Advanced Development of Next Generation Portable Ventilators

This is a Sources Sought Notice (SSN) and does not constitute a commitment by the Government. This is NOT a solicitation for proposals, proposal abstracts or quotations. The purpose of this notice is to conduct market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential sources to provide the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the U.S. Government and will not be returned. The Department of Health and Human Services (HHS) has a future requirement to support advanced development of domestically manufactured, next generation, portable, fully kitted (for operation "out of the box") ventilators through FDA clearance or pre-market approval. The ultimate purpose of the HHS/BARDA ventilator initiative is to eventually procure (to be determined under a separate procurement contract vehicle) advanced ventilators for the Strategic National Stockpile at a cost significantly lower than currently stocked ventilators. Therefore, a future RFP will also request a design to unit cost estimate with a goal of <=$3,000 per unit with tiered volume pricing as a consideration for award and further requires design to cost documentation prior to completion of the contract effort. The ventilator goal is to advance the technology to meet the operational and clinical needs during an all-hazards event (caused by chemical, biological, radiological, nuclear exposure, pandemic influenza, other biological outbreak, or natural disaster) and provide respiratory support for large numbers of severely ill patients. The ventilator must have increased capability to meet operational and clinical needs for treatment of respiratory compromised patients during an all-hazards event in which mass casualties and shortage of experienced care providers may be expected. The device should be able to provide the same standard of performance as current FDA pre-market cleared portable ventilators but with additional characteristics that meet the following recommended requirements; ease of use for an unskilled care provider, increased patient population range from neonate to adult, portability and useable in a non-clinical environment, standard of care safety, stockpiling and maintenance ease, and use in all hazards events. The Government may procure ventilators on a future follow on contract and is interested in defining manufacturing needs through this potential requirement. Therefore, the Government will also require a domestic manufacturing plan addressing the manufacturing processes, production capacity, and ramp up capability to meet emergency surge requirement to supply at least 1700 fully kitted ventilators in one month and to meet a capability goal of at least 10,000 fully kitted units within six (6) months. Domestic manufacturing is required as well and a plan to ensure production capability if and when foreign components / supplies would be challenged during an event. A potential Offeror must meet the following mandatory qualification criteria: 1. Historical documentation capability of Contractor (or subcontracted manufacturing partner) for at least one manufactured and marketed FDA cleared or pre-market approved ventilator. 2. Domestic manufacturing. Attached to this notice is a Draft Statement of Work (SOW). All five (5) objectives as stated in the Draft SOW must be satisfied with verifiable documentation provided. It is anticipated that a Request for Proposal (RFP) will be announced approximately March 2011 with proposals due a minimum of 45 days after RFP issuance. While the mandatory qualification criteria do not have to currently be met, all of the mandatory qualification criteria must be met by proposal submission. Proposals that do not meet the mandatory qualification criteria will not be considered for evaluation. The anticipated period of performance will be 36 months. The Government anticipates making multiple awards. The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code 339112. The small business size is 500 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a set-aside is possible. Teaming arrangements are encouraged. Any organization, especially small business concerns that can perform the work is encouraged to respond. Respondents to this sources sought notice may identify their interest by submitting a capability statement, including how they plan to meet the mandatory qualification criteria, the five (5) objectives stated in the Draft SOW, an anticipated delivery schedule of the product, and primary contact information at the organization (name, email, address and telephone number) handling this sources sought notice, in the event HHS has additional questions or requires clarification of the submitted information. Responses are limited to 10 pages. Data sets (i.e., tables, charts, graphs) and documents that are pertinent to the response can be submitted as appendices to the primary submission. All respondents and comments to this sources sought notice shall reference 11-100-SOL-00010 and be submitted to Kim L. Hall, Contracting Officer, at kim.hall@hhs.gov by 2:00 PM EST, February 14, 2011.