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)

Funding Opportunity Title

CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Clinical Trials Not Allowed

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-22-063

Companion Funding Opportunity

None

Assistance Listing Number(s)

 93.103

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions/organizations for inclusion into FDA's Veterinary Laboratory Investigation and Response Network Cooperative Agreement Program for Veterinary Diagnostic Laboratories. These Cooperative agreements are intended to:

1.  Strengthen coordination of veterinary diagnostic laboratory efforts as related to the national food safety system by supporting research and capacity building during case investigations, including chemical, microbiological, pathological, or other complex analyses to help determine cases of potential adulteration or contamination of animal foods or animal drugs.

2. Support validation and harmonization of analytical methods and equipment platforms, supporting research into questions arising during case investigations.

3. Strengthen coordination of veterinary diagnostic laboratory efforts as related to the national food safety system, as put forth in the FDA Food Safety Modernization Act (FSMA) by developing the Vet-LIRN laboratory Network's ability to investigate potential animal foodborne illness outbreaks.

4. Support training, quality assurance processes, proficiency exercises, and data sharing to support development of veterinary diagnostic laboratories.

5. Support laboratory efforts to obtain accreditation (AAVLD, ISO/IEC 17025 accreditation) or adopt a quality system comparable to international standards.

Key Dates
Posted Date

October 22, 2021

Open Date (Earliest Submission Date)

January 10, 2022, January 09, 2023, January 08, 2024

Letter of Intent Due Date(s)

December 10, 2021, December 09, 2022, December 08, 2023, by 11:59 PM Eastern Time

Application Due Date(s)

February 10, 2022, February 10, 2023, February 9, 2024, by 11:59 PM Eastern Time.

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

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

 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2022, March 2023, March 2024

Advisory Council Review

Not Applicable

Earliest Start Date

June 2022, June 2023, June 2024

Expiration Date

February 10, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

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


  4. Table of Contents

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

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


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

    The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) Office of Research Veterinary Laboratory Investigation and Response Network (Vet-LIRN) is announcing the availability of cooperative agreements for equipment, supplies, personnel, and training to Vet-LIRN laboratories in the United States. The cooperative agreements are to enable the analyses of animal diagnostic samples, animal foods, and animal drugs when laboratory investigations or surge testing are needed by Vet-LIRN and the FDA for analyses related to research and testing of microbiological or chemical contamination, either through intentional or unintentional means. These cooperative agreements are also intended to expand participation in networks to enhance Federal, State, local, and tribal food safety and security efforts.

    This program will increase the ability to conduct investigations via laboratory analysis by supporting new and rapid analytical techniques and providing for well-equipped and staffed laboratory facilities. The outcomes will result in increased Vet-LIRN laboratory research and capacity to investigate potential animal foodborne illness outbreaks by fostering training, the use of new technologies, and improving the effectiveness of collaborative partnerships.

    CVM is the FDA Center that regulates animal foods and animal drugs. During the 2007 pet food recall due to melamine adulteration of animal food ingredients, the FDA realized the need to establish rapid communication with veterinary diagnostic laboratories and increase the government’s ability to examine samples from animals adversely affected by contaminated or adulterated products. While FDA’s Office of Regulatory Affairs (ORA) is the primary inspection and analysis component of FDA, the Vet-LIRN program adds an essential component that is outside of ORA's usual investigations and testing programs by testing veterinary diagnostic samples. Examination of such samples has greatly facilitated early detection of animal foods or animal drugs adulteration or contamination. These efforts can contribute to overall food safety as animal food events could signal potential issues in the human food system.

    Increasingly, FDA has been called upon to expand the testing programs addressing the threats to food safety and security through both naturally occurring pathogen outbreaks and intentional terrorism events.  This mission has been expanded even more with the FDA Food Safety Modernization Act. Vet-LIRN’s investigations into reports of illness caused by animal food have led to recalls of contaminated products through investigation and testing that identified chemical or microbiological contaminants. Additional testing methods and matrix expansion to diagnostic samples have been used in such situations. Vet-LIRN laboratories provide an additional resource in the case of a large-scale outbreak or threat incident, which could exceed the analytical sample limits of FDA’s ORA laboratories. Vet-LIRN laboratories provide additional testing to inform FDA’s response to animal foods and animal drugs related contamination. This system of university, state, and federal veterinary diagnostic laboratories leverages their expertise and integrates resources to obtain needed veterinary diagnostic information. This cooperative agreement will facilitate methods standardization, training, validation, and proficiency testing of the partner laboratories. This includes work such as blinded method tests that resulted from research into new methods for testing animal or food samples. Such activities strengthen the overall food safety system by increasing the potential to detect contamination or adulteration which could affect animals raised for human consumption or companion animals consuming ingredients used in both animal and human food products.

    Veterinary diagnostic laboratories have limited redundancy, both in terms of analytical capabilities and analytical sample capacity. Some veterinary diagnostic laboratories lack the specialized equipment to perform the analyses and/or the specific methodological expertise in the types of analyses performed for rapid screening of samples from animals that have been sickened by foods and food products involving microbiological terrorism events or natural pathogenic organism contamination. Even fewer laboratories have sophisticated chemical contamination analytic capabilities. Funding offered by this program can provide laboratories with the infrastructure to enhance their testing capabilities for both microbiological and chemical methodologies.

    The pet food recall of 2007 was followed by the melamine infant formula event in 2008, demonstrating the close ties that animal food ingredients can have with human food. These events also serve to highlight the need for rapid communication, coordination and testing by veterinary diagnostic laboratories and FDA laboratories during contamination events and make readily apparent the need for surge testing by Vet-LIRN in the event of a large-scale outbreak or adulteration incident.

    The goal of CVM's cooperative agreement program is to partner with university, state, and federal veterinary diagnostic laboratory testing programs to identify and prioritize research needs to support CVM's case investigations and strengthen CVM's capability and capacity to conduct case investigations.  It is anticipated that the program's funding will accomplish these goals through the provision of equipment, supplies, and personnel; training in standardized testing methodologies; participation in proficiency testing in those methodologies; participation in method enhancement activities to extend analysis to additional matrices or analytes; and analysis of surveillance and emergency outbreak samples. In the event of large-scale microbiological or chemical contamination events affecting animal foods or animal drugs s, the Vet-LIRN laboratory may be asked to perform selected analyses of diagnostic samples collected and supplied to the laboratory by FDA or other government agencies through FDA, or from other Vet-LIRN laboratories. Some clinical samples may be directly sent to the laboratory, via Vet-LIRN Program Office (VPO) coordination, from a veterinarian working with the VPO on a case investigation. These samples may consist of, but are not limited to, the following: diagnostic animal clinical or post-mortem samples from sickened animals, environmental samples from animal food or animal drug production facilities, vermin sampled from food production facilities, and suppliers and food ingredients including grains, meats, fish products, dairy products and water. Surveillance samples obtained by FDA or collaborating diagnostic laboratories will also be tested. Numbers of samples and scheduling will be determined by the VPO in coordination with the grantees. FDA estimates that the analysis of up to 300 samples per lab per year may be needed. In addition, bacterial isolates from test samples may be submitted to other Vet-LIRN laboratories for further characterization.

    Grantees will conduct testing to investigate animal foods or animal drugs related illnesses or other large-scale animal food/feed emergency events requiring surge testing of implicated diagnostic or animal food samples.

    Grantees may also be involved with small scale, short-term projects as directed by the Vet-LIRN Program Office (VPO).

    There are three key project areas that will need to be addressed if a cooperative agreement award is to be made:

    (1) Participation in FDA/Vet-LIRN sample analysis. Samples could be collected by Federal, State, or local entities. Sample sources include:

    a. Surveillance assignments as designated by the VPO.

    b. Animal foods and animal drugs emergency outbreak testing (in coordination with Federal and State analytical requirements).

    c. Large-scale animal foods and animal drugs emergency event surge testing (in coordination with Federal and State analytical requirements).

    (2) Providing analytical data to support potential regulatory use through:

    a. Use of standardized methods, equipment platforms, and reporting methods (standardized analytical worksheets and electronic results reporting).

    b. Participation in proficiency testing and method training provided by the VPO.

    c. Investigating consumer report cases requested by VPO

    d. Implementation of standardized quality management systems for laboratories as determined by the VPO

    (3) Participation in additional research and special projects such as small-scale method development and/or method validation and matrix extension work as determined by the VPO. Post Award Supplemental Project funding may be available for projects. These projects are designed to address new developments in emerging regulatory science as well as urgent, novel or unmet needs. FDA anticipates additional projects to be conducted in collaboration with other Vet-LIRN laboratories or Federal Networks in response to public health needs that may not yet be known or identified at the time of the original Vet-LIRN award. In some cases, these projects may be conducted by Vet-LIRN laboratories in collaboration with investigators from the Agency. In this case, internal support for the FDA portion will be provided separately from the external support. 

     

    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

    New
    Renewal

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    FDA/CVM intends to fund up to $1,800,000, for fiscal year 2022 in support of this grant program. Funding for FY2023 and FY2024 will be contingent upon annual appropriations and availability of funding.

    It is anticipated that up to fifty (50) awards will be made, not to exceed $150,000 in total costs (direct plus indirect), per award.

    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: $150,000

    YR 02: $150,000

    YR 03: $150,000

    YR 04: $150,000

    YR 05: $150,000

    Award Project Period

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

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession

    NOTE: To be a Vet-LIRN cooperative agreement laboratory, an applicant institution must have an acceptance letter from the Vet-LIRN Project Office (VPO) approving the applicant institution as a Vet-LIRN laboratory prior to the application receipt date.  A copy of the VPO acceptance letter stating the laboratory is in the Vet-LIRN network must be submitted with the application as an appendix.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the HHS Grants Policy Statement, are not 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.

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Rene Vasquez
    Grants Management Specialist
    Email: rene.vasquez@fda.hhs.gov

    A technical session will be held for prospective applicants in January 2022 and as needed in 2023 and 2024.  The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

    Page Limitations

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

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Form

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

    For RENEWAL Applications:

    • 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 FD006700 from 5U01FD006700-02).
    • 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. 

    RENEWAL APPLICATIONS ONLY- 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.

    ALL APPLICATIONS - Research Strategy:

    In addition to the three key project areas:

    (1) Participation in FDA/Vet-LIRN sample analysis

    (2) Providing analytical data to support potential regulatory use

    (3) Participation in additional projects, i.e., method development and validation as determined by the VPO, the applicant's "Research Strategy" must specifically address the following in the cooperative agreement application:

    A: Laboratory Facilities

    A complete description of the name and address of the facility and the name of the most responsible

    individual of the facility must be provided.

    For the facility, the following information must be provided:

    (1) Floor diagrams of the laboratory, including current equipment;

    (2) Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities, such as the numbers and types of biosafety cabinet hoods and chemical fume hoods available;

    (3) Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures; and

    (4) A detailed description of laboratory access procedures, including a description of practices and systems which limit access to laboratory space by unauthorized personnel.

    B: Laboratory Personnel Qualifications

    Qualifications of all personnel that will be assigned to the project must be provided. In particular, information on personnel that have experience in pathologic, microbiological, and chemical analysis of animal diagnostic specimens must be provided.

    C: Laboratory Management Practices 

    For the laboratory, the following management information must be provided:

    (1) A summary description of any security procedures or processes to evaluate the background of laboratory personnel. This should include any procedures to evaluate subcontractors who have access to laboratory space, such as cleaning personnel;

    (2) A summary description of any quality management system defined, in development, or in place as it relates to quality control and quality assurance procedures and practices;

    (3) A summary description of staffing management, specifically to include abilities and procedures in place to recall personnel, establish extended workweeks, etc.; and

    (4) A summary description of procedures in place to monitor sample workflow, including the tracking and monitoring of sample analyses in progress to include a description of the laboratory work product review process. Additionally, the ability to perform and complete the analyses and provide a report of a sample analysis within an agreed upon time frame must be described.

    (5) Indicate that the investigator agrees to comply with the Cooperative Agreement Terms and Conditions of the Award.

    D: Sample Analysis Commitment

    The laboratory will be expected to analyze consumer case related, surveillance and emergency response diagnostic samples. Therefore, an estimate of the number of samples that will be analyzed for pathogenic organisms and toxins must be submitted. This estimate should be for a week period and also a one-year period. The estimate should also address the number of samples that can be analyzed in a one-week period. The procedures to be used should be referenced in the laboratory standard procedures documentation. In addition, if a cooperative agreement is awarded, awardees will be informed of any additional documentation that should be submitted to Vet-LRN. For Vet-LIRN's diagnostic pathogen investigations provide an estimate of the number of samples that can be submitted with appropriate metadata to Vet-LIRN regional sequencing laboratories.

    Ability and willingness to perform data entry into the Vet-LIRN portal or other agreed upon IT systems within agreed upon time frames after sample receipt (analysis dependent). The laboratory will be expected to analyze samples and report the results of the analysis into the Vet-LIRN portal or other agreed-upon system by the agreed upon time span.

    Ability and willingness to inform the VPO immediately upon detecting a sample that is positive for or

    cannot be ruled out for the presence of an analyte. As soon as a presumed positive analytical result for an analyte is obtained, the VPO should be notified.

    E: Laboratory Expertise

    Expertise in analyzing diagnostic specimens to rule out feed-based toxicants or bacteria. In addition, expertise in analyzing food/feed samples should be provided if present. Expertise in susceptibility testing of pathogens should be documented if the laboratory is requesting additional AMR testing funds. Relevant experience in genome sequencing should be described if the laboratory is applying for additional funds for sequencing or related to susceptibility testing if requested funds are for an AMR source lab.

    Laboratories should provide information on proficiency testing and their results from participation in the Vet-LIRN proficiency test program in the past. Participation in proficiency testing documents that a laboratory can provide meaningful data within a specific timeframe.

    F: Equipment

    Applicants should ensure that the equipment that will be used to accomplish the goals of the collaborative agreement is completely described in the facilities section of the application. Identify any equipment provided by Vet-LIRN.

    Unless approved by FDA, FDA provided equipment may not be transferred by the awardee’s laboratory, and the awardee’s laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee’s laboratory.

    NOTE: All equipment loaned by the FDA to selected laboratories must be maintained in working order to support analytical assignments given by the FDA. The FDA requires that all loaned equipment be covered by a service agreement (either a one year renewable or a multiyear service agreement). Grant funds may be used for the service agreements.

    G: Vet-LIRN AMR Monitoring Program

    VPO will consider proposals for funding beyond the base infrastructure to Vet-LIRN network "Source"

    laboratories to provide veterinary pathogen isolates and metadata to Vet-LIRN Whole Genome Sequencing (WGS) laboratories for archiving and sequencing, as well as testing for antimicrobial susceptibility testing with results sent to VPO. Letters of collaboration must accompany the application (in the Appendix). Provide details of the number of samples to be tested prior to submitting to the WGS laboratory. Provide also examples of proficiency testing either conducted to date or planned in the next fiscal year. Identify the methods and equipment platforms that will used to conduct isolate

    characterization. VPO will consider proposals for funding beyond the base infrastructure to Vet-LIRN network laboratories to conduct sequencing on samples from collaborating Vet-LIRN Source laboratories. Provide details of the number of samples that will be analyzed and submitted to Vet-LIRN NCBI BioProjects

    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: To be a Vet-LIRN cooperative agreement laboratory, an applicant institution must have an acceptance letter from the Vet-LIRN Project Office (VPO) approving the applicant institution as a Vet-LIRN laboratory prior to the application receipt date.  A copy of the VPO acceptance letter stating the laboratory is in the Vet-LIRN network must be submitted with the application as an 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. 

    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.

    These cooperative agreements are not to fund or conduct food inspections for food safety regulatory agencies.

    Allowable costs:

    1. Employee salaries, wages and fringe benefits, however, salary costs are limited to 20% of the direct cost

    2. Rental, purchasing, calibration, installation, and maintenance of equipment (service plans).

    3. Indirect costs

    4. Registration Fees

    5. Purchase of IT equipment, software, support. Specific programs may be requested by VPO to support reporting data

    6. Shipping and mailing of equipment, supplies and samples

    7. Travel - Funds should be requested in the budget to travel to meetings with FDA program staff about the progress of the project and for training. A portion of budgeted travel funds should be set aside for key personnel to attend an annual meeting recommended by the VPO and have key personnel to attend on-site visits by FDA. Up to $3000/year can be requested for travel

    8. Case investigations, a minimum of $2000 should be allocated for case investigations

    9. Accreditation fees

    10. Laboratory and office supplies

    11. Special Vet-LIRN projects - Funds should be requested for conducting Vet-LIRN investigations

    requested by VPO and for those Vet-LIRN laboratories participating in the pathogen sequencing project

    Non-allowable costs:

    1. Vehicle purchases

    2. New building construction

    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 (15 Points)

    Does the application demonstrate laboratory capabilities in areas needed by the Vet-LIRN network? Do the plans outline activities that are designed to meet the goals of the collaborative agreement? Will the laboratory be able to fulfill the conditions of the award? Are any research collaborative agreements with other Vet-LIRN partners submitted?   

    Investigator(s) (25 Points)

    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? Do the PIs have expertise in the use of pathologic, microbiological, and chemical analysis of animal diagnostic specimens and animal foods and animal drugs? Have the investigators indicated that they will accept the Cooperative Agreement Terms and Conditions of the Award?  

    Approach (15 Points)

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Does the application document the expertise in the use of desired techniques/technologies? Is the organization able to provide and demonstrate enhanced laboratory response including the abilities and procedures in place to recall personnel and establish extended work weeks and commitment to analyze emergency response samples? Does the strategy document the ability to quickly provide measurable, documented results and recommendations that may be shared with other Vet-LIRN network laboratories?

    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 children, justified in terms of the scientific goals and research strategy proposed? 

    Quality Assurance (20 Points)

    Is the laboratory AAVLD or ISO accredited? Are there any different existing quality systems?

    comparable to international standards used by the laboratory? What type of data management and sharing systems are in place? Has the laboratory participated in proficiency tests which document capability to provide meaningful data within a specific timeframe?

    Environment (25 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? Has a facility diagram been provided? Did the application include information on the variety and number of animal diagnostic specimens, animal foods, and animal drugs analyzed in the current testing programs? Did the application address the adequacy of their facilities, support services, quality control and quality assurance procedures and practices for animal diagnostic specimens, animal foods, and animal drugs analysis? 

    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

    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.

    If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

    Should you successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/forproviders/provider-obligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/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.

    Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

    Additional terms and conditions regarding FDA regulatory and CVM 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. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

    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.

    You must administer your project 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 (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English  proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and  https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

    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 as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

    Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following:

    (1) How often samples will be sent

    (2) Directions on how tests should be executed

    (3) On-site monitoring

    (4) Supply of equipment

    (5) FDA training on processes

    (6) Participation in proficiency tests and

    (7) Enhancement and extension of analytical methodology

    FDA will provide specific procedures and protocols for the three project areas (see section I of this document) to be used for the analysis of pathogens and toxicants in animal diagnostic necropsy or clinical samples, special project studies, and/or CVM regulated products.

    FDA may have additional equipment for Vet-LIRN projects or investigations delivered to the awardee's laboratory if the laboratory can accommodate that equipment. The equipment purchased will remain the property of FDA until such time as released as surplus property. (Title of federally-owned property remains vested in the Federal Government. Recipients shall submit annually an inventory listing of federally-owned property in their custody to the HHS awarding agency. Upon completion of the award or when the property is no longer needed, the recipient shall report the property to the HHS awarding agency for further agency use.)

    Only proposed projects designed to address all three project areas will be considered for funding. Applicants may also apply for personnel, training, method extension and surveillance sample analysis if they have the necessary equipment and it will be available for these projects. These cooperative agreements are not to fund or conduct food inspections for food safety regulatory agencies.

    It should be emphasized that in all of the projects, there is a particular desire to promote continuing, reliable testing for laboratory sample analyses of animal diagnostic necropsy or clinical samples for the rapid detection and identification of pathogenic organisms or toxicants. With this in mind, sample analyses should be completed no later than one week after receipt, and the results will be reported to Vet-LIRN. The format and reporting media will be established by Vet-LIRN. Shorter or longer timeframes may be needed for special testing such as proficiency tests or special assignments.

    2.A. 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.

    Participation in the Vet-LRN program will include access to non-public information from FDA. Therefore, in order to participate, laboratory officials must sign a confidentiality agreement.

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

    Additionally, PD/PIs will:

    1. The laboratory must maintain active participation in the Veterinary Investigation and Response Network (Vet-LIRN) and participate in regular telephone conference calls with Vet-LIRN staff and other cooperative agreement laboratories.

    2. The laboratory must successfully participate in proficiency tests or inter laboratory exercises and share laboratory results through the Vet-LIRN portal or other agreed-upon system.

    3. Cooperate with other awardees in the development and design of testing protocols as well as define common procedures for quality control, data analysis, and interpretation.

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

    5. The awardees will provide FDA any clinical samples obtained from diagnostic or surveillance cases if requested by FDA. Clinical samples include, but are not limited to the following: pathogen isolates, tissues from biopsies or necropsies, and histopathology slides. FDA may request that clinical samples and accompanying metadata be forwarded to FDA, other network or non-network laboratories for further characterization or evaluation.

    6. The awardees will provide FDA any data obtained from investigations if requested by FDA. FDA may also request data be entered into public databases such as Vet-LIRN NCBI BioProjects.

    7. 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.

    8. Any publication or oral presentation of the results of Vet-LIRN testing must undergo FDA Office of Research and Center review and approval process. This process can take 30-90 days.

    2. A.1. 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 direction 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.]

    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)

    Olgica Ceric
    Center for Veterinary Medicine (CVM)
    Telephone: 240-402-5419
    Email: olgica.ceric@fda.hhs.gov

    Objective Review Contact(s)

    Rene Vasquez
    Office of Operations, Office of Finance Budget & Acquisitions
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 301-796-3546
    Email: rene.vasquez@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Rene Vasquez
    Office of Operations, Office of Finance Budget & Acquisitions
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 301-796-3546
    Email: rene.vasquez@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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