P03 - POST JA TO SAM - 36C77023P0275.pdf

36C77023Q0365 - Pentetate Calcium & Zinc

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 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS

IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-23-AP-0716

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, Hines CMOP, Emergency Pharmacy Service (EPS), 2237: 765-23-3-715-0086

2. Nature and/or Description of the Action Being Processed:

This procurement is for Pentetate Calcium Trisodium and Pentetate Zinc Trisodium 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.

This is a one time firm fixed priced purchase with an estimated value of $6,705,468 for the All Hazard Emergency Caches (AHEC). This medication will be stored at all 144 the AHEC locations across the United States as directed by VHA directive 1047, to provide 30 days of emergency stock. Trisodium and Pentetate Zinc Trisodium is FDA approved for use in patient experiencing radiation injury due to exposure to Plutonium, Americum or Curium. The AHEC is overseen by the Emergency Pharmacy Service (EPS) located in Hines, IL. Product is to be shipped to Hines, IL. EPS to ensure that product is received and distributed to all 144 AHEC locations.

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

#1) NDC: 70651-001-03 - Pentetate Calcium Trisodium Pack size: 10 vials per pack Criteria: 1 lot & Exp date: May 2026.

QTY: 5,841/PG; $574.00/PG

#2) NDC: 70651-002-03 2- Pentetate Zinc Trisodium Pack size: 10 vials per pack Criteria: 1 lot & Exp date: May 2026.

QTY: 5,841/PG; $574.00/PG

This is an individual sole source justification to support the procurement of the pharmaceuticals listed above. The estimated value of the procurement is $6,705,468.00. The items are to be delivered by 09/15/2023.

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:

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(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):

Only One Responsible Source –

Hameln Pharma is the sole manufacturer of both Pentetate Calcium Trisodium and Pentetate Zinc Trisodium. According to the FDA Orange Book, there is no other pharmaceutically equivalent product available within the United States. The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. Hameln Pharma has authorized Golden States Medical System (GSMS) to be the sole distributer of this product to the United States.

This medication is required to be stocked in the AHEC as outlined by VHA directive 1047. This medication is intended to treat patients with radiation injury. EPS is requesting streamlined acquisition of this package to prevent any gaps in care in the event of a disaster. No other medication can fit the specific requirement of Pentetate Calcium Trisodium and Pentetate Zinc Trisodium.

Additionally, products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. Since there are no equivalents available for this order, we must sole source so the Veteran can receive their prescribed medication.

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

EPS has reached out to the Strategic National Stockpile (SNS), another federal agency, to locate other sources available for these medications. No other sources other than Hameln Pharma has been identified. Per the FDA Orange Book, FDA has not identified any other pharmaceutically equivalent product within the United States. EPS has reached out to Hameln Pharma and they stated that GSMS is the sole distributor of these medications to the United States.

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 and/or the IGCE and previous procurements.

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 and VAAR 810 market

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5 research was conducted. The procurement package was received on 06/15/202. Market research was conducted and EPS reached out to other federal agencies to locate other sources available for these medications. No other sources other than Hameln Pharma has been identified.

The FDA has not identified any other pharmaceutically equivalent product within the United

States. EPS has reached out to Hameln Pharma and they stated that GSMS is the sole distributor of these medication to the United States.

A sources sought notice was not posted for this acquisition based on the information stated in the above paragraph.

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 Market place. The national drug code(s) (NDC) 70651- 001-03, and 70651-002-03 was used to query the website and resulted in only one manufacturer who currently manufacture both the Pentetate Calcium Trisodium, and Pentetate Zinc Trisodium. The manufacturer Hameln Pharma manufactures its product non-domestically in Germany.

A search was conducted via U.S. Food and Drug Administration (FDA) National Drug Code Directory website (National Drug Code Directory (fda.gov)) using national drug code(s) (NDC) 70651-001-03, and 70651-002-03, which yielded only one manufacturer who manufactures Pentetate Calcium Trisodium, and Pentetate Zinc Trisodium. The manufacturer(s) Hameln Pharma manufacturers its product non-domestically in Germany.

The Contracting Officer conducted searches in VETCERT to determine if there are service-disabled, veteran-owned business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers of Pentetate Calcium Trisodium, and Pentetate Zinc Trisodium utilizing NAICs code 325412 and yielded a total of zero SDVOSB/VOSBs who identified as a manufacturer. Further searches in VETCERT confirmed that there are no SDVOSB/VOSBs who identify as authorized distributors of Pentetate Calcium Trisodium, or Pentetate Zinc Trisodium.

Market research was conducted via Dynamic Small Business search which resulted in zero small businesses who identified as authorized distributors.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: GSMS is the only manufacturer of these items; therefore this will be a sole source procurement. They are a Small Business. Due to the procurement being a sole source, the Buy American Act applies.

The items are manufactured in Germany, so a Non-availability determination will be completed prior to award.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Golden States Medical System (GSMS)

Anita Wrublevski SVP, Customer Service Excellence https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm

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Email: AWrublevski@gsms.us T: 805-477-9866 x201

11. 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: N/A

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.

6/20/2023

Name Date Title: Facility Program Manager Facility: Emergency Pharmacy Service-CMOP- GL

Digitally signed by KELLY MANN Date: 2023.06.20 15:56:56 -05'00'

Kelly L. Mann Contract Specialist Network Contracting Office 15 - CMOP TEAM 1

Date

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.

Larry Zaritz Contracting Officer

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.

KELLY MANN

mailto:AWrublevski@gsms.us

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Christy Pendlay Branch Chief

Benjamin DuFour Date Division Chief Network Contracting Office 15

CMOP TEAM

Andrew J. Raiber Director of Contracting Network Contracting Office 15

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.

Gerald F. Jacobs Acting Executive Director Regional Procurement Office-Central (VHA)