SOLICITATION NOTICE
R -- GMP Training
- Notice Date
- 5/6/2022 3:28:24 AM
- Notice Type
- Presolicitation
- NAICS
- 541330
— Engineering Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 22-003597
- Response Due
- 5/16/2022 9:00:00 AM
- Point of Contact
- Susan Nsangou, Phone: 3014969351
- E-Mail Address
-
susan.nsangou@nih.gov
(susan.nsangou@nih.gov)
- Description
- INTRODUCTION � This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The NIH Clinical Center, Office of Purchasing and Contracts, intends to negotiate and award a purchase order to UL Verification Services, Inc, for a comprehensive web-based GMP training program to support NIH aseptic processing facilities, as well as departments who provide support to these facilities. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541330 with a Size Standard of $16.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-06 dated May 1, 2022. 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. DESCRIPTION OF REQUIREMENT � The period of performance is one year and up to two option years. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, based GMP training program to support NIH aseptic processing facilities, as well as departments who provide support to these facilities.� Course subject matter should be comprehensive with a total of 40 courses, including, but not limited to Data Integrity, Good Documentation Practices, Corrective and Preventive Actions, Principles of Auditing, Handling an FDA Inspection, Failure Investigations and Writing and Reviewing SOPs.��� Justification for sole source is there is only one company with the comprehensive breath of courses that were developed in collaboration with FDA, thus assuring content is in-line with FDA expectations.� In addition, this company offers the courses in two different formats that have been used by NIH the past 3 years (web-based, and file based that can be downloaded into MasterControl system).� In accordance with FAR part 10, extensive market research was conducted to reach this determination. Additionally, knowledgeable individuals in the Government and Industry were contacted for market research purposes. None of the subject matter experts contacted were able to identify any contractor. Finally, a review of both the GSA Advantage and Dynamic Small Business Search returned no results. Therefore, only UL Engineering, Inc. is capable of meeting the needs of this requirement. APPLICABLE CLAUSES AND PROVISIONS The provision at FAR clause 52.213-4, Terms and Conditions - Simplified Acquisitions (Other Than Commercial Items) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. 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: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), 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 the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Susan Nsangou, Contracting Officer, susan.nsangou@nih.gov. US Mail and Fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/961ad7f229db4eb4a99dd2d0931d82de/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06319808-F 20220508/220506230055 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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