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 mechanical hemorrhage control products with a focus on proximal injuries. These products must be easy to operate in the expeditionary environment and provide the ability to inhibit blood loss on the battlefield. Responses are due to this request for information (RFI) on or before 2:00 P.M (EST), 29 November, 2012.
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 Force Medical Support Agency, Requirements Division (AFMSA/SG5R) is interested in collecting information on commercial-off-the-shelf (COTS) products available with the ability to mechanically inhibit blood loss and therefore assist in the prevention of death due to blood loss on the battlefield.
AFMSA/SG5R prefers COTS, government off-the-shelf (GOTS), and/or foreign off-the-shelf products. At this time, information is only being collected on research and development efforts that are within one year of commercial availability.
4. REQUIREMENTS: Information is currently being sought on mechanical hemorrhage control products with the ability to inhibit blood loss resulting from proximal injuries.
The response should address the products ability to address the following parameters:
1. FDA Compliance
a. Device should be "approved for market" (PMA), "cleared to market" (510k), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR 807.92(a)(3) for Class I and II devices).
2. Transportability
a. Weight
3. Clinical Indications
a. Ability to impede blood loss
4. Hemorrhagic Agent (if applicable)
a. Mechanism of action
5. Airworthiness Certification
a. Device should be able to meet all Department of Defense (DOD) Airworthiness Certification (AWC), Joint En Route Equipment Test Standard (JECETS), and Military Standard (MIL-STD-810G).
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.
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.
5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ashley Fredlock, Market Research Analyst, via e-mail to [email protected]. Email responses should be no larger than 10 megabytes (MB) in size. If larger attachments are required, please notify AFMESA 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), 29 November, 2012. 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 mechanical hemorrhage control products as characterized by the requirements addressed in this RFI. If unable to provide a product 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
[email protected]

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