P03 36C260-25-AP-2676.pdf

Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 03 Effective Date: 04/15/24

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C260-25-AP-2676 JOFOC Number: FY25-NCO20-1204

1. Contracting Activity: Department of Veterans Affairs, VISN 20, Puget Sound VA

Medical Center. 663-25-3-022-2202.

2. Nature and/or Description of the Action Being Processed: This is a request for IMPAVIDO, for treatment needed for a Veteran with Disseminated Cutaneous Acanthamboeba. Period of Performance 05/01/2025 to 10/30/2025, through Profounda, Inc.

$299,700.00.

3. Statutory Authority Permitting Other than Full and Open Competition:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

4. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

IMPAVIDO is manufactured by Profounda Inc, which also has exclusive licensing rights for Impavido in the United States. Impavido (miltefosine) is is the first and only oral prescription treatment for Disseminated Cutaneous Acanthamboeba. There are no other treatement alternatives available.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: N/A as this action will be a sole source.

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

Reasonable: The anticipated cost will be considered fair and reasonable. The cost mirrors that of purchase order 36C26025P0535, already determined fair and reasonable (FAR Part 15.404-1(b)(2)(ii), comparison of proposed prices to historical prices paid by the Government, for the same items).

VHAPG Part 806.3 OFOC Page 2 of 3

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

Reasons Market Research Was Not Conducted: Database to identify certified capable SDVOSBs and VOSBs. 171 vendors identified, but none are capable of delivering this drug.

Verified vendor – Profounda, Inc. was registered in SAM, SBA, IFCAP & Pharmacy Sharpoint. Verified that medication is not on contract through VA NAC. IMPAVIDO is manufactured by Profounda Inc, which also has exclusive licensing rights for Impavido in the United States. Impavido (miltefosine) is is the first and only oral prescription treatment for Disseminated Cutaneous Acanthamboeba. There are no other treatment alternatives available.

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

9. 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: IMPAVIDO is manufactured by Profounda Inc, which also has exclusive licensing rights for Impavido in the United States. Impavido (miltefosine) is is the first and only oral prescription treatment for Disseminated Cutaneous Acanthamboeba. There are no other treatment alternatives available.

10. 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.

Steven Sanders Program Analyst Puget Sound Health Care System

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

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

Jose Ronstadt Contracting Officer

VHAPG Part 806.3 OFOC Page 3 of 3

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Jacob Jackson Chief, Ancillary Patient Care