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 Veterinary Medicine (CVM)
Center for Food Safety and Applied Nutrition (CFSAN)

Funding Opportunity Title

Strategies that Support Global Food Safety (U01) Clinical Trial Not Allowed

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • May 27, 2021 - Notice to Extend the Application Due Date for RFA-FD-21-030. See Notice NOT-FD-21-015.

Funding Opportunity Announcement (FOA) Number

RFA-FDA-21-030

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.103 

Funding Opportunity Purpose

FDA announces its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) Department of Food Safety and Zoonoses (FOS) to support strategies that address global food safety.

This Cooperative Agreement is expected to contribute to the knowledge base of the current state of food safety and its accompanying scientific research to a global audience, including challenges, risks and emerging food safety trends, and other food safety research based on WHO’s existing network efforts, such as the Global Foodborne Infections Network (GFN), International Food Safety Authorities Network (INFOSAN), Global Environment Monitoring System for Food (GEMS/Food); Global Early Warning Systems for Animal Diseases Including Zoonoses (GLEWS); Foodborne Disease Burden Epidemiology Reference Group (FERG); Enable the sharing of scientific research findings and data through expert meetings, informational documents summarizing the latest research, investigations, studies, and technical consultations; Enhance capacity at international and national levels in such areas of laboratory analyses and scientific research engagement, surveillance, and risk assessment/risk management, including through the Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR); Contribute to the scientific, standard-setting work of the Codex Alimentarius Commission (Codex) through scientific advisory groups including the Joint Food and Agriculture Organization of the United Nations (FAO)/WHO Expert Committee on Food Additives (JECFA), the Joint FAO/WHO Meetings on Pesticide Residues (JMPR), the FAO/WHO Joint Meetings on Microbiological Risk Assessment (JEMRA), and the Joint FAO/WHO Expert Meetings on Nutrition (JEMNU) currently in development phase; Food safety projects (including the promotion of current scientific research) of mutual interest, and Enable participation of Member States through the Codex Trust Fund.   

Key Dates
Posted Date

March 25, 2021

Open Date (Earliest Submission Date)

March 25, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New Date - June 14, 2021, by 11:59 PM Eastern Time (as per NOT-FD-21-015).

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

June 2021

Advisory Council Review

Not Applicable

Earliest Start Date

September 2021

Expiration Date

May 25, 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.


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

WHO has responsibility for the provision of technical cooperation to its 194 Member States (national governments) in the area of food safety and zoonotic diseases.  Among the focus areas are: promoting relevant food safety research and relevant guidance, surveillance for food borne disease; identification of food contamination; management of mechanisms for information sharing; and 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 from a focus on food safety interventions at ports-of-entry toward an approach that emphasizes preventive, risk-based efforts incorporating the latest scientific studies and best-practices.  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)).  Codex was founded in 1963 to develop food standards, guidelines, and other related texts, such as codes of practice, under the Joint FAO/WHO Food Standards Programme. Currently, 185 Member States, including the United States through FDA and other U.S. Government agency technical and scientific experts, actively participate in Codex.

A significant outcome of the 63rd World Health Assembly in 2010 was a consensus resolution on advancing food safety initiatives, which, among other items, acknowledged the continuing need for closer collaboration between the health sector and other sectors, and increased action on food safety at the international and national levels, across the full length of the food-production chain, in order to reduce and prevent the incidence of food borne disease.  This resolution also closed a ten year gap in WHO governance dialogue on global food safety challenges, providing all Member States with a general pathway for global collaboration and enforcing the Secretariat’s role in technical cooperation. More recently, the 73rd World Health Assembly (2020) directed WHO to work on efforts to strengthen its food safety efforts by utilizing new technologies and scientific research outcomes and report out to member states on progress. It is imperative that FDA engage in these follow-up and implementation discussions (https://www.who.int/news/item/07-08-2020-73rd-world-health-assembly-decisions).

The FIVE KEYS TO SAFER FOOD was developed by WHO in collaboration with FDA.  The WHO FIVE KEYS TO SAFER FOOD provides training materials for consumers in the home and is now recognized as an international source for conducting national food safety education programs.  In 2008, a joint Food and Agriculture Organization (FAO)/WHO Expert Meeting on the microbiological hazards in fresh leafy vegetables and herbs also acknowledged the success of the FIVE KEYS TO SAFER FOOD as it reviewed the scientific data and made recommendations for limiting the risks associated with microbial contamination of these products.  An important recommendation from the meeting was the suggestion that WHO develop training and educational materials based on the FIVE KEYS TO SAFER FOOD concept.  As a result, WHO, working together with FDA, developed FIVE KEYS to Growing Safer Fruits and Vegetables: Promoting Health by Decreasing Microbial Contamination, a training program designed for educating rural workers who grow fresh fruits and vegetables for themselves, their families and for sale in local markets.

For nearly 30 years, FDA, through the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), has participated with WHO to support its 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). The evaluations that are produced by JECFA and the Expert Consultations provide a sound scientific basis for Codex's standard-setting activities that contribute to improved public health and food safety worldwide.

Many elements of preventive risk-based approaches to food safety reside within WHO.  For example:

•          The International Networks of Food Safety Authorities (INFOSAN), a joint FAO/WHO program consisting of 177 Member States, which aims to promote the rapid exchange of information during food safety related events, promote partnership and collaboration between countries, and help countries to strengthen their capacity to manage food safety risks;

•          The Global Foodborne Infections Network (GFN), a network of over 1,500 individuals from 700 institutions in 177 countries, that provide human resource expertise to promote integrated, laboratory-based surveillance and intersectoral collaboration in human health, veterinary, and food-related disciplines;

•          The Global Early Warning Systems for Animal Diseases Including Zoonoses (GLEWS), a joint system that coordinates alert mechanisms of the WHO, the FAO, and the World Organization for Animal Health (OIE) to assist in prediction, prevention, and control of zoonotic disease threats;

•          The Global Environment Monitoring System for Food (GEMS/Food), a program, which focuses on data collection and training related to dietary exposure of chemical hazards and involves a network of WHO Collaborating Center and national institutions from around the globe;

•          JECFA, the Joint FAO/WHO Meetings on Pesticide Residues (JMPR), the Joint FAO/WHO Meetings on Microbiological Risk Assessment (JEMRA), and the Joint FAO/WHO Expert Meetings on

•          The management of the Codex Trust Fund that supports active participation by developing countries in Codex standard setting activities.

•          The FIVE KEYS TO SAFER FOOD training materials developed to educate food handlers in safe food handling practices and FIVE KEYS to Growing Safer Fruits and Vegetables: Promoting Health by Decreasing Microbial Contamination, to educate rural farmers and workers.

•          AGISAR-  Advisory Group on Integrated Surveillance for Antimicrobial Resistance (AGISAR), which works to reduce the impact of antimicrobial resistance from the use of antimicrobial drugs in food animals through engagement with scientific research projects.

•          Foodborne Disease Burden Epidemiology Reference Group (FERG)- reports to the World Health Organization their estimates of the incidence, mortality, and disease burden caused by 31 foodborne hazards, and FERG is expected to use the period 2021-2026 to update its estimates based on the latest scientific research and trends

DETAILS

The cooperative agreement announced in this FOA represents the continuation of a long-standing collaboration between WHO and FDA in support of strategies and approaches that align with FDA's domestic and global food safety interests.  Relevant strategies include: 1) efforts to strengthen data and information systems so they are comparable, comprehensive, and robust, thereby allowing for better decision-making for all Member States; 2) enhanced capacity around the globe to improve detection of and response to food safety threats through preventive controls, data,

information, surveillance systems, and risk-based approaches; 3) promoting the latest scientific research relevant to food safety; and 4) global harmonization of science- based standards and adoption or adaption of international standards by national authorities.

This Cooperative Agreement is expected to support the following types of collaboration:

  • Contribute to the knowledge base of the current state of food safety globally, including challenges, risks, and emerging trends through an integrated information system based on  WHO's existing network efforts such as GFN, INFOSAN, GEMS/Food GLEWs, and FERG.
  • Enhance capacity at international and national levels in such areas of laboratory analyses,   surveillance, and risk assessment/risk management, including scientific research through AGISAR;
  • Contribute to the scientific, standard-setting work of Codex through scientific advisory groups including JECFA, JMPR, JEMRA, and JEMNU; and
  • Enable participation of Member States through the Codex Trust Fund.
  • Pursue food safety projects of mutual interest, including the promotion of the latest scientific research and its applications to food safety

Inherent in the cooperative agreement award is substantive involvement by the awarding agency. Accordingly, FDA will be actively engaged in the programmatic activities of the entire project funded by this cooperative agreement, including but not limited, to the following items:

FDA will appoint a project officer who will actively monitor the FDA-supported program under

this award and work closely and collaboratively with a core group of experts.  This core group of technical experts (CG/TE) from CFSAN, CVM, the Office of International Programs and other key areas in FDA will provide technical guidance and advice, as appropriate, to WHO in the implementation of this cooperative agreement.  Support can be from various sources including in-kind participation.

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. An award will provide one (1) year of support and include future recommended support for four (4) additional years contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/CFSAN intends to fund up to $1,000,000, for fiscal year 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: $1,000,000

YR 02: $1,000,000

YR 03: $1,000,000

YR 04: $1,000,000

YR 05: $1,000,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five (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

 The World Health Organization (WHO) Department of Food Safety and Zoonoses (FOS)

 
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 12 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 FD005937 from 5U01FD005937-05).
  • 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) (20 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 (15 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 (25 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?  

Environment (15 Points)

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?   

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.

Budget and Period of Support

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

2. Review and Selection Process

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

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the awardee must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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 CFSAN 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 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.

Special Terms and Conditions of Award

1. In recognition of WHO’s status as an international organization and the nonapplicability of national laws to its activities, WHO shall be responsible for administering the Notice of Award (NOA) in accordance with its rules and regulations. The parties acknowledge the existence of the terms and conditions set forth in “Section III --“TERMS AND CONDITIONS.  Without prejudice to its status as international organization and to its privileges and immunities, WHO will undertake all reasonable efforts to accommodate the terms and conditions set forth in Section III above. Notwithstanding the foregoing, in case of conflict or overlap between Section III and Section IV, Section IV shall prevail.

2. Should FDA or WHO become aware of any conflicts between WHO’s administration of the funds and the applicable grant regulations issued by the US Department of Health and Human Services (HHS) and/or U.S. laws, the parties shall notify one another and make reasonable efforts to find a mutually acceptable compromise solution.

3. Payment under this award will be made through the U.S. Department of Health and Human Services Payment Management System (DHHS). Recipient should request funds based on immediate disbursement requirements and disburse funds as soon as possible to minimize the Federal cash on hand in accordance with the policies established by the U.S. Treasury Department. FDA is not responsible for reimbursing the recipient for expired funds due to lack of periodic submission of voucher/invoices for payment. Future recommended support will be dependent on successful performance, and the availability of funds.

4. Cooperative Agreement: The administrative and funding mechanism used for this program is cooperative agreement, an "assistance" mechanism in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities.

5. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipients for the project, although specific tasks and activities may be shared among the recipients and FDA as defined below.

6. The recipient is responsible for obtaining approval for the development and design of FDA projects prior to execution.

7. The FDA, through the PO, will have access to methodologies and training tools, as well as report cleared for public dissemination, generated under this Cooperative Agreement and may periodically review these as well as progress reports two times a year. The FDA PO may use information obtained from these for the preparation

8. Nothing in this Notice of Grant or in any document relating thereto, shall be construed as constituting a waiver of privileges or immunities of WHO, or as its acceptance of the jurisdiction of the courts of any country over disputes arising out of this Agreement.

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 and dominant role in:

Planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.  

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.

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

The Project Scientist will monitor the project-related activities of the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the Project Scientist and the PD/PI.  Periodic site visits with the PD/PI and other officials of the grantee organization may also occur.  The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the Project Scientist.  In addition,

a.  FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.

b.  FDA will be directly involved in the guidance and development of the program. 

c.  The FDA Project Scientist will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

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

Areas of Joint Responsibility include:

Parties will have equal representation on all steering, project, scientific, and other committees formed to discuss only the work performed under this agreement.  This representation will include equal voting rights on projects and processes directly related to work carried out under this agreement.

Parties will act in good faith to recruit, develop, and maintain committee membership to include stakeholders representing sectors affected by the work performed under this agreement, e.g. academic investigators, medical device industry, healthcare providers, health care delivery organizations, professional organizations, and patient organizations, who can provide scientific input that may improve the outcomes of the work performed under this agreement.  These additional members may have voting rights, where appropriate according to written governance documents developed under this agreement.

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)

Julie Moss
Food and Drug Administration
Center of Food Safety and Applied Nutrition (CFSAN)
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: 240-402-2031
Email: Julie.Moss@fda.hhs.gov

Objective Review Contact(s)

Kiara Fowler

Office of Acquisitions & Grants Services (OAGS)

Food and Drug Administration

Telephone: 240-402-3099

Email: Kiara.fowler@fda.hhs.gov

Financial/Grants Management Contact(s)

Kiara Fowler

Office of Acquisitions & Grants Services (OAGS)

Food and Drug Administration

Telephone: 240-402-3099

Email: Kiara.Fowler@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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