S02_JnA_Q0203.pdf

Pharmaceutical Item 36C77024Q0203 VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0399

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237 # 760-24-2-050-0617, Leavenworth CMOP, Leavenworth, KS.

2. Nature and/or Description of the Action Being Processed: This procurement is for multiple pharmaceuticals; however, line item 7, Armour thyroid tablets, is the only brand name item requested. This brand name pharmaceutical is 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.

3. Description of Supplies/Services Required to Meet the Agency�s Needs: This individual brand name justification is to support the procurement of the Armour thyroid tablet listed below in the following table. The proposed procurement action will be a firm-fixed price contract award for the pharmaceuticals. Line item 7, Armour thyroid tablets, is the only product in this requirement that has a brand name requirement. Items are to be delivered 10 days after receipt of order.

Item Number

File Number

(IMF)

Description NDC Quantity Unit of Measure

Packaging Multiple

0007 6206 THYROID 30-32.5MG (1/2

GRAIN) TAB 100CT (T0751)

00456-0458-01 1008 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 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

Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22 Page 2 of 5

5. Demonstration that the Contractor�s 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 countermand physician orders. �Brand Specific� products are the same thing as �dispense as written� on a physician�s prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify �brand specific� products in the �VA PRINT NAME.� This is not always inclusive where a particular NDC has been determined to be �formulation specific� by clinical 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 SAM.gov. Only qualified vendors that have a state distributor license to comply with the Drug Supply Chain Security Act (DSCSA) regulations will be considered compliant with the requirements of this procurement.

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 on 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: In accordance with FAR Part 10, VAAR 810, market research has been conducted for this acquisition. The procurement packet was received on February 20, 2024. Market research was conducted beginning on March 7, 2024, for the upcoming acquisition.

A sources sought notice was not posted for this acquisition because pharmaceutical buys are routine, and the Contracting Officer is very knowledgeable about the marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA�s requirement.

Last Updated: 02/01/22 Page 3 of 5

Market research confirmed that these pharmaceuticals are not available from the Prime Vendor nor NAC. The are also unavailable at a fair and reasonable price from other contract vehicles or supply chains, such as but not limited to FSS; therefore, an open market procurement is the only option that remains for purchasing these products.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325412, Pharmaceutical Preparation Manufacturing, and yielded a total of 135 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 22 small businesses who identified as authorized distributors. These vendors are not manufacturers, but they are distributors for large business wholesalers.

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns) in the marketplace.

The national drug code (NDC) 00456-0458-01 was used to query the DailyMed website and resulted in Abbvie Inc., as the manufacturer.

Item Number

Description NDC Manufacturer Country of Origin

0001 THYROID 30-32.5MG (1/2 GRAIN)

TAB 100CT (T0751)

00456-0458-

Abbvie Inc. (Large Business)

USA

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the Non- Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small businesses have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no small business manufacturers that exist in the commercial marketplace. The CO has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code 325412. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. A small business set-aside is not feasible as a small business would not be able to comply with the NMR since there are presently no small business manufacturers.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Only line item 7 of this 11 line item requirement is requested as a brand name item; all other line items may have alternate National Drug Codes (NDC) submitted in the vendor�s quote submission.

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

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 for line item 7, Armour thyroid tablets, based on physician�s specific orders.

Last Updated: 02/01/22 Page 4 of 5

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.

Tristan Ferguson Date Inventory Management Specialist Leavenworth CMOP

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.

Prepared by:

Kelley Cunningham Date Contract Specialist Network Contracting Office 15 � CMOP Division

Approved by:

Michael McAlhaney Date Contracting Officer

Last Updated: 02/01/22 Page 5 of 5

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

J. Braden Smith Branch Chief Date