JA - FAR 13.5 - Sole Source Justification - SAT-7.5M - 36C257-26-AP-0209 - Redacted.pdf

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-26-AP-0209

JOFOC ID#: FY26 – NCO 17 - 45

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 5441 Babcock Rd., Ste. 302 San Antonio, TX 78240

2. Nature and/or Description of the Action Being Processed: This procurement is for Xofigo® in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501, Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

NCO-17 intends to place a new firm-fixed price indefinite-delivery/indefinite quantity contract, sole source with Cardinal Health 414, LLC, for procurement of the requested radiopharmaceutical item required by the South Texas Veterans Health Care System, Nuclear Medicine department. The contract will include a four (4) year ordering period. Delivery orders will be placed annually and on an as-needed basis for the anticipated estimated quantities.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Xofigo® (Radium Ra 223 Dichloride) is an FDA-approved treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

National Drug Code: 50419-0208-01

Estimated quantity: 10,000 (uCi)

Total estimated value: $REDACTED Delivery dates: 10/1/2025 – 9/30/2029

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Bayer Healthcare Pharmaceuticals obtained FDA approval for Xofigo® under new drug application number 203971. Xofigo® is a proprietary product of Bayer. Cardinal Health provided a terms and conditions form for the sales of Xofigo® to its customers in the United States. Xofigo® must be ordered through Cardinal Health’s Access Services program. Accordingly, Cardinal Health is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A special notice, notice of intent to sole source the procurement, was posted on SAM Contract Opportunities for this requirement under 36C25725Q0819 on 8/4/2025. The notice stated that all responsible sources may submit a proposal or quotation, which shall be considered by the agency.

The notice was archived in SAM on 8/26/2025 with no response to the notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The contracting officer has determined that the anticipated cost will be fair and reasonable.

Cardinal Health has proposed Bayer’s VA NAC contract Big 4 discount pricing on previous orders.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

A search of the mandatory sources for supply procurements, UNICOR and Ability One, identified that they do not offer radiopharmaceuticals. A search of GSA Advantage revealed that Xofigo® is not offered. A search of the VA NAC pharmaceutical catalog identified that Bayer Healthcare offers Xofigo® on 36F79720D0237. Bayer’s VA NAC contract expires on 3/31/2026. A search using the SBA’s Dynamic Small Business Search tool did not find a small business vendor that offers Xofigo®.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

Market research will be conducted prior to subsequent acquisitions to identify if there have been any changes to the marketplace.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

//SIGNED// 9/10/2025

REDACTED Date:

Supervisor, Nuclear Medicine South Texas Veterans Health Care System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

b. One Level Above the Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Branch Chief, Patient Administrative Support Network Contracting Office 17

Director of Contracting: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

//SIGNED// 9/16/2025

Director of Contracting Network Contracting Office 17

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

//SIGNED// 9/20/2025

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx