Scientific Reagents Supplies

Added: Jun 28, 2018 8:04 am 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 Laboratory Medicine, 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 Ori Gen Biomedical

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE:

The Intended procurement is classified under NAICS code 339112 with a Size Standard 1000 # of the employees.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-97May 31, 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 ($150,000).

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: Reagents Cellular Supplies
2. Background Information:
The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations.

The Cell Processing Section (CPS), Department of Transfusion Medicine, NIH CC 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 (Charles S. Carter Cellular Therapy Laboratory) 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:
This contract is to purchase supplies aiding in the culture of cellular therapy products. The intended use for the bags is set forth in standard operating procedures set by investigators. The culture bags are specific for manufacturing in protocols including but not limited to: Preparation of Autologous Transduced Lymphocytes Expressing Anti-CD22 Chimeric Antigen Receptor, Preparation of Autologous Transduced T Cells Expressing Anti-CD19 Chimeric Antigen Receptor, T Cells expressing a fully-human anti-CD30 Chimeric Antigen Receptor for treating CD30-expressing lymphomas, and
Transduction of Autologous T Cells with anti-HPV-16 E7 T-Cell Receptor.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The contractor will supply sufficient reagents and disposables to process approximately 150 cellular therapy products per year.
Shelf Life-Minimum - shelf life of any unopened disposable shall be at least 1 year unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory.
The reagents and disposables may include but not limited to those listed below:
PermaLife Cell Celture Bag, 7mL
PermaLife Cell Celture Bag, 30mL
PermaLife Cell Celture Bag, 70mL
PermaLife Cell Celture Bag, 120mL
PermaLife Cell Celture Bag, 240mL
PermaLife Cell Celture Bag, 325mL
Porective cap for female luer
Needle free spike

The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government.
Delivery Schedule
These reagents/disposables will be shipped overnight delivery Monday through Thursday to:
NIH/CC/DTM/Cell Processing Section
10 Center Drive
Bldg. 10/ Rm. 3C720
Bethesda, MD 20892-1288
Attention: Candice Gott
Shipments will use government carrier at the expense of the government unless otherwise arranged.
The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.
Government Responsibilities
The Cell Processing Section shall use the reagents and disposables in accordance with manufacturer's package inserts and approved IND/IDE uses if applicable.
The NIH CC Cell Processing Section shall inspect shipments upon receipt and report any damage, defects or errors in shipment to
Shipments will use government carrier at the expense of the government unless otherwise arranged.
The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.

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

The intended sole source is the only known source to meet the technical needs of the scientific equipment/supplies. 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 July 2, 2018 at 12:00 AM Eastern time and must reference solicitation number 18-011384. Responses may be submitted electronically to Priscilla Abalos, Contracting Specialist at Priscilla.abalos@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."