S02_JnA_Q0341.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-21-AP-0492

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, CMOP Leavenworth, KS.

2237 # 760-21-2-050-0997

2. Nature and/or Description of the Action Being Processed: This procurement is for thyroid pharmaceuticals 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. The proposed procurement action will be a new firm-fixed-price contract.

3. Description of Supplies/Services : This is an individual brand name justification to support the procurement of the pharmaceuticals listed below in the following table. Items are to be delivered 10 days after receipt of order.

Item Number

File Number

Description NDC Quantity Unit of Measure

Packaging Multiple

0001 6201 THYROID 120MG TAB

100CT (T0048)

00456- 0461-01

144 BT 100

0002 6202 THYROID 180MG TAB

100CT (T0050)

00456- 0462-01

96 BT 100

0003 6203 THYROID 90MG TAB

100CT (T0053)

00456- 0460-01

576 BT 100

0004 6204 THYROID 60-65MG (1

GRAIN) TAB 100CT

(T0749)

00456- 0459-01

1152 BT 100

0005 6205 THYROID 15MG (1/4

GRAIN) TAB 100CT

(T0750)

00456- 0457-01

864 BT 100

0006 6206 THYROID 30-32.5MG

(1/2 GRAIN) TAB

100CT (T0751

00456- 0458-01

864 BT 100

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

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 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 C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to

. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug in evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement was posted to Beta.SAM.gov and the FRQ will be posted as Other than Full and Open. Only qualified vendors will be able to submit quotes due to Name Brand only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based off competition or the IGCE.

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

Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties; however, non-manufacturer requirements apply and the VIP database search concluded there are no known SDVOSB or VOSB manufacturers of the above referenced pharmaceutical items for NAICS code 325412 not be met and a SDVOSB set-aside is not feasible.

Furthermore, in accordance with FAR Part 25, the Buy American Act (BAA), applies to the price factors of this solicitation.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be an

Other than Full and Open RFQ due to Brand Name only requirements.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified business vendors tend to vary from procurement to procurement.

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

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: No action is being taken at this time due to the fact that no NDC substitutions are permitted based on

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.

Julie Wise Date Inventory Management Specialist Leavenworth CMOP

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

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

Prepared by:

Kelley Cunningham Date Contract Specialist National CMOP Contracting Office (NCO 15)

Approved by:

Lori Nichols Fellows Date Contracting Officer

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

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.

Ralph Crum Date Branch Chief, CMOP 2