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SAMDAILY.US - ISSUE OF JULY 10, 2020 SAM #6798
SOLICITATION NOTICE

J -- Terumo/ Preventative maintenance Cobe 2991 and Elutra devices.

Notice Date

7/8/2020 12:32:41 PM
 

Notice Type

Presolicitation
 

NAICS

811219 — Other Electronic and Precision Equipment Repair and Maintenance
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

20-011766
 

Response Due

7/15/2020 12:30:00 PM
 

Archive Date

07/30/2020
 

Point of Contact

Grace Wong-Darko, Phone: 3014961199
 

E-Mail Address

Grace.Wong-Darko@nih.gov
(Grace.Wong-Darko@nih.gov)
 

Description

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: Terumo BCT, Inc. 10811 W COLLINS AVE LAKEWOOD, CO, 80215-4440 ��� UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $20.5 Mil. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-5, February 27, 2020. �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. PSC: J066 GENERAL INFORMATION 1. Title: Terumo/ Preventative maintenance Cobe 2991 and Elutra devices. 2. Background Information: The Center for Cellular Engineering manufactures cell based therapies for patients who either no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner including being enrolled on an appropriate preventative maintenance program to ensure proper operation these critical devices (21 CFR 211.63, 21 CFR 211.67). 3. Description: The Center for Cellular Engineering has 3 Elutra, 4 Cobe 2991 and 3 Spectra cell processing/apheresis devices. This project/contract is to purchase a preventative maintenance contract these 10 devices that are used in the manufacture of cell based therapies for patients enrolled on NIH sponsored clinical trials at the Clinical Center. Preventative maintenance is mandated by FDA regulations. The manufacturer of these highly specialized devices is the only party able to execute preventative maintenance and calibration of this device due to the proprietary nature of the devices and the software that controls these devices. 4. Period of Performance: Base + three option years. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 1. Requirements:� -QTY. 3 of 71800 Elutra System PM for account 100013136 Serial Numbers 1E00085, 1E00015, 1E00010. - QTY. 4 of 91000 Cobe 2991 System PM for account 100013136 Serial Numbers 2888, 3379, 3061, 3062. - QTY. 3 of 912991000 Cobe 2991 System PM for account 100013136 serial Numbers 2437, 2436, 2581. � 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 July 15, 2020, 3:30 PM Eastern time and must reference pre-solicitation number 20-011766 Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist 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.""
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/082f6e8e576543b7a49f3437145f5f4a/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN05714593-F 20200710/200708230140 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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