Cryo Assoc. / Laboratory MVE 1536P-190F-GB Freezers, software and installation.

INTRODUCTION
This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

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:

Cryo Associates, Inc.

7905A Airpark Rd,

Gaithersburg, MD 20879 USA

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 333415 with a Size Standard 1250.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-06 May 26, 2022. 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.


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: Cryo Assoc. / Laboratory MVE 1536P-190F-GB Freezers, software and installation.

2. Background Information:  The Center for Cellular Engineering is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes in support of more than 50 intramural clinical trials.  These services include (1) development, evaluation, and validation of cellular therapies for INDs and (2) manufacture of cellular therapy products for approved clinical trials.  The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product by the NIH.  To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products.  CCE manufactures cellular therapy products from more than 800 collections from patients and healthy donors per year.  The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases.  All products are manufactured using current good manufacturing practices (cGMP).  The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects.  The Center of Cellular Engineering needs to procure this equipment for a new facility located on the 12th floor of the E wing of building 10 of the Clinical Center at NIH. This is equipment is required to be delivered at the start of September 2022 to prevent delays in commissioning.

3. Purpose or Objective: purchase and installation and performance qualification of a Planar Kryo 750, 30 liter, front opening, controlled rate freezer; and installation of two (2) MVE 1536P-190F freezers.

4. DELIVERY: September 5th, 2022.

5. CONTRACTOR REQUIREMENTS

SCOPE:

Work to be performed

Independently, and not as an agent of the government, the contractor shall provide necessary personnel, supplies, and services to perform the work required by this contract as set forth in the sections.

The contractor shall perform the following:

• Install a Planar Kryo 750, 30 liter, front opening, controlled rate freezer
• Perform a IQ/PQ on the Planar Kryo 750, 30 liter, front opening, controlled rate freezer.
• Provide documentation confirming the successful installation and performance qualification of the Planar Kryo 750, 30 liter, front opening, controlled rate freezer.
• Deliver and install two (2) MVE 1536P-190F-GB FULL AUTO, GB

Tasks

1. Delivery of Planar Kryo 750, 30 liter, front opening, controlled rate freezer              
2. IQ/PQ Validation of Planar Kryo 750                                                                      
3. Delivery of 4 X Vial Baskets                                                                                                   
4. Delivery of 1 X Rack for blood bags                                                                                       
5. Delivery of 11X 250 ml Blood bag cassette                                                                         
6. Delivery of 22 X 50 ml Blood bag cassette                                                                          
7. Sign off on documentation by Center for Cellular Engineering Quality Assurance.
8. Delivery of two (2) MVE 1536P-190F-GB FULL AUTO, GB  
9. Installation of two (2) M MVE 1536P-190F-GB FULL AUTO, GB

Parts/Supplies

The contractor shall supply all parts and supplies needed for the installation and delivery.

Labor and Travel

The contractor shall provide all labor and travel at no additional cost for the duration of the contract.

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

This system is on site and has been validated for use on CC patients.  It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Cryo Associates, Inc.  With the continuation of using the same supplies will also help reduces the risk of a disruption in patient care. 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, and 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 July 5th, 2022, 9:00 AM Eastern time and must reference solicitation number 22-008324. Responses may be submitted electronically to Ms. Grace Wong-Darko, Contracting Specialist via email at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted.

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