Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

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

Components of Participating Organizations

FDA Center for Veterinary Medicine (CVM)

Funding Opportunity Title

Vet-LIRN Cooperative Agreement Program to Expand and Validate Testing Methods for Food Contaminants in Animal Diagnostic Specimens (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PA-13-244

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103 

Funding Opportunity Purpose

FDA developed the Veterinary Laboratory Investigation and Response Network (Vet- LIRN, formerly Vet-LRN) to increase the safety of human and animal health by investigating potential adverse events involving animal feed or animal drug contamination or adulteration. The testing of diagnostic specimens adds insight into investigations not routinely obtained from traditional food testing laboratories.  Such investigations require detection methods that are validated for organs and diagnostic samples such as urine and feces, which are not typical food matrices.  It is the purpose of this program to expand and validate detection methods among cooperative agreement laboratories.  This activity is designed to increase the suite of validated methods available for testing during outbreaks or events.  It is also designed to strengthen the collaborations and integration of the network laboratories to encourage seamless interactions during actual emergency related testing. Eligibility is limited to only Vet-LIRN network laboratories.

Key Dates
Posted Date

June 13, 2013

Open Date (Earliest Submission Date)

June 13, 2013

Letter of Intent Due Date(s)

July 1, 2013, March 15, 2014, and March 15, 2015

Application Due Date(s)

July 15, 2013, April 1, 2014 and April 1, 2015, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2013, May 2014 and May 2015

Advisory Council Review

Not Applicable

Earliest Start Date

September 1, 2013, August 1, 2014 and August 1, 2015

Expiration Date

April 2, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Grants Policy Statement). 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.


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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

Purpose:

FDA announces the availability of fiscal year (FY) 2013 funds to expand the Veterinary Laboratory Investigation and Response Network (Vet-LIRN) testing method validation efforts for testing samples on a network wide basis.  This program will address Vet-LIRN’s new programmatic needs consistent with the goals of FDA’s Strategic Priorities: Strategic Goals and Long-Term Objectives 3.2.3 Advance Animal Drug Safety and Effectiveness, Animal Drugs and Feeds Program and 3.2.3.5 Enhance response to food/feed and drug safety events.  Vet-LIRN program goals also will further the goals of the recently signed FDA Food Safety Modernization Act (FSMA) by facilitating laboratory efforts to gain accreditation by demonstrating proficiency in validated network methods.   It is the purpose of this collaborative program to facilitate method validation efforts on a network wide basis.  This new Vet-LIRN program will provide information, training, technical assistance, and technology transfer to network laboratories thereby furthering the testing capabilities of our diagnostic laboratory network.

Vet-LIRN’s mission is to maintain an integrated national and international network of veterinary diagnostic laboratories that can respond to acts of biological or chemical contamination or adulteration of animal feeds or drugs.   The cooperative agreements are designed to develop a suite of validated methods needed to analyze animal tissues, feed, or drug products when a laboratory surge capacity is needed by FDA for analyses related to feed or animal drug contamination.  These efforts will augment public health by ensuring the health of food producing animals and will result in improved human food safety and security. 

The program is expected to use, develop, and improve university, state, and federal veterinary diagnostic laboratories' testing programs to provide additional capabilities and capacity to FDA’s response abilities by providing equipment, supplies, and personnel to develop standardized testing methodologies for use with diagnostic specimens.  Once multi-laboratory validation has been accomplished, laboratories will assist in the transfer and training of those new methods to other Vet-LIRN laboratories.  In the event of large-scale microbiological or chemical contamination events affecting animal food/drug products, the recipients of funding may be asked to perform selected analyses of diagnostic samples collected and supplied to the laboratory by FDA or other government agencies through FDA.  The development of validated standard test methods will increase Vet-LIRN laboratory testing capability and capacity in order to serve Center for Veterinary Medicine’s needs for rapid turn-around times when responding to animal food/drug contamination events

Specific Areas of Interest:

FDA currently has standardized methods for a variety of food matrices, but is lacking methods for samples such as diagnostic animal clinical or post mortem samples from sickened animals or vermin sampled from food production facilities.  The current testing methodologies need to be expanded to the diagnostic matrices, and “in network” validation testing must be conducted to provide the network with standardized methods.  Hence, FDA is requesting proposals to develop methods for chemicals or pathogens which pose threats to animal feeds either as unintentional contaminants, or possible economic or bioterrorism adulterants. 

The methods must be validated for use with animal tissues or diagnostic samples such as blood, milk or urine.  Analytes of interest will be selected based on past reports of animal feed contamination events, importance for human food safety and effectiveness as indicators of metabolic alterations from excess ingestion.  The analytes of interest include, but are not limited to Mycotoxins (such as Aflatoxins, Ochratoxins, Patulin, Deoxynivalenol (DON vomitoxin), Zearalenone, Fumonisins, Penitrem A, Roquefortine), Phytotoxins, anticoagulants, and pesticides.  Additional analytes which may be present unintentionally or in excess in feeds include food additives such as glycerol, xylitol, sorbitol, and nitrites and trace elements such as copper, and zinc.    Validations of methods to detect microbial pathogens or enterotoxins are also needed for various tissue matrices.

Proposals should include:

1. A description of the preliminary method for each analyte and the matrix for testing validation
   (eg: Aflatoxin M1 in kidney and urine). 

2. A timeline and milestones for method expansion for each matrix.

3. Preliminary data on how the method performs.

4. A description of the validation procedures and how they comply with accepted validation protocols
   (see FDA Office of Foods validation procedures http://www.fda.gov/ScienceResearch/FieldScience/ucm273423.htm, also a FERN level 3 validation testing, the guideline can be requested from the Vet-LIRN program office or protocols such as AAOC guidelines    http://www.aoac.org/Official_Methods/Collaborative_Study_Validation_Guidelines.pdf).

5. A description of the collaborators in other Vet-LIRN laboratories, funding, or collaboration 
    agreements describing the work to be conducted in the collaborating laboratories.

6. A plan and milestones for transferring the method to other Vet-LIRN laboratories.

7. A description of the draft documentation which will be submitted following collaborative testing validation.

8. Timeline and milestones for the entire project.

Proposals that have multiple Vet-LIRN laboratory partners collaborating to validate methods will receive funding preference.

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.

Application Types Allowed

New

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

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.

FDA intends to fund up to 9 awards, corresponding to a total of $700,000, for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $99,000 total costs (direct and indirect costs) and need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application requesting support may not exceed five years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Only State, Federal, or University Vet-LIRN Laboratories are eligible for this award.   A Vet-LIRN Network acceptance letter must be on file with the Vet-LIRN Program Office at the time of application.

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. The HHS Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 HHS 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.

To be eligible the program director/principal investigator must be affiliated with the Vet-LIRN network laboratory, the applicant institution must have an approval letter from the VPO approving the applicant institution as a Vet-LIRN laboratory and the institution must have a current confidentiality agreement with HHS.

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.  

FDA will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the HHS Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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 IC staff to estimate the potential review workload and plan the review.   This letter will also allow the Vet-LIRN program office to notify potential applicants about a technical call to explain technical aspects of the program announcement.

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

The letter of intent should be emailed to renate.reimschuessel@fda.hhs.gov  and Oluyemisi.Akinneye@fda.hhs.gov.

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:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Letters of Support:  Include letters of support from laboratories collaborating for the validation of the proposed method

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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. FDA 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.  If a changed/corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

 Indirect costs are limited to 10%

Allowable costs:


1. Employee salaries, wages and fringe benefits, however, salary costs are limited to 30% of the direct cost.

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

3. Indirect costs up to 10% of direct.

4. Registration fees.

5. Purchase of IT equipment, software, support.

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.

8. Accreditation fees.

9. Laboratory and office supplies.

10. Subcontracting to third parties to participate in validation trials is recommended and allowed, but limited to 25% of each year's award. Participants in validation may provide "in Kind" support for validation instead of subcontracting.  Include a letter of support describing the "in Kind" contribution.

11. Research animals and associated costs for housing, husbandry and veterinary care.

Non-allowable costs:

1. Vehicle purchases.

2. New building construction.

3. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Funding Plan:  Funding for years 2 - 5 will be noncompetitive continuation of support and will depend on performance, program progress, and the availability of Federal funds.  

6. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 Managment. 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 by the Office of Acquisition and Grants (OAGS) and for responsiveness by the Vet-LIRN program office of FDA. Applications that are incomplete or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.,

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.

For this particular announcement, note the following: Review criteria are program specific and only the review criteria described below will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address the goals and needs of the cooperative agreement program?  Are the analytes chosen for method development important for feed/food safety?    20%  

Investigator(s)    

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 in developing methods?  Since the project is collaborative, has the investigator recruited other investigators with complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 30%  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 20 % 

Environment

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?  10% 

Collaboration

Does the project include a strong multi-laboratory validation component?  Are communications adequate for inter-laboratory studies?  Have adequate resources been allocated to the collaborative component of the project to ensure successful conclusion of the project in the established timeline.  20%  

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

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) Genome Wide Association Studies (GWAS).

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 Panel in accordance with FDA peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Appeals of initial peer 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 PA.  The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via email. 

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

Support will be in the form of a cooperative agreement. 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:

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur. There may be other regular meetings with the recipient(s) to assist in fulfilling the requirements of the cooperative agreement. Monitoring of the recipient should demonstrate that the laboratory is achieving the goals of the cooperative agreement and proposal.

The purpose of these cooperative agreements is to enhance FDA's ability to investigate potential adverse events involving animal feed or animal drug contamination or adulteration. By expanding the suite of validated methods for such contaminants in organs and diagnostic samples such as urine and feces, which are not typical food matrices, FDA will obtain greater insights into potential causes of feed related illnesses, information not routinely obtained from traditional food testing laboratories.

The following conditions of the award will apply to all funded applicants and must be maintained throughout the cooperative agreement.

1. The laboratory must maintain active participation in the Veterinary Investigation and Response Network (Vet-LIRN).

2. The laboratory must successfully participate in proficiency testing programs and share laboratory results through eLEXNET.

3. The awardees will participate in conference calls with the VPO and other laboratories funded in this program.

4.  The awardees will transfer methods and funds as agreed upon to other collaborating partner laboratories for multi-laboratory validation.

5.  The awardees will cooperate with other awardees in the development and design of the validation criteria and protocols.

6.  The awardees will define common procedures for quality control, data analysis, and interpretation.

7.  The awardees will develop and use uniform reporting forms.

8.  The awardees will work in a collaborative and collegial manner to foster the goals of the study.

9   Any publication or oral presentation of the results of this research project must undergo the usual FDA Office of Research and Center review and approval process. This process can take 30-90 days.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the HHS Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

A final progress report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management specialist within 90 days of the budget period end date of each twelve month cooperative agreement.  Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement. 

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required.  For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period. 

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.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Annual progress reports should include detailed progress on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal.  They should also provide details on the progress of the inter-laboratory collaborations and proficiency tests that the laboratory participated in.  If a template is provided by the VPO, the report should include that in the report.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding HHS grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Renate Reimschuessel
Director: Vet-LIRN
Food & Drug Administration
Center For Veterinary Medicine
Phone: 301-210-4024
Phone: renate.reimschuessel@fda.hhs.gov

Objective Review Contact(s)

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov

Financial/Grants Management Contact(s)

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov

Section VIII. Other Information

Recently issued trans-HHS policy notices may affect your application submission.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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NIH Funding Opportunities and Notices



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