6505--PET Prostate-Specific Membrane Antigen Radiopharmaceuticals Amend for Questions and Answers

Questions & Answers / Clarifications

This document provides answers to vendor questions regarding Solicitation 36C25226Q0211 for PET Prostate-Specific Membrane Antigen (PSMA) Radiopharmaceuticals.

• Contingency Plans: The awarded contractor will be responsible for providing contingency plans, including alternative sources, prior to award, to ensure delivery if local radiopharmacies are unable to provide routine delivery.
• Afternoon Deliveries: Routine orders will be scheduled in advance. Same-day afternoon delivery requests must be submitted before 10:00 AM (or an agreed-upon time) to allow for preparation and logistics.
• Sole Source Status: This Request for Quotation (RFQ) is not a sole source request.
• Approved PSMA Products: The solicitation pertains to multiple FDA-approved PSMA products, including fluciclovine F 18 (Axumin), gallium-68 PSMA-11 (Illuccix, Locametz), piflufolastat F 18 (Pylarify), and flotufolastat F 18 (Posluma).

These clarifications do not appear to alter the original solicitation's requirements or submission deadlines, but provide essential details on contractor responsibilities and product scope.

Amendment / Modification

• This amendment adds Attachment 1: Price Cost Schedule Template.

• Attachment 1: Price Cost Schedule Template has been added.

• No changes to proposal deadlines or submission requirements are indicated by this amendment.

Form / Attachment / Pricing Sheet

This document is a pricing cost schedule template for the PET-CT F-18 PSMA Prostate Imaging Radiopharmaceuticals opportunity. It is intended for offerors to fill in their pricing details.

• Solicitation Number: 36C25226Q0211
• Contract Title: PET-CT F-18 PSMA Prostate Imaging Radiopharmaceuticals
• Offeror Name: Field to be completed by the offeror.
• Date: Field to be completed by the offeror.
• Base Year Pricing (February 1, 2026 – January 31, 2027):
  • CLIN 1: F-18 PSMA Imaging Radiopharmaceutical (Unit Dose)
  • CLIN 2: Ancillary Delivery/Handling Fees (Lot)
  • CLIN 3: Unused Dose Fee (Per Dose)
• Fields for Estimated Annual Quantity, Unit Price, and Extended Price for each CLIN.
• Base Year Total: Field to be completed by the offeror.
• Offeror Authorized Signature, Printed Name & Title, Date: Fields for offeror's representative.

This template is crucial for bidders to provide their cost proposals for the specified radiopharmaceuticals and associated services. Bidders must accurately complete all fields, including unit prices and quantities, to determine the total cost for the base year. This information will be a key component of their overall bid.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (RFQ) for the provision of unit dose Positron Emission Tomography (PET) radiopharmaceuticals for diagnostic patient care, specifically for prostate cancer imaging. The Department of Veterans Affairs (VA), Network Contracting Office 12 (NCO 12), requires these pharmaceuticals for the Jesse Brown VA Medical Center in Chicago, IL. Due to the short shelf life (<6 hours) of these products, local production and delivery are essential. The VA intends to award a firm-fixed-price contract.

• Provision of FDA-approved Prostate-Specific Membrane Antigen (PSMA) targeted radiopharmaceuticals in unit doses.

• Daily routine deliveries (Monday-Friday) based on patient schedules; no routine weekend deliveries.

• Contractor must maintain proximity (preferably within 30 miles) to Jesse Brown VA Medical Center for urgent requests.

• Products must be properly labeled with calibrated activity, expiration, lot number, and hazard markings.

• Packaging must meet federal/state regulations and be clearly labeled RADIOACTIVE.

• Compliance with Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), Food and Drug Administration (FDA), and United States Pharmacopeia Chapter 825 (USP <825>) guidelines.

• Maintenance of an Illinois Emergency Management Agency (IEMA) license.

• Performance of Quality Control testing per USP <825>.

• A specific item is listed: F-18 PSMA Imaging Radiopharmaceutical, 9 mCi, Unit Dose, with an estimated annual quantity of 205.

• Unused dose fee policy: VA may request an unused dose fee of $450 if unused dose is due to patient no-show/cancellation and requested by 8:00 PM ET next business day.

• Contract Type: Firm-fixed-price.

• Period of Performance: February 1, 2026 – January 31, 2027 (12 months).

• Place of Performance: Jesse Brown VA Medical Center, 820 S. Damen Avenue, Chicago, IL 60612-422.

• Submission Deadline: January 26, 2026, 5:00 PM Eastern Time.

• Submission Method: Email to Stacy.Massey@va.gov.

• Evaluation Factors: Technical Acceptability (Pass/Fail based on PWS compliance), Delivery Reliability, Past Performance, and Price.

• Award will be made to the most advantageous offer, considering price and other factors. Technical proposals are evaluated on a Pass/Fail basis.

• Offerors must demonstrate compliance with all PWS requirements, delivery capabilities, relevant experience, and provide a completed Price Cost Schedule.

• Offerors must hold an active Federal Government contracts registration in the System for Award Management (SAM).

• This acquisition is unrestricted.

• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing) with a small business size standard of 1,300 employees.

• FSC/PSC Code: 6505 (Drugs and Biologicals).

• The solicitation incorporates numerous FAR and VAAR provisions and clauses by reference. Full text is available at www.acquisition.gov.

• Questions should be submitted in writing via email to the Contracting Officer.

• Offerors must hold an active SAM registration.

• Offerors agree to hold prices firm for 60 calendar days from the receipt date.