It is critical that applicants follow the 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.

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

The Food and Drug Administration (FDA) is announcing a cooperative agreement where supporting funds will be made available from the Office of International Programs (OIP). The goal of the funding is to strengthen global regulatory systems to ensure the safety and quality of food and medical products through activities that may include:

Development of global norms and standards for product regulation;

Generating and analyzing evidence of regulatory systems performance;

Provision of technical support to national regulatory systems strengthening efforts.

A. Background

The World Health Organization (WHO) was established in 1948, beginning with adoption of its Constitution by the International Health Conference in New York June 19-22, 1946. The United States Government (USG) is an original WHO member and WHO is recognized formally by the USG as a multilateral organization. WHO (1) provides leadership on matters critical to health and engaging in partnerships where joint action is needed; (2) shape the research agenda and stimulating the generation, translation and dissemination of knowledge; (3) set norms and standards and monitor their implementation; (4) articulate ethical and evidence-based policy options; (5) provide technical support and help build sustainable capacity; and (6) monitor the health situation and assess health trends around the globe; WHO has responsibility for helping to ensure access to essential medical products and foods of assured safety, quality, and efficacy within its 194 Member States. It does so in three primary areas: 1) developing global norms and standards; 2) articulating evidence-based policy options, including those relating to regulatory systems performance; 3) providing technical support to national regulatory authorities and governments, 4) work with relevant stakeholders to enable and promote a research agenda for better public health and regulatory decisions and actions by WHO member states. These activities help to strengthen national regulatory systems. In this era of globalization, products can be imported from anywhere in the world within increasingly complex supply chains. As national and global health programs work to scale up access to medicines, health products, and food, strong national regulatory systems are more important than ever before.

1. Medical Products:

What are the necessary constituents of an effective medical products regulatory system? This is an important question, and one which the U.S. Institute of Medicine (IOM) addressed, identifying few core elements of a successful regulatory system. These include a) sound government; 2) good manufacturing, clinical, and laboratory practices; c) staff development and professionalization; d) monitoring and evaluation of product quality using laboratories; e) inspection and surveillance of products throughout the supply chain; f) risk assessment, analysis, and management; and g) emergency response.

WHO helps to strengthen medical products regulatory systems through activities that include disseminating global quality norms and standards; facilitating the exchange of regulatory information; assessing regulatory authorities; providing training; distributing scientific materials and information on aspects of regulation from regional and global perspectives; expanding the global monitoring and surveillance system for falsified and substandard products; supporting national pharmacovigilance programs; and building capacity as a component of WHO’s prequalification programs.

Another important area of work on regulatory systems strengthening is through a new Member State Mechanism (MSMech) on Substandard, Spurious, Falsified, Falsely-labeled, and Counterfeit (SSFFC) medical products, which was established as part of a resolution at the 65th World Health Assembly in May of 2012. The MSMech is designed to address SSFFC issues and advance medical product safety and quality through the strengthening of national regulatory capacities. The first meeting of the MSMech occurred in Buenos Aires, Argentina in November of 2012, and the representatives agreed to form a global steering committee with representation from the WHO regions to support implementation of the workplan; the creation and management of selected work groups to address specific work areas; and the development of data-driven approaches to SSFFC issues. Participants also stressed the need for initiatives to educate consumers on the threats of SSFFC, for methodologies and instruments to obtain more accurate information about the nature and magnitude of the SSFFC problem, and for guidelines on how to better respond to the detection of SSFFC medical products.

FDA has been actively engaged with WHO on several these fronts. FDA experts participate in WHO drug and vaccine safety advisory committees, which develop important international norms and standards for the regulation of medical products. In addition, FDA has implemented several Cooperative Agreements with WHO on medical product safety and quality in the past few years. In 2010, OIP/FDA set up a Cooperative Agreement with WHO to develop a global monitoring platform for SSFFC medical products. A steering group of experts from relevant FDA Centers provides guidance, direction, and advice regarding this cooperative effort. The overarching priority is the exchange of information about and expertise on matters relating to SSFFC so that data can be collected and contribute to the formulation of policies and programs that combat the problem. The system allows participating countries to report SSFFC information using a simple, electronic rapid alert form. Once the information has been submitted, WHO can take the appropriate first-response measures to circulate such information to governments, WHO regional offices, and other stakeholders, as necessary. Analyses, threat assessments, thematic reporting, and bulletins based on the reported data may also be completed and shared. In 2013, OIP/FDA set up a five-year Cooperative Agreement with WHO to develop a Pharmacovigilance Project for Substandard and Falsified (SF, previously referred to as SSFFC) medical products; the grant supported regulatory capacity building strengthening in India and China by providing funding for training of regulators from these countries; supported stakeholders meetings for the SF Monitoring System; funded conducting and publishing the Public Health and Socio Economic Impact Study on Substandard and Falsified Medical Products and published the findings from the WHO Global Surveillance and Monitoring system for Substandard and Falsified Medical Products; funded the development and drafting of an article on the global curriculum effort to be published in the WHO Drug Information Journal disseminating the tools developed in the frameworks of the project to Member States, to mention a few.

2. Foods:

WHO has responsibility for the provision of technical cooperation to its 194 Member States (national governments) in the areas of food safety and zoonotic diseases. Among the focus areas are: a) surveillance for food borne disease; b) identification of food contamination; c) management of mechanisms for information sharing; and d) systems for emergency response, including outbreak investigations and governments food product recalls which may potentially have a global impact or cross national boundaries, and which may fall within the requirements of the International Health Regulations. WHO’s technical support complements a paradigm shift that is emerging around the globe; a shift, like that of FDA, from a focus on food safety interventions at ports-of-entry toward an approach that emphasizes preventive, risk-based efforts. This shift entails increasing accountability of entities along the supply chain that grow, harvest, manufacture, process, store, transport, distribute, and/or import foods for ensuring the safety of their products, while at the same time strengthening national authorities capacity and systems to be able to regulate these products efficiently and effectively. Along with the Food and Agriculture Organization of the United Nations (FAO), WHO also has a responsibility in relation to harmonizing international science-based food safety standards (e.g., as one of the founding institutions and technical advisory bodies to the Codex Alimentarius Commission (Codex). WHO helps to strengthen foods regulatory systems through activities that include a) disseminating global quality norms and standards; b) facilitating the exchange of regulatory information; c) assessing regulatory authorities; d) providing training; e) distributing scientific materials and information on aspects of regulation from regional and global perspectives; f) expanding the global monitoring and surveillance system for falsified and substandard products; g) supporting national pharmacovigilance programs; and h) building capacity as a component of WHO’s prequalification programs.

FDA's Center for Food Safety and Applied Nutrition (CFSAN) has been the primary point of engagement with WHO on food safety related issues. FDA, through CFSAN) and FDA's Center for Veterinary Medicine (CVM), has participated with WHO’s International Program on Chemical Safety (IPCS) in a Cooperative Agreement that supported WHO’s work in international risk assessment and its standard-setting activities for food ingredients, contaminants, and veterinary drug residues in food, including the Joint FAO/WHO Expert Committee on Food Additives (JECFA). CFSAN's cooperative agreement with WHO provides support for foods-related activities such as: Codex Alimentarius, INFOSAN, Global Foods Infections Network (GFN), and Whole Genome Sequencing (WGS). These efforts help to improve global food safety and build foreign regulatory counterparts' capacity in regulatory oversight and serve as a platform for bilateral and/or multilateral collaboration. This cooperative agreement will build on FDA's previous and existing work with WHO to strengthen food safety regulatory systems.

WHO is a major international health organization with the mandate, technical expertise, and broad reach to provide leadership on global health matters, shape an array of global and national health priorities, and set norms and standards. WHO has a mandate to assure access to safe food around the world, and is actively engaged in capacity building activities through its programs. Regulatory System Strengthening (RSS) continues to be a priority for FDA because more and more products are grown, manufactured, and processed abroad and meeting domestic priorities are impacted by national regulatory systems and increasingly complex supply chains around the globe. FDA and WHO are both interested in regulatory system strengthening and, therefore, this cooperative agreement will support FDA’s mission of protecting the health of the American people by ensuring the safety and effectiveness of imported products it regulates. Establishing this cooperative agreement will offer FDA the opportunity to influence food safety in countries where its regulated products are grown, manufactured, packages, processed, and transported.

B. Research Objectives

The Cooperative Agreement announced in this FOA represents the further expansion of well-established collaborations between WHO and FDA, through OIP, in support of research-based, data-driven and science-based public health strategies and approaches. These collaborations align well with FDA domestic and global goals on product safety and quality and better and more secured product supply chains. Relevant strategies include: 1) developing global norms and standards; 2) articulating evidence- and science-based and research-driven policy options, with emphasis on those relating to regulatory systems performance; and 3) providing technical support to national regulatory authorities and governments through systems strengthening efforts. This Cooperative Agreement is expected to support the following types of collaboration:

1. Developing global norms and standards

a) Enable the sharing of scientific findings and data through expert meetings and technical consultations;

b) Assist Member States in the implementation and subsequent evaluation of internationally-recognized standards and guidelines; e.g., WHO guidelines and standards and those emerging from standards development venues such as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);

c) Utilize WHO’s convening power to engage with relevant stakeholders on science-based norms and standards and on research and development agendas that are important to and may align well to the FDA mission;

2. Articulating evidence- and science-based policy options, including those relating to regulatory systems and regulatory systems performance

a) Contribute to the knowledgebase and global research agenda of current and future state of food and medical products regulation globally, including public health and regulatory challenges and risks, and emerging trends, including those that innovation, technology and research may underpin;

b) Enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions, enhanced knowledge management systems, coalitions, and networks, and future research endeavors that may contribute to regulatory science;

3. Providing technical, scientific and research-based support to national regulatory authorities and governments through systems strengthening efforts

a) Enable the strengthening of regulatory systems at the national and international levels in such critical domains as good manufacturing, clinical, and laboratory practices; curricula development that supports regulatory professionalization; monitoring and evaluation of product quality; laboratory capacity; inspection and surveillance of products throughout the supply chain; pharmacovigilance systems building and analyses; risk assessment, analysis, and management; and making the business case for investments in regulatory systems.

See Section VIII. Other Information for award authorities and regulations.

Program Priorities:

The Food and Drug Administration announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) for the Strengthening of Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products Program. The purpose of the Program is to identify, support, develop, conduct, and coordinate research efforts relating to the establishment of or the strengthening of current regulations in foreign countries for increased safety and effectiveness of FDA-regulated products that are manufactured under those regulations and are destined to the United States market for consumption. The Program seeks to advance FDA's mission by utilizing the WHO’s Member States expertise and extensive international contacts in foods and medical products safety as well as WHO's own programmatic expertise in those areas, to inform and support adequate growing, manufacture, processing, transportation, and distribution of imported products for the protection of public health in the United States. The Program will advance and expand research in support of foods and medical products regulations to ensure that non-compliance with FDA regulations of such products is lowered and that imported products are safe. Additionally, the program will provide a universal public benefit by creating opportunities for collaboration and research development globally, thereby resulting in better-informed and effective foods and medical regulation around the world.

Under this cooperative agreement, the applicant must propose science-based activities that will strengthen the regulatory systems for foods and medical products to ensure that such products are safe and effective. The applicant should track both short-term and long-term goals, and demonstrate how the proposed activities are related to FDA's regulation for foods and medical products under the Food, Drug, Cosmetic Act, as amended.

The application must include the following activities:

1. Propose a plan relying on WHO’s long history of coordinating international collaborative projects in support of foods and medical products safety and its established international contacts, for regulatory systems strengthening to support FDA approaches to increased safety of said products;

2. Identify, support, develop, conduct and coordinate multilateral research efforts in the areas of science and regulations that strengthen regulatory capacity of foreign regulators and advance the FDA's compliance of imported products with FDA regulation for the growing, manufacturing, marketing, transportation, and distribution of said products;

3. Plan, build, adapt, or expand data collection/information sharing mechanisms, management, and reporting protocols necessary to facilitate Program information exchanges, analysis and other research; and

4. Evaluate Program activities, processes, and outcomes, including summation evaluation, to document and disseminate results and outcomes.

Examples of potential research areas through WHO Cooperative Agreement could be, but not limited to:

1. Substandard and Falsified Medical Products (S&F): Development and coordination of a global information and data platform enabling government and academic institutions to initiate research and analyses around the public health risks and supply chains of S&F medical products, and the identification of areas where research would contribute to good regulatory practices and surveillance systems. Analyze various issues of relevance to product regulation, regulatory systems and regulatory capacity across WHO countries and sub-regions that potentially impact the safety and quality of products that reach consumers and patients around the globe. Substandard and falsified medical products may be of poor quality, unsafe or ineffective, threatening the health of those that take them. The problem of substandard and falsified medical products continues to increase, as globalized manufacturing and distribution systems grow ever more complex. That complexity heightens the risk that production errors will occur, or that medicines will degrade between factory and consumer. Increasing demand for medicines, vaccines and other medical products in almost every country, in addition to poor supply-chain management and the growth of e-commerce also creates opportunities for falsified medicines to be introduced into the supply chain. Following the November 2017 release of WHO Reports around substandard and falsified products and WHO Member States consensus around the definitions of substandard and falsified medical products, FDA resources could contribute to the development and sustainability of an information platform that enables governments and members of the research community to utilize the platform s data that would support of a range of future research endeavors. Subsequent research findings and publications would contribute to a much-needed evidence-base around substandard and falsified medical products for policy-makers, researchers, and health and regulatory systems more broadly;

2. Whole Genome Sequencing (WGS): WHO would contribute to the implementation of a global database information systems of genome sequences called GenomeTrakr to support the Program research goals and allow for efficient and timely information sharing with FDA and other partners. WHO will continue its implementation of a global database of genome sequences archived in an open-access genomic reference database called GenomeTrakr. The data in the GenomeTrakr can be used to find the contamination sources of current and future outbreaks. Such a database also enables a wide range of research and analyses opportunities of contributors to and participants in the Trakr. In the event of an outbreak, the agency often needs to trace back the steps an FDA-regulated food has taken to get to the American consumer to be able to identify not just the source of the food but also the specific type of the microbiological agent that caused the illness. WGS gives information at every nucleotide in an organism s genome. It clearly links related isolates from isolates that are genetically distinct, including metadata (year of collection, food, environment, geographical information) can further aid epidemiological analysis. WGS combines multiple microbiological tests into one: AM-R, subtyping, virulence, etc. Reduces outbreak investigation timeline. WGS is a powerful tool that supports outbreak analysis (sequence alone isn t enough). FDA CFSAN has been utilizing whole genome sequencing since 2008.

3. Capacity Building/Continuing Education Program: Develop such program on regulation development for foreign regulators of foods and medical products from select countries.

4. Good Manufacturing Practices: In the first year, draft a plan for how WHO will help countries strengthen their GMP regulatory capacity for foods, human drugs, and medical devices; the plan will describe how GMP strengthening will take place in the subsequent years; and

5. World Health Organization. WHO would coordinate and mobilize global network(s) and platform(s) via conferences, teleconferences and other regular engagements to share regulatory experience and expertise across foods, feeds, and medical products.

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

The following organization is eligible to apply:

• The World Health Organization

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.

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) (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.
• 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 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 Grants.gov 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.
• 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.

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.

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

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.

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.

It is critical that applicants follow the instructions in the Research Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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.

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

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

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

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

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.
• A portion of the budget should be reserved for travel to participate in site visits or attend meetings as requested by the FDA.

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

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

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

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:

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

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects.

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.

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

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.

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

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.

This initiative is not subject to intergovernmental review.

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

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.

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. 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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? Does the project provide significant contribution to support FDA's strategy to ensure the safety of its regulated products to protect the health of the American people?

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

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals based on sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs by using 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).

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).

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.

Applications will be evaluated for scientific and technical merit by an 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.

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.

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 in the HHS Grants Policy Statement.

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 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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 judgment 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 Office of International Program programmatic requirements may be part of the Notice of Award.

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 (HHS) 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, FDA's 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 although specific tasks and activities may be shared among the awardees and FDA as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the cooperative agreement and for day-to-day management of the project or program. The PD(s)/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

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 HHS, PHS, and FDA policies.

Additionally PD/PIs will:

1. Participate in site visits or attend meetings as requested by the FDA. A portion of the budget should be reserved for such travel.

2. FDA may also request data be made available through speaking engagements and publications, presentations at scientific symposia and seminars, while making sure that confidentiality and privacy of the data is protected.

3. The awardees will provide FDA any data obtained from investigations if requested by FDA.

4. Any publication or oral presentation of regarding outcomes of this grant must undergo FDA/CDER review and approval process. This process can take 30-90 days.

2. A.2. FDA Responsibilities

An FDA Project Officer (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.

Additionally, an agency program official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.

FDA will provide technical monitoring and/or guidance of the work, including monitoring of data analysis, interpretation of analytical findings and their significance.

FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.

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. FDA now requires all annual financial expenditure reports to 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 FSR/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. Failure to submit timely reports may affect future funding.

Performance Progress Reporting:

1. Annual progress reports are required. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR).

2. Grants with Multiple Years: When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR).

Information regarding submitting the RPPR is available at https://era.nih.gov/erahelp/commons/default.htm#cshid=1020

PROGRAM INCOME:

1. 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.

2. 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.

3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

PRIOR APPROVAL:

All requests that require prior approval must include the award number and bear the signature of an authorized official of the grantee business office as well as that of the PI/PD. Any requests involving funding issues must include a new proposed budget and a narrative justification of the requested changes. If a grantee questions whether prior approval is required for an activity or cost, they should contact the assigned Grants Management Specialist prior to expenditure of funds for clarification.

Below are activities that require prior approval from FDA:

CHANGE IN SCOPE OR OBJECTIVES

CHANGE IN KEY PERSONNEL

CHANGE IN GRANTEE ORGANIZATION

DEVIATION FROM TERMS AND CONDITIONS OF THE AWARD

CARRYOVER OF UNOBLIGATED BALANCES

NO COST EXTENSIONS

SIGNIFICANT REBUDGETING

.

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 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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 submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Layla I. Batarseh
Office of International Program
Telephone: 301-385-4196
Email: layla.batarseh@fda.hhs.gov

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

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

Awards are made under the authorization of Sections 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.