BTF 2020 SOW for Admin Core Task #1 FINAL 2.pdf

TASK 1 -STATEMENT OF

WORK

Biological Testing Facility-

Management, Administration and Database Activities

SUMMARY

A Task is required to conduct administrative activities including project management as well as storage of current biological inventory, archived documents and data, maintenance of equipment, and continued database maintenance activities in the Biological Testing Facility to support the mission of contraceptive drug development in

CDP, DIPHR, NICHD, NIH.

I. BACKGROUND

The National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for both men and women. The Biological Testing Facility for CDP has the scope and objective of conducting preclinical development activities associated with development of new products for contraception in men and women. The activities covered by this task are critical to the CDP program and cannot be interrupted.

II. SCOPE

To maintain administrative and management activities associated with all preclinical development activities required by CDP for development of new products for contraception in men and women.

III. OBJECTIVES

To maintain administrative activities including project management, storage of current biological inventory, archived documents and data, maintenance of equipment, and continued database maintenance. The activities associated with this task permit the contractor to execute effective and efficient administration, management, data storage and communication between the contractor staff and CDP, NICHD for all activities related to potential contraceptive products development.

IV. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all of the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed to perform the Statement of Work.

Specifically, the contractor shall

1. Perform administrative support of existing tasks.

2. Manage databases, data analysis, documentation, products and specimen/reagents.

3. Manage inventory and related information, archival data, documents and agents including tracking and record keeping with the capability to receive, format, store, ship and record Compounds/products and biological agents associated with the program.

4. Maintain NICHD database including annual database software subscription, manual data entry, scanning of NICHD historical documents and uploading files to NICHD database.

5. Archive NICHD histopathology materials, study samples and data.

6. Maintain government furnished property associated with the contract.

7. Conduct regular teleconferences, project-related on-site visits or other means of communication between the Administrative Team (primarily composed of the Principal Investigator (PI), Assoc. PI, and Project Manager) with the NICHD COR and CO; travel of PI, Assoc. PI and technical experts as required for continued successful contract performance and maintenance as requested by the

NICHD COR.

8. Continue support for Regulatory Affairs as needed.

Specific directions in the technical requirements in the conduct of the task may change as a result of programmatic modifications. The latest NICHD-approved requirements as defined by the task scope and objectives will define the specific technical requirements with which the Contractor shall comply.

V. PERIOD OF PERFORMANCE AND DELIVERABLES

The contractor shall be required to prepare and submit the following reports in the manner stated below:

1. Weekly teleconference and written summary to update progress with preparation of the meeting minutes and related documents as needed to be sent to the Contracting Officer Representative (COR).

2. Preparation of quarterly electronic progress reports (3 per year), an annual report (1 per year), and other contract deliverables; and miscellaneous administrative activities to ensure efficient overall management of the project.

VI. Technical Reports Delivery Schedule

Satisfactory performance of the contract is defined as satisfactorily performing the statement of work and delivering the following items.

REPORTING REQUIREMENTS AND DELIVERABLES -TASK 1

Item

Type of Deliverable

Recipients & Number of Copies

Reports Due

1. Quarterly Progress Report

1 Copy –COR 1 Copy – CO and CS

Within 30 calendar days after the end of the reporting period. Not due when Annual or Final Report is due.

2 Annual technical progress report

1 Copy –COR 1 Copy – CO and CS

Within 30 calendar days after the end of the reporting period. Not due when a Final Report is due.

3. Final Report 1 Copy –COR 1 Copy – CO and CS

First draft is due three months prior to the completion date of the contract. The final report is due 10 days before the completion date of the contract.