Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Biologics Evaluation and Research (CBER)

Funding Opportunity Title

Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products (U01) Clinical Trials Not Allowed

Activity Code

U01 Research Project - Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-21-031

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.103

Funding Opportunity Purpose

The Food and Drug Administration (FDA) announces its

intention to accept and consider a single source application for

award of a Cooperative Agreement to the World Health

Organization (WHO) in support of collaboration in regulatory systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological products that meet international standards.

Key Dates
Posted Date

April 9, 2021

Open Date (Earliest Submission Date)

April 13, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

July 13, 2021, by 11:59 PM Eastern Time.

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.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2021

Advisory Council Review

Not Applicable

Earliest Start Date

September 1, 2021

Expiration Date

July 14, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

     

    BACKGROUND:

    The World Health Organization (WHO) is the directing and coordinating authority on international health within the United Nations’ system.  Working with 194 Member States, across six regions, WHO coordinates international efforts to produce health guidelines and standards and helps countries to strengthen capacity and address public health issues.  WHO also promotes and supports research on matters related to health.  WHO fulfils its global public health objectives through its core functions:

    • Providing leadership and engaging in partnerships where joint action is needed;
    • Shaping the research agenda and generating and disseminating knowledge and information;
    • Setting norms and standards and promoting and monitoring their implementation;
    • Articulating ethical and evidence-based policy options;
    • Providing technical support and building sustainable institutional capacity; and
    • Monitoring the health situation in countries and regions and assessing health trends and needs.

    WHO assists countries to increase and sustain access to medical products to prevent, detect, and treat diseases, including reducing vaccine-preventable diseases.  The WHO also coordinates response to public health emergencies by monitoring the health situation, undertaking risk assessments, identifying priorities, providing technical guidance, sharing information and providing other forms of support to countries and regions.  Additionally, WHO utilizes its convening power to bring together relevant stakeholders to promote collaboration in addressing public health needs and issues efficiently.

    Providing regulatory oversight throughout the product life cycle (pre- and post-licensure) is a major challenge for many National Regulatory Authorities (NRAs).  With increasing numbers of new and complex products, rapid technological advances, complex quality concerns, and need for regulatory agility to respond to emerging and re-emerging infectious disease threats (e.g., COVID-19, Ebola, Zika, pandemic influenza, MERS etc.), there is increased urgency to strengthen regulatory authorities especially in low-and-middle-income countries (LMICs) as an integral part of the overall health system.  The WHO has an important role in strengthening regulatory systems and other supportive activities to increase access to high quality, safe, and effective biological products in all regions of the world and strengthen preparedness to respond to public health emergencies in a timely and efficient manner.

    The U.S. FDA’s Center for Biologics Evaluation and Research (FDA/CBER) has been a leader and active participant in the global community to improve human health in the world’s populations over many years.  FDA/CBER has longstanding collaborations with the WHO in the area of biologicals (vaccines, blood and blood products, relevant in vitro diagnostics, and cell, tissue, and gene therapies).  FDA/CBER has supported WHO through its commitment as a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization since 1998 with the current commitment running until February 2024 and anticipating future extensions.  The purpose, scope and areas of activity for each four-year term are captured in a set of “Terms of Reference” (TOR) mutually agreed to by FDA/CBER and WHO, and are reflective of their shared interest in supporting regulatory systems strengthening, development of global norms and standards, promoting standardization and global access to high quality, safe and effective biological products, and strengthening preparedness for responding to public health emergencies.   

    Regulatory Systems Strengthening:

    In this era of globalization, products can be imported from anywhere in the world making supply chains for biological products increasingly complex.  FDA's mission is to monitor and ensure the safety of the supply chain for medical and other products entering the United States from other parts of the world.  Strong regulatory systems in countries throughout the world helps FDA fulfil its mission to assure safety of the supply chain for medical products used by the U.S. population.

    National Regulatory Authorities (NRAs) play a vital role in the national health care system.  A robust regulatory system for medical products must include a legal framework, and the mandate to carry out and enforce critical functions including: marketing authorization (licensing); oversight of clinical trials; monitoring and evaluating product quality; oversight of good manufacturing, pre-clinical, and clinical practices; lot release; inspections (GMP compliance); and monitoring safety and vigilance (surveillance capacity) throughout the product life cycle.  Additionally, strong regulatory authorities play an integral role in responding effectively to public health emergencies.  The Ebola outbreaks in West Africa and the global COVID-19 pandemic are recent examples that highlight the critical role of regulatory authorities in addressing public health emergencies by making risk-based decisions for timely authorization of safe and effective diagnostics, medicines, and vaccines to detect, treat, and prevent disease, and monitor safety post-authorization when these products are used more broadly in the population.

    In 2014, the sixty-seventh World Health Assembly passed resolution WHA67.20 (“Regulatory System Strengthening for Medical Products”) emphasizing WHO’s role in strengthening regulatory systems for medical products, and in supporting NRAs and relevant regional and international networks that support regulatory activities.  The resolution mandates WHO to support Member States in: (i) evaluating national regulatory systems (using WHO’s Global Benchmarking Tool); (ii) generating and analyzing evidence of regulatory system performance; (iii) facilitating the formulation and implementation of institutional development plans to fill gaps and; (iv) providing technical support to NRAs and governments to address deficiencies and enhance capacity.  Resolution WHA67.20 gives WHO the mandate to promote and support regulatory system strengthening, including promoting principles of reliance, as an integrated part of health system development and is essential for increasing access to safe and effective medical products especially in low-and-middle-income countries.

    Development of Norms and Standards:

    The World Health Organization (WHO) has played a key role for over 50 years in establishing WHO International Biological Reference Materials and in developing WHO guidelines and recommendations on the production and control of vaccines and other biological products and technologies.  The WHO Expert Committee on Biological Standardization (ECBS) is commissioned by WHO to advise the Organization on international standards setting activities.

    International reference materials (physical standards) are essential for standardization and comparison of biological measurements worldwide.  Well-characterized preparations are needed as global measurement standards against which batches of biological products are assessed.  This is fundamental to ensuring the quality of biological products, the consistency of production of these products, and appropriate clinical dosing.  WHO International Biological Reference Materials serve as the basis for uniform reporting in characterization of biological products and designating their activity or potency in international units.

    Written guidelines and recommendations describe procedures for the manufacture and quality control testing of biological products to ensure that the products manufactured for human use follow best practices and conform to current international standards.  Regulatory guidance documents advise NRAs and manufacturers on the principles and critical parameters for manufacture and control of biological products and aim to promote regulatory convergence or harmonization, where possible, for products that have a global market.  Through guidelines and other written international standards, NRAs can maintain current knowledge of scientific and regulatory information needed to assess critical issues to ensure that biological products used in the country are safe, effective, and of high quality.

    WHO international standards play a critical role in responding to public health emergencies (e.g., COVID-19 pandemic, Ebola outbreak etc.) as timely availability of standards is essential for development by manufacturers, and authorization by regulators, of medical products necessary to detect, treat, and prevent emerging and re-emerging infectious diseases.  The importance of developing norms and standards tailored to the epidemic context is highlighted in WHO's "R&D Blueprint for Action to Prevent Epidemics" (2016).  WHO international standards are developed based on scientific consensus achieved through global consultations and implementation of these standards ensures the quality, safety, and effectiveness of biological products and related in vitro diagnostic tests used by Member States. 

    Product Safety and Vigilance:

    An important regulatory tool to assure vaccines are safe and effective is a robust pharmacovigilance system.  The decision to license a product is based on information available at the time of approval, and the conditions for use are specified in the product label. However, the knowledge related to the safety profile of the product can change over time through expanded use in greater numbers of people and in diverse populations. Rare adverse events often are not identified in clinical trials since the numbers of subjects enrolled in the trials are not large enough to detect low frequency signals.  Thus, it is essential to continue monitoring vaccine safety throughout the product life cycle and to obtain and analyze any additional safety information in near “real time.” 

    Vaccination is known to be the most cost–effective public health intervention and saves millions of lives every year.  To ensure continued success of vaccination programs, it is critical to have good vaccine safety monitoring mechanisms to maintain public confidence in vaccines. WHO estimates that more than half of its Member States still lack capacity for vaccine pharmacovigilance.  WHO plays an integral role in supporting countries to develop national capacities for the post-marketing surveillance of vaccines and other medical products, and in coordination of global networks to promote information sharing and international regulatory co-operation. 

    During 2019 - 2020, WHO and partners developed a strategic framework (“Global Vaccine Safety Blueprint 2.0”) to promote the establishment of effective vaccine pharmacovigilance systems in all countries.  Blueprint 2.0 outlines a strategic plan for strengthening global vaccine safety monitoring to meet current and future needs. The strategic plan highlights priorities around governance and systems development, regulatory framework, coordination of safety systems, surveillance and causality assessment, enhanced vaccine safety communications, and other factors integral to assuring that vaccines and other medical products are safe and effective throughout the product lifecycle.

    The Global Advisory Committee on Vaccine Safety (GACVS) is a WHO advisory body that provides independent, authoritative, scientific advice to WHO on vaccine safety issues of global or regional concern.  The GACVS rigorously reviews the latest knowledge concerning any aspect of vaccine safety pre- and post-licensure, evaluates causal relationships between vaccines and/or their components and adverse events attributed to them, and provides scientific recommendations to assist WHO, the WHO's Strategic Advisory Group of Experts (SAGE) for immunization, national governments and international organizations in formulating policies related to vaccine safety. This WHO advisory body plays a significant role in monitoring product safety and vigilance at the global level.

    WHO also supports countries and regions to strengthen hemovigilance to ensure safety of blood and blood products, and there is increasing focus on monitoring safety of advanced therapies (cell and gene therapies) as these products reach the market in countries worldwide further highlighting the need for adequate regulation and oversight of these products to assure patient safety.

    WHO Prequalification Program:

    The WHO Prequalification Program was established in response to the need to supply quality health products, including vaccines and in vitro diagnostic tests for the prevention, diagnosis and treatment of priority diseases in low-and-middle-income countries.  Through the prequalification program, WHO assures the quality, safety, efficacy of these products, and suitability for use in the target settings.

    For the Vaccine Prequalification Program, WHO provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs in different regions of the world.  An important part of the Vaccine Prequalification Program is WHO’s reliance upon a competent National Regulatory Authority (NRA) to provide regulatory oversight for the vaccine throughout the life cycle. In 2009, FDA entered into a confidentiality arrangement with WHO to enable FDA/CBER to serve as a reference NRA under this prequalification program, and the Center is currently a reference NRA for multiple U.S. licensed WHO prequalified vaccines.

    In addition to the Prequalification Program, WHO has an Emergency Use Listing (EUL) procedure that plays a critical role in responding to public health emergencies such as the Ebola outbreaks in West Africa and global COVID-19 pandemic.  EUL is a procedure that makes a risk-based assessment for listing unlicensed vaccines, therapeutics, and in vitro diagnostics to expedite access to these products for people affected by a public health emergency. WHO's EUL procedure assists UN procurement agencies and Member States in determining the acceptability of using specific products, based on the available quality, safety, efficacy and performance data, for use in a country or region to respond to a public health emergency.

    Research and development to increase access to safe and effective biological products and enhance preparedness for public health emergencies:

    Regulatory oversight is critical for ensuring that biological products used in humans are safe, effective, and of assured quality.  Regulatory research aims to contribute to the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated biological products.  Examples include tools to standardize assays used for regulatory purposes (e.g., development of correlates of immunity; correlates of safety; improved methods for product characterization; new or alternative potency assays etc.). Results based on methods and tools developed through regulatory research such as adaptive clinical trial designs, benefit/risk assessment, novel pharmacovigilance methodologies, and other tools can be informative for regulatory decision-making. Knowledge gained through mission-relevant research can play a significant role in CBER’s regulatory decision-making, policy development, and preparedness to address threats from existing or emerging infectious diseases. 

    The challenges of modern product development and globalization underscore the critical importance of advancing regulatory science to remain current with advances in basic and applied science and technology. Recent experiences in responding to the Ebola outbreak in West Africa and the global COVID-19 pandemic highlight the critical role of research and development as a core component of preparedness to address emerging and re-emerging pathogens with epidemic potential.

    RESEARCH OBJECTIVES:

    The FDA, with other HHS technical agencies and offices, the WHO, and other regulatory counterparts, are strategizing on approaches to increase access of the global population to safe and effective biological products for the prevention, diagnosis, and treatment of priority diseases, especially for use in low-and-middle-income countries. 

    This project represents an extension of a collaborative effort between FDA and the WHO to support scientific collaboration and enhance regulatory capabilities of National Regulatory Authorities and networks to advance global access to safe and effective vaccines and other biologicals that meet international standards. This project will further support science-based and data-driven public health strategies and approaches, and lead to improved technical cooperation between FDA, WHO, and its Member States. The project has the following goals:

    1.  Contributing to regulatory systems strengthening in low-and-middle-income countries (LMICs)

    • Support NRA assessments and analyses and synthesis of the data, and development of an Institutional Development Plan to enhance regulatory performance in low-and-middle-income countries.  Assessment of regulatory systems could include but is not limited to, analyses and synthesis of data from assessments of different NRAs using the WHO Global Benchmarking Tool.  NRA assessments also support WHO’s vaccine prequalification program;
    • Provide technical support to enable the strengthening of regulatory systems at the national and regional levels in such critical domains as good manufacturing, clinical, and laboratory practices; monitoring and evaluation of product quality; lot release; inspection and surveillance of products throughout the supply chain; development of pharmacovigilance systems and capacity for adverse event monitoring and analysis; risk assessment, analysis, and management etc.;
    • Analyze regulatory systems performance which can include assessment of quality of performance of regulatory functions (basic and advanced) as well as challenges, risks, and emerging trends, with the aim of further strengthening the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions;
    • Support sharing and application of knowledge, data and information through active participation in regional and global committees and networks, such as the African Vaccine Regulatory Forum (AVAREF), Expert Committee on Biological Standardization (ECBS), Global Advisory Committee on Vaccine Safety (GACVS), etc.
    • Expected outputs could include analyses, reports and data-driven strategy papers, among others.

    2.  Enhancing post-market surveillance of vaccine safety

    • Improve evaluation of centralized spontaneous reporting systems data including efficient and rigorous analysis of spontaneous reports of adverse events following immunization through improvements in application of standardized case definitions, data mining algorithms, analytic methods and tools, vaccine dictionaries, and development of case-based reasoning strategies (such as text mining and natural language processing; and statistical and mathematical algorithms), causality assessment and other relevant approaches; 
    • Improve utilization of national and regional pharmacovigilance assessment frameworks for collection of data using structured approaches (such as common data collection methods/tools, protocols and analytic methods) to advance and improve monitoring of safety and effectiveness of new vaccines following introduction in a specific country or regional setting;
    • Strengthen systems for monitoring, tracking, and evaluating safety of maternal immunization especially in low-and-middle-income countries (LMICs): Assessments of immunization safety of pregnant and lactating women could include but is not limited to standardization of case definitions (such as GAIA definitions) of prioritized obstetric and neonatal outcomes; strengthening platforms for data collection on vaccine use during pregnancy and passive and active adverse event monitoring including studies to test safety hypotheses following immunization of pregnant women;
    • Improve interoperability of global pharmacovigilance systems: Examples include the development and implementation of a database that would allow tracking or global distribution and use of any vaccine and enable linkages to existing global pharmacovigilance systems where those vaccines are in use, as a basis for rapid response to vaccine safety concerns arising in any country where a vaccine is distributed;
    • Improve approaches to rigorous vaccine safety studies in low-and-middle-income countries (LMICs): The basic requirements for a collaborative approach of this kind in LMICs are that the ideal methodology is simple (to implement easily and standardize for all sites); timely (so findings can be used in near real time for regulatory decision making) and; only uses resources already available in the local public health system.  An example of successful use of this approach is the proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination (study published in 2017).  Improving this approach, because of its flexibility and applicability to countries is one direction that could be taken.  Other approaches for active surveillance that are practical and feasible in LMIC settings, and which are likely to yield interpretable data on vaccine safety, can also be considered.

    3.  Development of global norms and standards

    • Enable the timely and effective sharing of scientific findings and data through international collaboration to develop WHO International Biological Reference Materials and WHO guidelines and recommendations on the production and control of vaccines and other biological products and technologies;
    • Assist Member States in the implementation of internationally-recognized standards and guidelines, e.g. WHO guidelines and standards and those emerging from standards development venues such as the International Council for Harmonisation of the Technical Requirements for Pharmaceuticals for Human Use (ICH);
    • Support WHO’s Global Influenza Programme and Essential Regulatory Laboratory activities including preparedness for and response to influenza and non-influenza (e.g., COVID-19) global infectious disease threats
    • Utilize WHO’s convening power to engage with relevant stakeholders in support of data-driven and science-based public health strategies and approaches to enhance global regulatory cooperation and convergence (standardization);
    • Expected outputs could include guideline documents, physical standards (e.g., reference reagents, reference panels etc.), reports and data-driven strategy papers, among others.

    4. Supporting regulatory mission relevant research and other activities to promote development and increased access to safe and effective biological products

    • Enable development of new tools, methodologies, and approaches to assess the safety, efficacy, quality, and performance of regulated biological products;
    • Support research and development efforts that increase preparedness for responding to emerging or re-emerging infectious diseases;
    • Support programs, including but not limited to WHO prequalification and Emergency Use Listing (EUL), that increase access to safe and effective biological products;
    • Expected outputs could include analyses, reports and data-driven strategy papers, among others.

    Inherent in the Cooperative Agreement award is substantive involvement by the awarding agency. Accordingly, FDA/CBER will have substantive involvement in the programmatic activities funded by this Cooperative Agreement. Substantive involvement includes, but is not limited, to the following:

    1. FDA will appoint a project officer or co-project officers who will actively monitor the FDA-supported  program under this award. FDA’s CBER will serve as the Technical Lead for FDA’s involvement.

    2. FDA will provide guidance, direction, and assistance in design and development of the approaches  and methods that may be used by the recipient.

    3. As appropriate to the implementation of this award, FDA will participate with WHO to determine  the scope of: (a) opportunities for diffusion and application of knowledge and (b) development of  reports and analyses, and (c) publication of articles and (d) media releases.

    4. Working collaboratively with the WHO and its Member States, FDA will participate in scientific meetings; design of assessments, and review, analysis, and publication of assessment findings,  where appropriate.

    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, FDA 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

    Renewal

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    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

    Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

    FDA/CBER intends to commit up to $2,000,000 in FY 2021 in support of this grant program.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $2,000,000

    YR 02: $2,000,000

    YR 03: $2,000,000

    YR 04: $2,000,000

    YR 05: $2,000,000

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    World Health Organization (WHO)

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
    Foreign components, as defined in the HHS 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. 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) – 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.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov 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 FDA 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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

     

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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 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.

    Page Limitations

    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:

    For this specific FOA, the Research Strategy section is limited to 30 pages

    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) Form

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

    • For field 4. a. Federal Identifier - The Federal Identifier is required.  Include only the IC and serial number of the previously assigned award number (e.g., use FD005959 from 5U01FD005959-05).
    • For field 8. TYPE OF APPLICATION - applicant must mark 'RENEWAL'.
    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. 

    R&R Budget

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

    • Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
    • If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
    • If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
    • Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.
    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 requirements:

    Research Strategy: The Research Strategy should include a brief Progress Report that summarizes Progress to Date and accomplishments achieved during the current funding period. The Progress Report should include a summary of the specific aims of the previous project period and the importance of the findings, progress made towards achievements, explanation on any significant changes to the specific aims and any new directions.

    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, with the following modification:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

    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 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    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 Institutions

    Foreign (non-U.S.) institutions must follow policies described in the HHS 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 Grants.gov

    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.

    Organizations must submit applications to 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, FDA's electronic system for grants administration. eRA Commons and Grants.gov 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 Grants.gov 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. Late applications will not be accepted for this FOA.

    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 FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75.

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

    Additional funding restrictions may be part of the Notice of Award.  

    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 How to Apply – Application Guide. 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 FDA. 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 assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.  

     

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit.

    Significance (25 Points)

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?  

    Investigator(s) (10 Points)

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

    Innovation (25 Points)

    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?   

    Approach (30 Points)

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    If the project involves human subjects and/or clinical research, are the plans to address

    1) the protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Budget (10 Points)

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

    Additional Review Considerations

    As applicable for the project proposed, reviewers will evaluate the following additional items, but will not give separate scores for these items and should not consider them in providing an overall score.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  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  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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or 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 individuals of all ages (including children and older adults) 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.

    Vertebrate Animals

    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.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

     Not Applicable

    Renewals

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

    Revisions

     Not Applicable

    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)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by an appropriate Objective Review Committee using the stated review criteria.

    As part of the objective review, all applications:

    • Will receive a written critique.

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

    Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by objective review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

    Section VI. Award Administration Information
    1. Award Notices

    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 recipient's business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. 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 in the HHS Grants Policy Statement, this FOA, and Notice of Award.

    2. Administrative and National Policy Requirements

    All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    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.  For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.   

    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), FDA 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 FDA grants and cooperative agreements.

    FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

    Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

    Additional terms and conditions regarding FDA regulatory and FDA/CBER programmatic requirements may be part of the Notice of Award.

    Standard Terms and Conditions of Award

    Reporting Requirements:

    All FDA grants require both Financial and Performance reporting.

    Financial Reporting:

    A. Cash Transaction Reports

    The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients, this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

    B. Financial Expenditure Reports

    A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

    Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter.

    Performance Progress Reporting:

    When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons.  The annual RPPR must include a detailed budget.  Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

    Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Salary Caps:

    None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

    of the current Executive Level II of the Federal Executive Pay Scale.

    Certificates of Confidentiality – 42 U.S.C. 241(d)

    Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions.   Certificates issued in this manner will not be issued as a separate document. 

    Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

    Acknowledgment of Federal Support:

    When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter “statements”)--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

    1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

    2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

    When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

    If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

    This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

    If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

    This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

    The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement.  Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA.  If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

    Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Prior Approval:

    All prior approval requests must be submitted using the Prior Approval module in eRA Commons.  Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

    For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval.  All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons.  ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

    The following activities require prior approval from FDA on all awards:

    1.         Change in Grantee Organization

    2.         Significant Rebudgeting

    3.         Change in Scope or Objectives

    4.         Deviation from Terms and Conditions of Award

    5.         Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

    6.         Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

    Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Audits and Monitoring:

    Audit Requirements:

    1.         Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

    2.         Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

    3.         For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

    U.S. Department of Health and Human Services

    Audit Resolution Division, Room 549D

    Attention: Robin Aldridge, Director

    200 Independence Avenue, SW

    Washington, DC 20201

    Monitoring:

    Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

    1.         Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

    •          Policies and procedures

    •          List of grant expenditures

    •          Accounting records

    •          Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)

    •          Financial statements

    •          Audit reports

    •          Other related documentation

    2.         Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

    3.         Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities.  Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

    All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner.  Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

    Financial Conflict of Interest (FCOI):

    This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

    Closeout Requirements (when applicable):

    A Final Research Performance Progress Report (FRPPR), Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period.  All closeout documents must be submitted electronically in eRA Commons.

    The Final FFR must indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements reported on the grantee's report to the Payment Management System and the charge advances in PMS.  It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

    Program Income:

    The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

    Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

    Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

    Treatment of Program Income:

    Prohibition on certain telecommunications and video surveillance services or equipment:

    (a) As described in 2 CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

    (1) Procure or obtain,

    (2) Extend or renew a contract to procure or obtain; or

    (3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

    i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

    ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

    iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

    Other:

    This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

    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 with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

    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 FDA 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 FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA 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 FDA as defined below.

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

    1. In the cooperative agreement mechanism, the Project Officer/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner.

    2. Have access to the data developed under these awards, subject to Government rights of access consistent with current DHHS and FDA policies.

    3. Assess and evaluate project and program activities in accordance with applicable guidance by FDA staff.

    4. Work directly with FDA Staff on the coordination of FDA program activities.

    5. Participate in meetings, work groups, and training as needed to plan and accomplish the goals of the FDA/WHO Cooperative Agreement.

    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 FDA policies.

    Additionally, an agency program official 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:

    The PD/PIs of WHO, FDA Offices and Centers, and the PSs and PC will be jointly responsible for the coordination and collaboration of WHO Cooperative Agreement activities and the integration of individual projects with other appropriate programs. Joint responsibilities include:

    1. Developing collaborative working groups to reduce duplication of effort and maximizing efficiencies.

    2. Organizing and conducting regular meetings to share progress and foster collaborations within FDA and WHO, by teleconference, virtual meeting, or face-to-face, as needed.

    Developing and implementing strategies for evaluating and reporting the effectiveness of the Cooperative Agreement.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a Grant Officer from the FDA, one FDA/CBER designee, and a third designee selected by WHO with expertise in the relevant area. 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 Notice of Award.

    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 terms and conditions of award and the HHS 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 FDA 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. 

    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 submission by the due date, and post submission issues)


    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726

    Email: support@grants.gov

    Scientific/Research Contact(s)

    Gopa Raychaudhuri, PhD
    Center for Biologics Evaluation and Research
    Telephone: 240-402-8000
    Email: Gopa.Raychaudhuri@fda.hhs.gov

    Objective Review Contact(s)

    Gordana Zuber
    Grants Management Specialist
    Telephone: 301-348-1747
    Email: Gordana.Zuber@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Gordana Zuber
    Grants Management Specialist
    Telephone: 301-348-1747
    Email: Gordana.Zuber@fda.hhs.gov

    Section VIII. Other Information

    All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, 45 CFR 75 and Notice of Award.

    Authority and Regulations

    Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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