REPORTING: Funded Projects Pilot; Developing Standardized Forms

Pilot to Develop Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements

LFFM Sample and Activity Plan_Proposal Template.xlsx

REPORTING: Funded Projects Pilot; Developing Standardized Forms

OMB: 0910-0909

Document [xlsx]
Download: xlsx | pdf

Overview

CoverSheet
M-HF
M-AF
C-HF
C-AF
WGS
SP-MDV
M-FD
C-FD
R-FD
CC Dev

Sheet 1: CoverSheet
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)


Recipient Name Select
State Select Recipient Name
Federal Award Identification Number Select Recipient Name
Report Frequency Annual
Date Completed
Project Period Start Date 9/1/2020
Project End Date 6/30/2025
Budget Period Start Date 7/1/2023
Budget Period End Date 6/30/2024
Principal Investigator (PI)
PI Email
PI Phone
Other contacts for This Budget Period's planning




LFFM Tracks Were you Approved and Funded for this Track in the current budget period? Is your lab proposing work for this track in the next budget period? Are you proposing the next budget period's work at the same funding level as the current budget period (e.g., sample tier for M-HAF or C-HAF) - note, you cannot increase your sample tier beyond what your original LFFM application was approved for; however, you can reduce your tier voluntarily
M-HF


M-AF


C-HF


C-AF


WGS


C-C/C


M-C/C


SP-MDV


M-FD


C-FD


R-FD


SP-IT


SP-Sample Collection


Sheet 2: M-HF
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)




















Recipient Name State Track Commodity Analyte Is this a backup commodity-hazard pair for the applicable budget period for this plan? FDA or State proposed Commodity-Hazard pair? Characterization to be performed and name of laboratory performing characterization - Serotyping, Enumeration, WGS Derivation of Screening Method(s) Derivation of Confirmatory Method(s) Do your screening/confirmatory method(s) include modifications (describe) Do you already use this method for testing foods in your lab? Do you need to develop/validate/verify the method for this matrix prior to beginning collections? Is the Method on your ISO Scope of Accreditation? Date and Source of most recent PT covering analyte Number of Samples - Annually Number of unique analyses Count towards Sample Load Collection Organization/Program Collection Location(s) - list all that apply Collection Details Additional Comments
State X Dept. of Health Lab State X M-HF enoki mushrooms Listeria monocytogenes no FDA LM enumeration; WGS - to be done by State X Dept of Health Lab AOAC OMA 999.06 VIDAS LIS BAM Ch 10 no yes no yes Dec. 2021 50 1 50 State X Dept of Health Food Regulatory Program (D) Retail – Grocery will collect packaged product at retail

Sheet 3: M-AF
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)


















Recpiient Name State Track Commodity Analyte Is this a backup commodity-hazard pair for the applicable budget period for this plan? FDA or State proposed Commodity-Hazard pair? Characterization to be performed and name of laboratory performing characterization - Serotyping, Enumeration, WGS Derivation of Screening Method(s) Derivation of Confirmatory Method(s) Do your screening/confirmatory method(s) include modifications (describe) Do you already use this method for testing foods in your lab? Do you need to develop/validate/verify the method for this matrix prior to beginning collections? Is the Method on your ISO Scope of Accreditation? Date and Source of most recent PT covering analyte Number of Samples - Annually Collection Organization/Program Collection Location(s) - list all that apply Collection Details Additional Comments
State X Dept. of Ag Lab State X M-AF Fish meal Salmonella no FDA WGS, molecuar serotyping (SeqSero) - to be done by State X Dept of Ag Lab AOAC OMA 2004.03 VIDAS SLM BAM Ch 5 no yes no yes Dec. 2021 50 State X Dept of Ag AFRPS Program (M) Manufacturer/Processor Will collect at ingredient manufacturers; pet food manufacturers. none

Sheet 4: C-HF
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)


















Recipient Name State Track Commodity Analyte Class Specific Analytes (e.g., list elements or mycotoxins that testing will include) Is this a backup commodity-hazard pair for the applicable budget period for this plan? FDA or State proposed Commodity-Hazard pair? Method Derivation (what is it based on, including version #) Does your method include modifications (describe) Do you already use this technology for testing foods in your lab? Do you need to develop/validate/verify the the method for this matrix prior to beginning collections? Is the Method on your ISO Scope of Accreditation? verify you can meet required MLOD/MLOQ (please list MLOD/MLOQ if state-proposed) Date and source of most recent PT covering method/instrument Number of Samples - Annually Collection Organization/Program Collection Location(s) - list all that apply Collection Details Additional Comments
State X Dept. of Health Lab State X C-HF Infant and Toddler Foods (rice-based) Toxic Elements Total As; speciate iAs if over action level no FDA Total Arsenic: EAM 4.7 VERSION 1.2. Any samples above 100 ppb total arsenic: EAM 4.11 LC-ICP-MS for iAs determination. VERSION 1.1 no yes no yes yes Dec. 2021 50 State X Dept of Health Food Regulatory Program (D) Retail – Grocery will collect packaged product at retail SRP aware that iAs findings over action level are to be treated as preliminary, pending consult with FDA

Sheet 5: C-AF
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)


















Recipient Name State Track Commodity Analyte Class Specific Analytes (e.g., list elements or mycotoxins that testing will include) Is this a backup commodity-hazard pair for the applicable budget period for this plan? FDA or State proposed Commodity-Hazard pair? Method Derivation (what is it based on, including version #) Does your method include modifications (describe) Do you already use this technology for testing foods in your lab? Do you need to develop/validate/verify the the method for this matrix prior to beginning collections? Is the Method on your ISO Scope of Accreditation? Verify you can meet required MLOD/MLOQ (please list MLOD/MLOQ if state-proposed) Date and source of most recent PT covering method/instrument Number of Samples - Annually Collection Organization/Program Collection Location(s) - list all that apply Collection Details Additional Comments
State X Dept. of Health Lab State X C-AF Extruded Cat Food (Kibble)
Contaminant and Nutrient Levels + Moisture		 Cu, Zn, Fe, As, Cd, Hg, Pb; Moisture no FDA EAM 4.4 (Cu, Zn, Fe), Version 1.1; EAM 4.7 (Cu, Zn, As, Cd, Hg, Pb), Version 1.2; AOAC OMA 934.01 (Moisture) no yes no yes yes Dec. 2021 50 State X Dept of Ag AFRPS Program (D) Retail will collect packaged product at retail - pet stores none

Sheet 6: WGS
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)


Recipient Name State Proposed WGS Tier/Number of Isolates for for the applicable budget period for this plan (per funding level; 100/250/400 isolates per budget period) Is this the same WGS Tier as the previous budget period? note, you cannot increase your WGS tier beyond what your original LFFM application was approved for; however, you can reduce your tier voluntarily
State A A 250 isolates/year yes

Sheet 7: SP-MDV
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)







Recipient Name State Project FDA or state-proposed MDV Project Carryover of previous budget period's Project? Confirm lab meets any eligibility requirements (please describe) Confirm lab has required equipment (please describe) Describe willingness/intent of lab to use new method capability in future (e.g., HAF Track testing in later budget periods, state surveillance testing, other applications/impact to state agency public health mission) First choice or backup choice?
State A A ICP-OES MLV FDA-proposed MDV Project yes approved in YR2 for ICP-OES MLV project Lab has ICP-OES Will utilize new testing capability in YR4 HAF Track testing, if appropriate commodity-hazard pairs are offered; as well as use for state surveillance testing. N/A - not a YR3 request
State A A Matrix Extension of Loop-Mediated Isothermal Amplification (LAMP) for Salmonella Detection in Human Foods FDA-proposed MDV Project no Lab is approved for SP-MDV Track Lab has ABI7500 Fast Will utilize new testing capability in YR4 HAF Track testing, if appropriate commodity-hazard pairs are offered; as well as use for state surveillance testing. first choice

Sheet 8: M-FD
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)





Recipient Name State Track Project/Objective Category Project/Objective Details Required/Optional Description
State A A M-FD PTs Participate in all FERN Food Defense PTs and Exercises Required Any additional detail supporting this objective
State A A M-FD Maintain Readiness to receive and analyze food defense samples Participates in FERN PTs and maintains readiness for screening and confirmation for Bacillus anthracis, Yersinia pestis and Francisella tularensis; and screening for Ricin, Abrin, and Staph Toxin. Plan to participate in FERN Triage in 2022 Required Any additional detail supporting this objective
State A A M-FD Surge Capacity Provide analytical surge capacity for FDA and other states for food defense/emergency response, Rapid Response Team (RRT) testing situations Optional Any additional detail supporting this objective
State A A M-FD Method Updates Participate in Triage Method workgroup Optional Any additional detail supporting this objective
State A A M-FD Special Projects Cbot MALDI-TOF Project Matrix Extension Optional Any additional detail supporting this objective

Sheet 9: C-FD









Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)






Recipient Name State Track Project/Objective Category Project/Objective Details Required/Optional Description
State A A C-FD PTs Participate in all FERN PTs and Exercises Required Any additional detail supporting this objective
State A A C-FD Maintain Readiness to receive and analyze food defense samples CHE.0006, CHE.0008, and CHE.0009 (EAM 4.7) Required Any additional detail supporting this objective
State A A C-FD Surge Capacity Provide analytical surge capacity for FDA and other states for food defense/emergency response, Rapid Response Team (RRT) testing situations. Can support: melamine/cyanuric acid, poison/toxin screen, etc. Optional Any additional detail supporting this objective
State A A C-FD Addressing Method Gaps Nitrate/nitite in foods method development Optional Any additional detail supporting this objective
State A A C-FD Special Projects Participate in Chem-FD Exercise Optional Any additional detail supporting this objective

Sheet 10: R-FD
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)





Recipient Name State Track Project/Objective Category Project/Objective Details Required/Optional Description
State A A R-FD PTs Participate in annual FERN Rad Exercise Required Any additional detail supporting this objective
State A A R-FD Maintain Readiness to receive and analyze food defense samples We maintain standard methods for gross alpha/beta, gamma, alpha, and liquid scintiliation coutning for a variety of matrices. Required Any additional detail supporting this objective
State A A R-FD Surge Capacity Provide analytical surge capacity for FDA and other states for food defense/emergency response, Rapid Response Team (RRT) testing situations Optional Any additional detail supporting this objective
State A A R-FD Method Updates Validate a method to Determine Po-210 in Food by Alpha Spectroscopy Optional Any additional detail supporting this objective

Sheet 11: CC Dev
Instructions to complete this form are available to LFFM grantees on the Food Emergency Response Network (FERN) Portal (www.fernlab.org)






Recipient Name State Discipline (Chem/Micro) Project Confirm lab meets any eligibility requirements (please describe) Confirm lab has required equipment (please describe) Describe willingness/intent of lab to use new capability/capacity in future (e.g., HAF Track testing in later budget periods, state surveillance testing, participate in future MDV projects to expand the method/testing, other applications/impact to state agency public health mission) First choice or backup choice?
State A A Micro Recovery and identification of Salmonella from agricultural water using dead-ended ultrafiltration (DEUF) Lab participated in YR2 C/C DEUF Track Lab can conduct DEUF testing for EHEC and Cyclospora Will utilize to support outbreak testing related to produce farm environmental assessments. Will utilize new testing capability in YR4 HAF Track testing, if appropriate commodity-hazard pairs are offered. First choice - Micro
State A A Chem FDA Harmonized Pesticide Method Lab is approved for C/C Track Lab has LC Triple Quad ABSciex 6500 and GC Triple Quad Agilent Will utilize new testing capability in YR4 HAF Track testing, if appropriate commodity-hazard pairs are offered; as well as use for state surveillance testing. first choice - chem
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