposed research program will be established. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the program and appointing members of an Advisory Committee, as appropriate, and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.

The contact PD/PI must be affiliated with the low and middle income (LMIC) African institution submitting the application where the proposed research program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa, U.S. or other high-income country (HIC) institutions may be proposed. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program.

3. Additional Information on Eligibility

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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 activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Troyer
Telephone: 301-312-3276
Fax: 301-435-1580

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Organize the Research Strategy in the subsections identified below.

1) Background and Significance

Provide a compelling justification for the resources proposed for development in the context of the H3Africa Consortium and sample sharing plans and the ultimate potential impact on human health.

2) Progress Report and Preliminary Data

Applicants should present any preliminary studies along with demonstrations of feasibility, pitfalls, and alternative approaches including, but not limited to, the following:

  • Supporting H3Africa projects to submit samples to the H3Africa Biorepositories
  • Ongoing collaborations to develop shared resources, such as a consortium catalog and a Web portal
  • Shipping samples across international borders
  • Tracking and receipt of biosamples from a large number of collection sites
  • Biospecimen QC
  • Processing of samples to create multiple aliquots of DNA
  • Distribution of biosamples to recipients

Applicants should also describe their current capacity, usage, projected future usage for H3Africa consortium DNA samples, and projected capacity that is available for other sample types and use by other projects.

3) Approach

Describe the plans, procedures, and processes to sustain and develop the H3Africa Biorepositories:

Proposed plans should describe how valuable biosamples will be received, processed, stored, and distributed by the H3Africa Biorepositories. Plans should address how the proposed procedures and processes will ensure efficient, cost-effective, standardized biobanking, and distribution of verified and high-quality samples that will advance biomedical research.

Address each of the following key areas:

Receipt of samples Describe the general procedures that will be used to provide to participants or sites with training, instructions, and, if necessary, materials needed to ensure shipping processes that are in accordance with standard industry practice. The application should also describe planned systems to document the handling and archiving of all shipments, including documenting exceptions and corrective measures.

Shipments Describe the approach to establishing arrangements with commercial vendors to provide timely and cost-effective shipping of biosamples among multiple sites, the Biorepository, end-users and/or analytic laboratories.

Sample processing If applicable for services and sustainability plans, the applicant should describe any plans to process saliva, blood, or urine biospecimens using established protocols to produce high-quality materials, including plasma, serum, red blood cells, buffy coats, and DNA, and other potential biospecimens or cell derivatives for subsequent analysis. The plans should take into account the future use of Biobank automation and use barcoded tubes and racks. Consideration should be given to special processing needs for samples to be used for measures of environmental exposures (i.e. metal-free tubes).

Storage Describe the facilities and plans to store biosamples under optimal conditions to minimize loss, damage, or contamination. The application should include information about the suitability of the facility to perform the proposed work and, if applicable for sustainability plans, achieve biohazard containment, complying with all safety guidelines and regulations, as well as federal and local laws.

QA and QC systems Describe the quality control (QC) and quality assurance (QA) programs that will be implemented for all aspects of H3Africa Biorepository operations, including but not limited to:

  • Receipt, processing, and storage of biosamples
  • Mechanical functioning of freezers and other storage equipment, including alarm and back-up systems
  • Preservation of biological properties of biosamples during storage
  • Packaging and shipping of material
  • Accuracy of data entry and database maintenance in the inventory database
  • Timely shipment, receipt, and processing of biosamples.

Security and back-up Describe the proposed security and back-up systems and a plan for disaster recovery following a natural or man-made disaster. The plan should include provisions to maintain an adequate number of empty, functional storage units to serve as back-up units in the event of freezer failures, and to create a back-up facility located at a second site, in case of catastrophic loss. The application should describe the fire, smoke, and mechanical failure alarms, and fire control equipment, as well as the plan to alert key personnel at any time in the event of fire, mechanical failure of one or more freezers, or other emergency.

In addition, describe the proposed emergency back-up generator system that is capable of handling the complete power supply, in the case of electrical power failure, with a minimum of 72 hours of fuel available for the generator(s), and the plans for maintaining the back-up system to ensure proper operation.

Describe plans to prevent access to samples and data by unauthorized individuals.

Information systems - Describe the proposed robust information systems that will allow detailed tracking of sample receipt, processing, storage and distribution, rapid retrieval of samples, and metadata associated with the sample, and that permit efficient, rapid, and flexible reporting. Include information about the ability to rapidly and efficiently download and upload information, to readily transfer information to researchers or other entities submitting or receiving samples, and to efficiently handle sample and data destruction per participant revocation of consent. Describe plans to ensure state-of-the-art security for all electronic databases. Describe how the information systems will interface with other H3Africa Biorepositories, H3ABioNet, and H3Africa projects.

Sustainability Describe additional capabilities to be developed, outreach to stakeholders, users, and customers, and a business plan for attracting funds to increase the Biorepository capacity and services and sustaining an active Biorepository after H3Africa core funding ends.

Succession plan Describe plans to arrange transfer of samples for storage, or appropriate elimination of samples if required.

Additional Application Elements:

Applicants must also address each of the following key elements:

Milestones: Specific milestones should be presented that will be met to accomplish the aims. Annual milestones must be provided in the context of a study timeline. These milestones will provide clear indicators of a project’s continued success or emergent difficulties. Milestones are goals that include clear and quantitative criteria for success. Milestones should include timely receipt, processing of sample submissions, and distribution; accuracy of inventory; quality of processed samples; quality and yield of extracted DNA; and clear communication and data transfer timelines with H3ABioNet and the H3Africa consortium. Achievement of milestones will be evaluated by NIH, and funding of non-competing award years will depend on milestone accomplishment, among other considerations.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, are required to provide a Data Sharing Plan and Genomic Data Sharing Plan.
  • The NIH is committed to the principle of rapid data, model, and software release to the scientific community.
  • The H3Africa DBAC, with assistance from the H3Africa Coordinating Center and AESA, will manage the primary process of approving access to and use of biospecimens.
  • The NIH Genomic Data Sharing Policy will apply to any large-scale human or non-human genomic data, as well as the use of these data for subsequent research (
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) 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. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to (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. NIH and systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Letter of Support Indicating 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 Consortium 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

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" ( to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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 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.

Does the proposed biorepository address the needs of the research consortium that it will serve? Is the scope of activities proposed for the biorepository appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the biorepository? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the biorepository? Does the applicant have experience overseeing selection and management of subawards, if needed?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the biorepository will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the biorepository will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Resource Sharing Plan

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) Genomic Data Sharing Plan (GDS).

Will the institutional environment in which the biorepository will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the biorepository proposed? Will the biorepository benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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


Does the application include adequate plans to ensure future sustainability? Are the plans appropriate, adequate, and sufficient to ensure future sustainability? How will the activities initiated under this award be sustained at the conclusion of the award period? Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained research enterprise? Does the application include adequate plans to ensure future sustainability?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

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

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 score.

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.

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).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
  • 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 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 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 National Advisory Council for Human Genome Research. 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.
  • Overall program balance in the H3Africa program.
  • Relevance of the proposed project to the goals of H3Africa.
  • Commitment to compliance with H3Africa policies and procedures.
  • Potential for establishing a sustainable research program.
  • Potential for establishing sustainability.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see; and Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at

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 Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below

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

  • All aspects of the study, including any modification of study 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.
  • Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by H3Africa staff and ensure that the data produced meets the quality standards agreed to at the beginning of the project by the H3Africa Consortium.
  • Awardee(s) will ensure that the data are submitted to the H3Africa Bioinformatics Network, that samples are deposited in the H3Africa Biorepositories, 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 agree to accept close coordination, cooperation, and participation of H3Africa staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
  • Awardees agree to the governance of the Consortium through the Steering Committee
  • PD(s)/PI(s) will serve as active members of the H3Africa Steering Committee and will participate directly or by proxy on relevant H3Africa Working Groups.
  • Awardees 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:

  • The Project Scientists will negotiate goals with the awardees as needed, serve as a liaison between the awardees and 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.
  • The Project Scientists will participate (with H3Africa investigators) in the group process of deciding optimal research approaches and protocol designs and contributing to the adjustment of research protocols or approaches as warranted.
  • Project Scientists will attend Steering Committee meetings as non-voting members, serve on H3Africa Working Groups, and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Participation on the H3Africa Steering Committee. On voting matters, each funded project will have one vote and each funding agency will have a single vote. The Steering Committee will: (1) discuss progress in meeting the goals of various H3Africa projects and of H3Africa as a whole; (2) 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; (3) endorse and oversee progress and products of Working Groups within the Consortium; (4) meet twice a year in person in conjunction with network meetings and conduct intermittent conference calls.

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. It will have three members: 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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 on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: (preferred method of contact)
Telephone: 301-945-7573 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Dr. Jennifer Troyer
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3565

Dr. Bonnie Joubert
National Institute of Environmental Health Services (NIEHS)
Telephone: 984-287-3276

Dr. Sudha Srinivasan
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 240-627-3062

Peer Review Contact(s)

Dr. Rudy Pozzatti
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739

Financial/Grants Management Contact(s)

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858

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 Part 75.

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