SOURCES SOUGHT
A -- Clinical Trial Network for Antibacterial Drugs - Request for Information (RFI)
- Notice Date
- 2/4/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- BARDA-RFI-Clinical_Trial_Network_for_Antibacterial_Drugs
- Archive Date
- 4/25/2016
- Point of Contact
- Christopher T. Scott, Phone: 2022058580
- E-Mail Address
-
christopher.scott@hhs.gov
(christopher.scott@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI - Clinical Trial Network for Antibacterial Drugs 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 the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA's Broad Spectrum Antimicrobial's (BSA) program supports public: private partnerships for the development of novel antimicrobial therapies. The goal of the BSA program is to make new antibacterial therapies available for clinical use to treat serious infections including those caused by bacteria that are resistant to commonly used antibacterial drugs. One major component of antibacterial drug development is the planning and execution of Phase III clinical trials. These studies are typically large, expensive, and technically challenging to execute for certain disease indications (e.g. hospital-acquired/ventilator-associated bacterial pneumonia). At present, the planning and establishment of the complex infrastructure needed to conduct a Phase III clinical trial for an antibacterial drug candidate is done de novo, with each sponsor investing time and resources to set up the trial each time one is to be conducted. One way antibacterial drug development could be incentivized is through introducing efficiencies in the execution of these often large and complex clinical trials. The development of a clinical trial network that focuses on certain serious infections including infections where a significant proportion are caused by Gram negative bacteria and utilizes a master clinical protocol may represent a means of improving the efficiency of clinical trial execution. The 2014 U.S. National Strategy on Combating Antibiotic Resistant Bacteria calls out this specific approach to reducing obstacles faced by drug companies developing new antibacterial drugs and states that the United States Government will examine the feasibility of generating and applying master clinical protocols to multiple test groups of patients while sharing a common control group. 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. PLEASE SEE ATTACHMENT FOR ADDITIONAL DETAILS.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/BARDA-RFI-Clinical_Trial_Network_for_Antibacterial_Drugs/listing.html)
- Place of Performance
- Address: Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 200 C Street SW, Washington, District of Columbia, 20024, United States
- Zip Code: 20024
- Zip Code: 20024
- Record
- SN04010333-W 20160206/160204235136-c49bbf90a77767a69c9cdf148879f711 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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