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U.S. Department of Health and Human Services

Requirements Branch

Division of Medical Countermeasures Strategy and Requirements

The MCSR Requirements Branch leads the development and management of scenario-based analyses, integrated capabilities documents, research requirements, and product-specific requirements documents, all of which are tied to assessments of risks to national health security.  The Branch manages the requirement-setting process with engagement from subject matter experts, including experts in medical consequence and public health response assessments, from throughout the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). A lean requirements framework was designed and implemented for the PHEMCE, enabling increased throughput of these high-priority MCM requirement deliverables.

Developing Requirements for Critical Medical Countermeasures Against Natural and Intentional Threats

The requirement process provides critical information to support PHEMCE leadership in the allocation of limited resources for research, development, acquisition, stockpiling, and planning for the use of medical countermeasures (MCMs). This process informs PHEMCE partner acquisition and research strategies and contracts.

Figure: Overlap of the Requirements and Acquisitions Processes

In this figure there are five entities which from left to right are Scenario Based Analysis, Integrated Capabilities Document, Product Specific Requirement, SNS Annual Review, and Acquisition and Stockpiling.  All entities are included in the Requirements Process and the final three are also included in the Acquisitions Process.  Scenario-based analyses include policy analysis, modeling results, MCM product categories and need based assessments.  The Integrated Capabilities Document includes capabilities gaps and operational quantity.  The Product Specific Requirement includes MCM Product Characteristics and Stockpiling Goal.  The Acquisition Strategy and Acquisition Goal include budget, manufacturing and market factors, research factors and acquisition target.
MCSR administers and leads PHEMCE Integrated Program Teams and Working Groups in support of generating requirement documents to recommend specific MCM categories, MCM product characteristics, and stockpiling goals.  Scenario Based Analyses detail the critical types of MCMs desired, and the number of people who would benefit from MCMs during public health emergencies.  Integrated Capabilities Documents describe the core capabilities required of the medical and public health system and project the quantity of MCMs that could be used effectively in the types of scenarios considered.   Product Specific Requirements describe the desired product profiles, recommend a stockpiling goal, and contribute to the development of acquisition strategies for stockpiling MCMs.   Research Requirements describe characteristics of future medical countermeasures for threat areas where there are very few products available, and these Research Requirements guide product research in those threat areas. 
 
Prior to making individual investment recommendations, the PHEMCE assesses MCM needs across the entire threat portfolio through prioritization discussions including the Strategic National Stockpile Annual Review — weighing scientific opportunity, available resources, and other factors — consistent with the PHEMCE prioritization framework provided in the 2012 PHEMCE Strategy and Implementation Plan.      
 

  • This page last reviewed: September 24, 2014