Inactive

Amendment #1. This Request for Information is hereby revised as follows: The last sentence under "Description" paragraph is changed. From: "Any request for proposal shall be issued at the sole discret... Amendment #1. This Request for Information is hereby revised as follows: The last sentence under "Description" paragraph is changed. From: "Any request for proposal shall be issued at the sole discretion of BARDA, and will include cost sharing between the US Government and the contractor in accordance with FAR 16.303." To: " It is anticipated that any proposal or solution request will include cost sharing between the US Government and the contractor. If and when a formal solicitation or proposal request materializes, the US Government will determine the most advantageous contract or agreement type, including Other Transaction Authority (OTA)." ______________________________________________________________________________________ This request is from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA). BARDA seeks information from DOMESTIC firms currently manufacturing pharmaceutical consumables, raw materials related to pharmaceutical product manufacturing, and/or who are engaged in drug production and manufacturing, and who are interested in or are currently executing manufacturing capacity expansion efforts. Specific manufacturing areas of interest include: Consumables products manufacturing including, but not limited to: Bags Tubing Braided hose Assemblies Filters Buffers Dry and liquid media Ion exchangers Resins Drug Production and Manufacturing Formulation Fill Finish Labeling and Packaging Storage Raw materials manufacturing, including but not limited to: Lipids Cholesterol Ribonucleotide Triphosphate (NTPs) Reagents and key starting materials manufacturing Other products that support the COVID-19 vaccine supply chain and manufacturing process Information is requested for the purpose of determining availability of pharmaceutical manufacturing capacity from DOMESTIC sources for current and future pandemic response. Information is also being requested to establish near (6-9 months), mid (9-18 months) and long term (18-36 months) supply chain sustainment goals to meet growing mid-long-term demands. Lastly, information is requested for development/expansion of new manufacturing technologies in these areas which may improve the state of the art for domestic supply chain sustainment. Interested firms are requested to submit white papers (2-8 pages) providing: Description of products manufactured in support of vaccine development and manufacturing Description of how the product(s) support the vaccine development/manufacturing process (e.g. what stage of the process the product(s) is/are utilized and how they are employed, and which higher level supply chain producers are supported). Typical product manufacturing lead time, current backlog and projected backlog for next 24 months. Description of any ongoing or planned efforts to increase/expand DOMESTIC C manufacturing capacity, to include planned expansion effort, schedule and cost, and whether the planned effort can be accelerated, with associated cost and schedule impacts. Current annualized throughput (units/year) and translation to annualized number of vaccine doses supported. Description of planned/potential increase in domestic manufacturing capacity throughput. Use current throughput as baseline, with projected expansion/increase expressed as percent increase over baseline. Describe any anticipated acceleration of planned/potential expansion effort if additional funding is available to support the effort. Include projected schedule savings and associated funding increase required. Provide details regarding when new throughput/capabilities could come online, in terms of percent increase over baseline, in 3 month increments for next 24months (e.g. (notional percentages only) 10% increase in 3 months, 20% increase in 6 months, 40% increase in 9 months, 100% increase in 12 months, etc) THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. NO SOLICITATION CURRENTLY EXISTS. This information will be used by BARDA to identify potential gaps in near and long-term vaccine consumables and raw materials supply chains, and to develop plans to close those gaps. White papers submitted in response to this sources sought may result in a request by BARDA for submission of a formal proposal to expand/accelerate current consumables/raw materials manufacturing capability to meet emerging anticipated demands. It is anticipated that any proposal or solution request will include cost sharing between the US Government and the contractor. If and when a formal solicitation or proposal request materializes, the US Government will determine the most advantageous contract or agreement type, including Other Transaction Authority (OTA).