Testing of Government-Owned Adjuvant

This is a Sources Sought Notice (SSN) and is issued for information and planning purposes only. This Notice is NOT a Request for Proposal (RFP), a Request for Quotation (RFQ), an Invitation for Bid (IFB), a Solicitation, or a guarantee that the Department of Health and Human Services (DHHS), Office of Acquisition Management, Contracts and Grants (AMCG) will contract for the services contained in this Notice. The information requested will be used by the USG as market research in accordance with Part 10 of the Federal Acquisition Regulation to identify potential small businesses as well as other sources capable of fulling this requirement. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. Background: The National Strategy for Pandemic Influenza (2005) describes the activities to be undertaken before a pandemic to ensure preparedness. The strategy seeks to "establish domestic production capacity and stockpile of countermeasures to ensure sufficient vaccine to vaccinate frontline personnel and at risk-populations." One of the goals in the Implementation Plan for the National Strategy for Pandemic Influenza (2006) is the "establishment and maintenance of stockpiles of pre-pandemic vaccine adequate to immunize 20 million persons against influenza viruses that pose a pandemic threat." Since 2005, the government has stockpiled millions of doses of influenza pre-pandemic vaccines and adjuvants and placed them on stability product monitoring programs. This sources sought notice is focused on adjuvants - to continue the maintenance of these products in long-term storage. The contractor must be able to conduct stability testing on a government owned adjuvant, which consists of a squalene-based oil-in water emulsion. Scope and Purpose: Continued testing of a government- owned adjuvant, a squalene-based oil-in-water emulsion that has been in long term storage for more than five years The Contractor shall: - Have experience in testing adjuvant - squalene based oil in water emulsions- in plastic bags and in glass bottles. - Have FDA-compliant validated protocols and assays in place within four (4) months after award. - Receive bulk material as specified by HHS. - Conduct testing (as listed in Table 1) of the government owned adjuvant upon receipt (time 0). - Conduct leachable/extractable testing on adjuvant in bags and bottles upon receipt of bulk adjuvant (time 0) - Submit a final report to HHS. If the result meets the requirement specification, the contractor will continue to perform stability and leachable testing on an annual basis up to 5 years. Submission Information/Instructions: Questions: All questions pertaining to the notice are due by 10AM (EST) Wednesday, 03 February 2017 via email to Contracting Officer, Dorothy McMillan at Dorothy.McMillan@hhs.gov. Only one set of questions per contractor will be accepted. Response Due Date: Qualified Offerors should submit the Capability Statement no longer than 5 pages in response to this sources sought notice electronically by 10AM (EST) Wednesday, 15 February 2017 via email to the Contracting Officer, Dorothy McMillan at Dorothy.McMillan@hhs.gov TABLE 1 Testing Sterility pH Mean Particle Size Number of Large Particles Squalene Content Carbonyl Content (formaldehyde, acetaldehyde and acetone) Appearance Polysorbate 80 Content Sorbitan Trioleate Content