Food Safety and Security Monitoring Project (93.448)

Program

93.448 Food Safety and Security Monitoring Project

Federal Agency

Agency: Department of Health and Human Services
Office: Food and Drug Administration

Authorization

Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188.

Program Number

93.448

Last Known Status

Active

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. Funding restrictions are as noted in the Funding Opportunity Announcement and the Terms and Conditions of Award.

Eligibility Requirements

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 and the applicable DHHS Grants Policy Statement. OMB Circular No. A-87 applies to this program.

Application and Award Process

Preapplication Coordination

Preapplication coordination is required. Environmental impact information is not required for this program. This program is 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 the program for review.

Application Procedure

This program is excluded from coverage under OMB Circular No. A-102. This program is excluded from coverage under OMB Circular No. A-110. The standard application forms and procedures as required by 45 CFR 72, and as outlined in the Funding Opportunity Announcement (FOA) as published in the NIH Guide or Federal Register 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 relevance. Geographic distribution will be a consideration in the award selection process.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Range of Approval/Disapproval Time

From 90 to 120 days. 90-120 days.

Appeals

From 30 to 60 days.

Renewals

From 90 to 120 days. Renewals are available. Procedures are the same as for new applications.

Assistance Considerations

Formula and Matching Requirements

Statutory formulas are not applicable to this program.

Matching requirements are not applicable to this program.

MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

The length of support will depend on the nature of the project, program relevance and the availability of funds. For those projects with an expected duration of more than 1 year, future recommended support, up to five years will depend on: 1) performance during the preceding year and, 2) the availability of Federal funds. See the following for information on how assistance is awarded/released: Domestic awards are made available through the Payment Management System (PMS).

Post Assistance Requirements

Reports

Program reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of Award. Cash reports are not applicable. Progress Reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of Award. Expenditure reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of Award. Performance monitoring is required as stated in the Funding Opportunity Announcement and the Terms and Conditions of Award.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. 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 $300,000 ($500,000 for fiscal years ending after December 31, 2003) 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. 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.

Program Accomplishments

Not Applicable.

Financial Information

Account Identification

75-0600-0-1-554.

Obligations

(Cooperative Agreements) FY 08 $6,158,271; FY 09 est $6,159,722; FY 10 est $2,800,000

Range and Average of Financial Assistance

An average of $350,000 total cost per award per year (direct and indirect costs combined) for up to five years as established in the Funding Opportunity Announcements, recommended by Ad Hoc Review and indicated in the Notice of Grant Award.

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.

Related Programs

93.103 Food and Drug Administration_Research; 93.449 Ruminant Feed Ban Support Project

Information Contacts

Regional or Local Office

See Regional Agency Offices. See Headquarters Office below.

Headquarters Office

Jennifer Gabb Division of Federal-State Relations,, Office of Regulatory Affairs (ORA), Food and Drug Administration, HFC-140, 5600 Fishers Lane, Rm 1207, Rockville, Maryland 20857 Email: jennifer.gabb@fda.hhs.gov Phone: 3018272899

Web Site Address

http://www.fda.gov/ora/fed_state/default.htm; or http://www.grants.gov.

Examples of Funded Projects

Not Applicable.

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 program guidelines as published in the Funding Opportunity Announcement in the Federal Register Notice and/or NIH Guide. All responsive applications will undergo a programmatic/scientific review by an Ad Hoc Review 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.