FDA Presolicitation Notice - ELISpot reader.pdf
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- FDA ELISpot Reader
- Solicitation number
- 75F40126Q135613
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This is a presolicitation notice for a federal contract opportunity issued by the FDA's Center for Biologics Evaluation and Research (CBER), Office of Plasma Protein Therapeutics (OPPT), Division of Hemostasis. The solicitation number is 75F40126Q135613, and the FDA is seeking an ELISpot (Enzyme-linked ImmunoSpot) reader to support regulatory research activities focused on immunogenicity assessment. The product code is PSC 6640 (Laboratory Equipment and Supplies) and NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing).
The acquisition will not be set aside for small businesses; any business regardless of size may submit a quotation. The government intends to award a Firm-Fixed-Price contract to the lowest-priced technically acceptable and responsible offeror, evaluating offers on their ability to meet specified requirements. The baseline equipment being solicited is a CTL S6 Entry Analyzer; however, the government will consider "brand name or equal" submissions provided the equivalent product meets all specific physical, functional, and performance features listed in the Minimum Technical Requirements. The evaluation methodology prioritizes price, evaluating the lowest-priced offer first and proceeding to subsequent offers if technical acceptability is not demonstrated. Interested parties should contact Tim Walbert, Contract Specialist/Officer, at timothy.walbert@fda.hhs.gov to request a copy of the full solicitation.
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FDA Presolicitation Notice - ELISpot Reader This notice is issued in accordance with RFO Subpart 12.2, specifically 12.201-1(c)(2) and the requirements therein.
Point of Contact Tim Walbert Contract Specialist/Officer Office of Finance, Budget, and Acquisitions Office of Acquisitions and Grants Services timothy.walbert@fda.hhs.gov
Notice of Set-Aside This acquisition will not be set aside for small businesses; any business, regardless of size, may submit a quote.
Product Codes PSC: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing
Notice Type: Presolicitation Solicitation #: 75F40126Q135613
Description The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Plasma Protein Therapeutics (OPPT), Division of Hemostasis requires an Enzyme-linked ImmunoSpot (ELISpot)ELISpot reader to support ongoing and expanding regulatory research activities focused on immunogenicity assessment.
All responsible sources may submit a quotation which will be considered by the agency. For a copy of the solicitation, please submit a request to Tim Walbert at the e-mail address above.
Procedures for Contract Award Essential to this acquisition is the use of “brand name or equal” when describing specific components and their salient performance characteristics in this RFQ. In this case, “brand name or equal” applies to a CTL S6 Entry Analyzer in its entirety. Where an offeror submits an “equal” product, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements.
The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In this case, the Government intends to award a Firm‐Fixed‐Price contract resulting from this Solicitation to the lowest-priced technically acceptable and responsible offeror.
Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.
mailto:timothy.walbert@fda.hhs.gov
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