SOURCES SOUGHT
A -- Clinical and Regulatory Management
- Notice Date
- 12/13/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U.S. 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-17-CSPDA
- Archive Date
- 1/12/2017
- Point of Contact
- Christopher, Phone: 3016191342
- E-Mail Address
-
christopher.m.sult.civ@mail.mil
(christopher.m.sult.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This Sources Sought notice is published only to encourage interested parties to gather information about sources that can meet the requirements discussed below. THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A SOURCES SOUGHT NOTICE. NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS SOURCES SOUGHT. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1. SUBJECT: The United States Army Medical Acquisition Activity (USAMRAA) is conducting market research on sources qualified and approved to perform clinical and regulatory management for the Food and Drug Administration (FDA) approval of Terumo BCT's Cold Stored Platelet (CSP) Trima - Platelet Additive Solution (PAS) product. 2. DISCLAIMER: This sources sought notice 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 sources sought notice. Responses to this sources sought 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 sources sought notice. All information received in response to this sources sought notice that is marked Proprietary will be handled accordingly. Information as responses to the notice will not be returned. At this time, the Government 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 management of severe hemorrhage due to trauma, in addition to requiring surgical repair of damaged organs and tissues, requires the replacement of large volumes of blood products, including platelets. Platelets are a normal component of blood and a key initiating factor in hemostasis (blood clotting). Liquid platelets, due to their very short storage life, are difficult to reliably supply to the battlefield. A cold stored platelet product will reduce waste and simultaneously increase the availability of platelets to Roles of Care (ROC) 2 and 3 on the battlefield. The U.S. Army Medical Materiel Development Activity (USAMMDA) plans to develop the Terumo BCT's TPAS+ to satisfy the Army's capability need for platelets on the battlefield. 4. REQUIREMENTS: The Government is seeking sources qualified and approved to perform clinical and regulatory management for FDA approval of the Terumo BCT's Cold Stored Platelet (CSP) Trima - Platelet additive solution (PAS) product. a. The source shall be qualified and approved by Terumo BCT to: i. Conduct GCP clinical trials in a manner consistent with all applicable regulations and guidelines for blood products and biologics. ii. Develop clinical protocols capable of gaining FDA approval. iii. Develop and maintain a regulatory approach sufficient to meet applicable regulations. iv. Identify clinical trial locations v. Provide oversight of pre-clinical studies and GCP compliant Phase 1 and Phase 2 clinical trials. vi. Produce documentation in a manner consistent with FDA expectations and any other applicable regulations. vii. Document potential tasks during the execution of this requirement to include: 1) Selection, validation, and oversight of clinical research occurring at all study sites 2) Guidance and review in preparation of the Program Master Plan and associated Standard Operating Procedures (SOP) and protocols 3) Assist the Government in facilities and equipment inspection and monitoring 4) Technical review and consultation for the Government during project execution 5) Technical review of any additional clinical records, reports, etc. 5. CONTACT INFORMATION: Electronic responses to this sources sought notice shall be addressed to Mr. Christopher Sult, Contract Specialist, email: christopher.m.sult.civ@mail.mil no later than (NLT) 28 December 2016, 4:00 PM EDT. This sources sought notice is not a commercial solicitation and the Government will not pay for any information or items in reference to this notice. 6. RESPONSE SUBMISSION: Responses in reference to this sources sought notice shall be submitted via e-mail. Please include point of contact (POC), phone number, email address, and web site information. Respondents shall certify whether the company they represent is a U.S. business. The response should describe the company's capability to offer, field, and sustain a solution as characterized by the requirements addressed in this notice. If unable to provide a solution capable of meeting all requirements, the respondent should offer tradeoff considerations for unmet requirements. Respondents should mark all proprietary data as appropriate. USAMRAA and USAMMDA will protect proprietary information from unauthorized use and disclosure. Unless clearly marked otherwise, submission of a response to this sources sought notice signifies agreement to allow USAMMDA personnel to use the information to aid in developing an acquisition approach. 7. LATE SUBMISSIONS: Failure to respond to this sources sought notice does not preclude participation in any future requirements, nor will information provided in response to this notice be used to exclude anyone from responding to any future RFPs. Communications with USAMRAA in regards to this sources sought notice shall be submitted in writing. Responses received after the closing deadline of this sources sought notice shall not 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. 8. OWNERSHIP OF RESPONSES TO THE SOURCES SOUGHT NOTICE: All material submitted in response to this sources sought notice shall become the property of Government. 9. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall the Government be responsible for any contractor expenses in preparation of this sources sought notice, such as: submission costs, any other expenses or costs, damages, or any other nature incurred. Respondents understand and agree that submission of a response to this sources sought notice is at their own risk and expense, and the Government is released from any claim for damages or other liability arising out of the notice process. 10. ERRORS IN RESPONSE: USAMRAA shall not be liable for any errors in a respondent's response. The respondent is responsible for careful review of its entire response to ensure that all information is complete and correct. Respondents are liable for all error or omissions contained in their responses. 11. ADDENDUM: USAMRAA reserves the right to issue an addendum to this sources sought notice at any time for any reason. All interested, capable, and responsible sources that wish to respond to this sources sought notice are encouraged to submit documentation on their specific capabilities. In addition to relevant and relative capability statements, past performance, and other information, the Government requests responses to provide, as a minimum, the following: 1) Title Page: The capability package shall be assembled with a title page containing the following information: Company name, address, point of contact, telephone number, DUNS number, cage code, and business size. Please include any socio-economic information. 2) Experience: Offeror shall provide prior/current experiences for the same or similar size and scope including contract number, POC, and company or agency. Indicate whether a prime or subcontractor, contract value, and Government or commercial POC with current telephone number and email address. RESPONSES TO THIS SOURCES SOUGHT NOTICE WILL NOT BE RETURNED.
- Web Link
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- Record
- SN04349859-W 20161215/161213234200-766a19f17ad2373a3d14fe95a97eb9ea (fbodaily.com)
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