Biosciences/ 45x SAS Disposable Sampling Heads for Petri Plates.

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:

Bioscience International

11333 Woodglen Drive

Rockville, MD 20852 USA

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 339112 with a Size Standard 1000.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-08, July 14, 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: Biosciences/ 45x SAS Disposable Sampling Heads for Petri Plates. Double-bagged, individually wrapped, irradiated, five-year shelf life. 40 heads per box.

2. Background Information:  The disposable sampling heads is needed in CCE to support our new environmental monitoring (EM) program in order to meet FDA and industry EM regulatory standards in the manufacturing of clinical products. This EM program will bring increased viable air sampling throughout our two existing manufacturing facilities, with a third facility coming online in early 2021. These disposable sampling heads will provide clean and sterile sampling heads while we perform the sampling of various EM sites using the viable air sampling equipment. Failure to procure these heads will prohibit CCE in executing our EM program and will result in CCE not meeting the FDA and regulatory standards in the manufacturing of cellular products for patient use.

3. Purpose or Objective: The disposable sampling heads will provide clean and sterile sampling heads while we perform the sampling of various EM sites using the viable air sampling equipment.

Scope:

  The SAS Disposable Sampling Heads for Petri Plates. Double-bagged, individually wrapped, irradiated, five-year shelf life. 40 heads per box.  45 boxes needed by 12/15/2020.

4. Delivery: 21 Days A.R.O.

Delivery Location:

NIH/CC/DTM/Center Cellular Engineering

10 Center Drive

Bldg. 10/ Rm.3C720

Bethesda, MD 20892-1288

Attention:  Carl Perez

The contractor shall bear the cost of replacement for supplies found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.

Government Responsibilities

1.       The Center Cellular Engineering shall use the reagents in accordance with manufacturer’s package inserts and approved IND/IDE uses if applicable.

2.       The NIH CC Center Cellular Engineering shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. 

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 Biosciences International Inc.  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, 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 November 27th, 3:00 PM Eastern time and must reference solicitation number 21-001988. 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."