U.S. Food and Drug Administration (FDA)
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.
Center for Veterinary Medicine (CVM)
CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18)
U18 Research Demonstration – Cooperative Agreements
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. This cooperative agreement program is intended to build domestic laboratory capacity as put forth in the Food Safety Modernization Act (FSMA), by developing the Vet-LIRN laboratory Network capabilities and capacity to investigate potential animal foodborne illness outbreaks.
The Cooperative agreements are intended to:
1. Strengthen coordination of veterinary diagnostic laboratory efforts as related to the national food safety system
2. Support training, quality assurance processes, proficiency evaluations, data sharing to support national capacity/capability development.
3. Support harmonizing analytical methods and equipment platforms.
4. Support laboratory efforts to obtain accreditation (AAVLD, ISO/IEC 17025 accreditation) or adopt a quality system comparable to international standards.
5. Provide testing results during case investigations of potential animal food or drug adulteration or contamination.
January 27, 2017
February 22, 2017
February 15, 2017
April 23, 2017, February 15, 2018, February 15, 2019, 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.
May 2017, March 2018, March 2018
February 16, 2019)
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The Food and Drug Administration (FDA), 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 and animal food/drug products in the event that laboratory investigations or surge capacity are needed by Vet-LIRN and the FDA for analyses related to 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. The Vet-LIRN cooperative agreements are intended to fulfill requirements put forth in the Food Safety Modernization Act (FSMA) - Title 1 SEC. 110, SEC E, Building Domestic Capacity via development and enhancement of “surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks.”
This program will increase capability for laboratory analysis as outlined in Title 1 SEC. 110, SEC E to build food defense capabilities by “identifying new and rapid analytical techniques” and “to provide for well-equipped and staffed laboratory facilities” and Title 1 SEC. 205. SEC D. to “Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of foodborne illness.” The outcomes will result in increased Vet-LIRN laboratory capabilities 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 food 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, the examination of veterinary diagnostic samples. Examination of such samples has greatly facilitated early detection of animal food/drug 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 Food Safety Modernization Act (FSMA). Vet-LIRN’s investigations into reports of illness caused by animal food have led to recalls of contaminated products. Additional testing capabilities and matrix expansion to diagnostic samples have been used in such situations. Vet-LIRN laboratories provide an additional resource in the case of large-scale outbreak or threat incident, which could exceed the analytical sample capacity of FDA’s ORA laboratories. Vet-LIRN laboratories provide additional capabilities and capacity to FDA’s response to animal food/drug 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 and proficiency testing of the partner laboratories. Such activities strengthen the overall food safety system by developing increased capacity and capabilities to detect 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 which 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 capabilities by Vet-LIRN in the event of a large scale outbreak or adulteration incident.
The goal of CVM's cooperative agreement program is to complement, develop, improve and use university, state, and federal veterinary diagnostic laboratories testing programs. 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 capability; and analysis of surveillance and emergency outbreak samples. In the event of large-scale microbiological or chemical contamination events affecting animal food/drug products, 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 food or drug production facilities, vermin sampled from food production facilities or 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 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 food or drug related illnesses or other large-scale animal food/feed emergency events requiring surge capacity 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 food/drug emergency outbreak testing (in coordination with Federal and State analytical requirements).
c. Large-scale animal food/drug emergency event surge capacity (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 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.SeeSection VIII. Other Information for award authorities and regulations.
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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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 $1,200,000, for fiscal year 2017 in support of this grant program.
It is anticipated that up to thirty-five (35) awards will be made, not to exceed $75,000 in total costs (direct plus indirect), per award.
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: $75,000
YR 02: $75,000
YR 03: $75,000
YR 04: $75,000
YR 05: $75,000
The scope of the proposed project should determine the project period. The maximum project period is five (5) years.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
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)
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.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
To be a Vet-LIRN cooperative agreement laboratory, an applicant institution must have an acceptance letter from the VPO approving the applicant institution as a Vet-LIRN laboratory prior to the application receipt date.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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:
The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:
A technical session will be held for prospective applicants in March 2017. 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.
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:
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 eLEXNET or Securesheet 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 eLEXNET or Securesheet 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.
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 laboratory capability to provide meaningful data within a specific timeframe.
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 Sequencing Project.
VPO will consider proposals for funding beyond the base infrastructure to Vet-LIRN network "Source" laboratories with Research Collaborative Agreements (RCAs) to provide veterinary pathogen isolates and metadata to Vet-LIRN Regional Whole Genome Sequencing (WGS) laboratories for archiving and sequencing. Letters of collaboration or copies of the RCAs/MTAs 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 with WGS capabilities conducting 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:
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.
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
These cooperative agreements are not to fund or conduct food inspections for food safety regulatory agencies.
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
1. Vehicle purchases
2. New building construction
Additional funding restrictions may be part of the Notice of Award.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process.
Reviewers will consider each of the review criteria below in the determination of scientific merit.
Does the 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PIs have expertise in the use of pathologic, microbiological, and chemical analysis of animal diagnostic specimens and animal food/drugs? Have the investigators indicated that they will accept the Cooperative Agreement Terms and Conditions of the Award?
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?
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 capability 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 FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals 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?
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 and animal food/drugs samples 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 and animal food/drugs samples analysis?
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.
For research that involves human subjects but does not involve one of the six 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 six 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.
When the proposed project involves human subjects and/or FDA-defined 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 children 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.
As part of the objective review, all applications:
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:
Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all FDA grants and cooperative agreements.
HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.
Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.
Additional terms and conditions regarding FDA regulatory and CVM programmatic requirements may be part of the Notice of Award.
Cooperative Agreement Terms and Conditions of Award
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:
(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 a continuing, reliable capability and capacity 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. 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 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.
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.
2.A.1. Principal Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the cooperative agreement and for day-to-day management of the project or program. The PD(s)/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.
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 eLEXNET or Secure sheet
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: pathogen isolates, tissues from biopsies or necropsies, histopathology slides, etc. 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.2. FDA Responsibilities
An FDA Project Officer (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.
Additionally, an agency program official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.
FDA will provide technical monitoring and/or 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.
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 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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
Contact Center Telephone: 800-518-4726
Center for Veterinary Medicine (CVM))
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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