Part I Overview Information


Department of Health and Human Services

Participating Organizations
Food and Drug Administration (FDA) http://www.fda.gov

Components of Participating Organizations
N/A

Title:  FDA FERN Microbiological Cooperative Agreement Program (U18)

Note:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-09-215

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.103

Key Dates
Release/Posted Date: June 16, 2009
Opening Date: June 15, 2009 (Earliest date an application may be submitted to Grants.gov)

Letters of Intent Receipt Date(s): N/A
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s):  July 29, 2009, July 29, 2010, July 29, 2011
AIDS Application Due Date(s): N/A
Peer Review Date(s): August 2009, August 2010, August 2011
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): September, 2009, September 2010, September 2011 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July 30, 2011

Due Dates for E.O. 12372
Single Point of Contact program under E.O. 12372 is applicable for FDA. http://www.whitehouse.gov/omb/grants/spoc.html

Additional Overview Content

Executive Summary

These grant 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.

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.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements

3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Objectives

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 Laboratory 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 that 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 Food Emergency Response Network.   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.

The 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.

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:

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

a.     Surveillance assignments as designated by FERN NPO.

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

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

(2)           Providing of analytical data for potential regulatory utilization through:

a.     Usage 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 FERN NPO.

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

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

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). This program is described in the Catalog of Federal Domestic Assistance under number 93.448.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the U18 Cooperative Agreement award mechanism to provide support for testing, by means of a research design, the effectiveness of the transfer and application of techniques or interventions derived from a research base for the control of diseases or disorders or for the promotion of health.  The project should be capable of making conclusions which are generalizable to other sites.  These are usually cooperative programs between participating principal investigators, institutions, and the Food and Drug Administration.

In the Cooperative Agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI.2. Administrative Requirements, “Cooperative Agreement Terms and Conditions of Award”.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).  Applicants must complete and submit a detailed categorical budget using the Research & Related Budget Component.

2. Funds Available

Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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 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.

Under this announcement, the FDA anticipates providing approximately $10,000,000 Total costs (direct costs plus indirect costs) in support of this program in Fiscal Year 2009.  It is estimated that up to 20 cooperative agreements at a level requested but not exceeding $250,000 total (direct plus indirect costs) for the first year will be awarded. An additional 2 years of support up to approximately $250,000 (direct plus indirect costs) each year will be available, depending upon fiscal year appropriations, and successful performance.

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.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined annually by FDA procedures, the receipt of a non-competing continuation application, submission of an acceptable final yearly task force report and the availability of Federal funds.

FDA grants policies as described in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

This cooperative agreement program is only available to State, Local, and Tribal government FERN laboratories and is authorized by section 312 of the Bioterrorism Act. 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 will be made available to interested Federal, State, Local, and Tribal government FERN laboratories.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

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

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is programmatically distinct.

Resubmissions. Not applicable.

Renewals.  Not applicable.  

Responsiveness is defined as submission of a complete application on or before the required submission date as listed above.  If applications are found to be non-responsive, the application will not be considered for review..

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

o  Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact Grants Info -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-480-0434.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to FDA. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by FDA (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan

Research & Related Subaward Budget Attachment(s) Form
PHS398 Checklist
(See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)  

SPECIAL INSTRUCTIONS  

The face page of the application should indicate “FDA FERN Microbiological Cooperative Agreement Program PAR-09-215”.

Applications should include the following:

(1) A title which has the term FDA FERN Microbiological Cooperative Agreement Program or other similar description to assist in the identification of the request;

(2) The necessary checklist and assurances pages provided in each application package.

In addition to the three key project areas, 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 upgrade 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.

Applications Involving a Single Institution

When all responsible personnel are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Sub award Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub award budget form. 

Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are required when using the Non-Modular budget format.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: June 15, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): July 29, 2009, July 29, 2010, July 29, 2011
Peer Review Date(s): August, 2009, August 2010, August 2011
Council Review Date(s): N/A

Earliest Anticipated Start Date(s): September 2009, September 2010, September 2011

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

and those responsible for the scientific planning and organization of the project. Attach a biographical sketch for Responsible Personnel (PD/PI), Co-Chair, key personnel

Budget Information: Enter the direct costs requested. Provide a narrative budget justification for each proposed personnel position, including role and proposed level of effort and for each item of cost requested.

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 awardee’s laboratory to a third party, and the awardee’s laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee’s laboratory.

These grants are not to fund or conduct food inspections for food safety regulatory agencies. They may not be utilized for new building construction.

Responsible Personnel (PD/PI) Credential (e.g., Agency Login)

The FDA requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections:

Submit one attachment, which may not exceed 25 pages, under the Research Design and Methods section (line Item 5). While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document separating sections into distinct PDF attachments just before uploading the files.  This approach will enable applicants to better monitor formatting requirements such as page limits.  All attachments must be provided to FDA in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used.  Letters of agreement to participate from key speakers and participants should be attached at line item 16.  Do not complete Sections 2-4 and the Human Subjects Sections (6-10) of the PHS 398 Research Plan.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plans(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

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 the ORA/DFSR and in accordance with FDA peer review procedures using the review criteria stated below.

As part of the scientific peer review, all applications will:

The goal of ORA's cooperative agreement program is to complement, develop, and improve State, local, and Indian tribal food safety and security testing programs. This will be accomplished through the provision of equipment, supplies, personnel, facility upgrades, training in current food 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 terrorism or natural pathogenic organism outbreak event affecting foods or food products, the recipient may be required to perform selected 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, vodka).  Environmental samples will also be involved for analysis.

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

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 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:

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

Significance: Does this project address an important problem? If the aims of the application are achieved, how will food safety knowledge be advanced? What will be the effect of this project on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual framework, design, and topics adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple Responsible Personnel (PDs/PIs), is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the Responsible Personnel (PDs/PIs)?

Innovation:  Is the project topic original and innovative? For example: Does the project address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 

Responsible Personnel (Principal Investigators/Project Directors): Are the Responsible Personnel (PDs/PIs) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other staff? Do (es) the Responsible Personnel (PDs/PIs) and respective team bring complementary and integrated expertise to the conference (if applicable)?

Environment:  Do(es) the facilities in which the project will take place contribute to the probability of success? Do the proposed topics benefit from unique features of the stakeholder environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating of applications.

2.A. Additional Review Considerations

Budget and Period of Support:  The reasonableness of the proposed budget and the requested period of support in relation to the proposed plan. Does the amount requested from FDA appear reasonable as partial support of the total conference given the plan, facilities, travel, and speakers?  The priority score should not be affected by the evaluation of the budget.

Previous Experience:  Is there previous experience with the organization or the principal investigator in similar undertakings?  If so, what?

Review and Selection Process:  All applications submitted in response to this RFA will first be reviewed for responsiveness by grants management and program staff.

Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts. Final funding decisions will be made by the Commissioner of Food and Drugs or his or her designee.

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

2.B. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

The successful applicants will receive notice of pending award about two weeks after review of applications through the Grants Management contact.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as referenced in the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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.

2. Administrative and National Policy Requirements

FDA will support projects covered by this notice under Title XVII of the Public Health Service Act (42 U.S.C. 1702).

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

The grants will be subject to all policies and requirements that govern Grant Programs of the PHS, including the provisions of 45 CFR Part92.  Activities under this notice will be supported under Section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC § 247b-20). 

The following Terms and Conditions will be incorporated into the award statement and will be provided to the PDPI(s) as well as to the appropriate institutional official, at the time 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 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 will remain the property of FDA until such time as released as surplus property.

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. These grants 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 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.

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 (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 NIH 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.  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 the 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 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 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.

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.

2. A.2. FDA Responsibilities

An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards 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 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 normal scientific and programmatic stewardship of the award and will be named in the award notice.

3. Reporting

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

An agency Program Official or Center Program Director/Project Officer will be responsible for the normal 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; and

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

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Reports must be submitted two months prior to the next budget period start date. The Progress Report should include a report of the previous meeting supported by the current grant, as well as a full description of the next planned meeting.

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 ORA/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. 

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Tim McGrath
FDA/ ORA
Division of Field Science
5600 Fishers Lane, Rm. 12-41
Rockville, MD  20857
Telephone: (301) 827-1028
Email: timothy.mcgrath@fda.hhs.gov

2. Peer Review Contact(s):

Jennifer Gabb
FDA/ ORA
Division of Federal Relations
5600 Fishers Lane, Rm. 12-07
Rockville, MD  20857
Telephone: (301) 827-2899
Email: Jennifer.gabb@fda.hhs.gov

3. Financial/Grants Management Contact(s):

Camille R. Peake
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105
Rockville, MD 20857
Telephone: (301) 827-7168
Fax: 301-827-7101
Email: Camille.Peake@fda.hhs.gov

Section VIII. Other Information


Required Federal Citations

URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA funding must be self-contained within specified page limitations.  Unless otherwise specified in an FDA solicitation, internet addresses (URLs) should not be used to provide information necessary for the review because reviewers are under no obligation to view the Internet sites. 

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
The grants will be subject to all policies and requirements that govern Grant Programs of the PHS, including the provisions of 45 CFR Part 92.  Activities under this notice will be supported under Section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC § 247b-20). 

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

This program is described in the Catalog of Federal Domestic Assistance (CFDA 93.103) at http://www.cfda.gov/ and is subject to the intergovernmental review requirements of Executive Order 12372.

The PHS strongly encourages all grant 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.

Freedom of Information:  Data included in the application which have been specifically identified by the applicant as containing restricted and/or proprietary (confidential) information may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).


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