BIOLOGICAL DEFENSE – Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability, July 2017

Document Title: Biological Defense – Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability, July 2017 Released: 2017-07-24 The Black Vault Entry: https://www.theblackvault.com/documentarchive/biological-defense-additional-information-congress-may-find-useful-considers-dods-advanced-development-manufacturing-capability-july-2017/ Canonical PDF: https://documents.theblackvault.com/documents/gao/685889.pdf The Department of Defense's Advanced Development and Manufacturing facility, specializing in manufacturing biologics, has been a topic of interest for Congress. The facility's capabilities and costs have been a subject of discussion, particularly with the recent technological advancements in flexible manufacturing. Provenance: This document was released on July 24, 2017, as a result of a Freedom of Information Act (FOIA) request. The United States Government Accountability Office (GAO) conducted an analysis of the Department of Defense's (DOD) report to Congress on the Advanced Development and Manufacturing (ADM) facility. The GAO's report, GAO-17-701, was issued in May 2017 and was made publicly available after redactions. The Document: The Department of Defense included information in its report to Congress addressing the six required elements regarding the ADM facility. These elements included a description of the ADM facility and its capabilities, information on program goals and estimated completion costs, a copy of a 2009 analysis of alternatives, and the department's medical countermeasures production plans for the ADM facility. The GAO identified additional information related to these elements that may be useful for congressional oversight. According to the GAO, DOD's sustainment payments for priority access to the ADM capability will be budgeted as a cost of developing medical countermeasures, similar to the model used with DOD-owned laboratories. However, discussions with officials indicate that the total costs to the ADM capability contractor to operate and maintain the ADM facility were not fully known at the time of DOD's report and are not fully covered by the DOD-provided sustainment payments. The GAO also found that the three HHS facilities were not analyzed as alternatives to the DOD ADM facility, although HHS officials said that DOD could separately contract for medical countermeasures with any of HHS's facilities. Officials from DOD's ADM program office stated that the HHS facilities are not appropriate for DOD's needs, but an official from one of the three HHS facilities informed the GAO that they currently produce medical countermeasures for DOD. Context: The GAO's report was issued in response to a provision in the National Defense Authorization Act for Fiscal Year 2016 that required DOD to submit a report to Congress addressing six required elements regarding the ADM facility. The GAO compared DOD's report and cost-benefit analysis with the legislatively required elements and analyzed documents from DOD, HHS, and their private-sector partners. Outro: This is what the public record looks like at its most ordinary. The Department of Defense's Advanced Development and Manufacturing facility has been a topic of interest for Congress, and this report provides additional information that may be useful for congressional oversight. Storyflo.com. Document URL: https://documents.theblackvault.com/documents/gao/685889.pdf