SPECIAL NOTICE
A -- Clinical Trial in Support of Trauma Indications for Lyophilized Canine Blood Products - RFI Canine Blood Products
- Notice Date
- 9/11/2019
- Notice Type
- Special Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of the Army, US Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-19-RFI-PDM01
- Archive Date
- 10/10/2019
- Point of Contact
- Peter D. Mitchell, Phone: 3016191355
- E-Mail Address
-
peter.d.mitchell8.civ@mail.mil
(peter.d.mitchell8.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- RFI 1. RFI Title: Clinical Trial in Support of Trauma Indications for Lyophilized Canine Blood Products 2. Agency: United States Army Medical Research and Development Command (USAMRDC) 3. Office: United States Army Medical Materiel Development Activity (USAMMDA) 4. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD. 5. Subject: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission to develop and manage medical materiel to protect and sustain the Warfighter, this request for information is seeking entities capable of a conducting a clinical trial necessary to obtain a treatment indication for hemorrhagic shock secondary to trauma, and determine administration guidelines for canine lyophilized platelets and canine lyophilized plasma. 6. 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 that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. At this time, the Government intends to award a contract to Bodevet, Inc. using other than full and open competition pursuant to the authority at FAR 6.302-1. This Request for Information is being published in accordance with DFARS PGI 206.302-1. 7. Description: The USAMMDA's mission is to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active duty personnel in the operational environment. Military Working Dogs (MWDs) have a critical role in both protecting human lives and supporting military objectives while at home station and in an operational environment, and are the military's current most successful countermeasure to detecting explosive devices. MWDs work in close conjunction with their handlers and Service Members. They are exposed to the same combat trauma threats and non-combat injuries. The leading cause of preventable Service Member death in the operational environment is uncontrolled bleeding. As such, blood products are critical to saving Service Member lives and similarly, canine products are necessary to provide the complete veterinary care for DoD-owned animals authorized by AR 40-905. Principles of Veterinary Medical Ethics of the American Veterinary Medical Association, para VIIb states that in an emergency, "veterinarians have an ethical responsibility to provide essential services for animals when necessary to save life or relieve suffering." All Roles of veterinary care in an operational environment handle emergencies, and must have blood products available to treat clinically indicated MWDs and Contract Working Dogs (CWDs) to meet this standard of care. However, this capability is not currently available in theater. The lack of canine blood and blood products in the operational environment presents a challenge for treatment of our Military and Contract Working Dogs that requires a solution. MWDs save Service Member lives, and therefore maintaining or restoring their health, and the handler-MWD team integrity, is critical to unimpeded operations and force health protection. The Defense Health Program intends to share in the cost of product development through a clinical trial necessary to obtain a treatment indication for hemorrhagic shock secondary to trauma, and determine administration guidelines for canine lyophilized platelets and canine lyophilized plasma. Anticipated activities include the design and conduct of a Phase 2/3 clinical trial that establishes/confirms dosing of canine lyophilized platelets and canine lyophilized plasma, alone and combined, relative to the current standard of care for hemorrhagic shock secondary to trauma in canine patients. The contractor will conduct all activities in compliance with FDA CVM regulations, current Good Manufacturing Processes (cGMP), and other applicable regulations as necessary. 8. Submission Instructions: Entities interested in submitting a response must furnish a Capabilities Statement. Submissions shall be kept to one to three pages. The subject header of the email for submission of questions and/or the RFI response shall be: "RFI Response: Clinical Trial in Support of Trauma Indications for Lyophilized Canine Blood Products." All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission must include the following information: Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, and if applicable, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. Information in sufficient detail regarding how your firm is able to meet this requirement, as well as previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 9. Submission Due Date and Contact Information: Responses must be submitted electronically by 10:00 am Eastern Time 25 September 2019 via e-mail to Peter Mitchell at peter.d.mitchell8.civ@mail.mil. Telephonic communication will not be considered responsive.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-19-RFI-PDM01/listing.html)
- Place of Performance
- Address: FREDERCK, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN05441192-W 20190913/190912054205-e956ad4902b18f6ab58acf1555200bc8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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