Biological Specimen and Investigational Product (CSN BSIP) Storage Facility

UPDATED: FIRST ATTACHMENT WAS FOR SDCC and ACCIDENTALLY UPLOADED, PLEASE REFERENCE THE RPF 75A50119R00028.

Please note: ALL OFFERORS MUST BE REGISTERED IN AND HAVE AN ACTIVE SAM.GOV ACCOUNT AT THE TIME A PROPOSAL IS SUBMITTED.

Questions may be submitted in accordance with Section L.7. INQUIRIES, and are due by email to the Contracting Officer by 12 PM ET on September 16, 2019. Answers to Potential Offeror's questions will be posted by a formal amendment to the RFP.

.

This requirement was previously synopsized in accordance with FAR 5.2 in FBO under https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-BSIP/listing.html and https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-(CTPE-SDCC-BSIP)/listing.html

Description

The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417, 42 U.S.C. § 241 et seq. (PAHPA: https://www.govinfo.gov/content/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf ) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 114-255, (https://www.congress.gov/bill/114th-congress/house-bill/34/text) authorizes the Office of Biomedical Advanced Research and Development Authority (BARDA) to accelerate development and to improve the availability of transformative medical countermeasures (MCMs). These products include innovative vaccines, therapeutics, diagnostics, procedures, and medical devices to protect Americans from potentially fatal health security threats caused by intentional acts or that result from natural or accidental incidents. The required capabilities of the performance of the Clinical Studies Network (CSN) is to advance development of MCMs by efficiently enabling rigorous Phase 1-4 clinical trials to assess safety and efficacy of MCMs to save lives.

The purpose of this solicitation is to extend and further refine the current CSN infrastructure and services available for advanced clinical development of MCMs. This RFP solicits proposals to acquire centralized storage services with state-of-the-science biological specimen (BP) and investigational product (IP) resource practices that promote specimen and data quality, adhere to legal requirements, and follow published best practices guidelines for the collection, receipt, storage, protection, processing, tracking, retrieval, packaging, and shipping of BS and IP retained samples obtained in CSN clinical studies. Details for this requirement listed below are found in the RFP. With this solicitation, the BARDA CSN seeks to engage a single Offeror to:

1. Provide centralized biological specimen storage with standardized processes that include Commercial Off-The-Shelf (COTs) tracking and inventory management.

2. Provide long-term storage of biological specimens (possibly non-clinical specimens) and investigational product retained samples across BARDA-supported studies.

3. Manage transport of biological specimens and investigational product retained samples for end-of-study archiving and future use (retrieving, labeling, shipping, tracking, etc.).

4. Transfer legacy biological specimens and investigational product retained samples currently in temporary storage provided by contract research organizations, with associated inventory data, to the Biological Specimen and Investigational Product storage facility (BSIP) as part of the initial activities for this contract.

BSIP CONTAINS MANDATORY CRITERIA FOR ELIGIBILITY IN SECTION M OF THE RFP.

Specimens that are received by the BSIP will be de-coded, and no personally identifiable information (PII) will ship with specimens. Biological specimens will include specimens obtained from human subjects (and possibly non-human subjects), or potentially other protocol-mandated specimens, and may include live viruses, bacteria or other microorganisms that need to be handled accordingly.

This will be full and open competition using the Indefinite Delivery, Indefinite Quantity (IDIQ) as defined in FAR 16.5 (Indefinite Delivery Contracts). The intent is to award a single-award IDIQ contract for the 'CSN Biological Specimen and Investigational Product (CSN BSIP) Storage Facility'. The projected period of performance is 10 years, including a 5-year Base CLIN and five one year Option CLINs. Task orders will be issued under the IDIQ. The BSIP awardee will be sole provider of services under this contract. The Contracting Officer will determine the individual task order type on a case-by-case basis. In the performance of task orders, the CO and Contractor may use Cost Reimbursement including Cost plus Fixed Fee (CPFF) or firm-fixed price (FFP).

In addition to the BSIP, the CSN will award contracts for a statistical and data coordinating center (SDCC), and for clinical trial planning and execution (CTPE) for routine services and/or response services relating to emergencies. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA Clinical Studies Network (CSN).

.