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| 93.448 FOOD SAFETY AND SECURITY MONITORING PROJECT |
| FEDERAL AGENCY |
| FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| AUTHORIZATION |
| Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188. |
| OBJECTIVES |
| To complement, develop and improve State, Indian Tribal, and local food safety and security testing programs through the provision of supplies, personnel, facility upgrades, training in current food testing methodologies and participation in proficiency testing to establish additional reliable laboratory sample analysis capacity and analysis of surveillance samples. A new program will be included to complement, develop and improve State, Indian Tribal, and local food safety and security analyses of foods and food products related to radiological terrorism or other emergency situations through the provision of supplies, personnel, facility upgrades, training in current food testing methodologies, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, participation in method enhancement activities to extend analysis capability, and analysis of surveillance samples in the event of a large-scale radiological terrorism event affecting foods or food products. |
| TYPES OF ASSISTANCE |
| Cooperative Agreements. |
| USES AND USE RESTRICTIONS |
| The grants and cooperative agreements are intended to expand participation in networks to enhance Federal, State, local and tribal food safety and security efforts. In addition to the promotion of a continuing, reliable capability and capacity for laboratory sample analyses of foods and food products for the rapid detection and identification of toxic chemicals, toxins or radiological terrorism affecting foods or food products. These funds cannot be used to fund or conduct food inspections for food safety regulatory agencies. They may not be used for new building construction, however remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 25% of the grant. |
| Applicant Eligibility |
| These cooperative agreement and grants programs are only available to State, Local and Tribal government Food Emergency Response (FERN) laboratories. |
| Beneficiary Eligibility |
| Ultimately the general population will be the beneficiary of more rapid and reliable food testing to enhance food safety efforts. The FERN laboratory network will also benefit from better testing methods, equipment and training. |
| Credentials/Documentation |
| Applications must present a plan and furnish evidence that facilities, personnel and equipment are appropriate to carry out the plan. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments and Executive Order 12372 as it applies. |
| Preapplication Coordination |
| These programs are eligible for coverage under E.O. 12372, "Intergovernmental Review of Federal Programs." An applicant should consult the office or official designated as the Single Point of Contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected this program. |
| Application Procedure |
| The standard application forms and procedures as required by 45 CFR 72, and as outlined in the Request for Application (RFA) and/or the Funding Opportunity Announcement as published in the NIH Guide and as furnished by the FDA through grants.gov must be used for this program. All new and competing continuations or competing supplemental research grants must be submitted through Grants.gov. The application packages are posted under "APPLY" section of this announcement under http:\\www.grants.gov. |
| Award Procedure |
| All accepted applications receive a scientific review for technical merit and a recommendation for approval by an appropriate initial ad hoc review group. All approved and scored applications compete for available funds on the basis of score, scientific merit and program analysis. Geographic distribution will be a consideration in the award selection process. |
| Deadlines |
| Applications will be due no later than 30 days after publication in the Federal Register and/or the NIH Guide. |
| Range of Approval/Disapproval Time |
| 90-120 days. |
| Appeals |
| None. |
| Renewals |
| Renewals are available. Procedures are the same as for new applications. |
| Formula and Matching Requirements |
| None. |
| Length and Time Phasing of Assistance |
| The length of support will depend on the nature of the project. For those projects with an expected duration of more than 1 year, a 2nd or 3rd year of non-competitive continuation of support will depend on: 1) performance during the preceding year and, 2) availability of Federal funds. |
| Reports |
| For continuing grants and cooperative agreements, quarterly reports or as determined by the Project Officer, and an annual program progress report as well as a final Financial Status Report is required. |
| Audits |
| In accordance with the provisions of OMB Circular No. A-133 (Revised June 27, 2003), "Audits of States, Local Governments and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or program-specific audit conducted for that year under the nonfederal audit requirement except as noted in Circular A-133." In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials. |
| Records |
| All grant and cooperative agreement documentation must be retained for 3 years from the day on which the grantee submits the final financial status report for the project period. Progress reports, expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the final financial status report for the project period. Financial and programmatic records, supporting documents, statistical records and all other records that are required by the terms of the gran or may be considered pertinent to a grant must be retained for 3 years from the date the grantee submits the final financial status report for the project period. See 45 CFR 74.53 and 92.42 for exceptions and qualification to the 3 year retention requirement. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants. |
| Account Identification |
| 75-0600-0-1-554. |
| Obligations |
| For Food Safety and Security Monitoring Project for Chemical Analysis: FY 07 est $2,333,495; and FY 08 est $2,403,500, and FY 09 $2,500,000. For Food Safety and Security Monitoring Project for Radiological Analysis: FY 07 est. $750,000; and FY 08 est. $750,000 and FY 09 est. $750,000. |
| Range and Average of Financial Assistance |
| An average of $350,000 total cost per award per year(direct plus indirect combined) for up to 3 years. |
| PROGRAM ACCOMPLISHMENTS |
| For the Food Safety and Security Monitoring Program for Chemical Analysis: award of 8 cooperative agreements and supply of necessary equipment and training to begin the analysis. Equipment is in place and training has been accomplished. Labs have been involved in: participation in proficiency testing for Food Emergency Response Network (FERN), participation in method development and method validation for food safety and food defense methods, and participation in food defense surveillance assignments. The 8 Chemistry Cooperative Agreement labs participated in the FDA's Pet Food surveillance assignment. For the Food Safety and Security Monitoring Program for Radiological Analysis: award of 3 cooperative agreements, now starting second year. Equipment has been purchased, and some minor remodeling of existing facility is underway. Training has been accomplished, and method development/validation is ongoing. Two new Radiological Cooperative Agreements have been awarded, with funding started FY08. Equipment has been ordered. Some initial training has occurred. |
| REGULATIONS, GUIDELINES, AND LITERATURE |
| 42 CFR Part 52-Grants for Research Projects; 45 CFR Part 74 - Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospital, Other Nonprofit Organizations and Commercial Organizations; and certain grants and agreements with States, Local Governments and Indian Tribal Governments; 45 CFR Part 92-Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments; the HHS Grants Policy Statement (most recent update) available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm; Executive Order 12372, Intergovernmental Review of Federal Programs as implemented through 45 CFR Part 100-Intergovernmental Review of Department of Health and Human Services Programs and Activities. |
| Regional or Local Office |
| Regional and Local Office information will be provided in the application packet, if applicable. |
| Headquarters Office |
| Program Contact: Jennifer Gabb, Division of Federal-State Relations,, Office of Regulatory Affairs (ORA), Food and Drug Administration, HFC-140, 5600 Fishers Lane, Rm 1207, Rockville, MD 20857, Telephone: (301) 827-2899, E-mail: jennifer.gabb@fda.hhs.gov. |
| Web Site Address |
| http://www.fda.gov/ora/fed_state/default.htm; or http://www.grants.gov |
| RELATED PROGRAMS |
| None. |
| EXAMPLES OF FUNDED PROJECTS |
| For Food Safety and Security Monitoring Project for Chemical Analysis: Virginia Food Safety and Security Monitoring Project; Minnesota Food Safety and Security Monitoring Project; Arizona Food Safety and Security Monitoring Project. For Food Safety and Security Monitoring Project for Radiological Analysis: Surge Capacity Program. |
| CRITERIA FOR SELECTING PROPOSALS |
| All applications will be reviewed for responsiveness by the Grants Management staff and the Office of Regulatory Affairs (ORA). To be responsive, the application must be submitted in accordance with the requirements of the Federal Register Notice and/or NIH Guide. All responsive applications will be reviewed by an ad hoc committee. Each application will be scored and ranked based on the following criteria: a) adequacy of facilities, expertise of project staff, equipment, support services, commitment to analyze surveillance samples, and quality management practices needed for the project; b) expertise in the use of gas chromatography/mass spectrometry for the analysis of foods or animal tissues; c) expertise in the use of liquid chromatography/mass spectrometry for the analysis of foods or animal tissues; d) expertise in the use of inductively coupled plasma/mass spectrometry for the analysis of foods or animal tissues; e) expertise in the use of ELISA and other antibody based analyses for the identification of toxins in foods or animal tissues; f) current food or animal tissue analysis programs; g) the rationale and design to meet the goals of the cooperative agreement; h) quality control and quality assurance procedures and practices; i) abilities and procedures in place to recall personnel, establish extended work-weeks. All funding decisions will be made by the Commissioner of Food and Drug Administration or his designee. |
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General Services Administration Office of Chief Acquisition Officer Regulatory and Federal Assistance Division (VIR) |
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