36C26226Q0580.docx

SUBJECT*

VA San Diego PSMA

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist Hestia Sim Hestia.Sim@va.gov

PLACE OF PERFORMANCE

VA San Diego Healthcare System

Nuclear Medicine Service

3350 La Jolla Village Drive

San Diego CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a combined synopsis/solicitation for commercial supplies, issued unrestricted and full/open among Federal Supply Schedule (FSS) contract holders, and prepared in accordance with the format in FAR Subpart 8.4, as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a request for quotes under solicitation number: 36C26226Q0580

The Department of Veterans Affairs Network Contracting Office (NCO) 22 is looking for a contractor who can supply the Gallium-68 (GA-68) Prostate Specific Membrane Antigen (PSMA) radiopharmaceutical for VA San Diego Healthcare System located in San Diego, California. The Contractor shall furnish all supplies/services at participating VA medical centers. Shipping term is FOB Destination. Shipping must be included in the unit cost.

The solicitation will be in accordance with FAR Subpart 8.4, Federal Supply Schedule, and Veteran Affairs Acquisition Regulations as supplemented with additional information in this notice. The North American Industrial Classification System (NAICS) code for this requirement is 325412, Size Standard 1,300 Employees. The Contractor shall adhere to all federal and state laws and regulations in effect during the term of this contract. The Government intends to award a firm-fixed-price contract. The Contract begins on the date of award.

“System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.”

In advancement of Section 2 of Executive Order 14208, the removal of requirements related to Executive Order 14057 eliminates all non-statutory sustainability requirements or preferences in purchases of food service wares, including paper straws. In addition to removing requirements related to Executive Order 14057, the attachment also reflects recent updates to Code of Federal Regulation citations for the U.S. Department of Agriculture’s BioPreferred® Program, a statutory purchasing preference program.

Key solicitation milestones are: Submit any questions regarding this procurement via email to Hestia.Sim@va.gov no later than 10am Pacific Local Time Tuesday, April 7, 2026. No questions will be answered after this date/time unless determined to be in the best interest of the Government as determined by the Contracting Officer. Telephonic questions will not be accepted or returned. RFI responses will be responded to as necessary in amendment format which will be posted to contract opportunities at http://SAM.gov.

Due to time constraints, responses to the solicitation shall be due on Friday, April 10, 2026, at 10:00 Pacific Time. Offerors are advised that it is your responsibility to review and monitor the website frequently to ensure you have the most up to date information, including amendments. Correspondence or questions may be directed to Hestia Sim, Contracting Specialist at Hestia.Sim@va.gov with " 36C26226Q0580, VA San Diego PSMA” in the subject line within 48 hours of release of this notice. Telephone inquiries will not be honored. Inquiries after the allotted period may not be responded to due to the time constraints of the procurement. All offerors must be registered in www.sam.gov to do business with the Government. Ensure your registration is correct, current and has not expired.

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Table of Contents

SECTION B - CONTINUATION OF SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Submit invoices electronically through https://portal.tungsten-network.com ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

1. SCOPE

Manufacturing and delivery of sterile/aseptic, USP 825 compliant, Gallium-68 Prostate-Specific Membrane Antigen (PSMA) agent equivalent to ILLUCCIX® (3-5mCi per unit dose) for diagnosis of patients with, or suspected of, having prostate cancer receiving services at VA San Diego Healthcare System Nuclear Medicine Service. Delivery services must meet all Department of Transportation (DoT) requirements for shipment and delivery of radioactive drugs.

PERIOD OF PERFORMANCE (POP):

Base: 7/1/2026 – 12/31/2026 Option Year 1 (OY1): 1/1/2027 – 12/31/2027 Option Year 2 (OY2): 1/1/2028 – 12/31/2028 Option Year 3 (OY3): 1/1/2029 – 12/31/2029 Option Year 4 (OY4): 1/1/2030 – 12/31/2030

PARTICIPATING VA HEALTHCARE SYSTEMS:

VA San Diego Healthcare System 3350 La Jolla Village Drive Nuclear Medicine Service San Diego, CA 92161

2. ROUTINE ORDERS

Routine orders require delivery on the next business day, unless specified elsewhere in this contract.

3. DELIVERABLES

The quantities cited above chart are estimated quantities for base and all option periods; quantities are not a contractual statement of precise quantities that the Government will order. The quantities given are estimated only, and no guarantee of their accuracy is either given or implied. The Government will only pay for quantities that are actually ordered and for which the services are fulfilled.

4. SALIENT CHARACTERISTICS

Equivalent PSMA must meet following salient characteristics:

· Must be FDA-approved.

· Must be suitable for use as a PSMA-targeted prostate PET imaging agent for prostate cancer detection.

· Must be labeled with Gallium-68 (GA-68). Substitution with any other radionuclide is not acceptable to continue the previously conducted clinical studies.

· Must help select candidates for PSMA-directed therapy.

5. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS:

VA San Diego HEALTHCARE SYSTEM:

Delivery Location – Nuclear Medicine Service, Main Hospital, 4 West, 4th Floor Normal Work Hours – 7:00am to 4:00pm, Monday through Friday

6. PACKAGING AND MARKING

a) The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

b) Items must be properly packaged to prevent damage during shipping, handling, and storage.

c) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

d) Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered, and items/quality shipped.

7. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

8. SAFETY GUIDELINES AND REQUIREMENTS

The Contractor shall perform all functions of the contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The Contractor shall self-report any violations to the program office manager within twenty-four (24) hours. Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements.

9. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT

Juneteenth 19

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

10. CONTRACTOR DELIVERY PERSONNEL

All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English.

11. PARKING AND SPEED LIMIT

Park only in areas designated by the Program Office Manager or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the Program Office Manager of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Security, the offenses will be handled in Federal Court as they are Federal offenses.

12. INVOICE AND PAYMENT

No advanced payments will be authorized. The contractor shall submit invoices monthly. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Illuccix or equivalent GA-68 PSMA Contract Period: Base POP Begin: 07-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Illuccix or equivalent GA-68 PSMA Contract Period: Option 1 POP Begin: 01-01-2027 POP End: 12-31-2027

Illuccix or equivalent GA-68 PSMA Contract Period: Option 2 POP Begin: 01-01-2028 POP End: 12-31-2028

Illuccix or equivalent GA-68 PSMA Contract Period: Option 3 POP Begin: 01-01-2029 POP End: 12-31-2029

Illuccix or equivalent GA-68 PSMA Contract Period: Option 4 POP Begin: 01-01-2030 POP End: 12-31-2030

B.4 DELIVERY SCHEDULE

160.00

320.00

325.00

330.00

335.00

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SECTION C - CONTRACT CLAUSES

C.1 FSS RFQ INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence.

C.2 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/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.3 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN 2023) (DEVIATION)

(a) In an effort to increase contracting opportunities for Veterans, depending on the evaluation factors included in the solicitation, VA will evaluate responses received based on the schedule Contractor’s certified service-disabled veteran-owned small business/veteran-owned small business (SDVOSB/VOSB) status; and/or their proposed use of certified SDVOSB/VOSB listed in the SBA certification database on the SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/ (see 13 CFR 128) as subcontractors or teaming partners.

(b) To receive credit under this clause a contractor or subcontractor must be listed, at time of submission of offer/quotes and at time of award, as certified SDVOSB/VOSB in the SBA certification database on the SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/ (see 13 CFR 128) and be otherwise eligible in accordance with SBA size Standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13 CFR 121, 125 and 128.).

(c) A certified SDVOSB listed in the SBA certification database schedule holder will receive full credit, and a certified VOSB listed in the SBA certification database schedule holder will receive partial credit for the SDVOSB/VOSB status evaluation factor.

(d) Offerors other than SDVOSBs or VOSBs proposing to use certified SDVOSBs/VOSBs listed in the SBA certification database as subcontractors/teaming partners, will receive some consideration under this evaluation factor. To receive consideration, offerors must provide in their proposals:

(1) The name(s) and contact information of the certified SDVOSB(s)/VOSB(s) listed in the SBA certification database with whom they intend to team or subcontract.

(2) A brief description of the proposed team or subcontractor(s) arrangement.

(3) The approximate dollar value of the proposed teaming arrangements or subcontract(s).

(4) Evidence of teaming partner/ subcontractor’s listing in the SBA certification database.

(e) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.4 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND BPAS (JAN 2023) (DEVIATION)

(a) The Contractor agrees, if selected on the basis of having certified service-disabled veteran-owned small business (SDVOSB) or veteran-owned small business (VOSB) status (see 13 CFR 128), to comply with the eligibility requirements in subpart 819.70, including the limitation on subcontracting requirements at 13 CFR 125.6.

(b) The Contractor agrees, if selected for award on the basis of teaming/subcontracting in accordance with 852.208–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors—Orders and BPAs, to use the evaluated firm(s) as proposed or if approved by contracting officer to substitute one or more certified SDVOSB/VOSB listed in the SBA certification database for work of the same or similar value.

(c) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

(a) The Contractor shall conform to the standards established by: Food and Drug Administration (FDA) Department of Transportation (DOT) as to manufacturing and delivery of radiopharmaceuticals.

(b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(c) Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title and number of the publication to: Food and Drug Administration (FDA)

(d) The offeror shall contact the Contracting Officer if response is not received within two weeks of the request.

(End of Clause)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Department of Veterans Affairs VA San Diego Healthcare System Main Hospital, 4 West, 4th Floor, 3350 La Jolla Village Drive San Diego CA 92161 (End of Clause)

C.8 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

(a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for:

Shall be provided upon award.

(End of Clause)

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

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SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

INTENTIONALLY LEFT BLANK.

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SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

(a) All actual and potential offerors are encouraged to provide feedback on the preaward and debriefing processes, as applicable. Feedback may be provided to agencies up to 45 days after award. The feedback is anonymous, unless the participant self-identifies in the survey. Actual and potential offerors can participate in the survey by selecting the following link: https:// www.acquisition.gov/360.

(b) The Contracting Officer will not review the information provided until after contract award and will not consider it in the award decision. The survey is voluntary and does not convey any protections, rights, or grounds for protest. It creates a way for actual and potential offerors to provide the Government constructive feedback about the preaward and debriefing processes, as applicable, used for a specific acquisition.

(End of Clause)

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) 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.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)