SOLICITATION NOTICE
J -- Miltenyi/ 5x CliniMACS Plus and 4x CliniMACS Prodigy instruments Maintenance Agreement.
- Notice Date
- 4/20/2021 1:25:00 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
- 21-008308
- Response Due
- 4/28/2021 5:00:00 AM
- Archive Date
- 05/13/2021
- 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: Miltenyi Biotec, Inc. 2303 Lindberg St. Auburn, CA, 95602-9562 United States. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $20.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-02, November 23, 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. GENERAL INFORMATION 1. Title: Miltenyi/ 5x CliniMACS Plus and 4x CliniMACS Prodigy instruments Maintenance Agreement. 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 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 (21 CFR 211.63, 21 CFR 211.67). The Center for Cellular Engineering has 4 CliniMACS Prodigy automated cell processors (0085, 0146, 0327, 0611) and 5 CliniMACS Plus (0274, 0727, 0619, 0728 & 0562) selection devices. The FDA regulates facilities that manufacture cell based therapies in accordance with the following codes of Federal Regulations 21 CFR 210,211,600 and 1271. 21 CFR 211.67 which state that all equipment shall be maintained as appropriate. This project/contract is to purchase a preventative maintenance contract for 4 CliniMACS Prodigy (0085, 0146, 0327, 0611) and 5 CliniMACS Plus (0274, 0727, 0619, 0728 & 0562) devices that are used in the manufacture of cell based therapies. Preventative maintenance is mandated by FDA regulations. The manufacturer of this highly specialized device is the only party able to execute preventative maintenance and calibration of this device. 3. Purpose or Objective: This acquisition is for procuring a preventative maintenance contract for a CliniMACS Prodigy (0085, 0146, 0327, 0611) and CliniMACS Plus (0274, 0727, 0619, 0728 & 0562) located in the Center for Cellular Engineering 2J, 3T and 5B Cell Production Facility where it is used to manufacture cell based therapies for patients with advanced metastatic cancer enrolled on NIH clinical trials. 4. Period of Performance will be between 5/10/21 and 9/24/2022. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner 21 CFR 211.63, 21 CFR 211.67. Performance Requirements/Work Areas This service maintains the CliniMACS Prodigy (S/N: 0085, 0146, 0327, 0611) and CliniMACS Plus (S/N: 0274, 0727, 0619, 0728 & 0562) devices located in the Center for Cellular Engineering 2J, 3T and 5B Cell Production Facilities in an operational state in accordance with FDA mandates. 1.1 ��� Objectives Purchase a preventative maintenance package for CliniMACS Prodigy (0085, 0146, 0327, 0611) and CliniMACS Plus (0274, 0727, 0619, 0728 & 0562) devices located in the Center for Cellular Engineering 2J, 3T and 5B Cell Production Facilities. The vendor will provide a maintenance report for review by the Center for Cellular Engineering Quality Assurance team. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner 21 CFR 211.63, 21 CFR 211.67 The manufacturer of the device, Miltenyi Biotec is the sole entity able to perform this maintenance as the software and parts for this device are proprietary. The contractor shall conduct the following tasks: The vendor will provide preventative maintenance on the CliniMACS Prodigy (0085, 0146, 0327, 0611) and CliniMACS Plus (0274, 0727, 0619, 0728 & 0562) devices. � � � �2. The vendor will provide a preventative maintenance report for review by the Center for Cellular Engineering Quality Assurance team. 1.2�������� End Results/Deliverables A preventative maintenance report will be provided to the Center for Cellular Engineering�s Quality Assurance team to review. 1.3�������� Progress/Compliance The Government requires the following from contractors in order to monitor progress and ensure compliance: ����� Weekly Status Report����������� ����� Weekly Meetings ����� Monthly Progress Report ����� Project Management Team (PMT) Meetings ����� Program Reviews ����� Outlines and Drafts 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 Miltenyi. �With the continuation of using the same system 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 April 28th, 2020, 8:00 AM Eastern time and must reference solicitation number 21-008308. 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/34e4f403d5994f5da6a74a26085d816a/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN05977469-F 20210422/210420230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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