Attachment_F_-_Task_Order_Mapping_Matrix.xls

XLS spreadsheet 51 KB Posted

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Biologics Effectiveness and Safety (BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Products
Solicitation number
FDA-18-223-SOL-1196210
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Attachment F

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SOW Task

Task Order #0001Name (*, if sub) - Labor Category (K if key)Name -
Principal Investigator (K)Name -
Project Manager (K)Name -
Physician (K)Name -
Epidemiologist (K)Total
Proposed Labor Hours
Task 1: Data Provision Requirements# of hours per year
Task 2: Exposure and Outcome Validation# of hours per year
Task 3: Develop, Implement, and Validate New, Innovative Methods To Address Automated Reporting of Adverse Events For CBER-Regulated Products# of hours per year
Task 4: Electronic Reporting of Adverse Event Case Reports to CBER FAERS# of hours per year
Task 5: Experience and Expertise with Data, Tools, and Studies# of hours per year
Task 6: Operations and Management# of hours per year
Task 7: Communications and Outreach# of hours per year
Total# of hours per year
Skillset/Experience
Project Management Professional (PMP)Experience
Certification (YR)
SASExperience
Certification (YR)
SPSSExperience
Certification (YR)
TBDExperience
Certification (YR)
TBDExperience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)
Experience
Certification (YR)

&CAPPENDIX 1

Instructions

In the (first row) columns, include the resource’s name and labor category, an asterisk (if the resource is a sub-contractor) and “(K)” if key personnel.
In Rows 3 - 9, enter number of hours estimated for each position. Use 1920 hours per year per full-time employee as the basis of estimate. For example, the numbers entered in the 'per labor hours' column per employee, should equal the '# hours per year'. If a task is not applicable, please enter N/A in Column G.
For each skill set "Experience" row, enter the number of years of experience for proposed staff
For each skill set "Certification" row, enter the name of certifications and the year received for proposed staff
If there are additional skill sets the Quoter would like to provide, please add them in the rows after Row ___ (currently labeled "tbd".)

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