SOURCES SOUGHT
65 -- AFICA Hypothermia Device - Hypothermia Device RFI Response Form
- Notice Date
- 7/10/2015
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- AFICA - AFICA- CONUS
- ZIP Code
- 00000
- Solicitation Number
- FA8052-15-RFI-HypothermiaDevice
- Archive Date
- 8/25/2015
- Point of Contact
- Ashley Fredlock, Phone: 301-619-8600
- E-Mail Address
-
AFMSA.SG5T.Market@us.af.mil
(AFMSA.SG5T.Market@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- Hypothermia Device RFI Response Form THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1. SUBJECT : The Air Force Medical Evaluation Support Activity (AFMESA) is conducting market research on a hypothermia device suitable for use in pre-hospital trauma care and patient care in the military expeditionary medical environment. Responses are due to this request for information (RFI) by 2:00 P.M. (EST) on August 10, 2015. 2. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided as a response to the RFI will not be returned. AFMESA will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future request for proposal (RFP). 3. BACKGROUND: The Air Combat Command Surgeon's Medical Modernization Division (ACC/SGR) is interested in new and novel technology which can provide non-invasive heating/warming for prevention and treatment of hypothermic patients from the point of injury to an advanced level of medical care. The degree of hypothermia may exacerbate hemorrhage so prevention during combat operations and with casualty care at all levels is very important. ACC/SGR prefers commercial off-the-shelf (COTS), government off-the-shelf (GOTS), and foreign off-the-shelf (FOTS), and research and development (R&D) options that fulfill the capabilities outlined below. Manufacturers are encouraged to submit a response to this RFI, even if a system does not meet all the requirements at this time. For requirements that are not met, trade-off considerations will also be considered. 4. REQUIREMENTS: Information is currently being sought on hypothermia devices meeting the requirements listed below. Responses should address the requirements identified in this RFI, particularly those outlined in 4A and 4B below. 4A. MANDATORY REQUIREMENTS: The candidate hypothermia device must satisfy the following top-level requirements: •· Device must be "approved for market" (PMA), "cleared to market" (FDA 510k approval), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR807.97(a)(3) for class I and II devices) •· Capable of obtaining Joint Airworthiness Certification (JAC) consisting of a "Safe-to-Fly" (STF) letter from the USAF for fixed and rotary wing aircraft and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification Memorandum (ACM). In accordance with Army Regulation 40-61 and Air Force Instruction (AFI) 11-202, the U.S. Army Aeromedical Research Laboratory ( USAARL ; Fort Rucker, AL) and USAF Aeromedical Branch ( ASC/WNUP ; Wright-Patterson AFB, OH) Aeromedical Test Laboratory (ATL) are the primary test organizations for performing airworthiness and STF certification testing. 4B. FURTHER SPECIFICATIONS/CHARACTERISTICS: Refer to the RFI Response Form for details. AFMESA seeks information about academic, prototype, developmental, foreign and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above. 5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Ashley Fredlock, Market Research Analyst, via e-mail to AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify Ms. Fredlock at the above listed email address. Each RFI response will receive a confirmation email; if a confirmation is not received please call 301-619-8600. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail. Responses must be received by this office on or before 2:00 P.M. (EST) on August 10, 2015. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information. The response should describe the company's capability to offer, field, and sustain the hypothermia device as characterized by the requirements addressed in this RFI. If unable to provide a hypothermia device capable of meeting all requirements, the respondent should offer trade-off considerations. Please ensure responses specifically address each requirement listed in section 4. Requirements. At a minimum, please complete and return the table provided. Additional detailed information is encouraged. 6. LATE SUBMISSIONS: Failure to respond to this RFI does not preclude participation in any future competition, nor will information provided in response to this RFI be used to exclude anyone from responding to any future requests for proposals. Communications with AFMESA in regard to this RFI will only be permitted in writing during the RFI response period. Responses to the RFI received by AFMESA after the submittal deadline and time indicated may be considered. The respondent assumes the risk of the method of dispatch chosen. Postmarking by the submittal date and time shall not substitute for actual response receipt. 7. OWNERSHIP OF RESPONSE TO RFI: All informational material submitted in response to this request becomes property of AFMESA. Physical samples will be returned to the vendor at the owner's expense. 8. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall AFMESA be responsible for any response preparation expenses, submission costs, or any other expenses, costs, or damages of whatever nature incurred as a result of the respondent's participation in this RFI process. Respondent understands and agrees that they submit a response at their own risk and expense, and release AFMESA from any claim for damages or other liability arising out of the RFI process. 9. ERRORS IN RESPONSE: AFMESA shall not be liable for any errors in respondent's response. Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all error or omissions contained in their responses. 10. ADDENDUM: AFMESA reserves the right to issue an addendum to this RFI at any time for any reason. 11. CONTACT INFORMATION: Ms. Ashley A. Fredlock Air Force Medical Evaluation Support Activity (AFMESA) 1270 Montevue Lane (Area B) Fort Detrick, MD 21702 Phone: 301-619-8600 AFMSA.SG5T.Market@us.af.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/08a0df2023f1eb9248baef9c1eb7caa4)
- Place of Performance
- Address: Air Force Medical Evaluation Support Activity (AFMESA), 1270 Montevue Lane (Area B), Fort Detrick, MD 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN03793407-W 20150712/150710235413-08a0df2023f1eb9248baef9c1eb7caa4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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