Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process. National Institutes of Health (NIH)
Components of Participating Organizations	Center for Veterinary Medicine, Office of Research-Veterinary Laboratory Response Network)
Funding Opportunity Title	CVM Vet-LRN Veterinary Diagnostic Laboratory Program - (U18)
Activity Code	U18 Research Demonstration Cooperative Agreements
Announcement Type	New
Related Notices	June 10, 2014 - Notice of Change to Funds Available and Anticipated Number of Awards for PA-12-194. See Notice NOT-FD-14-011. June 19, 2012 - Notice of Correction to Award Budget for PA-12-194. See Notice NOT-FD-12-017.
Funding Opportunity Announcement (FOA) Number	PA-12-194
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) issued by the Food and Drug Administration (FDA) Veterinary Laboratory Response Network (Vet-LRN) Veterinary Diagnostic Laboratory Cooperative Agreement Program (U18) is to solicit applications from institutions/ organizations for inclusion into its Veterinary Diagnostic Cooperative Agreement Program. The Vet-LRN cooperative agreements are intended to provide increased sample analyses in the event of 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. These samples could involve animal food/feed/drugs, environmental samples related to animal food/feed/drug production and/or animal diagnostic necropsy or clinical samples, and will be collected by Federal, State, or local agencies. Numbers of samples and scheduling of samples will be done by the Vet-LRN Program Office (VPO) at the Center for Veterinary Medicine in coordination with State/Local lab authorities. Federal or State surveillance assignments will also be a source of samples for lab analysis. The FDA estimates that the analysis of 100 samples per year would be optimal. These cooperative agreements will also be used to implement standardized analysis results through the usage of standardized methods, equipment platforms (provided by the award), analytical worksheets, and electronic reporting. Also provided will be training and proficiency testing for each method/platform. Minimal quality management systems will be initiated for each lab, based on existing systems in place in each lab and consultations between the VPO and each lab management group. Grantees will also be involved in small-scale, short-term method development and method validation projects as directed by the VPO. Matrix extension assignments may be needed and can have the potential of requiring rapid turn-around times to respond to animal food/drug contamination events. Funds will be awarded for supplies, equipment, personnel time and some of the yearly operating and maintenance costs. Each laboratory shall develop its own consensus decision making, size and format. Federal agency representatives may be invited to be nonmember liaisons or advisors to the laboratory and its meetings. Award funds may not be used for Federal employees to travel to or participate in these meetings.

Posted Date	June 4, 2012
Open Date (Earliest Submission Date)	June 1, 2012 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Application Due Date(s): July 2, 2012, April 15, 2013 and April 15, 2014 are due, by 5:00 PM local time of applicant organization. Resubmission Due Date(s): October 15, 2012, October 15, 2013 and October 15, 2014 are due, by 5:00 PM local time of applicant organization. This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	July, 2012, December 2012, June, 2013, December, 2013, June, 2014 and December 2014
Advisory Council Review	Not Applicable
Earliest Start Date(s)	August, 2012, January, 2013, July, 2013, January 2014, July, 2014 and January 2015
Expiration Date	October 16, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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

1. Objectives

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) Office of Research Veterinary Laboratory Response Network (Vet-LRN) is announcing the availability of cooperative agreements for equipment, supplies, personnel, and training to Vet-LRN 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 surge capacity is needed by Vet-LRN 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.

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-LRN program will add a component that is outside of ORA's usual investigations and testing programs, the examination of veterinary diagnostic samples. Examination of such samples will greatly facilitate 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 program addressing the increasing threat 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). FDA has developed a suite of microbiological screening and analysis methodologies that are used to evaluate foods and food products in such situations. However, in the event of a large-scale outbreak or threat incident, analytical sample capacity in ORA field laboratories has a finite limit, even with the added capacity offered by FDA’s Food Emergency Response Network (FERN).

Vet-LRN laboratories can 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.

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-LRN 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 recipient may be asked to perform selected analyses of diagnostic samples collected and supplied to the laboratory by FDA or other government agencies through FDA. 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 and food ingredients including grains, meats, fish products, dairy products and water.

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-LRN 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 State analytical requirements).

c. Large-scale animal food/drug emergency event surge capacity (in coordination with State analytical requirements).

(2) Providing analytical data for 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. Implementation of standardized quality management systems for laboratories as determined by the VPO

(3) Participation in small-scale method development, method validation and matrix extension work as determined by the VPO.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	Under this announcement, FDA-CVM anticipates providing approximately $500,000 Total Costs (direct costs plus indirect costs) per year in support of this program in Fiscal Year 2012. It is estimated that up to 30 cooperative agreements at the level requested, but not exceeding $16,500 total costs (direct costs plus up to 10% indirect costs) for the first year, will be awarded. The total amount awarded and the number of awards will depend upon the number of applications, quality, duration, and costs of the applications received and subject to the availability of funds. Multiple year awards may be made for laboratories. The total project period for an application requesting support may not exceed five years. Continued funding of a non-competing continuation application is contingent upon satisfactory progress as determined annually by FDA procedures, submission of an acceptable mid-year report (see section VI.2.3), an annual program progress report with the non-competing continuation application, and subject to the availability of Federal funds.
Award Budget	Application budgets are not limited to $15,000 direct, with a maximum of 10% indirect costs.
Award Project Period	An additional 4 years of support, up to $16,500 ($15,000 direct plus a maximum of 10% indirect costs) each year will be available, depending upon fiscal year appropriations, and successful performance. The total project period for an application requesting support may not exceed five years.

FDA 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

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

This cooperative agreement program is only available to Vet-LRN 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 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 the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

To be a Vet-LRN cooperative agreement laboratory, an applicant institution must have an approval letter from the VPO approving the applicant institution as a Vet-LRN 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.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

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

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

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

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

All page limitations described in the SF424 Application Guide and must be followed, with the following exception:

• For this specific FOA, the Research Strategy section is limited to 10 pages.

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

In addition to the three key project areas, the applicant's "Research Strategy" must specifically address the following in the cooperative agreement application:

Laboratory Facilities. A complete description of the name and address of the facility and the name of the most responsible individual of the facility.

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.

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.

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.

Sample Analysis Commitment. The laboratory will be expected to analyze 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 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.

Ability and willingness to perform data entry into eLEXNET 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 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.

Resource Sharing Plan

The following resource sharing policies do not apply to this FOA:
Data Sharing Plan. Not Applicable
Sharing Model Organisms. Not Applicable
Genome Wide Association Studies (GWAS). Not Applicable

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Grants Office. Applications that are incomplete will not be reviewed.

Applicants Must:

Demonstrate ability to meet sample analysis requirements, both capability and capacity.

Be assessed for relevance of the proposed project to program priorities.

Be assessed to determine that program criteria will include overall program balance in terms of geography with respect to existing and projected laboratory sample analysis and testing capacity and capability.

The goal of Vet-LRN’s cooperative agreement program is to complement, develop, and improve Federal, State, Local and tribal animal food/drug safety and security testing programs. This will be accomplished through the provision of equipment, supplies, and personnel; training in current testing methodologies; participation in proficiency testing to establish additional reliable laboratory sample analysis capacity; analysis of surveillance samples; and in cooperation with FDA, participation in method enhancement activities designed to extend analytical capabilities. In the event of a large-scale microbiological or chemical terrorism or natural pathogenic organism outbreak event affecting animal food or drug products, the recipient may be requested to perform selected analyses of animal diagnostic samples, and/or domestic and imported animal food/drug samples collected and supplied to the laboratory by FDA or other government agencies through FDA.

These samples may include diagnostic animal clinical or post mortem samples from sickened animals, environmental samples from animal food or drug production facilities; vermin sampled from feed or food production facilities; and food ingredients including grains, meats, fish products, dairy products and water.

Applications will be given an overall score and judged based on all of the following criteria:

All cooperative agreement projects that are developed at State, local, and tribal levels 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 Federal, State, local, and tribal government FERN laboratories.

The ad hoc expert panel will review the application based on the following scientific and technical merit criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:

The rationale and design to meet the goals of the cooperative agreement.

Cooperators must provide information concerning animal food safety/ threat agent testing in association with suggested animal diagnostic sample or animal food/drug matrices and documentation that they possess the basic analytic resources, including laboratory infrastructure and personnel.

Cooperators must document expertise in the use of pathologic, microbiological and chemical analysis of animal diagnostic specimens and animal food/drugs.

Provide information on the variety and number of samples analyzed in the current testing programs.

Provide information on the adequacy of their facilities, support services, quality control and quality assurance procedures and practices for animal food and environmental sample analysis.

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.

Document the ability to quickly provide measurable, documented results and recommendations that may be shared with other Vet-LRN laboratories.

Cooperator agrees to participate in Vet-LRN programs such as methods development, animal food/drug defense assignments, training, and proficiency testing when available.

Willingness to establish knowledge in and training for utilization of the Incident Command System. http://www.fda.gov/EmergencyPreparedness/EmergencyResponse/ucm253643.htm

(NOTE: Where personnel costs are requested, documentation must be provided to associate these costs with the specific deliverables.)

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

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

For this particular announcement, note the following:

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CVM/Vet-LRN and in accordance with FDA peer review procedures using the review criteria stated below.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PIs have expertise in the use of pathologic, microbiological and chemical analysis of animal diagnostic specimens and animal food/drugs.

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Environment

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

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Applicants can only resubmit once the summary statement has been provided so that reviewers comments can be provided. The reapplication will be assessed based upon adequate response to the reviewers comments. Additional policies on resubmissions can be found in the applicable Application Instruction Guide.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable..

Select Agent Research

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

Resource Sharing Plans

Not Applicable.

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) in accordance with FDA objective review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will receive a written critique.

To be a Vet-LRN cooperative agreement laboratory, an applicant institution must have an approval letter from the VPO approving the applicant institution as a Vet-LRN laboratory prior to the application receipt date.

Applications will be assigned to the appropriate FDA Center. Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

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, and (6) 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 and/or CVM regulated products.

FDA may have additional equipment for Vet-LRN 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 utilization.)

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-LRN. The format and reporting media will be established by Vet-LRN. 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. Participate in regular telephone conference calls with Vet-LRN staff and other cooperative agreement laboratories.
   
   
2. 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.
   
   
3. Participate in site visits or meetings as requested by the FDA.
   
   
4. Any publication or oral presentation of the results of testing must undergo FDA Office of Research and Center review and approval process. This process can take 30-90 days.
   
   
5. The awardees will provide FDA any pathogen isolates obtained from diagnostic cases if requested by FDA. In addition tissues or slides from necropsy samples will be forwarded to laboratories for further evaluation if requested by FDA.

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.

3. Reporting

An agency Program Official or Center Program Director/Project Officer will be responsible for the scientific and programmatic stewardship of the award and will be named in the NoA.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi-annually by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

Required mid-year and annual reports: For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the noncompeting continuation application (PHS 2590) will be considered the program progress report for the fourth quarter of the budget period.

Mid-year progress reports must contain, but are not limited to the following:

1. A status report on the installation, training, and operational readiness of any equipment that is provided;
2. A summary report on any proficiency testing performed;
3. A summary status of samples analyzed and time to complete individual sample testing;
4. A summary description of any other testing performed on the equipment; and
5. Status and results of method extension and enhancement studies.

4. Monitoring Activities

The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer.

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the testing requirements.

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

Reports must be submitted two months prior to the next budget period start date.

A Request for a Non-Competing Continuation Grant Progress Report (PHS 2590) with specific reporting instructions will be sent to Grantees two to three months prior to the start of the next budget period by the CVM Vet-LRN Project Officer.

A Financial Status Report (FSR) is required no later than 90 days after the end of each budget period. A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Renate Reimschuessel
Program Director Vet-LRN
Office of Research
Center for Veterinary Medicine
Food and Drug Administration
8401 Muirkirk Road
Laurel, Maryland 20708
Telephone: (301) 210-4024
Email: renate.reimschuessel@fda.hhs.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Vieda Hubbard
Office of Acquisition and Grants Services (HFA-500)
Food and Drug Administration
5630 Fishers Lane, Room 1079
Rockville, Maryland 20857
Telephone: (301) 827-7177
Email: Vieda.Hubbard@fda.hhs.gov

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

1.A. Access to Research Data through the Freedom of Information Act (FOIA)

The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. The government may withhold information pursuant to the exemptions and exclusions contained in the FOIA. The exact language of the exemptions can be found in the FOIA. Additional information on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR part 5) and FDA regulations implementing the FOIA (21 CFR part 20). Also, see the HHS Web site http://www.hhs.gov/foia/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm

Data included in the application may be considered trade secret or confidential commercial information within the meaning of relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.

1.B. Use of Animals in Research

Recipients of PHS support for activities involving live vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals as applicable http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf as mandated by the Health Research Extension Act of 1985 http://grants.nih.gov/grants/olaw/references/hrea1985.htm and the USDA Animal Welfare Regulations http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

1.C. Smoke-Free Workplace

The PHS strongly encourages all recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

1.D. Authority and Regulation

This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http://www.cfda.gov/

FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 http://www.hhs.gov/grantsnet/adminis/gpd/index.htm