SOLICITATION NOTICE
65 -- Advanced Development of Next Generation Portable Ventilators
- Notice Date
- 2/5/2010
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, 330 Independence Avenue, SW, Rm G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- 10-100-sol-00013
- Point of Contact
- Kim Hall, Phone: 202-205-1587, RoseMary T Mann, Phone: 202-260-1572
- E-Mail Address
-
kim.hall@hhs.gov, rosemary.mann@hhs.gov
(kim.hall@hhs.gov, rosemary.mann@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The purpose of this Request for Proposal is to support advanced development of domestically manufactured, next generation, portable, fully kitted (for operation “out of the box”) ventilators with a goal of FDA clearance or pre-market approval. The ultimate purpose of the HHS/BARDA ventilator initiative is to procure (the amount and schedule 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. The RFP also requests a design to unit cost estimate with a goal of <=$3000 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 development 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. Notice: The purpose of this Request for Proposal (RFP) is to enter into a contract to support advanced development of domestically manufactured, next generation, portable, fully kitted (for operation “out of the box”) ventilators with a goal of FDA clearance or pre-market approval. Though procurement is not a portion of this contract, eventual unit costs are important for consideration. The RFP also requests a design to unit cost estimate with a goal of <=$3000 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 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 follow on contract and is interested in defining manufacturing needs through this contract. 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. The anticipated period of performance will be a base period of 36 months. Additional details and requirements will be described in the solicitation. RFP No. 10-100-SOL-00013 will be available electronically through FedBizOpps on or about March 31, 2010. Proposals will be due a minimum of 45 days after RFP issuance. Any responsible Offeror may submit a proposal that will be considered by the U.S. Government (USG). This notice does not commit the USG to the award of a contract. Only written or email requests directly from the requestor for this solicitation will be accepted. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses to this notice shall be identified with RFP No. 10-100-SOL-00013, name of the firm, name of requestor, mailing address, telephone number, FAX number and email address and should be submitted to the Contracting Office address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of August 2010. This requirement will be full and open competition. Small businesses are encouraged to respond. Note: A Sources Sought Notice was previously issued for this requirement under 10-100-SOL-00002.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/10-100-sol-00013/listing.html)
- Record
- SN02059655-W 20100207/100205235737-e873fd04118d7808e3028aad5a5348a0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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