REPORTING: Funded Projects Pilot; Developing Standardized Forms

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

LFFM Program Report.xlsx

REPORTING: Funded Projects Pilot; Developing Standardized Forms

OMB: 0910-0909

Document [xlsx]
Download: xlsx | pdf

Overview

Coversheet
All_Tracks
M-HF
M-AF
M-FD
M-WGS
M-CC
C-HF
C-FD
C-AF
R-FD
SP-SC
SP-IT
SP-MDV
SP-CoV2
Budget


Sheet 1: Coversheet





































































































Recipent Name (Select)
Select





State
Select Recipient Name










Federal Award Identification Number
Select Recipient Name










Report Frequency
Mid-Year Report Annual Report









Date Completed








































Project Period Start Date












Project End Date












Budget Period Start Date












Budget Period End Date








































Principal Investigator (PI)







PI Email







PI Phone


























Tracks Column1 Report OPEI Awardee Name Track Other Coversheet Responses






M - Food Defense

#N/A Select All LFFM Tracks







M - Human Food

#N/A Select All LFFM Tracks







M - Animal Food

#N/A Select All LFFM Tracks







M - WGS

#N/A Select All LFFM Tracks







M - Capability/Capacity

#N/A Select All LFFM Tracks







C - Food Defense

#N/A Select All LFFM Tracks







C - Human Food

#N/A Select All LFFM Tracks







C - Animal Food

#N/A Select All LFFM Tracks







R - Food Defense

#N/A Select All LFFM Tracks







SP - IT

#N/A Select All LFFM Tracks







SP - MD/V

#N/A Select All LFFM Tracks







SP - Sample Collection

#N/A Select All LFFM Tracks







SP - SARS-CoV-2 in Wastewater

#N/A Select All LFFM Tracks























































































Sheet 2: All_Tracks














































































Grant Track: ALL LFFM Tracks





















Activity from Previous Budget Period (Mid-Year & Annual)









Did you have MDV, CC, or IT work that was funded in a prior budget period that you are completing in this budget period and wish to report highlights/fulfillment of requirements from the prior budget period ?






Track Budget Period funded Work remaining in order to successfully complete Track requirements Accomplishments completed this budget period





1









2









3









4









5









6









7









8









9









10





















Note: Information reported for the following sections should be specific to this budget period.


















20.88 Agreement (Mid-Year & Annual)










Do you maintain a valid 20.88 agreement with FDA?









If yes, when does your agreement expire?










If no, please explain why:





















FERN Membership (Mid-Year & Annual)










Is your lab currently a FERN member?








If no, list the date of planned application to FERN:























ISO Accreditation (Complete for Annual report only)







Current ISO 17025 accreditation status of your laboratory:









Will your laboratory be accredited to ISO/IEC 17025:2017?










Note: Attach scope of accreditation to your submission email.







Changes to Accreditation since last reporting:








If not Accredited to ISO 17025, please explain how you maintain a Quality System that ensures quality assurance and quality control of laboratory testing. This may include describing other accreditations your laboratory has, if relevant to LFFM activities.



















ORA DX (Mid-Year & Annual)










Have you successfully submitted data to FDA this budget period via the ORA DX (any workflow)?







Workflow Number of Samples Submitted Type of Sampling Comments





1









2









3









4









5









6









7









8









9









10





















Facilities (Mid-Year & Annual)










Do you have facilities needed to operate under this CAP? No, the lab does not have all facilities needed.








Have you maintained these facilities needed to operate under this CAP?




















Positions/Hiring (Mid-Year & Annual)










Are all needed positions filled?









If no, how and when will you fill the vacant positions?
























Instrumentation (Annual)







Have you obtained or replaced instrumentation/equipment in order to operate under this Cooperative Agreement in this Budget Period?





If yes, please fill in the requested information below:







Description of Item
(e.g. analysis used for)
Common Name
(e.g. ICP, GCMS, MiSeq, etc.)
Make/Model New/Replaced Status Total Number of Operational Instruments used for CAPs List Tracks this Instrumentation Supported OPEI Awardee Name Track InstrumentationOtherResponse
1






#N/A Select ALL LFFM Tracks
2






#N/A Select ALL LFFM Tracks
3






#N/A Select ALL LFFM Tracks
4






#N/A Select ALL LFFM Tracks
5






#N/A Select ALL LFFM Tracks
6






#N/A Select ALL LFFM Tracks
7






#N/A Select ALL LFFM Tracks
8






#N/A Select ALL LFFM Tracks
9






#N/A Select ALL LFFM Tracks
10






#N/A Select ALL LFFM Tracks








Training Received (Mid-Year & Annual)






















Training Title Training Provider Number of People Trained Tracks this Training Supported OPEI Awardee Name Track TrainingOtherResponse


1



#N/A Select ALL LFFM Tracks



2



#N/A Select ALL LFFM Tracks



3



#N/A Select ALL LFFM Tracks



4



#N/A Select ALL LFFM Tracks



5



#N/A Select ALL LFFM Tracks



6



#N/A Select ALL LFFM Tracks



7



#N/A Select ALL LFFM Tracks



8



#N/A Select ALL LFFM Tracks



9



#N/A Select ALL LFFM Tracks



10



#N/A Select ALL LFFM Tracks



11



#N/A Select ALL LFFM Tracks



12



#N/A Select ALL LFFM Tracks



13



#N/A Select ALL LFFM Tracks



14



#N/A Select ALL LFFM Tracks



15



#N/A Select ALL LFFM Tracks



16



#N/A Select ALL LFFM Tracks



17



#N/A Select ALL LFFM Tracks



18



#N/A Select ALL LFFM Tracks



19



#N/A Select ALL LFFM Tracks



20



#N/A Select ALL LFFM Tracks











Meetings (Mid-Year & Annual)










List all professional meetings/conferences where attendance supported work related to one or more Tracks below:






Meeting Name Meeting Start Date
(M/D/YYYY)
Meeting End Date
(M/D/YYYY)
Meeting Format How Many People Attended Tracks this Meeting Supported OPEI Awardee Name Track

1





#N/A Select ALL LFFM Tracks

2





#N/A Select ALL LFFM Tracks

3





#N/A Select ALL LFFM Tracks

4





#N/A Select ALL LFFM Tracks

5





#N/A Select ALL LFFM Tracks

6





#N/A Select ALL LFFM Tracks

7





#N/A Select ALL LFFM Tracks

8





#N/A Select ALL LFFM Tracks

9





#N/A Select ALL LFFM Tracks

10





#N/A Select ALL LFFM Tracks

11





#N/A Select ALL LFFM Tracks

12





#N/A Select ALL LFFM Tracks

13





#N/A Select ALL LFFM Tracks

14





#N/A Select ALL LFFM Tracks

15





#N/A Select ALL LFFM Tracks

16





#N/A Select ALL LFFM Tracks

17





#N/A Select ALL LFFM Tracks

18





#N/A Select ALL LFFM Tracks

19





#N/A Select ALL LFFM Tracks

20





#N/A Select ALL LFFM Tracks



























Presentations (Mid-Year & Annual)









Title Author/Presenter(s)
(list)
Journal/Meeting
(enter name)
Link to Presentation Status Date Presented OPEI Awardee Name Track








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks








#N/A Select ALL LFFM Tracks


























Please confirm the following will be included with the email submission of this report as attachments:







Required Attachments:










Laboratory Organization Structure










ISO/IEC 17025:2017 Scope of Acreditation







































































































































Sheet 3: M-HF




























































































































































Grant Track: M-HF

















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative

1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select M-HF


2 Equipment $0.00 $0.00 $0.00 #N/A Select M-HF


3 Travel $0.00 $0.00 $0.00 #N/A Select M-HF


4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select M-HF


5 Publication Costs $0.00 $0.00 $0.00 #N/A Select M-HF


6 Consultant Services $0.00 $0.00 $0.00 #N/A Select M-HF


7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select M-HF


8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select M-HF


9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select M-HF


10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select M-HF


11 Other Costs $0.00 $0.00 $0.00 #N/A Select M-HF


12 Total Budget $0.00 $0.00 $0.00 #N/A Select M-HF


13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select M-HF


14 Additional Budget Comments:





























M-HF Key Personnel (Mid-Year & Annual)









The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award. Laboratories may also list names of key personnel from the State Regulatory Program (SRP) who handle LFFM Sample collection planning and positive sample follow-up – this will allow those staff to receive the LFFM weekly email (they will not be added to the meeting invites or FERNlab.org workgroup for the analytical track).




Last Name, First Name CAP Role
(If an individual has more than one role for
M-HF they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select M-HF
2





#N/A Select M-HF
3





#N/A Select M-HF
4





#N/A Select M-HF
5





#N/A Select M-HF
6





#N/A Select M-HF
7





#N/A Select M-HF
8





#N/A Select M-HF
9





#N/A Select M-HF
10





#N/A Select M-HF
11





#N/A Select M-HF
12





#N/A Select M-HF
13





#N/A Select M-HF
14





#N/A Select M-HF
15





#N/A Select M-HF
16





#N/A Select M-HF
17





#N/A Select M-HF
18





#N/A Select M-HF
19





#N/A Select M-HF
20





#N/A Select M-HF

















M-HF Training/Mentorship Administered (Mid-Year & Annual)




















Total number of M-HF related Training/Mentorship Events Administered:








Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses


1


#N/A Select M-HF



2


#N/A Select M-HF



3


#N/A Select M-HF



4


#N/A Select M-HF



5


#N/A Select M-HF



6


#N/A Select M-HF



7


#N/A Select M-HF



8


#N/A Select M-HF



9


#N/A Select M-HF



10


#N/A Select M-HF



11


#N/A Select M-HF



12


#N/A Select M-HF



13


#N/A Select M-HF



14


#N/A Select M-HF



15


#N/A Select M-HF



16


#N/A Select M-HF



17


#N/A Select M-HF



18


#N/A Select M-HF



19


#N/A Select M-HF



20


#N/A Select M-HF















M-HF Training Needed (Mid-Year & Annual)









Does your laboratory need M-HF related training?







Describe training need:








1





2





3





4





5





6





7





8





9





10

















M-HF Mentorship Needed (Mid-Year & Annual)









Are you in need of help finding a M-HF Mentor lab?







Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:




1






2






3






4






5






6






7






8






9






10










M-HF Small-scale Projects (Annual)




















Projects listed here should include the following:
1) FDA-requested special assignments (testing events) above and beyond the approved sampling plan for the budget period;
2) Method development/validation/other work required during an emergency/outbreak situation, where FDA approved re-direction of approved sampling plan;
3) Participation in FDA-directed matrix extension/method development/method validation work outside of the project formally assigned for the MDV track;
4) Work required as part of a Capability/Capacity development effort.





Project Name Scope Description





















































M-HF Proficiency Testing (Annual)




















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to commodity/hazard pairs on your approved sampling plan for the Budget Period.






PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses

1



#N/A Select M-HF


2



#N/A Select M-HF


3



#N/A Select M-HF


4



#N/A Select M-HF


5



#N/A Select M-HF


6



#N/A Select M-HF


7



#N/A Select M-HF


8



#N/A Select M-HF


9



#N/A Select M-HF


10



#N/A Select M-HF






M-HF FDA Form 431 or e431 (Mid-Year & Annual)









Are you using the FDA Form 431 or e431?







If no, do the documents you are using cover all the items within the 431?







Explain your answer:








State Regulatory Action on M-HF Samples (Mid-Year & Annual)




















Sample Number Matrix List Contaminant found Date analytical package sent to SRP/FDA Describe any State regulatory actions such as recalls taken as a result of laboratory findings (including dates) Describe any joint response with FDA as a result of laboratory findings (including dates) OPEI Awardee Name Track MHF Other Response
1





#N/A Select M-HF
2





#N/A Select M-HF
3





#N/A Select M-HF
4





#N/A Select M-HF
5





#N/A Select M-HF
6





#N/A Select M-HF
7





#N/A Select M-HF
8





#N/A Select M-HF
9





#N/A Select M-HF
10





#N/A Select M-HF




M-HF Track Additional Information (Mid-Year & Annual)









If there is any other information you would like to provide regarding your program within the M-HF track please enter it below:















































































































Sheet 4: M-AF




























































































































































Grant Track: M-AF

















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Other Response Narrative

1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select M-AF


2 Equipment $0.00 $0.00 $0.00 #N/A Select M-AF


3 Travel $0.00 $0.00 $0.00 #N/A Select M-AF


4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select M-AF


5 Publication Costs $0.00 $0.00 $0.00 #N/A Select M-AF


6 Consultant Services $0.00 $0.00 $0.00 #N/A Select M-AF


7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select M-AF


8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select M-AF


9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select M-AF


10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select M-AF


11 Other Costs $0.00 $0.00 $0.00 #N/A Select M-AF


12 Total Budget $0.00 $0.00 $0.00 #N/A Select M-AF


13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select M-AF


14 Additional Budget Comments:










M-AF Key Personnel (Mid-Year & Annual)









The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award. Laboratories may also list names of key personnel from the State Regulatory Program (SRP) who handle LFFM Sample collection planning and positive sample follow-up – this will allow those staff to receive the LFFM weekly email (they will not be added to the meeting invites or FERNlab.org workgroup for the analytical track).




Last Name, First Name CAP Role
(If an individual has more than one role for
M-AF they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select M-AF
2





#N/A Select M-AF
3





#N/A Select M-AF
4





#N/A Select M-AF
5





#N/A Select M-AF
6





#N/A Select M-AF
7





#N/A Select M-AF
8





#N/A Select M-AF
9





#N/A Select M-AF
10





#N/A Select M-AF
11





#N/A Select M-AF
12





#N/A Select M-AF
13





#N/A Select M-AF
14





#N/A Select M-AF
15





#N/A Select M-AF
16





#N/A Select M-AF
17





#N/A Select M-AF
18





#N/A Select M-AF
19





#N/A Select M-AF
20





#N/A Select M-AF




M-AF Training/Mentorship Administered (Mid-Year & Annual)




















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses


1


#N/A Select M-AF



2


#N/A Select M-AF



3


#N/A Select M-AF



4


#N/A Select M-AF



5


#N/A Select M-AF



6


#N/A Select M-AF



7


#N/A Select M-AF



8


#N/A Select M-AF



9


#N/A Select M-AF



10


#N/A Select M-AF



11


#N/A Select M-AF



12


#N/A Select M-AF



13


#N/A Select M-AF



14


#N/A Select M-AF



15


#N/A Select M-AF



16


#N/A Select M-AF



17


#N/A Select M-AF



18


#N/A Select M-AF



19


#N/A Select M-AF



20


#N/A Select M-AF















M-AF Training Needed (Mid-Year & Annual)









Does your laboratory need M-AF related training?







Describe training need:








1





2





3





4





5





6





7





8





9





10




























M-AF Mentorship Needed (Mid-Year & Annual)









Are you in need of help finding a M-AF Mentor lab?







Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:




1






2






3






4






5






6






7






8






9






10










M-AF Small-scale Projects (Annual)




















Projects listed here should include the following:
1) FDA-directed special assignments (testing events) above and beyond the approved sampling plan for the year;
2) Method development/validation/other work required during an emergency/outbreak situation, where FDA approved re-direction of approved sampling plan;
3) Participation in FDA-directed matrix extension/method development/method validation work outside of the project formally assigned for the MDV track;
4) Work required as part of a Capability/Capacity development effort.





Project Name Scope Description





















































M-AF Proficiency Testing (Annual)




















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to commodity/hazard pairs on your approved sampling plan for the year.






PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses

1



#N/A Select M-AF


2



#N/A Select M-AF


3



#N/A Select M-AF


4



#N/A Select M-AF


5



#N/A Select M-AF


6



#N/A Select M-AF


7



#N/A Select M-AF


8



#N/A Select M-AF


9



#N/A Select M-AF


10



#N/A Select M-AF






M-AF FDA Form 431 or e431 (Mid-Year & Annual)









Are you using the FDA Form 431 or e431?







If no, do the documents you are using cover all the items within the 431?







Explain your answer:








State Regulatory Action on M-AF Samples (Mid-Year & Annual)




















Sample Number Matrix Contaminant found Date analytical package sent to SRP/FDA Describe any State regulatory actions such as recalls taken as a result of laboratory findings (including dates) Describe any joint response with FDA as a result of laboratory findings (including dates) OPEI Awardee Name Track MAF Other Response
1





#N/A Select M-AF
2





#N/A Select M-AF
3





#N/A Select M-AF
4





#N/A Select M-AF
5





#N/A Select M-AF
6





#N/A Select M-AF
7





#N/A Select M-AF
8





#N/A Select M-AF
9





#N/A Select M-AF
10





#N/A Select M-AF




M-AF Track Additional Information (Mid-Year & Annual)









If there is any other information you would like to provide regarding your program within the M-AF track please enter it below:


























































































































Sheet 5: M-FD





























































































































































































































































































































Grant Track: M-FD































Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative








1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select M-FD









2 Equipment $0.00 $0.00 $0.00 #N/A Select M-FD









3 Travel $0.00 $0.00 $0.00 #N/A Select M-FD









4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select M-FD









5 Publication Costs $0.00 $0.00 $0.00 #N/A Select M-FD









6 Consultant Services $0.00 $0.00 $0.00 #N/A Select M-FD









7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select M-FD









8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select M-FD









9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select M-FD









10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select M-FD









11 Other Costs $0.00 $0.00 $0.00 #N/A Select M-FD









12 Total Budget $0.00 $0.00 $0.00 #N/A Select M-FD









13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select M-FD









14 Additional Budget Comments:































M-FD Key Personnel (Mid-Year & Annual)
















The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.











Last Name, First Name CAP Role
(If an individual has more than one role for
M-FD they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track







1





#N/A Select M-FD







2





#N/A Select M-FD







3





#N/A Select M-FD







4





#N/A Select M-FD







5





#N/A Select M-FD







6





#N/A Select M-FD







7





#N/A Select M-FD







8





#N/A Select M-FD







9





#N/A Select M-FD







10





#N/A Select M-FD







11





#N/A Select M-FD







12





#N/A Select M-FD







13





#N/A Select M-FD







14





#N/A Select M-FD







15





#N/A Select M-FD







16





#N/A Select M-FD







17





#N/A Select M-FD







18





#N/A Select M-FD







19





#N/A Select M-FD







20





#N/A Select M-FD

























M-FD Training/Mentorship Administered (Mid-Year & Annual)


































Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses









1


#N/A Select M-FD










2


#N/A Select M-FD










3


#N/A Select M-FD










4


#N/A Select M-FD










5


#N/A Select M-FD










6


#N/A Select M-FD










7


#N/A Select M-FD










8


#N/A Select M-FD










9


#N/A Select M-FD










10


#N/A Select M-FD










11


#N/A Select M-FD










12


#N/A Select M-FD










13


#N/A Select M-FD










14


#N/A Select M-FD










15


#N/A Select M-FD










16


#N/A Select M-FD










17


#N/A Select M-FD










18


#N/A Select M-FD










19


#N/A Select M-FD










20


#N/A Select M-FD





























M-FD Training Needed (Mid-Year & Annual)
















Does your laboratory need M-FD related training?














Describe training need:















1












2












3












4












5












6












7












8












9












10































M-FD Mentorship Needed (Mid-Year & Annual)
















Are you in need of help finding a M-FD Mentor lab?














Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:











1













2













3













4













5













6













7













8













9













10































M-FD Expansions of Capabilities/Capacities for Food Defense testing (Mid-Year & Annual)


































Please describe increases or expansions in capabilities or capacities for food Defense testing (increases in trained personnel, new capabilities developed, etc.). Make sure Food Defense related trainings are also itemized in the Trainings section on All-Tracks Tab:












































If your lab utilized funding to implement a new method under the Food Defense Track, please fill in the chart below:
















Was Equipment Purchased? If No equipment was purchased, explain below: Were supplies, reagents, media, standards, etc. purchased? If No supplies were purchased, explain below: Training Received? Describe Training Received
(or explain if no training was received for this method)
Competency Demonstrated? If competency was not demonstrated explain below: OPEI Awardee Name Track CC Narrative




1







#N/A Select M-FD





2







#N/A Select M-FD





3







#N/A Select M-FD





4







#N/A Select M-FD





5







#N/A Select M-FD





6







#N/A Select M-FD





7







#N/A Select M-FD





8







#N/A Select M-FD





9







#N/A Select M-FD





10







#N/A Select M-FD















M-FD Maintenance of Key Food Defense Capabilities/Methods (Mid-Year & Annual)


































Complete the following table to document your current capabilities for key food defense methods. Use the drop-down to select methods for which your lab has established capability, or is in the process of building capability. Filling out this table may also assist laboratories in identifying steps you may need to take to increase capability and/or capacity for any of these methods. The chart below is populated with methods that have been identified as key capabilities for this Food Defense Track, but there is space to enter other methods that are not currently listed. Only select or add methods for which you have established capability, or have committed to establishing capability as an objective of the Track.












Methods Methods Comments (required for an "Other" response) Equipment in House & Operational? Equipment Comments
(required for a "No" response)
Supplies, Reagents, Media in House and Within Date Supplies Comments
(required for a "No" response)
Number Analysts Trained Name of PT/Competency Exercise Provider Date of Last Competency Determination Laboratory Performance Laboratory Performance Comments
(required for "unacceptable" performance)
Summarize Next Steps to Maintain Capability, Increase Capacity or Document Needs OPEI Awardee Name Track PT and FD responses
1












#N/A Select M-FD
2












#N/A Select M-FD
3












#N/A Select M-FD
4












#N/A Select M-FD
5












#N/A Select M-FD
6












#N/A Select M-FD
7












#N/A Select M-FD
8












#N/A Select M-FD
9












#N/A Select M-FD
10












#N/A Select M-FD










M-FD Food Defense Activities i.e. FDA-assigned samples, exercises, responses (Mid-Year & Annual)


































Activity Description of Activity and Highlights












1














2














3














4














5














6














7














8














9














10

































Is your laboratory registered for Select Agents or Toxins?














If so, at what level?














Does your lab have an APHIS permit for controlled materials transport?














Do you have laboratory staff that can package and ship Category A?














Do you have laboratory staff that can package and ship Select Agents?














Does your laboratory have BSL2 facilities in which BSL-2+ work can be completed?














Does your laboratory have BSL3 facilities?














If so, are they operational?














Can you accept food samples for testing?































M-FD Track Additional Information (Mid-Year & Annual)
















If there is any other information you would like to provide regarding your program within the M-FD track please enter it below:




























































































































































































































Sheet 6: M-WGS















































































































































Grant Track: M-WGS















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative
1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select M-WGS

2 Equipment $0.00 $0.00 $0.00 #N/A Select M-WGS

3 Travel $0.00 $0.00 $0.00 #N/A Select M-WGS

4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select M-WGS

5 Publication Costs $0.00 $0.00 $0.00 #N/A Select M-WGS

6 Consultant Services $0.00 $0.00 $0.00 #N/A Select M-WGS

7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select M-WGS

8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select M-WGS

9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select M-WGS

10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select M-WGS

11 Other Costs $0.00 $0.00 $0.00 #N/A Select M-WGS

12 Total Budget $0.00 $0.00 $0.00 #N/A Select M-WGS

13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select M-WGS

14 Additional Budget Comments:









M-WGS Key Personnel (Mid-Year & Annual)








The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.



Last Name, First Name CAP Role
(If an individual has more than one role for
M-WGS they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select M-WGS
2





#N/A Select M-WGS
3





#N/A Select M-WGS
4





#N/A Select M-WGS
5





#N/A Select M-WGS
6





#N/A Select M-WGS
7





#N/A Select M-WGS
8





#N/A Select M-WGS
9





#N/A Select M-WGS
10





#N/A Select M-WGS
11





#N/A Select M-WGS
12





#N/A Select M-WGS
13





#N/A Select M-WGS
14





#N/A Select M-WGS
15





#N/A Select M-WGS
16





#N/A Select M-WGS
17





#N/A Select M-WGS
18





#N/A Select M-WGS
19





#N/A Select M-WGS
20





#N/A Select M-WGS


M-WGS Training/Mentorship Administered (Mid-Year & Annual)


















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses

1


#N/A Select M-WGS


2


#N/A Select M-WGS


3


#N/A Select M-WGS


4


#N/A Select M-WGS


5


#N/A Select M-WGS


6


#N/A Select M-WGS


7


#N/A Select M-WGS


8


#N/A Select M-WGS


9


#N/A Select M-WGS


10


#N/A Select M-WGS


11


#N/A Select M-WGS


12


#N/A Select M-WGS


13


#N/A Select M-WGS


14


#N/A Select M-WGS


15


#N/A Select M-WGS


16


#N/A Select M-WGS


17


#N/A Select M-WGS


18


#N/A Select M-WGS


19


#N/A Select M-WGS


20


#N/A Select M-WGS













M-WGS Training Needed (Mid-Year & Annual)








Does your laboratory need M-WGS related training?






Describe training need:







1




2




3




4




5




6




7




8




9




10

























M-WGS Mentorship Needed (Mid-Year & Annual)








Are you in need of help finding a M-WGS Mentor lab?






Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:



1





2





3





4





5





6





7





8





9





10

















M-WGS Proficiency Testing (Annual)


















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to the work performed under this Track.





PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses
1



#N/A Select M-WGS

2



#N/A Select M-WGS

3



#N/A Select M-WGS

4



#N/A Select M-WGS

5



#N/A Select M-WGS

6



#N/A Select M-WGS

7



#N/A Select M-WGS

8



#N/A Select M-WGS

9



#N/A Select M-WGS

10



#N/A Select M-WGS













M-WGS Collaborations (Mid-Year & Annual)









Please select "Yes" for those collaboration types that apply or "No" for those that do not below:




Specific Projects (sets of Isolates) the Lab is Sequencing FDA Directed Project Academia Collaboration International Collaboration Other Historical Isolate Sets Comments OPEI Awardee Name Track
1





#N/A Select M-WGS
2





#N/A Select M-WGS
3





#N/A Select M-WGS
4





#N/A Select M-WGS
5





#N/A Select M-WGS
6





#N/A Select M-WGS
7





#N/A Select M-WGS
8





#N/A Select M-WGS
9





#N/A Select M-WGS
10





#N/A Select M-WGS












M-WGS Track Additional Information (Mid-Year & Annual)








If there is any other information you would like to provide regarding your program within the M-WGS track please enter it below:














































































































Sheet 7: M-CC










































































































































































































Grant Track: M-CC





















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative



1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select M-CC




2 Equipment $0.00 $0.00 $0.00 #N/A Select M-CC




3 Travel $0.00 $0.00 $0.00 #N/A Select M-CC




4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select M-CC




5 Publication Costs $0.00 $0.00 $0.00 #N/A Select M-CC




6 Consultant Services $0.00 $0.00 $0.00 #N/A Select M-CC




7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select M-CC




8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select M-CC




9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select M-CC




10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select M-CC




11 Other Costs $0.00 $0.00 $0.00 #N/A Select M-CC




12 Total Budget $0.00 $0.00 $0.00 #N/A Select M-CC




13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select M-CC




14 Additional Budget Comments:


















M-CC Key Personnel (Mid-Year & Annual)











The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.






Last Name, First Name CAP Role
(If an individual has more than one role for
M-CC they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track


1





#N/A Select M-CC


2





#N/A Select M-CC


3





#N/A Select M-CC


4





#N/A Select M-CC


5





#N/A Select M-CC


6





#N/A Select M-CC


7





#N/A Select M-CC


8





#N/A Select M-CC


9





#N/A Select M-CC


10





#N/A Select M-CC


11





#N/A Select M-CC


12





#N/A Select M-CC


13





#N/A Select M-CC


14





#N/A Select M-CC


15





#N/A Select M-CC


16





#N/A Select M-CC


17





#N/A Select M-CC


18





#N/A Select M-CC


19





#N/A Select M-CC


20





#N/A Select M-CC










M-CC Training/Mentorship Administered (Mid-Year & Annual)
























Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses




1


#N/A Select M-CC





2


#N/A Select M-CC





3


#N/A Select M-CC





4


#N/A Select M-CC





5


#N/A Select M-CC





6


#N/A Select M-CC





7


#N/A Select M-CC





8


#N/A Select M-CC





9


#N/A Select M-CC





10


#N/A Select M-CC





11


#N/A Select M-CC





12


#N/A Select M-CC





13


#N/A Select M-CC





14


#N/A Select M-CC





15


#N/A Select M-CC





16


#N/A Select M-CC





17


#N/A Select M-CC





18


#N/A Select M-CC





19


#N/A Select M-CC





20


#N/A Select M-CC



















M-CC Training Needed (Mid-Year & Annual)











Does your laboratory need M-CC related training?









Describe training need:










1







2







3







4







5







6







7







8







9







10


































M-CC Mentorship Needed (Mid-Year & Annual)











Are you in need of help finding a M-CC Mentor lab?









Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:






1








2








3








4








5








6








7








8








9








10


















M-CC Capability/Capacity Development (Mid-Year & Annual)
























Please describe highlights as they align with the M-CC Development Grant Track:

































If your lab was funded to implement a new method under the M-CC Development Track please fill in chart below:











Was Equipment Purchased? If No equipment was purchased, explain below: Were supplies, reagents, media, standards, etc. purchased? If No supplies were purchased, explain below: Training Received? Describe Training Received
(or explain if no training was received for this method)
Competency Demonstrated? If competency was not demonstrated explain below: OPEI Awardee Name Track CC Other Responses
1







#N/A Select M-CC
2







#N/A Select M-CC
3







#N/A Select M-CC
4







#N/A Select M-CC
5







#N/A Select M-CC
6







#N/A Select M-CC
7







#N/A Select M-CC
8







#N/A Select M-CC
9







#N/A Select M-CC
10







#N/A Select M-CC










M-CC Proficiency Testing (Annual)
























Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to the work performed under this Track.








PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses



1



#N/A Select M-CC




2



#N/A Select M-CC




3



#N/A Select M-CC




4



#N/A Select M-CC




5



#N/A Select M-CC




6



#N/A Select M-CC




7



#N/A Select M-CC




8



#N/A Select M-CC




9



#N/A Select M-CC




10



#N/A Select M-CC












M-CC Track Additional Information (Mid-Year & Annual)











If there is any other information you would like to provide regarding your program within the M-CC track please enter it below:






























































































































































Sheet 8: C-HF







































































































































































Grant Track: C-HF

















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative

1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select C-HF


2 Equipment $0.00 $0.00 $0.00 #N/A Select C-HF


3 Travel $0.00 $0.00 $0.00 #N/A Select C-HF


4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select C-HF


5 Publication Costs $0.00 $0.00 $0.00 #N/A Select C-HF


6 Consultant Services $0.00 $0.00 $0.00 #N/A Select C-HF


7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select C-HF


8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select C-HF


9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select C-HF


10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select C-HF


11 Other Costs $0.00 $0.00 $0.00 #N/A Select C-HF


12 Total Budget $0.00 $0.00 $0.00 #N/A Select C-HF


13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select C-HF



Additional Budget Comments:


#N/A Select C-HF 0

14 Additional Budget Comments:










C-HF Key Personnel (Mid-Year & Annual)









The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award. Laboratories may also list names of key personnel from the State Regulatory Program (SRP) who handle LFFM Sample collection planning and positive sample follow-up – this will allow those staff to receive the LFFM weekly email (they will not be added to the meeting invites or FERNlab.org workgroup for the analytical track).




Last Name, First Name CAP Role
(If an individual has more than one role for
C-HF they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select C-HF
2





#N/A Select C-HF
3





#N/A Select C-HF
4





#N/A Select C-HF
5





#N/A Select C-HF
6





#N/A Select C-HF
7





#N/A Select C-HF
8





#N/A Select C-HF
9





#N/A Select C-HF
10





#N/A Select C-HF
11





#N/A Select C-HF
12





#N/A Select C-HF
13





#N/A Select C-HF
14





#N/A Select C-HF
15





#N/A Select C-HF
16





#N/A Select C-HF
17





#N/A Select C-HF
18





#N/A Select C-HF
19





#N/A Select C-HF
20





#N/A Select C-HF




C-HF Training/Mentorship Administered (Mid-Year & Annual)




















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses


1


#N/A Select C-HF



2


#N/A Select C-HF



3


#N/A Select C-HF



4


#N/A Select C-HF



5


#N/A Select C-HF



6


#N/A Select C-HF



7


#N/A Select C-HF



8


#N/A Select C-HF



9


#N/A Select C-HF



10


#N/A Select C-HF



11


#N/A Select C-HF



12


#N/A Select C-HF



13


#N/A Select C-HF



14


#N/A Select C-HF



15


#N/A Select C-HF



16


#N/A Select C-HF



17


#N/A Select C-HF



18


#N/A Select C-HF



19


#N/A Select C-HF



20


#N/A Select C-HF















C-HF Training Needed (Mid-Year & Annual)









Does your laboratory need C-HF related training?







Describe training need:








1





2





3





4





5





6





7





8





9





10




























C-HF Mentorship Needed (Mid-Year & Annual)









Are you in need of help finding a C-HF Mentor lab?







Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:




1






2






3






4






5






6






7






8






9






10










C-HF Small-scale Projects (Annual)




















Projects listed here should include the following:
1) FDA-directed special assignments (testing events) above and beyond the approved sampling plan for the year;
2) Method development/validation/other work required during an emergency/outbreak situation, where FDA approved re-direction of approved sampling plan;
3) Participation in FDA-directed matrix extension/method development/method validation work outside of the project formally assigned for the MDV track;
4) Work required as part of a Capability/Capacity development effort.





Project Name Scope Description





















































C-HF Proficiency Testing (Annual)




















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to commodity/hazard pairs on your approved sampling plan for the year.






PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses

1



#N/A Select C-HF


2



#N/A Select C-HF


3



#N/A Select C-HF


4



#N/A Select C-HF


5



#N/A Select C-HF


6



#N/A Select C-HF


7



#N/A Select C-HF


8



#N/A Select C-HF


9



#N/A Select C-HF


10



#N/A Select C-HF








C-HF FDA Form 431 or e431 (Mid-Year & Annual)









Are you using the FDA Form 431 or e431?







If no, do the documents you are using cover all the items within the 431?







Explain your answer:








State Regulatory Action on C-HF Samples (Mid-Year & Annual)




















Sample Number Matrix Contaminant found Date analytical package sent to SRP/FDA Describe any State regulatory actions such as recalls taken as a result of laboratory findings (including dates) Describe any joint response with FDA as a result of laboratory findings (including dates) OPEI Awardee Name Track CHF Other Responses
1





#N/A Select C-HF
2





#N/A Select C-HF
3





#N/A Select C-HF
4





#N/A Select C-HF
5





#N/A Select C-HF
6





#N/A Select C-HF
7





#N/A Select C-HF
8





#N/A Select C-HF
9





#N/A Select C-HF
10





#N/A Select C-HF




C-HF Track Additional Information (Mid-Year & Annual)









If there is any other information you would like to provide regarding your program within the C-HF track please enter it below:






























































































































Sheet 9: C-FD















































































































































































































































































































































Grant Track: C-FD































Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative








1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select C-FD









2 Equipment $0.00 $0.00 $0.00 #N/A Select C-FD









3 Travel $0.00 $0.00 $0.00 #N/A Select C-FD









4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select C-FD









5 Publication Costs $0.00 $0.00 $0.00 #N/A Select C-FD









6 Consultant Services $0.00 $0.00 $0.00 #N/A Select C-FD









7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select C-FD









8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select C-FD









9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select C-FD









10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select C-FD









11 Other Costs $0.00 $0.00 $0.00 #N/A Select C-FD









12 Total Budget $0.00 $0.00 $0.00 #N/A Select C-FD









13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select C-FD









14 Additional Budget Comments:































C-FD Key Personnel (Mid-Year & Annual)
















The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.











Last Name, First Name CAP Role
(If an individual has more than one role for
C-FD they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track







1





#N/A Select C-FD







2





#N/A Select C-FD







3





#N/A Select C-FD







4





#N/A Select C-FD







5





#N/A Select C-FD







6





#N/A Select C-FD







7





#N/A Select C-FD







8





#N/A Select C-FD







9





#N/A Select C-FD







10





#N/A Select C-FD







11





#N/A Select C-FD







12





#N/A Select C-FD







13





#N/A Select C-FD







14





#N/A Select C-FD







15





#N/A Select C-FD







16





#N/A Select C-FD







17





#N/A Select C-FD







18





#N/A Select C-FD







19





#N/A Select C-FD







20





#N/A Select C-FD

























C-FD Training/Mentorship Administered (Mid-Year & Annual)


































Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses









1


#N/A Select C-FD










2


#N/A Select C-FD










3


#N/A Select C-FD










4


#N/A Select C-FD










5


#N/A Select C-FD










6


#N/A Select C-FD










7


#N/A Select C-FD










8


#N/A Select C-FD










9


#N/A Select C-FD










10


#N/A Select C-FD










11


#N/A Select C-FD










12


#N/A Select C-FD










13


#N/A Select C-FD










14


#N/A Select C-FD










15


#N/A Select C-FD










16


#N/A Select C-FD










17


#N/A Select C-FD










18


#N/A Select C-FD










19


#N/A Select C-FD










20


#N/A Select C-FD





























C-FD Training Needed (Mid-Year & Annual)
















Does your laboratory need C-FD related training?














Describe training need:















1












2












3












4












5












6












7












8












9












10

















































C-FD Mentorship Needed (Mid-Year & Annual)
















Are you in need of help finding a C-FD Mentor lab?














Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:











1













2













3













4













5













6













7













8













9













10































C-FD Expansions of Capabilities/Capacities for Food Defense testing (Mid-Year & Annual)


































Please describe increases or expansions in capabilities or capacities for food Defense testing (increases in trained personnel, new capabilities developed, etc.). Make sure Food Defense related trainings are also itemized in the Trainings section on All-Tracks Tab:












































If your lab utilized funding to implement a new method under the Food Defense Track, please fill in the chart below:
















Was Equipment Purchased? If No equipment was purchased, explain below: Were supplies, reagents, media, standards, etc. purchased? If No supplies were purchased, explain below: Training Received? Describe Training Received
(or explain if no training was received for this method)
Competency Demonstrated? If competency was not demonstrated explain below: OPEI Awardee Name Track Other Responses




1







#N/A Select C-FD





2







#N/A Select C-FD





3







#N/A Select C-FD





4







#N/A Select C-FD





5







#N/A Select C-FD





6







#N/A Select C-FD





7







#N/A Select C-FD





8







#N/A Select C-FD





9







#N/A Select C-FD





10







#N/A Select C-FD
















































C-FD Maintenance of Key Food Defense Capabilities/Methods (Mid-Year & Annual)


































Complete the following table to document your current capabilities for key food defense methods. Use the drop-down to select methods for which your lab has established capability, or is in the process of building capability. Filling out this table may also assist laboratories in identifying steps you may need to take to increase capability and/or capacity for any of these methods. The chart below is populated with methods that have been identified as key capabilities for this Food Defense Track, but there is space to enter other methods that are not currently listed. Only select or add methods for which you have established capability, or have committed to establishing capability as an objective of the Track.












Methods Methods Comments (required for an "Other" response) Equipment in House & Operational? Equipment Comments
(required for a "No" response)
Supplies, Reagents, Media in House and Within Date Supplies Comments
(required for a "No" response)
Number Analysts Trained Name of PT/Competency Exercise Provider Date of Last Competency Determination Laboratory Performance Laboratory Performance Comments
(required for "unacceptable" performance)
Summarize Next Steps to Maintain Capability, Increase Capacity or Document Needs OPEI Awardee Name Track Other Responses
1












#N/A Select C-FD
2












#N/A Select C-FD
3












#N/A Select C-FD
4












#N/A Select C-FD
5












#N/A Select C-FD
6












#N/A Select C-FD
7












#N/A Select C-FD
8












#N/A Select C-FD
9












#N/A Select C-FD
10












#N/A Select C-FD












C-FD Food Defense Activities i.e. FDA-assigned samples, exercises, responses (Mid-Year & Annual)


































Activity Description of Activity and Highlights












1














2














3














4














5














6














7














8














9














10


















































C-FD Track Additional Information (Mid-Year & Annual)
















If there is any other information you would like to provide regarding your program within the C-FD track please enter it below:














































































































































































































































Sheet 10: C-AF







































































































































































Grant Track: C-AF

















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative

1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select C-AF


2 Equipment $0.00 $0.00 $0.00 #N/A Select C-AF


3 Travel $0.00 $0.00 $0.00 #N/A Select C-AF


4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select C-AF


5 Publication Costs $0.00 $0.00 $0.00 #N/A Select C-AF


6 Consultant Services $0.00 $0.00 $0.00 #N/A Select C-AF


7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select C-AF


8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select C-AF


9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select C-AF


10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select C-AF


11 Other Costs $0.00 $0.00 $0.00 #N/A Select C-AF


12 Total Budget $0.00 $0.00 $0.00 #N/A Select C-AF


13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select C-AF


14 Additional Budget Comments:










C-AF Key Personnel (Mid-Year & Annual)









The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award. Laboratories may also list names of key personnel from the State Regulatory Program (SRP) who handle LFFM Sample collection planning and positive sample follow-up – this will allow those staff to receive the LFFM weekly email (they will not be added to the meeting invites or FERNlab.org workgroup for the analytical track).




Last Name, First Name CAP Role
(If an individual has more than one role for
C-AF they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select C-AF
2





#N/A Select C-AF
3





#N/A Select C-AF
4





#N/A Select C-AF
5





#N/A Select C-AF
6





#N/A Select C-AF
7





#N/A Select C-AF
8





#N/A Select C-AF
9





#N/A Select C-AF
10





#N/A Select C-AF
11





#N/A Select C-AF
12





#N/A Select C-AF
13





#N/A Select C-AF
14





#N/A Select C-AF
15





#N/A Select C-AF
16





#N/A Select C-AF
17





#N/A Select C-AF
18





#N/A Select C-AF
19





#N/A Select C-AF
20





#N/A Select C-AF




C-AF Training/Mentorship Administered (Mid-Year & Annual)




















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses


1


#N/A Select C-AF



2


#N/A Select C-AF



3


#N/A Select C-AF



4


#N/A Select C-AF



5


#N/A Select C-AF



6


#N/A Select C-AF



7


#N/A Select C-AF



8


#N/A Select C-AF



9


#N/A Select C-AF



10


#N/A Select C-AF



11


#N/A Select C-AF



12


#N/A Select C-AF



13


#N/A Select C-AF



14


#N/A Select C-AF



15


#N/A Select C-AF



16


#N/A Select C-AF



17


#N/A Select C-AF



18


#N/A Select C-AF



19


#N/A Select C-AF



20


#N/A Select C-AF















C-AF Training Needed (Mid-Year & Annual)









Does your laboratory need C-AF related training?







Describe training need:








1





2





3





4





5





6





7





8





9





10




























C-AF Mentorship Needed (Mid-Year & Annual)









Are you in need of help finding a C-AF Mentor lab?







Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:




1






2






3






4






5






6






7






8






9






10










C-AF Small-scale Projects (Annual)




















Projects listed here should include the following:
1) FDA-directed special assignments (testing events) above and beyond the approved sampling plan for the year;
2) Method development/validation/other work required during an emergency/outbreak situation, where FDA approved re-direction of approved sampling plan;
3) Participation in FDA-directed matrix extension/method development/method validation work outside of the project formally assigned for the MDV track;
4) Work required as part of a Capability/Capacity development effort.





Project Name Scope Description





















































C-AF Proficiency Testing (Annual)




















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to commodity/hazard pairs on your approved sampling plan for the budget period.






PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses

1



#N/A Select C-AF


2



#N/A Select C-AF


3



#N/A Select C-AF


4



#N/A Select C-AF


5



#N/A Select C-AF


6



#N/A Select C-AF


7



#N/A Select C-AF


8



#N/A Select C-AF


9



#N/A Select C-AF


10



#N/A Select C-AF






C-AF FDA Form 431 or e431 (Mid-Year & Annual)









Are you using the FDA Form 431 or e431?







If no, do the documents you are using cover all the items within the 431?







Explain your answer:








State Regulatory Action on C-AF Samples (Mid-Year & Annual)




















Sample Number Matrix Contaminant found Date analytical package sent to SRP/FDA Describe any State regulatory actions such as recalls taken as a result of laboratory findings (including dates) Describe any joint response with FDA as a result of laboratory findings (including dates) OPEI Awardee Name Track CAF Other Responses
1





#N/A Select C-AF
2





#N/A Select C-AF
3





#N/A Select C-AF
4





#N/A Select C-AF
5





#N/A Select C-AF
6





#N/A Select C-AF
7





#N/A Select C-AF
8





#N/A Select C-AF
9





#N/A Select C-AF
10





#N/A Select C-AF




C-AF Track Additional Information (Mid-Year & Annual)









If there is any other information you would like to provide regarding your program within the C-AF track please enter it below:






























































































































Sheet 11: R-FD















































































































































































































































































































































Grant Track: R-FD































Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative








1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select R-FD









2 Equipment $0.00 $0.00 $0.00 #N/A Select R-FD









3 Travel $0.00 $0.00 $0.00 #N/A Select R-FD









4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select R-FD









5 Publication Costs $0.00 $0.00 $0.00 #N/A Select R-FD









6 Consultant Services $0.00 $0.00 $0.00 #N/A Select R-FD









7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select R-FD









8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select R-FD









9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select R-FD









10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select R-FD









11 Other Costs $0.00 $0.00 $0.00 #N/A Select R-FD









12 Total Budget $0.00 $0.00 $0.00 #N/A Select R-FD









13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select R-FD









14 Additional Budget Comments:































R-FD Key Personnel (Mid-Year & Annual)
















The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.











Last Name, First Name CAP Role
(If an individual has more than one role for
R-FD they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track







1





#N/A Select R-FD







2





#N/A Select R-FD







3





#N/A Select R-FD







4





#N/A Select R-FD







5





#N/A Select R-FD







6





#N/A Select R-FD







7





#N/A Select R-FD







8





#N/A Select R-FD







9





#N/A Select R-FD







10





#N/A Select R-FD







11





#N/A Select R-FD







12





#N/A Select R-FD







13





#N/A Select R-FD







14





#N/A Select R-FD







15





#N/A Select R-FD







16





#N/A Select R-FD







17





#N/A Select R-FD







18





#N/A Select R-FD







19





#N/A Select R-FD







20





#N/A Select R-FD

























R-FD Training/Mentorship Administered (Mid-Year & Annual)


































Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses









1


#N/A Select R-FD










2


#N/A Select R-FD










3


#N/A Select R-FD










4


#N/A Select R-FD










5


#N/A Select R-FD










6


#N/A Select R-FD










7


#N/A Select R-FD










8


#N/A Select R-FD










9


#N/A Select R-FD










10


#N/A Select R-FD










11


#N/A Select R-FD










12


#N/A Select R-FD










13


#N/A Select R-FD










14


#N/A Select R-FD










15


#N/A Select R-FD










16


#N/A Select R-FD










17


#N/A Select R-FD










18


#N/A Select R-FD










19


#N/A Select R-FD










20


#N/A Select R-FD





























R-FD Training Needed (Mid-Year & Annual)
















Does your laboratory need R-FD related training?














Describe training need:















1












2












3












4












5












6












7












8












9












10

















































R-FD Mentorship Needed (Mid-Year & Annual)
















Are you in need of help finding a R-FD Mentor lab?














Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:











1













2













3













4













5













6













7













8













9













10































R-FD Expansions of Capabilities/Capacities for Food Defense testing (Mid-Year & Annual)


































Please describe increases or expansions in capabilities or capacities for food Defense testing (increases in trained personnel, new capabilities developed, etc.). Make sure Food Defense related trainings are also itemized in the Trainings section on All-Tracks Tab:












































If your lab utilized funding to implement a new method under the Food Defense Track, please fill in the chart below:
















Was Equipment Purchased? If No equipment was purchased, explain below: Were supplies, reagents, media, standards, etc. purchased? If No supplies were purchased, explain below: Training Received? Describe Training Received
(or explain if no training was received for this method)
Competency Demonstrated? If competency was not demonstrated explain below: OPEI Awardee Name Track CC Other Responses




1







#N/A Select R-FD





2







#N/A Select R-FD





3







#N/A Select R-FD





4







#N/A Select R-FD





5







#N/A Select R-FD





6







#N/A Select R-FD





7







#N/A Select R-FD





8







#N/A Select R-FD





9







#N/A Select R-FD





10







#N/A Select R-FD























R-FD Maintenance of Key Food Defense Capabilities/Methods (Mid-Year & Annual)


































Complete the following table to document your current capabilities for key food defense methods. Use the drop-down to select methods for which your lab has established capability, or is in the process of building capability. Filling out this table may also assist laboratories in identifying steps you may need to take to increase capability and/or capacity for any of these methods. The chart below is populated with methods that have been identified as key capabilities for this Food Defense Track, but there is space to enter other methods that are not currently listed. Only select or add methods for which you have established capability, or have committed to establishing capability as an objective of the Track.












Methods Methods Comments (required for an "Other" response) Equipment in House & Operational? Equipment Comments
(required for a "No" response)
Supplies, Reagents, Media in House and Within Date Supplies Comments
(required for a "No" response)
Number Analysts Trained Name of PT/Competency Exercise Provider Date of Last Competency Determination Laboratory Performance Laboratory Performance Comments
(required for "unacceptable" performance)
Summarize Next Steps to Maintain Capability, Increase Capacity or Document Needs OPEI Awardee Name Track PT Other Responses
1












#N/A Select R-FD
2












#N/A Select R-FD
3












#N/A Select R-FD
4












#N/A Select R-FD
5












#N/A Select R-FD
6












#N/A Select R-FD
7












#N/A Select R-FD
8












#N/A Select R-FD
9












#N/A Select R-FD
10












#N/A Select R-FD


















R-FD Food Defense Activities i.e. FDA-assigned samples, exercises, responses (Mid-Year & Annual)


































Activity Description of Activity and Highlights












1














2














3














4














5














6














7














8














9














10


















































R-FD Track Additional Information (Mid-Year & Annual)
















If there is any other information you would like to provide regarding your program within the R-FD track please enter it below:














































































































































































































































Sheet 12: SP-SC















































































































































Grant Track: SP-SC















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative
1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select SP-SC

2 Equipment $0.00 $0.00 $0.00 #N/A Select SP-SC

3 Travel $0.00 $0.00 $0.00 #N/A Select SP-SC

4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select SP-SC

5 Publication Costs $0.00 $0.00 $0.00 #N/A Select SP-SC

6 Consultant Services $0.00 $0.00 $0.00 #N/A Select SP-SC

7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select SP-SC

8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select SP-SC

9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select SP-SC

10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select SP-SC

11 Other Costs $0.00 $0.00 $0.00 #N/A Select SP-SC

12 Total Budget $0.00 $0.00 $0.00 #N/A Select SP-SC

13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select SP-SC

14 Additional Budget Comments:







SP-SC Key Personnel (Mid-Year & Annual)








The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.



Last Name, First Name CAP Role
(If an individual has more than one role for
SP-SC they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select SP-SC
2





#N/A Select SP-SC
3





#N/A Select SP-SC
4





#N/A Select SP-SC
5





#N/A Select SP-SC
6





#N/A Select SP-SC
7





#N/A Select SP-SC
8





#N/A Select SP-SC
9





#N/A Select SP-SC
10





#N/A Select SP-SC
11





#N/A Select SP-SC
12





#N/A Select SP-SC
13





#N/A Select SP-SC
14





#N/A Select SP-SC
15





#N/A Select SP-SC
16





#N/A Select SP-SC
17





#N/A Select SP-SC
18





#N/A Select SP-SC
19





#N/A Select SP-SC
20





#N/A Select SP-SC


SP-SC Training/Mentorship Administered (Mid-Year & Annual)


















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses

1


#N/A Select SP-SC


2


#N/A Select SP-SC


3


#N/A Select SP-SC


4


#N/A Select SP-SC


5


#N/A Select SP-SC


6


#N/A Select SP-SC


7


#N/A Select SP-SC


8


#N/A Select SP-SC


9


#N/A Select SP-SC


10


#N/A Select SP-SC


11


#N/A Select SP-SC


12


#N/A Select SP-SC


13


#N/A Select SP-SC


14


#N/A Select SP-SC


15


#N/A Select SP-SC


16


#N/A Select SP-SC


17


#N/A Select SP-SC


18


#N/A Select SP-SC


19


#N/A Select SP-SC


20


#N/A Select SP-SC













SP-SC Training Needed (Mid-Year & Annual)








Does your laboratory need SP-SC related training?






Describe training need:







1




2




3




4




5




6




7




8




9




10

























SP-SC Mentorship Needed (Mid-Year & Annual)








Are you in need of help finding a SP-SC Mentor lab?






Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:



1





2





3





4





5





6





7





8





9





10







SP-SC Competency Verification Exercises (Annual)


















Please fill in the requested information about proficiency testing and/or competency exercises:








Exercise Description Exercise Organizer Collector Performance If unacceptable, explain below Column1 Awardee Name Track SPSC Other Responses
1




Select SP-SC

2




Select SP-SC

3




Select SP-SC

4




Select SP-SC

5




Select SP-SC

6




Select SP-SC

7




Select SP-SC

8




Select SP-SC

9




Select SP-SC

10




Select SP-SC



SP-SC Track Additional Information (Mid-Year & Annual)








If there is any other information you would like to provide regarding your program within the SP-SC track please enter it below:














































































































Sheet 13: SP-IT


























































































































































































Grant Track: SP-IT



















Reminder – only complete this tab if you were selected for participation in this track in this budget period. If you have highlights related to ORA DX work from a prior budget period in which you were selected for participation, that you are completing in this budget period, please use space provided in Tab “AllTracks"


















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative


2 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select SP-IT



3 Equipment $0.00 $0.00 $0.00 #N/A Select SP-IT



4 Travel $0.00 $0.00 $0.00 #N/A Select SP-IT



5 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select SP-IT



6 Publication Costs $0.00 $0.00 $0.00 #N/A Select SP-IT



7 Consultant Services $0.00 $0.00 $0.00 #N/A Select SP-IT



8 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select SP-IT



9 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select SP-IT



10 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select SP-IT



11 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select SP-IT



12 Other Costs $0.00 $0.00 $0.00 #N/A Select SP-IT




Total Budget $0.00 $0.00 $0.00 #N/A Select SP-IT



17 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select SP-IT



20 Additional Budget Comments:













SP-IT Key Personnel (Mid-Year & Annual)










The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.





Last Name, First Name CAP Role
(If an individual has more than one role for
SP-IT they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track

1





#N/A Select SP-IT

2





#N/A Select SP-IT

3





#N/A Select SP-IT

4





#N/A Select SP-IT

5





#N/A Select SP-IT

6





#N/A Select SP-IT

7





#N/A Select SP-IT

8





#N/A Select SP-IT

9





#N/A Select SP-IT

10





#N/A Select SP-IT

11





#N/A Select SP-IT

12





#N/A Select SP-IT

13





#N/A Select SP-IT

14





#N/A Select SP-IT

15





#N/A Select SP-IT

16





#N/A Select SP-IT

17





#N/A Select SP-IT

18





#N/A Select SP-IT

19





#N/A Select SP-IT

20





#N/A Select SP-IT







SP-IT Training/Mentorship Administered (Mid-Year & Annual)






















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track Training Other Responses



1


#N/A Select SP-IT




2


#N/A Select SP-IT




3


#N/A Select SP-IT




4


#N/A Select SP-IT




5


#N/A Select SP-IT




6


#N/A Select SP-IT




7


#N/A Select SP-IT




8


#N/A Select SP-IT




9


#N/A Select SP-IT




10


#N/A Select SP-IT




11


#N/A Select SP-IT




12


#N/A Select SP-IT




13


#N/A Select SP-IT




14


#N/A Select SP-IT




15


#N/A Select SP-IT




16


#N/A Select SP-IT




17


#N/A Select SP-IT




18


#N/A Select SP-IT




19


#N/A Select SP-IT




20


#N/A Select SP-IT

















SP-IT Training Needed (Mid-Year & Annual)










Does your laboratory need SP-IT related training?








Describe training need:









1






2






3






4






5






6






7






8






9






10



















SP-IT Mentorship Needed (Mid-Year & Annual)










Are you in need of help finding a SP-IT Mentor lab?








Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:





1







2







3







4







5







6







7







8







9







10













ORA Data exchange (ORA DX) Adoption (Mid-Year & Annual)






















Are you participating in NSFDX?







Are you participating in ORAPP?







Are you participating in DX Client?







Did you participate in an onboarding session and complete the FDA questionnaire for the overview of NFSDX, ORAPP, and DX?







(NSFDX only) Have you entered into a Memorandum of Understanding (MOU) with FDA?







(NSFDX only) Have you entered into an Interconnection Security Agreement (ISA) with FDA?



















Have you assessed the current IT capabilities of your laboratory as it pertains to sample collection and analytical data, including conducting an analysis of which fields can be mapped to FDA data elements, system changes needed to capture missing data, and any that would need to be developed?







If not, when do you plan to complete this activity (MM/DD/YYYY)?



















Please list planned activities for adoption of ORA DX workflow and highlights, specific to this budget period:










Activities Description





1







2







3







4







5







6







7







8







9







10























SP-IT Track Additional Information (Mid-Year & Annual)










If there is any other information you would like to provide regarding your program within the SP-IT track please enter it below:


























































































































































Sheet 14: SP-MDV















































































































































































































































Grant Track: SP-MD/V























Reminder – only complete this tab if you are selected for this participation this track in this budget period. If you have accomplishments related to Method Development/Method Validation work from a prior budget period in which you were selected for participation, please use space provided in Tab “AllTracks"






















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative




1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select SP-MD/V





2 Equipment $0.00 $0.00 $0.00 #N/A Select SP-MD/V





3 Travel $0.00 $0.00 $0.00 #N/A Select SP-MD/V





4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select SP-MD/V





5 Publication Costs $0.00 $0.00 $0.00 #N/A Select SP-MD/V





6 Consultant Services $0.00 $0.00 $0.00 #N/A Select SP-MD/V





7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select SP-MD/V





8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select SP-MD/V





9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select SP-MD/V





10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select SP-MD/V





11 Other Costs $0.00 $0.00 $0.00 #N/A Select SP-MD/V





12 Total Budget $0.00 $0.00 $0.00 #N/A Select SP-MD/V





13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select SP-MD/V





14 Additional Budget Comments:



















SP-MD/V Key Personnel (Mid-Year & Annual)












The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.







Last Name, First Name CAP Role
(If an individual has more than one role for
SP-MD/V they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track (receive emails, invite to FERNlab.org workgroup, meeting invites, etc.) Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track



1





#N/A Select SP-MD/V



2





#N/A Select SP-MD/V



3





#N/A Select SP-MD/V



4





#N/A Select SP-MD/V



5





#N/A Select SP-MD/V



6





#N/A Select SP-MD/V



7





#N/A Select SP-MD/V



8





#N/A Select SP-MD/V



9





#N/A Select SP-MD/V



10





#N/A Select SP-MD/V



11





#N/A Select SP-MD/V



12





#N/A Select SP-MD/V



13





#N/A Select SP-MD/V



14





#N/A Select SP-MD/V



15





#N/A Select SP-MD/V



16





#N/A Select SP-MD/V



17





#N/A Select SP-MD/V



18





#N/A Select SP-MD/V



19





#N/A Select SP-MD/V



20





#N/A Select SP-MD/V











Method Development and Method Validation Summary (Annual)






























Intended Outcome(s) of this Project (mark yes for all that apply)






Name of MDV Project Type of Project If Type of Project is Other, Describe Below Multi or Single Lab New or Revised Method to be Submitted to FDA or FERN Methods Coordination Committee In-house Implementation of the Method Response/Emergency use to Support State or Local Regulatory Programs What reference materials or known samples were used in this track to complete the MDV project If the MDV Project is related to response/emergency activities describe below OPEI Awardee Name Track SPMDV Other Responses
1








#N/A Select SP-MD/V
2








#N/A Select SP-MD/V
3








#N/A Select SP-MD/V








Method Development and Method Validation Planned Activities and Highlights (Mid-Year & Annual)












Please list planned activities for this MDV project and highlights, specific to this budget period.












Activities Description







1









2









3









4









5









6









7









8









9









10



















SP-MD/V Track Additional Information (Mid-Year & Annual)












If there is any other information you would like to provide regarding your program within the SP-MD/V track please enter it below:














































































































































































Sheet 15: SP-CoV2















































































































































Grant Track: SP-CoV2















Expenses Total Budgeted Expended to Date Projected Expenses OPEI Awardee Name Track Budget Narrative
1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00 #N/A Select SP-CoV2

2 Equipment $0.00 $0.00 $0.00 #N/A Select SP-CoV2

3 Travel $0.00 $0.00 $0.00 #N/A Select SP-CoV2

4 Materials and Supplies $0.00 $0.00 $0.00 #N/A Select SP-CoV2

5 Publication Costs $0.00 $0.00 $0.00 #N/A Select SP-CoV2

6 Consultant Services $0.00 $0.00 $0.00 #N/A Select SP-CoV2

7 ADP/Computer Services $0.00 $0.00 $0.00 #N/A Select SP-CoV2

8 Subawards/Contractual Costs $0.00 $0.00 $0.00 #N/A Select SP-CoV2

9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00 #N/A Select SP-CoV2

10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00 #N/A Select SP-CoV2

11 Other Costs $0.00 $0.00 $0.00 #N/A Select SP-CoV2

12 Total Budget $0.00 $0.00 $0.00 #N/A Select SP-CoV2

13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00

#N/A Select SP-CoV2

14 Additional Budget Comments:







SP-CoV2 Key Personnel (Mid-Year & Annual)








The following section will be used to update contact lists for this Track. Please include all personnel that work on this Track, even if they are not funded under the award.



Last Name, First Name CAP Role
(If an individual has more than one role for
SP-CoV2 they may be listed for each CAP funded role)
Email Phone Include this person on distribution list for this Track
(receive emails, invite to FERNlab.org workgroup, meeting invites, etc.)
Total expected CAP funded Calendar Months for this role OPEI Awardee Name Track
1





#N/A Select SP-CoV2
2





#N/A Select SP-CoV2
3





#N/A Select SP-CoV2
4





#N/A Select SP-CoV2
5





#N/A Select SP-CoV2
6





#N/A Select SP-CoV2
7





#N/A Select SP-CoV2
8





#N/A Select SP-CoV2
9





#N/A Select SP-CoV2
10





#N/A Select SP-CoV2
11





#N/A Select SP-CoV2
12





#N/A Select SP-CoV2
13





#N/A Select SP-CoV2
14





#N/A Select SP-CoV2
15





#N/A Select SP-CoV2
16





#N/A Select SP-CoV2
17





#N/A Select SP-CoV2
18





#N/A Select SP-CoV2
19





#N/A Select SP-CoV2
20





#N/A Select SP-CoV2












SP-CoV2 Training/Mentorship Administered (Mid-Year & Annual)


















Describe Mentorship/Training Topic Laboratories Mentored/Trained Number of People Trained OPEI Awardee Name Track SPCoV2 Other Responses

1


#N/A Select SP-CoV2


2


#N/A Select SP-CoV2


3


#N/A Select SP-CoV2


4


#N/A Select SP-CoV2


5


#N/A Select SP-CoV2


6


#N/A Select SP-CoV2


7


#N/A Select SP-CoV2


8


#N/A Select SP-CoV2


9


#N/A Select SP-CoV2


10


#N/A Select SP-CoV2


11


#N/A Select SP-CoV2


12


#N/A Select SP-CoV2


13


#N/A Select SP-CoV2


14


#N/A Select SP-CoV2


15


#N/A Select SP-CoV2


16


#N/A Select SP-CoV2


17


#N/A Select SP-CoV2


18


#N/A Select SP-CoV2


19


#N/A Select SP-CoV2


20


#N/A Select SP-CoV2













SP-CoV2 Training Needed (Mid-Year & Annual)








Does your laboratory need SP-CoV2 related training?






Describe training need:







1




2




3




4




5




6




7




8




9




10















SP-CoV2 Mentorship Needed (Mid-Year & Annual)








Are you in need of help finding a SP-CoV2 Mentor lab?






Describe mentoring need If you have a particular laboratory affiliated with this CAP you would like to assist you list them below:



1





2





3





4





5





6





7





8





9





10


















SP-CoV2 Proficiency Testing (Annual)


















Please fill in the requested information about proficiency testing and/or competency exercises. Only report PTs/Competency Exercises related to the work performed under this Track.





PT/Exercise Description
(Include analyte(s) and matrices)
PT/Exercise Provider Laboratory Performance If unacceptable, explain below OPEI Awardee Name Track PT Other Responses
1



#N/A Select SP-CoV2

2



#N/A Select SP-CoV2

3



#N/A Select SP-CoV2

4



#N/A Select SP-CoV2

5



#N/A Select SP-CoV2

6



#N/A Select SP-CoV2

7



#N/A Select SP-CoV2

8



#N/A Select SP-CoV2

9



#N/A Select SP-CoV2

10



#N/A Select SP-CoV2
































SP-CoV2 Track Additional Information (Mid-Year & Annual)








If there is any other information you would like to provide regarding your program within the SP-CoV2 track please enter it below:














































































































Sheet 16: Budget






























































































































































































Grant Track: All LFFM Tracks

























Expenses Total Budgeted Expended to Date Total Projected Expenses









1 Total Salary, Wages, and Fringe Benefits $0.00 $0.00 $0.00









2 Equipment $0.00 $0.00 $0.00

3 Travel $0.00 $0.00 $0.00

4 Materials and Supplies $0.00 $0.00 $0.00

5 Publication Costs $0.00 $0.00 $0.00

6 Consultant Services $0.00 $0.00 $0.00

7 ADP/Computer Services $0.00 $0.00 $0.00

8 Subawards/Contractual Costs $0.00 $0.00 $0.00

9 Equipment/Facility Rental/User Fees $0.00 $0.00 $0.00

10 Federal F&A (Indirect Costs) $0.00 $0.00 $0.00

11 Other Costs $0.00 $0.00 $0.00









12 Total Budget $0.00 $0.00 $0.00









13 Estimated unobligated funds (at RPPR submission, this value will be used to determine your offset for next year) $0.00











14 Additional Budget Comments M-HF: 0









Additional Budget Comments M-AF: 0









Additional Budget Comments M-FD: 0









Additional Budget Comments M-WGS: 0









Additional Budget Comments M-CC: 0









Additional Budget Comments C-HF: 0









Additional Budget Comments C-AF: 0









Additional Budget Comments C-FD: 0









Additional Budget Comments R-FD: 0









Additional Budget Comments SP-SC: 0









Additional Budget Comments SP-IT: 0









Additional Budget Comments SP-MDV: 0









Additional Budget Comments SP-CoV2: 0











































































































































































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