MODIFICATION
65 -- Request for Information - Mechanical Ventilators
- Notice Date
- 2/24/2014
- Notice Type
- Modification/Amendment
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2014-RFI-16388
- Archive Date
- 4/2/2014
- Point of Contact
- David M. Kelley, Phone: 7704882662
- E-Mail Address
-
vrb7@cdc.gov
(vrb7@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- NAICS Codes: 339112 and 423450 Title: Request for Information - Mechanical Ventilators Synopsis: This is a request for information. It is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to: (1) Obtain product listings of full-featured critical care and transportable, portable or home care mechanical ventilators and their associated ancillary supplies. (2) Obtain information on the manufacturing capability and capacity to provide mechanical ventilators. (3) Make use of this information to inform acquisition strategies that may be used to support preparedness and response to public health emergencies requiring the use of mechanical ventilators. Background: Within the Federal government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases. The 2009 H1N1 influenza pandemic exemplified the unpredictability and rapidity with which a novel influenza strain can impact the world's population. With a historic effort from both Government and industry partners, vaccines were developed and available to the public six months after the initial outbreak. Despite high infection rates, the 2009 H1N1 virus was only mildly pathogenic, with relatively low rates of accompanying morbidity and mortality in the general population. However, it is possible that future pandemics will feature morbidity and mortality rates comparable with more severe pandemics such as 1957. The ever-present and ever-evolving threat of pandemic influenza presents a compelling need for the federal government to optimize preparedness using medical countermeasures currently available in the marketplace and to develop innovation in the prevention and treatment of influenza disease. Mechanical ventilators are a critical life-saving non-pharmaceutical medical countermeasure for patients experiencing respiratory failure that could result from the consequences of a pandemic influenza, emerging infectious disease or other chemical, biological or radiological event. These events can quickly overwhelm the hospital resources of the locale and the region. In a public health emergency resulting in respiratory failure for a large number of patients, hospitals will need to surge the medical capabilities needed to provide mechanical ventilation. Requirement: The Assistant Secretary for Preparedness and Response (ASPR) and the Centers for Disease Control and Prevention (CDC) are seeking information from the manufacturing community on mechanical ventilator products and manufacturing capabilities that serve all members of the U.S. population, including the general adult population, children, elderly individuals, pregnant women, diabetic individuals, individuals with mental and physical disabilities, the immune-compromised, hyper-allergenic individuals and those with pre-existing medical conditions. Submission Instructions: Respondents (manufacturers) are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents (manufacturers) are asked to provide a cover page that contains the following information: (1) All Point of Contact information (email addresses, phone numbers, and mailing address) (2) DUNS number (3) All relevant NAICS Codes (4) Identification as a large or small business. If small, indicate the classification. (5) Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. Respondents (Manufacturers) are asked to provide the following information: 1. Product literature and specifications sheets for mechanical ventilator products (attach as an electronic pdf or Microsoft Word documents). These include critical care and transportable, portable, or home care mechanical ventilators for: a) Products that are commercially available, licensed by the FDA or other regulatory authority, and used for mechanical ventilation in the US and/or abroad; and b) Products in advanced development with data that may support their deployment in an emergency mass-casualty incident. 2. General Information on the Company's line of products and market capabilities (attach as an electronic pdf or Microsoft Word document) 3. Information on manufacturing capabilities, capacities and market information that address the following questions (Use accompanying Microsoft Excel Spreadsheet): a) The location of manufacture for each ventilator model (country, city, State). b) Length of time (years) each model has been in production. c) Length of time (years) each model will be supported by the servicing department. d) The maintenance schedule and estimated average annual life cycle costs for each model. e) Estimated number of ventilator units currently in use in the United States. f) Estimated number of ventilator units sold for disaster preparedness for each model (units per State). g) The current average monthly manufacturing production over the past year (units per month). h) The maximum monthly manufacturing surge that can be achieved and sustained over a 12-week period. i) The ramp up time needed (days) to meet maximum production. j) The time (in days) required to deliver 1000 ventilator units, 2500 units, 5000 units (non-surge). k) Countries where raw materials, components, subassemblies, etc. are sourced from. l) List of required accessories for each model (adult/child circuits, inlet filters, bacterial filters, heat/moisture exchangers, closed circuit suction catheters, PEEP valves and other related items). Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid HHS, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This REQUEST FOR INFORMATION is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only. Responses to this REQUEST FOR INFORMATION notice, along with a firm's capability statement referencing "Request for Information - Mechanical Ventilators" may be submitted electronically via email to the three points of contact listed below NO LATER THAN 5PM EST, March 18, 2014).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2014-RFI-16388/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03295002-W 20140226/140224234427-a8ed98d15b58cd3ea4bedbe2c3e1664b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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