Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations	Office of Regulatory Affairs
Funding Opportunity Title	FDA FERN Microbiological Cooperative Agreement Continuation Program (U18)
Activity Code	U18 Research Demonstration Cooperative Agreements
Announcement Type	Reissue of PAR-09-215
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-FD-12-018
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.448
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions/ organizations for inclusion into FDA's FERN Microbiology Cooperative Agreement Program. The FERN cooperative agreements are intended to target state, local, and tribal FERN labs to provide increased sample analyses in the event of food outbreaks or other large-scale food emergency events requiring surge capacity testing of implicated food samples.  These samples could involve foods and/or environmental samples related to foods, and will be collected by Federal, State, or local agencies. Selected labs with existing sample collection capabilities may be tasked with sample collection activities in support of this program. Numbers of samples and scheduling of samples will be done by the FERN National Program Office (NPO) 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 500 samples per year would be optimal. These cooperative agreements will also be utilized to implement standardized analysis results through the usage of standardized methods, equipment platforms (provided by the grant), 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 FERN NPO 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 FERN NPO.  Matrix extension assignments are also required and can have the potential of requiring rapid turn-around times to respond to food outbreaks. Grant funds will be awarded for the equipment, an FTE and some of the yearly operating and maintenance costs.

Posted Date	May 4, 2012
Open Date (Earliest Submission Date)	May 15, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	July 1, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July, 2012
Advisory Council Review	Not Applicable
Earliest Start Date(s)	August, 2012
Expiration Date	July 2, 2012
Due Dates for E.O. 12372	July 1, 2012

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 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

Background

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Network (FERN) microbiological laboratories of State, local, and tribal governments. The cooperative agreements are to enable the analyses of foods and food products in the event that laboratory surge capacity is needed by FERN and the FDA for analyses related to microbiological contamination, either through intentional or unintentional means. These grants are also intended to expand participation in networks to enhance Federal, State, local, and tribal food safety and security efforts.

ORA is the primary inspection and analysis component of FDA and has some 1,600 investigators, inspectors, and analysts who cover the country's approximately 95,000 FDA regulated businesses. These investigators inspect more than 15,000 facilities a year and ORA laboratories analyze several thousand samples per year. ORA conducts special investigations, conducts food inspection recall audits, performs consumer complaint inspections, and collects samples of regulated products.  ORA also funds a majority of the FERN.   Increasingly, ORA 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 microbiological terrorism events.

Toward these ends, ORA 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. Information from ongoing relationships with State partners through the FERN indicates limited redundancy in State food testing laboratories, both in terms of analytical capabilities and analytical sample capacity. Some State food testing laboratories lack the specialized equipment to perform the analyses and/or the specific methodological expertise in the types of analyses performed for screening foods and food products involving microbiological terrorism events or natural pathogenic organism outbreak.

Recent outbreaks of food borne pathogens serve to highlight the need for the ability to quickly track down and isolate a dangerous pathogen through food testing during a natural outbreak event. These occurrences also make readily apparent the need for surge capabilities of FERN in the event of a large scale outbreak.

The events of September 11, 2001, spotlighted the need to enhance the security of the United States food supply. Congress responded by passing the Bioterrorism Act, which was signed into law on June 12, 2002.

Subtitle A of the Bioterrorism Act, Protection of Food Supply, section 312-Surveillance and Information Grants and Authorities, amends part B of Title III of the Public Health Service Act to authorize the Secretary of Health and Human Services (the Secretary) to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts. This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

Objectives

The goal of ORA's cooperative agreement program is to complement, develop, improve and utilize State, local and Indian tribal food safety and security testing programs. With cooperative agreement grant funds this will be accomplished through the provision of supplies, personnel, facility/equipment upgrades, training in current food testing methodologies, participation in proficiency testing for current food testing 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 contamination events affecting foods or food products, the recipient may be required to perform selected microbiological analyses of domestic and imported food 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: Vegetables and fruits (fresh and packaged); juices (concentrate and diluted); grains and grain products; seafood and other fish products; milk and other dairy products; infant formula; baby foods; bottled water; condiments; and alcoholic products (beer, wine, scotch).

There are three key project areas identified for this grant that must be addressed:

Participation in FDA/FERN sample analysis.  Samples could be collected by Federal, State, or local entities.  Sample sources include:

Surveillance assignments as designated by FERN NPO.

Food emergency outbreak testing (in coordination with State analytical requirements).

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

NOTE: Selected labs with existing sample collection capabilities may be tasked with sample collection activities in support of this program.

Providing of analytical data for potential regulatory utilization through:

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

Participation in proficiency testing and method training provided by FERN NPO.

Implementation of standardized quality management systems for laboratories as determined by FERN NPO.

Participation in small-scale method development, method validation and matrix extension work as determined by FERN NPO.

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. Grant funds may not be used for Federal employees to travel to or participate in these meetings.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Renewal The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The Office of Regulatory Affairs intends to commit approximately $4 million in FY 2012. It is estimated that up to 15 awards will be made, not to exceed $250,000 in total costs (direct and indirect) per award. Future year amounts will depend on annual appropriations..
Award Budget	Application budgets need to reflect actual needs of the proposed project. Not to exceed $250,000 in total costs.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 3 years. Future recommended support will depend on the availability of funds and approved performance.

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

Governments

• State Governments
• County Governments
• Indian/Native American Tribal Governments (Federally Recognized)

This cooperative agreement program is only available to State, Local, and Tribal government FERN laboratories that are currently receiving funding under the FDA FERN Microbiological Cooperative Agreement Program. The FERN microbiological cooperative agreement program laboratories have spent the last three years building capability, capacity and demonstrating competency in FDA regulatory testing methodologies and reporting requirements. These laboratories have developed the quality control measures and standardized procedures that are required by FDA/FERN as a basis for a cohesive national food testing program, and have demonstrated proficiency in a nationally run surveillance program.

All grant application projects that are developed at State, Local, and Tribal levels must have national implication or application that can enhance Federal food safety and security programs. At the discretion of FDA, successful project formats may be made available to interested Federal, State, Local, and Tribal government FERN laboratories.

To be a FERN Microbiological laboratory, an applicant institution must have an approval letter from the FERN National Program Office approving the applicant institution as a FERN laboratory prior to the application receipt date.

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.

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.

Not Applicable.

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 must be followed, with the following exceptions:

• For this specific FOA, the Research Strategy section is limited to 15 pages.

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

The face page of the application should indicate FDA FERN Microbiological Cooperative Agreement Program .

Applications should include the following:

• An applicant specific title which has the term FDA FERN Microbiological Cooperative Agreement Program or other similar description to assist in the identification of the request.

The applicant 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 where the equipment will be installed must be provided.

For the facility, the following information must be provided:

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

(2) Area where the equipment is to be installed. The installation of equipment in a laboratory will require adequate and appropriate space and physical plant supplies (power, water, etc.);

(3) A description of the envisaged space, to include a floor-plan diagram;

(4) 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;

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

(6) A detailed description of any proposed facilities upgrades including drawings and cost estimates; and

(7) A detailed description of laboratory access procedures, including a description of practices and systems which limit access to laboratory space by unauthorized personnel. Additional procedures for access to the space(s) dedicated to the equipment provided, if any, should also be provided.

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 real time PCR, VIDAS, immunomagnetic separation, biochemical analysis and ELISA 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 required to analyze surveillance and emergency response food samples. Therefore, an estimate of the number of food 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 are listed as methods on FERN eLEXNET or the FDA’s Bacteriological Analytical Manual. In addition, if a cooperative agreement is awarded, awardees will be informed of any additional documentation that should be submitted to FERN.

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 FERN NPO 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 FERN NPO should be notified.

Applicants should also consider the application scoring criteria (Significance, Investigator(s), Innovation, Approach and Environment) in Section V. when completing the Research Strategy attachment.

Do not complete the Human Subject section of the PHS 398 Research Plan.

The necessary checklist and assurances pages provided in each application package

Resource Sharing Plan

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

• Generally, Resource Sharing Plans (Data Sharing Plan) 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.

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 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

Only proposed projects designed to address all three project areas will be considered for funding. Applicants may also apply for only facility upgrades, personnel, training, method extension and surveillance sample analysis if they have the necessary equipment and it will be available for these projects. Where personnel costs are requested, documentation must be provided to associate these costs with the specific deliverables.

Funds are not to be utilized to conduct food inspections for food safety regulatory agencies, or for new building construction.

A decrease in the amount of the non-competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Appropriated funds shall not be used to purchase promotional items when they are not a necessary expense.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined by the FDA program/technical staff, the receipt of a non-competing continuation application, submission of an acceptable annual report and the availability of Federal funds

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

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 NIH.

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 Grants Management Office and responsiveness by components of participating organizations, FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in as noted below:

Post-submission grant application materials are those submitted after submission of the grant application but prior to the initial review.  This option is to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, not to correct oversights/errors discovered after submission of the application.

Acceptable post-submission materials include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution (e.g., PI moves to another university)

News of an article accepted for publication (a copy of the article should not be sent)

Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:

Updated Specific Aims or Research Strategy pages

Late-breaking research findings

New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Only the review criteria described below will be considered in the review process. As part of the FDA Mission, all applications submitted to the FDA are evaluated for scientific and technical merit through the FDA initial review process as established by the supporting component and approved through the Grants Management Office.

For this particular announcement, note the following:

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.

Reviewers will consider the applicant responses to the following when scoring the application, and incorporate these responses into their scores within the Significance, Investigator(s), Innovation, Approach and Environment scoring sections below.

• Rationale and design to meet the goals of the cooperative agreement.
• Provide information concerning food safety/ threat agent testing in association with suggested food matrices and documentation that they possess the basic food analytic resources, including laboratory infrastructure and personnel. 
• Document expertise in the use of real time PCR, pathogen analysis, immunomagnetic separation, ELFA, and ELISA in the analysis of foods or environmental samples. 
• Provide information on the variety and number of samples analyzed in the current food or environmental testing programs.
• Provide information on the adequacy of their facilities, support services, quality control and quality assurance procedures and practices for 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 utilizing FERN methods.
• Document the ability to quickly provide measurable, documented results and recommendations that may be shared with other FERN laboratories (state, local, and federal).
• Agrees to participate in FERN programs such as methods development, food defense assignments, training, and proficiency testing when available.
• Document the knowledge in and training for utilization of the Incident Command System.

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 are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Significance=20% of score

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(s)/PI(S), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Investigator=20% of score

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?

Innovation=20% of score

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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Approach=20% of score

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?

Environment=20% of score

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.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

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. For instance, does the amount requested from FDA appear reasonable as partial support of the total work plan, facilities, staff, etc? Is the budget organized, reasonable and clearly stated? Does the budget account for the proposed work plan?

Applications will be evaluated for scientific and technical merit by appropriate Ad Hoc Review Group(s) in accordance with DHHS objective review policy and procedure, using the stated review criteria.

As part of the scientific peer reviews, all applications:

• Will receive a written critique.

Appeals of initial 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 the review group.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the review of the application is completed, the PD/PI will receive a copy of the Summary Statement (written critique) electronically via e-mail. 

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

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their work.

An agency Program Official or Project Officer will be responsible for the normal technical 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

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, the 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. 

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 toxins in food.

FDA will provide guidance on the specific foods to be collected for analysis by the successful applicant.

FDA will purchase and have all needed major equipment for the three project areas delivered to the awardee's laboratory. The equipment purchased by FDA will remain the property of FDA under loan to the awardee s laboratory for a specified time period with a review every twelve months. FDA may terminate the loan at any time. The equipment may not be transferred by the awardees' laboratory to a third party, and the awardees' laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardees' laboratory.

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

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 foods and food products for the rapid detection and identification of pathogenic organisms or toxins. With this in mind, sample analyses should be completed no later than one week after receipt, and the results will be reported to FERN. The format and reporting media will be established by FERN. Shorter timeframes may be sought for special testing such as proficiency tests or special assignments.

Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/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 has 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.

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 DHHS, PHS, and FDA policies.

The PD(s)/PI(s) will have the primary responsibility for:

Overall management of the study and agree to work cooperatively

Developing and implementing systems necessary for communications among the various study organizational components.

All data and samples and shared freely by methods and within time periods to be specified by the Project Officer.

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 DHHS, PHS, and FDA policies.

FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The designated FDA Project Officer will serve as a member of any established the Steering Committee and have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The awardees agree to accept assistance from the designated FDA Project Officer. This person will participate, in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of project activity

Additionally, an agency program official may be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

If a Steering Committee, is established it should be comprised of the PD(s)/PI(s) of the cooperative agreement, the leaders of additional performance sites, the FDA Project Officer, and the FDA agency program official will have primary responsibility for finalizing standard procedures, and measures common to all funded projects. The steering committee will meet every three to six months, or as dictated by the needs of the project. Each full member of the Steering Committee will have one vote, and all major decisions will be determined by majority vote of the Steering Committee. Awardees will be required to accept and implement policies approved by the Steering Committee.

The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of project activity and policy decisions and will define the rules regarding access to data and samples.

Dispute Resolution:

Any disagreements that may arise in technical or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardees. This special dispute resolution procedure does not alter the awardees' right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

A mid-year Progress Report is required no later than 180 days after the award and beginning of the budget period. The mid-year Progress Report should contain a description of project activities covering a six-month period. A report template will be provided to grantees by the Grants Management staff.

Mid-year, Annual and Final 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; and

4. A summary description of any other testing performed on the equipment.

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 following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

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.

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Tim McGrath
FDA/ORA/Division of Field Science
Division of Field Science
5600 Fishers Lane, Rm. 12-41
Rockville, MD  20857
Telephone: (301) 827-1028
Email: [email protected]

William J. Foust
FDA/ORA/Division of Federal-State Relations
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: [email protected]

Gladys Melendez
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 1078
Rockville, MD 20857
Telephone: (301) 827-7175
Fax: 301-827-1044
Email: [email protected]

A full list of policy notices published by FDA or NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. FDA will support the projects covered by this notice under the authority of section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188) (42 USC  247b-20).