INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

Becton, Dickinson & Company
1 Becton Drive
Franklin Lakes, NJ 07417

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 with a Size Standard 1,000 employees.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: FACS Canto system
2. Background Information: The CC is a clinical research hospital providing medical services for patients participating in human research protocols at the NIH. The CC provides patient facilities, services for clinical investigations, research in related areas, and training programs for residents.

The Center for Cellular Engineering (CCE): (1) manufactures cell and gene therapies for phase I and II clinical trials; (2) processes hematopoietic stem cell grafts for transplantation at the NIH Clinical Center; (3) develops new cell therapies; (4) performs in-process and lot release testing of cell and gene therapies; (5) develops new assays to test cell and gene therapies; (6) prepares chemistry, manufacturing, and controls (CMC) documents for investigational new drugs (IND) and summary data for annual reports to the Food and Drug Administration (FDA); (7) teaches Department of Transfusion Medicine (DTM) staff and visiting fellows about cell and gene therapy concepts and techniques; and (8) provides transfusion medicine and cell therapy medical consultant services.
3. Purpose or Objective: The purpose of this procurement is to obtain a FACS CANTO II / 10 color. This instrument is used to identify and enumerate specific leukocyte populations using characteristic monoclonal antibody combinations, staining intensity, and light scatter properties to aid in the diagnosis and treatment of malignancies. This is very sophisticated pieces of equipment which require many months of experience to operate.

4. Delivery: 30 Days A.R.O.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1xBD FACS 7-Color Setup Beads 25 Tests
1xBD FACSDiva CS&T Research Beads Kit 50T
1xFACSCanto IVD 10 color configuration
1xWorkstation Bundle Z240SFF FACSCanto 10C
1xNEC 23 Inch LED
1xFACSCanto Loader Option IVD
1xScanner Digital Imager 2D Handhld Canto+
1xBD FACSflow Sheath Fluid 20L
1xFACS Shutdown Solution
1xBD FACS Clean Solution 5L
Shipping and Handling

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

1. If another instrument is purchased, CCE will need to train the 2 technologists and then maintain their competency on a totally different system than the current system in the laboratory and this would be costly.

2. There would be a lack of compatibility of the laboratory methods if there are two different systems, which would require separate validations and protocols to be needed. In addition, protocols are re‐validated yearly, so an additional re‐validation would be required if a different Flow Cytometry System was procured.

3. The laboratory will be required to maintain a separate set of reagents, controls, supply items, and parts inventory if a different system was procured.

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.
CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by August 13, 2018, 1:00 PM Eastern time and must reference solicitation number 18-009031. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at [email protected]. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."