Statement of Work (SOW)--SLEPDH 8-25-2020.doc

STATEMENT OF WORK

1) Project Title.

Digitization, harmonization and standardization of Shelf Life Extension Program (SLEP) analytical worksheets

2) Description of Work

i. Background

The FDA-DOD Shelf Life Extension Program (SLEP) for stockpiled human drugs is a key component of the U.S. military’s protection efforts against endemic and pandemic diseases, and the threats posed by chemical, biological, radiological or nuclear weapons. The FDA-DOD SLEP is a US Strategic National Stockpile that now supports the efforts of additional SNS stockpiles such as CDC, VA and the State Department to extend the shelf-life of their stockpiled products. It is the FDA/CDER goal to safeguard the public health. Therefore, the drug products stored/stockpiled must always be available for release during the time of emergency. The DOD stockpiled drugs are analyzed at various FDA field laboratories, and if the data meets the drug quality, the shelf life of the expired drugs are extended each time. The program was established in 1986 and the workflow is based on a paper to paper, site to site platform. The CDER SLEP coordinator has worked with FDA IT and CDER IT business units to design an electronic platform to support the growing requirements of the SLEP program. This electronic platform was created first to secure the nearly 100,000 FDA-DOD paper documents and as a result create a relational database that would provide electronic transfer of SLEP review documents from FDA ORA labs and lab data from FDA ORA labs to the CDER SLEP coordinator for review and approval of SLEP drug product extensions in the Strategic National Stockpiles. The FDA-DOD’s Shelf Life Extension Program saves the US government nearly a billion dollars a year. It is anticipated that the completion of the database, digitizing the paper documents to electronic files, thus creating an electronic workflow platform, will meet the government requirements to effectively administer the SLEP program.

ii. Objectives The FDA-DOD Shelf Life Extension Program ensures that products stored as part of the National and Regional Stockpiles that meet quality standards and continue to remain in the stockpiles beyond the expiration date assigned by the product manufacturers. The two primary objectives are: (1) to secure the SLEP paper documents into Data Federal’s proprietary FREEDOM database (i.e. about 90% complete) and to create an electronic workflow platform through the electronic harmonization and (2)standardization of the SLEP analytical review worksheets among the FDA ORA laboratories that conduct SLEP work. Additional background and specific objectives are:

1) The SLEP administrators/coordinators have worked in collaboration with DATA FEDERAL (www.datafederal.com) to develop a 4-phased approach to improve data access and storage via the FREEDOM database from Data Federal, that allows the FDA to improve the effectiveness in the drug expiry program. The Data Federal is a private company that already hosting and maintaining FDA SLEP records in their record holders, databases/servers. The FDA field labs can directly upload the data worksheets on to the FREEDOM, where it can be accessed at different nodal points for data analysis and SLEP extension approvals. This budget is complete the digitization process and to provide for their data linking and electronic transfer interfaces as well as services to maintain records on their servers where they can be accessed from computers present at different nodal points such as CDER-white oak and FDA field laboratories at different places such as Philadelphia labs, Detroit labs etc. The first phase is on-going with digitization for eliminating of backlog of manually entered extensions. The Phase 2 is also ongoing with Data Federal and with some of the FDA ORA field laboratories to electronically upload the analytical worksheets manually on the FREEDOM. The planning for Phases 3 and 4 is still going on.

2) The second objective is the digitization of all pending prior worksheets and approval documents into the Data Federal proprietary FREEDOM database.

3) The third objective is to directly source data from the equipment in FDA’s field labs to the FREEDOM, which will help in deriving efficiencies in data integrity and records maintaining. This will also help both in eliminating data entry errors and manual steps. However, there are various formidable challenges such as cooperation of Water’s and Agilent’s with Data Federal in coordinating with instruments inter-phasing, and more importantly guiding through regulatory IT requirement. Currently, after the instruments runs the analysis, the data is tabulated, and the organized analytical worksheets are uploaded in a pdf format on to the FREEDOM FDA-DOD SLEP electronic database. Only one or two field laboratories have these bare minimum capabilities.

iii. Requirements of Vendor (DPQR) The Data Federal shall be required to provide the following services in performance of the requirements of the Statement of Work:

a. Conduct: To achieve the objectives of the project, Data Federal will coordinate with FDA-SLEP administrators (Athar Masood, Patrick J. Faustino, Miah Schneider, etc.) to organize technical meetings as necessary (either monthly or bimonthly)for status updates of how the digitization and integration work is proceeding, and to discuss the, progress of the project, risk assessments, delivery times etc

b. Continue with the digitization process of work-sheets and maintaining of the records with integrity on the FREEDOM electronic database.

c. Work with FDA field labs, and Agilent and Waters instrument vendors in automating the process of direct data upload from the analytical instruments on to the FREEDOM electronic database.

d. Holding and maintaining the analytical worksheets and SLEP related records in their FREEDOM database with integrity.

e. Provide regular reports \quarterly to ensure project completion.

3) Reporting Requirements and Deliverable Items.

a. Quarterly status reports in Word document are to be submitted to the project coordinator.

b. A yearly report in Word document is to be submitted to the project coordinator (TBD).

c. Pre-Meeting Agenda, and Post Meeting Notes/Report

d. Data Federal will produce a statement of work detailing requirements and the associated level of effort to source data from Empower and Open Lab repositories

e. Work towards integration/automation of data uploads from field labs analytical instruments on to FREEDOM. Although, completion of the task is not deemed necessary as it depends upon various factors.

4) Duration of Project.

a. It is estimated that the project will be completed within 12 months after award.