OMB Number: 0910-0909 Exp Date: XX/XX/XXXX See bottom of page for PRA statement | |||||||||||||
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 | ||||||||||
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 | |||||||||||
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) |
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: | ||||||||||
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) |
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: | ||||||||||
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) |
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: | |||||||||||||||||
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) |
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: | |||||||||
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) |
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: | ||||||||||||
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) |
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: | ||||||||||
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) |
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 | |||||||||||||||||
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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 | |||||||||||||||||
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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: | |||||||||||||||||
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) |
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 | ||||||||||
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3 | ||||||||||
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5 | ||||||||||
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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 | ||||||||||
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9 | ||||||||||
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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: | ||||||||||
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) |
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 | |||||||||||||||||
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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 | |||||||||||||||||
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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 | |||||||||||||||||
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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: | |||||||||||||||||
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) |
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: | |||||||||
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) |
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: | |||||||||||
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) |
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: | |||||||||||||
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) |
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: | |||||||||
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 | |||||||||||||
File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
File Modified | 0000-00-00 |
File Created | 0000-00-00 |