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

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

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

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) Office of Research Veterinary Laboratory Investigation and Response Network (Vet-LIRN) is announcing the availability of cooperative agreements for potential research and related activities identified by Vet-LIRN Program Office (VPO). These agreements may include funds for equipment, supplies, personnel, and training for Vet-LIRN laboratories in the United States. The cooperative agreements are designed to facilitate the effective and coordinated 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 (a)(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 (c) to build food defense capabilities by identifying "new and rapid analytical techniques and by providing "for well-equipped and staffed laboratory facilities. Pursuant to Title 1 SEC. 205(c)(1)(D), this program will also "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 recognized the need to strengthen the capacity, collaboration, and integration of food safety laboratories and networks. FDA also recognized 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. For example, the pet food recall of 2007 was followed by the 2008 melamine infant formula contamination in China, demonstrating the close ties that animal food ingredients can have with human food.

Increasingly, FDA has been called upon to expand the testing and research 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 labs, however, 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. FDA s Vet-LIRN Network of university, state and federal veterinary diagnostic laboratories leverages its expertise and integrates resources to obtain needed veterinary diagnostic information. 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.

The nature of being a response network requires a certain amount of flexibility to rapidly adapt to human and animal food safety issues, as well as the needs of the Agency. Results of testing may indicate the need for additional surveillance of specific food product times or analytes. Additionally, the need to develop a new method or expand a test to a new matrix had arisen several times in the years since the creation of the Network. The current cooperative agreement will facilitate research activities that are needed to adapt to current and emerging testing needs. They will also allow the network to leverage emerging technologies such as whole genome sequencing (WGS) to be used during epidemiologic tracebacks and case investigations related to foodborne illness outbreaks. The results of Network testing can provide real time data on emerging animal food safety and public health pathogens needed for the Agency to make informed regulatory decisions.

The current funding opportunity will address areas for potential research and related activities designated by the VPO in order to address emerging needs. Projects may be proactive - to prepare for potential emergency response, or reactive - to respond during a contamination event. For the 2018 FY such areas for potential research and related activities include, but are not limited to:

1. Increasing the capacity of laboratories conducting pathogen susceptibility testing by funding the updating or purchasing of additional equipment.

2. Procurement of supplies needed for WGS testing efforts or method improvement.

3. Purchase of equipment needed to conduct diagnostic testing for Vet-LIRN case investigations.

4. Develop/validate rapid tests to identify the source genera within animal food products.

5. Develop/validate methods to quantify nutritional components in animal food, i.e. Thiamine in cat food.

6. Develop/validate methods to detect contaminants or adulterants in in animal food, i.e. pentobarbital.

7. Conduct increased testing in response to a new need identified by the VPO.

8. Participation in multi-laboratory blinded tests to validate newly developed Vet-LIRN Network methods.

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 unaddressed areas for potential research and related activities that may not yet be known or identified at the time of the original Vet-LIRN award. FDA anticipates supplemental projects to be conducted in collaboration with other Vet-LIRN laboratories or Federal Networks in response to newly identified public health needs. In some cases these projects may be conducted by Vet-LIRN laboratories in collaboration with investigators from the Agency. In this case, internal support for the FDA portion will be provided separately from the external support.

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

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

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Governments

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

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

This cooperative agreement program is only available to Vet-LIRN veterinary diagnostic laboratories. All application projects must have national implication or application that can enhance Federal animal food/drug safety and security programs. At the discretion of FDA, successful project formats will be made available to interested Vet-LRN laboratories

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

In addition, the following material must be provided:

A copy of the VPO acceptance letter stating the laboratory is in the Vet-LIRN network

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

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

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

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

The letter of intent should be sent to:

Bryce Jones
Telephone: 240-402-2111
Email: [email protected]

A technical session will be held for prospective applicants in March 2018. 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 Research Strategy section is limited to 10 pages.

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

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

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.

The applicant must specifically address, and will be critiqued on the following in the cooperative agreement application.

1. The proposed project should enhance the safety of human and animal foods by increasing the capacity of the laboratory to perform activities including research which improves Vet-LIRN network case investigations or surveillance efforts.

2. The applicant laboratory must demonstrate the availability of adequately trained staff and facilities to conduct the proposed activities.

3. For method projects - the applicants must demonstrate the ability to conduct research to forward method development or validation for priority analytes. In addition, collaborators at other laboratories must be identified with letters of support and financial commitments for completing validation activities must be outlined. Provide details of methodology for each proposed analyte.

4. For equipment requests - adequately justify the need for the equipment and describe how it will benefit the public health and safety goals of the Vet-LIRN network. Provide an estimate of the increased capacity for screening samples if part the project will support a surveillance activities.

5. For supply requests - adequately justify the need for the supplies and describe how the supplies will benefit human and animal food safety. Provide a description of how the increased capacity for screening samples will support surveillance activities

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

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.

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

Additional funding restrictions may be part of the Notice of Award.

Allowable costs include but are not limited to:

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.

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.

8. Accreditation fees.

9. Laboratory and office supplies.

10. Additional Special Vet-LIRN projects - projects that arise to respond to outbreaks or high priority food safety events.

Non-allowable costs:

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Has this project been identified as a area for potential research and related activities by the VPO?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For equipment and supply applications: Is this an effective use of funds? Is the relevance/impact of the proposed budget toward achieving the goals/aims of the cooperative agreement?

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

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

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.

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

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

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 Objective Review Committee are adequate and whether substantial changes are clearly evident.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Response to requests by the Vet-LIRN program office to address emerging issues

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.

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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 FDA CENTER NAME programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

SPECIAL TERMS AND CONDITIONS

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Substantive involvement includes, but is not limited to, the following:

(1) General guidance on activities which includes surveillance components

(2) Site visits from the VPO

(3) Providing equipment need by collaborating laboratories, especially if multiple laboratories are collaborating and need similar equipment platforms.

(4) Training for investigators regarding quality and harmonization between laboratories

(5) Opportunities to participate in proficiency tests

(6) Facilitating advancement of research which expands or validates analytical methodology by providing laboratories samples for self evaluations of their method performance.

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

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

4. 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.

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

6. 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.

7. 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.

8. 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.

9. 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.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Dr. Olgica Ceric
Center for Veterinary Medicine (CVM)
Telephone: 240-402-5419
Email: [email protected]

Rene Vasquez
Grants Management Specialist
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-796-3546
Email: [email protected]

Rene Vasquez
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-796-3546
Email: [email protected]

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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.