Toxicity testing on a new PET ligand for the NIH

Acquisition Description:

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested.

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-04.

The North American Industry Classification System (NAICS) code for this procurement is

541380– TESTING LABORATORIES AND SERVICES.

The Solicitation number is RFQ-CC-25-002889 and the solicitation is issued as a Request for Quotes (RFQ).

The Clinical Center has a requirement for a single dose, single species Toxicity Study in Rats with 14-day Recovery for a proposed PET ligand (Fluoine-18-Fluorocellobiose).  The results of this study will be provided to the FDA as per the Center for Drug Evaluation and Research (CDER) requirements. This is a necessary step for the Investigational New Drug (IND) application. Offerors are referred to the attached Statement of Work (SOW) for all technical requirements and standards of service.  The period of performance is for a one year twelve (12 month) base period.  All services will be requested from the NIH, Clinical Center in Bethesda, Maryland.

Interested parties who meet the requirements as outlined in the SOW are invited to submit a proposal, including statements of how the proposal will meet the Government requirements.  All information furnished shall be legible, typed and must contain sufficient detail to allow the government to evaluate and determine best value, see TECHNICAL EVALUATION CRITERIA-SOW.

The technical and past performance combined will be significantly more important than cost. However, cost/price will be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. Please submit the technical and cost proposals separately, clearly labeled.

Place of Performance or Delivery:

Estimated POP: 4/11/2025 – 4/10/2026

Place of Performance/Delivery/Performance contact:

NIH-CC

10 Center Drive

NIHBC 10, Room B1N264B

Attn: Dina Hammoud

Bethesda, MD 20852

The following FAR provisions apply to this acquisition:

FAR 52.212-1 Instructions to Offerors Commercial Items (SEPT 2023)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (DEC 2022)

FAR 52.204-7 System for Award Management (OCT 2018)

(Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (JAN 2017)

52.204–26 Covered Telecommunications Equipment or Services-Representation

(OCT 2020) *** Must complete representation if attached to this solicitation- see attachment 52.204-26

The following FAR contract clauses apply to this acquisition:

FAR 52-212-4 Contract Terms and Conditions Commercial Items (DEC 2022)

FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (SEP 2023)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

FAR 52.204-13 System for Award Management Maintenance (Oct 2018)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 2015)

52.252-2 -- Clauses Incorporated by Reference. (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://farsite.hill.af.mil/vffara.htm.

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.

The government intends to award a “firm fixed price” order (in the form of a PO, IDIQ, or BPA) to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The government will evaluate quotes to determine the proposal that conforms to the solicitation and presents the best value to the government (eg. the most advantageous to the Government based on price, performance, availability of funds, etc.). The award will be made based on technical capability to meet the requirements/technical factors, price, and past performance.

Submission shall be received not later than 04/04/2025 by @ 03:00 PM EST.

Offers may be emailed to Lu Chang at <lu-chang.lu@nih.gov> by the date and time stated above.

Late submission shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this solicitation should be forwarded in writing via email to the respective contacts above.

Offers shall include RFQ number in the subject line (RFQ-CC-25-002889).

Offers shall also include the price, delivery timeframes, and any other required documentation/information as mentioned above. Offers that do not meet these requirements may be excluded from consideration.