SOLICITATION NOTICE
65 -- Sepax 2 RM Cell Separation System
- Notice Date
- 8/1/2018
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18-009379
- Archive Date
- 8/28/2018
- Point of Contact
- Grace P. Wong-Darko, Phone: 3014961199
- E-Mail Address
-
wongdarkogp@nih.gov
(wongdarkogp@nih.gov)
- Small Business Set-Aside
- N/A
- 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 Department of Transfusion Medicine (DTM), 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: GE Healthcare Bio-sciences Corp. 100 Results Way Marlborough, MA, 01752-3078 UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 with a Size Standard 1000 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: Sepax 2 RM Cell Separation System (with software and training). 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 Cell Processing Section (CPS) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies 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. To provide these services, CPS operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or 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 good manufacturing practices (GMP). 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. Each subject must consent to participate in a NIH Clinical Research Study. 3. Purpose or Objective: The DTM, CPS is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH, and it is critical that the following is acquired in order to tailored to each of the >30 different patient-care clinical research protocols supported. 4. Delivery: 30 days A.R.O. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 2x Sepax 2 RM 2x Traceability Activation 2x Barcode reader 2x NeatCell Software 2x IOQ/Training 1x Transport and handling charges CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This clinical research trial is ongoing and utilizing Sepax 2 RM Cell Separation System 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, 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, 12:00 PM Eastern time and must reference solicitation number 18-009379. 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
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-009379/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN05016485-W 20180803/180801231733-53eb687c519b5049aa2e8fae0a46b158 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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