A02_Notice_of_Intent_to_Sole_Source_with_the_Fisher_Bioscience.pdf

Notice of Intent – Sole Source:

Date: Friday, 19 October 2018

Contracting Office Zip Code: 21702‐9232

Classification Code: 541380 “Testing Laboratories”

Contracting Office Address: US Army Medical Research Acquisition Activity (USAMRAA) 1504 Porter Street Fort Detrick, MD 21702‐5014

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to award on a sole source basis IAW FAR 6.302‐1(a)(2)(iii), to Fisher Bioservices, Inc. for oversight and management of biorepository and chemical information system.

Solicitation Number: W81XWH18R0002

Responses Date: 10:00am eastern, Friday, 02 November 2018

Point of Contact: Julie L. Burns at julia.l.burns3.civ@mail.mil

Anticipated Contract Award Date: 01 December 2018

Contractor: Fisher Bioservices, Inc.

Description: The Experimental Therapeutics (ET) Branch is part of the Walter Reed Army Institute of Research (WRAIR). The mission of the ET Branch is to discover and develop new pharmaceutical agents to protect military members from death, disease, and injury. The ET Branch is the nation’s primary developer of new drugs to prevent and/or treat malaria and leishmaniosis. Collectively, ET engages in drug discovery, drug efficacy and mechanism evaluation, and formal preclinical and clinical development.

The scope of this requirement is the operation, oversight, and management of a biorepository facility for variety of compounds and chemical samples and administration and maintenance of all manual and digital chemical information and inventory systems, including the relational database system (RDS) and associated third‐party Laboratory Information Management System (LIMS). Task include, but are not limited to:

*The contractor shall meet and have a secure biorepository facility that is fully compliant with all Federal, State, and location regulatory requirements.

*The contractor shall receive, ship, store, and maintain approximately 1 million samples of approximately 800,000 different compounds, with an additional average of approximately 5,000‐6,000 new compounds and chemical samples entering the program annually. (NOTE: The term “compound” includes, but is not limited to, chemical elements, molecules, drugs, formulations, pharmaceuticals, natural products, radioisotopes, radioactive samples, and

Notice of Intent – Sole Source:

mixtures (including investigational new drugs (INDs) (Phases 0‐3) as well as approximately up to 2 Ci each of 3H (tritium) or 14C (carbon‐14) radiolabeled chemicals).

Below is a breakdown of the compounds currently stored in the biorepository by type of storage:

Ambient Regular storage 97.6177%

DEA (Class 5 safe) storage .1288%

Freezer storage .1091%

Refrigerator storage .4474%

Segregated Hazard storage .1310%

Dry storage .2074%

Inert Gas storage .0218%

Radioactive storage .0164%

Hand Inventory/Clinical Interest materials (refrigerated, freezer, room temperature storage)

1.3204%

* The contractor shall have a permit to store radiolabeled chemicals and a permit to ship all materials from the state in which the repository is located to CONUS and OCONUS locations.

* The contractor shall store, administer, and maintain manual, digital, and imaged chemical information and inventory systems for the storage and retrieval of chemical sample data sheets, investigational new drugs (INDs), clinical protocols, and other documents.

* The contractor shall use the Laboratory Information Management System (LIMS) to manage an inventory information database for all compounds and chemical samples stored at the biorepository and provide administration and maintenance of the relational database system (RDS).

This notice of intent is for information purposes only. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to clearly articulate the ability to provide these exact services outlined above. A request for documentation will not be considered as an affirmative response by a vendor. If no responses are received by the close date of this publication notice to the effect that comparable services are available from other source AND that it is more advantageous to the Government to use another source compared to obtaining these services through a sole‐source contract, then a sole source acquisition award will be made to Fisher Bioservices, Inc.