THIS IS A SOURCES SOUGHT NOTICE ONLY.

This Sources Sought Notice (SSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the Government. The Government is currently conducting 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 & Human Services (HHS) has a future requirement to support advanced development of domestically manufactured next generation portable ventilators with accessory components at a low cost of <$2,000/unit that will advance the technology to provide respiratory support for large numbers of severely ill patients during a pandemic influenza outbreak. Characteristics of the new technology should minimally include the following: 1) a basic volume flow-controlled device; 2) light weight battery with extended battery life exceeding the current industry standard of 4-12 hours with a rechargeable battery that is capable of recharging within 2-4 hours; 3) flexibility to accommodate a wide patient population from neonate to adult; 4) intuitive user interface for ease of use in a clinical setting so that inexperienced health care providers with no respiratory support training could safely use the device; 5) small, lighter weight than current portable ventilators and easily transportable for storage in the Strategic National Stockpile (SNS); 6) a closed-loop inspiratory pressure control system that can operate with minimal time and attention from staff; 7) accommodate a universal breathing circuit and connectors; 8) adequate shielding for radio frequency interference (RFI), electromagnetic interference (EMI) and conductive interference; 9) software must be easily upgradeable to the state-of-the-art to extend the product life-cycle; 10) real time monitoring of O2 saturation, CO2 and respiratory rate; 11) stable shelf life and ease of maintenance for stockpiling and use; 12) recognizable and operational audible and visual alarm system; and 13) should accommodate a humidification moisture exchanges (HME) or a humidifier and a pulse oximeter. A potential Offeror must be able to ramp up production in an emergency to supply at least 1,700 ventilators in one month to meet a capability goal of at least 10,000 units within six (6) months of a pandemic influenza outbreak.

A potential Offeror must meet the following mandatory qualification criteria:

1. All aspects of manufacturing and distributing capabilities for the ventilator and subcomponent parts/accessories shall be compliant with FDA Quality System Regulations.

2. It is essential that efforts funded as a result of this acquisition shall lead to FDA 510(k) pre-market clearance of next generation portable ventilators.

3. Documentation that the Offeror has taken all steps necessary to secure access to all intellectual property, know-how and tangible materials for commercialization of the proposed next generation portable ventilator to fulfill the Government’s obligations, unencumbered by legal and patent constraints.

4. The Offeror shall demonstrate the likelihood that 10,000 ventilators can be manufactured within six (6) months of a pandemic influenza outbreak.

5. The Offeror must verify that stockpiles of raw materials, parts and accessory components necessary to manufacture 10,000 ventilators in six (6) months are domestically available.

6. The Offeror shall provide proof that their facility and subcomponent contractors/suppliers/vendors have pandemic influenza plans in place to ensure U.S. Government contracts will be honored during a pandemic influenza outbreak.

It is anticipated that a Request for Proposal (RFP) will be announced approximately June 2008 with proposals due in July 2008. 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 would not be considered for evaluation.

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, 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. Potential respondents are also requested to include whether or not they are a large or small business. Small businesses are encouraged to respond. All respondents and comments to this sources sought notice shall reference HHS-Sources Sought-Ventilators-April 2008 and be submitted to Kim L. Hall, Contract Specialist, at kim.hall@hhs.gov by 1:00 PM EST, April 28, 2008.