SOW.pdf

NAVAL MEDICAL RESEARCH CENTER – ADVANCED MEDICAL DEVELOPMENT

STATEMENT OF WORK

FOR

DOCUMENT LIBRARY OF RDT&E ACQUISITION PROCESSES FOR

NAVY ADVANCED MEDICAL DEVELOPMENT

14 December 2017

1. BACKGROUND: The Naval Medical Research Center (NMRC) is Navy enterprise headquarters for a worldwide network of medical research laboratories dedicated to providing world-class, operationally relevant health and medical research solutions for the Warfighter anytime, anywhere. The NMRC Advanced Medical Development Program (AMD) is the medical advanced developer responsible for the development of medical products for Naval Warfighters through excellence in acquisition supporting total life-cycle management of critical medical capabilities development. AMD is responsible for all activities associated with establishing and executing Program Office functions within the Department of Navy (DoN) for medical Research, Development, Test, and Evaluation (RDT&E) and for materiel development, adaptation, and transition of medical solutions for the Warfighter.

Navy Medicine relies on multiple organizations to execute end-to-end medical acquisition and executes this mission through various implementers and stakeholders in different chains-of-command as a matrixed entity. As such, AMD must be able to coordinate and communicate program information in many forms to varying audiences with minimal lead time. All program documentation must demonstrate program compliance with official instruction for Department of Defense (DoD) Acquisition System Development Processes (DODI 5000.02), SECNAV Instruction (5000.02E), Federal Acquisition Regulations (FAR), and DoD Grant and Agreement Regulations (DODGARs), and address Navy medical capability gaps and requirements.

2. PURPOSE: The purpose of this acquisition is to codify and document AMD processes, execution activities, successes, and other program information into a library of formal program documentation. This compilation will enable AMD leadership to rapidly convey robust program plans and processes and associated trade-space analysis decisions based on performance, and fact-of-life constraints on annual and Future Year Defense Program (FYDP) bases. The enhanced capability to communicate, coordinate, and share information across stakeholders will directly benefit AMD, the Navy Medicine Enterprise, and ultimately, the warfighter.

3. SCOPE: The Contractor shall deliver a Program documentation library based on Defense Acquisition and Systems Engineering principles, Department of the Navy and Navy Medicine organization, and AMD’s processes, execution activities, successes, and other related program information. Program documents shall demonstrate AMD’s compliance with applicable acquisition guidelines, instructions, and regulations. Program documentation shall be prepared based on a portfolio-based approach modeled after successful business strategies and should be tailorable by the Government after delivery. The Government will provide information to be incorporated into the document library product through document-sharing and verbal exchange which should be supplemented through independent findings by the Contractor. The Contractor will not provide input on the strategic direction of the program nor any form of program requirements.

The Contractor shall demonstrate technical experience that aligns with DoD Systems Acquisition, strategic planning, and program management; significant knowledge and experience with the development and application of Defense Acquisition System;

demonstrated technical writing experience; training, certification, or significant experience in execution of Department of Defense medical acquisition and R&D programs; demonstrated success in drafting and publishing formal reports for external distribution such as After Action Reports, Portfolio Execution Handbooks, and other program information; extensive expertise on the organization of the Department of the Navy, in particular, the functions of/within the Secretariat, Shore Establishment, and Fleet Forces; working knowledge about the Defense Medicine community; demonstrated ability to interpret data/knowledge and accurately translate into integrated concepts and processes; working knowledge about the Federal Drug Administration (FDA) and new drug/biologics approval process.

4. DELIVERABLES: All deliverables shall be provided electronically in Microsoft-compatible file format to the Technical Point of Contact (TPOC), and Procuring Contracting Officer (PCO) specified in the contract.

4.1 Technical Execution Plan: Report components include Work Summary, Schedule, Assumptions, Potential Issues, Spend Plan, and Additional Information. Submission is required 6-business days after award.

4.2 Financial Status Reports: Report components include total award amount, previously invoiced amount, expenditures this reporting period (invoiced & unbilled), total invoiced YTD, remaining Unliquidated Obligations (ULO). Values should be should be broken down by labor, materials, contracts, travel, and other expenses for each activity. Submission is required monthly and at the conclusion of the performance period.

4.3 Program Plan: Document components should be finalized with the TPOC during the evolution of the product. In general, it should be structured based on standard components commonly communicated about a DoD acquisition advanced development portfolio. At minimum, the document should include mission, vision, organization, processes for decisions and execution, program areas, current portfolio of projects, POM and FYDP projections, a five-year plan, and descriptions of each initiative/product line. Draft submission is required 16 Feb 2018. Second draft is required by 02 Mar 2018. Final submission is required by 30 Mar 2018.

4.4 Program Brief: Document components should be finalized with the TPOC during the evolution of the product. In general, it should be structured based on standard components commonly communicated about a DoD acquisition advanced development portfolio. The document should be derived from the Program Plan (Deliverable 5.3) but more succinct. It should also include technical summaries of successes and current projects. Draft submission is required 16 Feb 2018. Final submission of “abbreviated” format is required by 02 Mar 2018 and will include a quad chart for each initiative/product line. The final “full” submission is required by 30 Mar 2018 and will include supporting description slides for each initiative/product line. Supporting slides should include typical content usually presented in Milestone Decision briefings.

4.5 Program Communications Plan: This document will provide AMD with a strategic approach and mechanism(s) for conveying program information and reporting successes.

Document components should be finalized with the TPOC during the evolution of the product.

Draft submission is required 02 Mar 2018. Final submission is required by 30 Mar 2018.

4.6 Medical Initiative and Proposal Evaluation Standard Operating Procedure. This document will formalize and document AMD process for evaluation of medical development initiatives and proposals received by AMD. Document components should be finalized with the TPOC during the evolution of the product. Draft submission is required 06 Apr 2018. Final submission is required by 30 Apr 2018.

4.7 Recommendations for Improved Program Structure/Processes: Report components should convey gaps in program processes and execution with respect to compliance with standard DoD Acquisition governing documents (DODI 5000.02, SECNAVINST 5000.02e, FAR, DODGERs, etc.). Submission is required by 23 Apr 2018.

4.8 Final Technical Report: Report components include Task Summary, Work

Accomplished Summary, Issues, Lessons-Learned, and Additional Information. Report should highlight areas where AMD can achieve better alignment with governing documents.

Submission is required by 30 Apr 2018.

5. PERIOD OF PERFORMANCE: 120 days from date of contract award.