Attachment_C_pgs_20-21rev.pdf

SOLICITATION: 16‐223‐SOL‐00101

TASK ORDER: Attachment C

Provide timetable for installation of equipment

The Contractor shall submit the following deliverables to the COR:

Item Deliverable /Event Frequency Timeline Reference

1 Management plan which inludes

Communication Plan, Risk

Management Plan, Staffing Plan, Training Plan, Quality Control, Data

Entry and MedDRA Coding Quality

Assurance Plans, and plan for physical FISMA inspection

One time 30 days after contract award

Section 4.1.2

Management plan

W Contingency Plan One time 30 days after contract award

Section 4.1.2

Management plan

3 Meetings agenda and notes from the meeting ; kickoff, pre‐ production, ad hoc weekly, monthly, program review

Varies Time varies kickoff is 10 days of award

Section 4.16.

meetings

4 Quality Metrics Reporting Monthly and as needed

After 60 day transition

Section 4.1.7

Performance

Reporting and

Metrics

7 Data Entry Quality Report Weekly After 60 day transition

Sections 4.1.7

Performance

Reporting and

Metrics

8 FAERS and DQRS reports for six month program review . See

Appendix D

Every 6‐ months during

Program

Review

After six months Section 4.1.6

Meetings

9 Facility Space Plan One time Submitted with

Contractor’s Task

Order Proposal

Appendix A

SOLICITATION: 16‐223‐SOL‐00101

TASK ORDER: Attachment C

10 Training Plan One time and update if requested by

FDA

10 days after contract award

Section 4.6.1

Task area 8‐ training

11 Certification of MedDRA coding

Competency

Used for each new MedDRA coder

Before any new

MedDRA coder can do production work

Section 4.6.4

Evaluation of

Compentency

13 ICSR information submitted to

Manufacturers related to the MMP

Ongoing Take over full responsibility at end of transition but will be working on production during transition

Section 4.2.1.2

CTU tasks

Drug Manufacturer Quarterly report

Quarterly Starts at the end of the transition period

Section 4.2

Task Area 2

FAERS‐DMP

Document

Processing, Handling, Correspondenc e and Delivery

15 Industry MedDRA Coding Quality

Assurance Document

Monthly Starts at end of transition period

Section 4.2.6

16 DQRS assignment letters Ongoing ;

weekly to FDA

Field offices

Full performance at end of transition period

Section 4.3

5 TASK ORDER PERIOD OF PERFORMANCE

The period of performance end date of this order shall be 12 months from the performance start date.

6 PLACE OF PERFORMANCE

The contractor will be required to work at the contractor site and provide courier services to multiple

FDA facilities each weekday. See Appendix C

The contractor may submit a telework plan for COR approval. The plan shall include provisions for the

COR to suspend teleworking