R--Questions and Answers

1. Does the government intend for this overall effort to provide support only to the Pharmaceutical Systems Project Management Office or is this effort intended to provide support to additional PMOs and other offices within USAMMDA and / or USAMMA? Answer: Currently, USAMMDA is supported though several disjointed service contracts. This situation does not optimally leverage each contractor's capabilities across the activity and often leads to uneconomical management and pricing. The intent is to gain greater control of USAMMDA requirements through a central manager, which will have visibility of all service support for better employment. Four other entities within USAMMDA would potentially require support (additionally, any USAMRMC element could potentially be added to this requirement at a later date via a modification). 2. Reference Part B - Requirements 2.a. Government Acquisition Program Management Office support - does the government mean staff with DAU training (certified as PM Level 2 or 3) or does the government mean administrative office support? Answer: Requirement - Government Acquisition Program Management Office Support- Does not imply DAU certified personnel. Requires personnel with sufficient experience to adequately perform support required in areas (i - v), without further training. 3. Reference Part B - Requirements 2.a Product Manager Technical and Administrative Support - Please define. Does the government mean contractor staff with scientific expertise related to drug / vaccine product development (FDA requirements) or in the specific areas related to the basic research (pharmacology, biochemistry, microbiology etc) Answer: Government implies - provide technical and functional program management support to include lifecycle oversight for pharmaceutical products. Requires personnel highly qualified and experience to provide technical expertise to program manager. 4. Reference Part B - Requirements 2.a Information Technology support - does the government require help desk type support or does this refer to IT management related to establishing websites and monitoring those web sites? Please clarify Answer: Government implies - requires both IT (Help Desk) and IT Management support at the Division (Program Management Office) level. The IT support will deliver improved electronic tools (and required training packages) for our Integrated Product Teams; will be in support of identifying a commercial off the shelf (COTS) or modified COTS solution to replace the current MS Access based financial planning, execution & reporting tool that is utilized in life cycle program management; provide improved communication venues (such as international teleconference capabilities) for collaboration with overseas and US-based development partners; and provide Knowledge Management expertise in use of our electronic data management system. 5. Reference Part B - Requirements 2.b Foreign government support - How is this different that the support provided by the Internationals Affairs Office, Headquarters USAMRMC? Answer: Government implies - requirement is to support and assist the government in achieving necessary agreements for global access to products in accordance with FDA regulations and US State Department regulations. 6. Reference Part B - Requirements 2.c Medical Product Development Support - Please define the level of support provided under this option. Does the government wish the successful contractor to offer the option of conducting pre-clinical as well as clinical trials? Or does the government simply require staff with the technical capability to provide oversight and review of the results? Answer: Government implies - both support to assist the Program Manager in the selection of product testing and manufacturing facilities for clinical/non-clinical studies and to task vendors to conduct pre-clinical studies and clinical studies (world-wide). 7. Reference Part B - Requirements 2.c Medical Product Development Support - Regulatory support - How does this requirement differ from the support provided under the recently awarded RASS contract? Answer: Government implies support to the Program Management Office for the development and review of regulatory related documents for submission to FDA. 8. In Part B, Requirements, section 2, subsection c., parts ii.-iv., please clarify the extent of the support to be provided. In other words, does support indicate provision of services such as report review, auditing, and protocol development, or does support indicate the contractor will conduct the manufacturing, testing, nonclinical and clinical studies? Answer: Government implies - Support provisioning of services such as conduct manufacture of drug product, perform required product testing, conduct non-clinical studies, conduct clinical studies (world-wide), report creation, reviews, and auditing of manufacturing and testing processes.