Pathogen_Reduction_Technologies_RFI.pdf

PROCUREMENT SENSITIVE

FOR OFFICIAL USE ONLY

REQUEST FOR INFORMATION

TITLE: Pathogen Reduction Technologies for Blood Products

1. Background

The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities’ ability to withstand adversity, strengthening our health and response systems, and enhancing national health security.

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

BARDA supports the advanced research, development, and procurement of medical countermeasures (MCMs) against a variety of Chemical, Biological, Radiological and Nuclear (CBRN) threats and in recent years has significantly expanded its investment in therapeutics for radiation exposure. Current BARDA initiatives include the development of MCMs to mitigate systemic injuries caused by a radiation incident.

Modeling projections indicate blood transfusions will be needed to treat a significant number of patients suffering from trauma associated with a radiation blast and thrombocytopenia associated with acute radiation syndrome. BARDA is interested in ensuring the available blood products in such an incident are safe and effective. People that are exposed to radiation have the potential to become neutropenic and therefore are more susceptible to infection. Inexpensive, effective means of pathogen inactivation or reduction of blood products are important.

2. Description

2.1 ASPR/BARDA is issuing this Request for Information (RFI) to identify the readiness of pathogen reduction technologies for blood products for the treatment of trauma and acute radiation syndrome.

BARDA intends to use responses to this RFI for planning potential future acquisitions. BARDA seeks pertinent marketplace data on availabilities and capabilities to strengthen BARDA’s understanding of the current and future marketplace as well as enhance its ability to obtain quality services and products economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any potential contracts under this notice. This is strictly for market research.

2.2 THIS IS NOT A SOLICITATION FOR PROPOSALS. THIS IS A REQUEST FOR INFORMATION ONLY.

This RFI is for planning purposes only and is issued in accordance with FAR Clause 52.215‐3. No solicitation document exists at this time. The information provided in the RFI is subject to change and is not binding on the Government. Issuance of this notice does not constitute any obligation on the part of the Government to procure the supplies or to issue a solicitation. In addition, the Government is under no obligation to pay direct or indirect costs or charges that arise as a result of Responder submission of responses to this RFI or the Government's use of such information. Responses to this notice cannot be accepted as offers. The Government reserves the right to reject, in whole or in part, any Contractor's input resulting from this RFI. No contract will be awarded from this announcement. ASPR/BARDA has not made a commitment to contract any products or services, and release of this RFI should not be construed as a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. Any information that the vendor considers proprietary should be clearly marked as such. Information is being requested in order to make potential future requirements better for industry and the Government.

3. Description of the information requested

3.1 BARDA is seeking capability statements from qualified businesses (large or small) having the ability to provide pathogen reduction technology for blood products needed to treat trauma and symptoms associated with acute radiation syndrome.

3.2 The narrative (including figures, schematics, diagrams, photographs, etc.) should describe the capabilities and address the following:

a. Description of currently available pathogen reduction technology for blood products, including the Technology Readiness Level of the proposed products. Make sure to distinguish the TRL level by blood product (Whole Blood, Red Blood Cells, Plasma, Platelets, etc.) See:

https://www.medicalcountermeasures.gov/federal‐initiatives/guidance/integrated‐trls.aspx,

b. The narrative should also address the following:

1. Primary indication

2. Potential market penetration

3. Technology roll out plan for blood center adoption

4. Product development plan

5. Regulatory strategy

6. Engagements with the FDA

7. Log reduction information on bacteria, viruses and fungi

8. In vitro characterization (i.e., blood component efficacy, etc.)

9. Non‐clinical studies

10. Clinical studies

11. Manufacturing process & release testing (include time to release of final product)

12. Storage conditions & stability testing

Offerors’ opinions regarding the difficulty and/or feasibility of the potential requirements or http://www.medicalcountermeasures.gov/federal proposed acquisitions, possible solutions and approaches that may currently exist in the market place, and information regarding innovative ideas or concepts relative to this proposed solicitation are encouraged.

c. All capability statements must provide the following:

1. Company name and address

2. Point of contact

3. Phone/fax/email

4. NAICS Code(s)

5. Business size and status

6. Capability information in response to the project requirements and qualifications identified in this notice

4. Key Assumption: Industry will be able to meet all requirements, as addressed.

5. Restrictions: Responses should be limited to 15 pages and may be sent electronically to Christopher.Scott@hhs.gov. Responses are due no later than August 30, 2019 by 5PM US EDT.

6. Administrative Information:

a. Contracting Officer: The Contracting Officer is the only person authorized to accept responses to this RFI. All comments and/or questions shall be submitted to the Contracting Officer and not to BARDA.

b. The Contracting Officer for administration:

Name: Christopher Scott Address: 200 C St SW, Washington DC 20024 Phone: (202) 205‐8580 Email: Christopher.Scott@hhs.gov

c. The BARDA Points of Contact:

Name: Ashley Cecere Address: 200 C St SW, Washington DC 20024 Phone: (202)691‐2056 Email: Ashley.cecere@hhs.gov

Name: Beryl Voigt Address: 200 C St SW, Washington DC 20024 Phone: (202)205‐3608 Email: Beryl.Voigt@hhs.gov mailto:jason.bell@hhs.gov mailto:jason.bell@hhs.gov mailto:Christopher.Scott@hhs.gov mailto:Ashley.cecere@hhs.gov mailto:Ashley.cecere@hhs.gov mailto:Beryl.Voigt@hhs.gov