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Research and Innovation

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DHA-PI 3200.01: Research and Development (R&D) Enterprise Activity (EA)

Policy

This Defense Health Agency-Procedural Instruction (DHA-PI), based on the authority of References (a) and (b), and in accordance with the guidance of References (c) through (p): a. Establishes the Defense Health Agency’s (DHA) procedures for the Deputy Assistant Director (DAD), R&D to manage and execute, on behalf of the Assistant Secretary of Defense for Health Affairs (ASD(HA)), the portion of the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation assigned to it (referred to as the “DHP Science and Technology (S&T) Program)”. The DHP S&T Program includes Budget Activities (BAs) 6.1-6.3 and 6.6. The ASD(HA) provides policy, direction, and guidance to inform planning, programming, budgeting, and execution of the DHP RDT&E appropriation in accordance with statute, regulation, and policy in Reference (a). The DAD-R&D, and Component Acquisition Executive (CAE) manage and execute DHP RDT&E Program funds aligned to them on behalf of the ASD(HA). The CAE is responsible for managing BAs 6.4, 6.5, and 6.7 funding, as well as Procurement and Operations and Maintenance funding required to support DHP-funded Acquisition Programs, regardless of acquisition activity. b. Supports the Director, DHA, in developing appropriate DHA management models to maximize efficiencies in the management and execution of DHP RDT&E-funded activities carried out by the Combatant Commands (CCMDs), Services, Uniformed Services University of the Health Sciences (USU), Defense Agencies, and other DoD Components, as applicable. c. Codifies processes to confirm DHP RDT&E funds are applied towards medical priorities and aligned to ASD(HA) policy, direction, and guidance to develop and deliver innovative medical products and solutions that increase the readiness of the DoD medical mission in accordance with Reference (a). d. Supports the following objectives of the R&D EA: (1) Increasing the quantity, quality, and pace of medical research through improved programmatic organization, processes, and oversight. (2) Ensuring DHP RDT&E funded efforts align to ASD(HA) published program guidance that provides resourcing guidance and translates national, departmental, and Service priorities into specific program objectives. (3) Verifying alignment of DHP RDT&E funds to medical priorities and to ASD(HA) policy, direction, and guidance to ensure the development and delivery of medical materiel and knowledge solutions. (4) Facilitating coordination with the CCMDs, Services, USU, Defense Agencies, and other DoD Components, as applicable, to ensure DHP RDT&E funded activities address joint medical capability gaps, and avoid unnecessary duplication.

Guidance on the Establishment of a Human Cell, Tissue, and Cellular and Tissue Based Products Program

Policy

This memorandum requests the Services resource a Human Cell, Tissue, and Cellular and Tissue Based Products (HCT/Ps) Program that complies with regulatory standards for management and oversight of HCT/Ps, according to the best fit for their Service.

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