FAR-Part13-5-JA_ACC Brand Name DSUVIA_SAC APPR_POST-SAC1 REDACTED_Redacted.pdf

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – BRAND NAME JUSTIFICATION AND APPROVAL

Program/Equipment: U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO), requires the procurement of U.S. Food and Drug Administration (FDA) Sufentanil NanoTab brand name

DSUVIA.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $

Prepared by:

Maribel C. Fratina.

Telephone:

Contract Specialist Date:

Email: maribel.c.fratina.civ@mail.mil

Contracting Officer: Contracting Officer Telephone:

Date:

Email:

Technical: Program Manager Telephone:

Date:

Email:

Requirements: Program Manager Telephone:

Date:

Email:

Reviews: I have reviewed this justification and find it adequate to support brand name

Program Manager:

Typed Name:

DSN:

Signature:

mailto:maribel.c.fratina.civ@mail.mil

Control No.:

Equipment: U.S. Food and Drug Administration (FDA) Sufentanil NanoTab brand name

DSUVIA

Signature: Legal Counsel:

Typed Name:

Telephone:

Signature:

Control No.:

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Brand Name Justification and Approval

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702.

2. Description of Action: The U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO), requires U.S.

Food and Drug Administration (FDA) Sufentanil NanoTab brand name DSUVIA. The Government projects award for September 2020 and fiscal year funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: The U.S. Army Medical Materiel Development Activity (USAMMDA) WPAC PMO has an immediate requirement for one (1) lot of 3,200 boxes (30,000 tablets), with three (3) optional Contract Line Item Numbers (CLINs) to procure up to 3,000 boxes per CLIN of U.S. Food and Drug Administration (FDA) Sufentanil NanoTab brand name DSUVIA that is indicated for use in adults in a certified medically supervised healthcare setting, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Brand name DSUVIA is required for the success of USAMMDA WPAC PMO clinical trial; specifically, this trial mandates brand name DSUVIA, National Stock Number (NSN) 6505-01-678-1097 be compared to Oral Transmucosal Fentanyl Citrate (OTFC). DSUVIA is currently included in various Army medical Sets Kits and Outfits (SKO) assemblages. Before DSUVIA is added to the Tactical Combat Casualty Care (TCCC) clinical practice guideline, the committee must investigate comparative data between DSUVIA and OTFC. The success of clinical trial mandates the use of brand name DSUVIA.

Base Period: 14 September 2020 to 13 September 2021 Value: $ Option Period 1: 14 September 2021 to 13 September 2022 Value: $ Option Period 2: 14 September 2022 to 13 September 2023 Value: $ Option Period 3: 14 September 2023 to 13 September 2024 Value: $

Total: $

Control No.: ( )

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency

Exclusive licensing agreements

Industrial mobilization

Other: FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name). AcelRx Pharmaceuticals, Inc., and DMS Pharmaceutical Group, Inc., can provide brand name DSUVIA.

5. Reason for Authority Cited:

The USAMMDA WPAC PMO requires DSUVIA in order to conduct a comparative clinical trial to aid clinical practice guideline development. The goal of the clinical trial is gain information regarding acceptability of DSUVIA compared to that of Oral Transmucosal Fentanyl Citrate (OTFC) in an Emergency Room setting in patients with moderate to severe pain requiring an opioid. The clinical trial must be conducted with brand name DSUVIA. AcelRx Pharmaceuticals, Inc.,(DUNS: 789244774; CAGE Code: 5ZVQ4) designated as a small business, and DMS Pharmaceutical Group, Inc., (DUNS: 883533879; CAGE Code: 1UNB0) designated as a small business, as well as several other Contractors have been identified by the Contract Specialist (CS) as potential sources capable of providing the required brand name DSUVIA. There are no authorized generic versions of DSUVIA, so the brand-name product must be purchased from authorized sellers. The clinical study specifically mandates DSUVIA to be compared with OTFC.

Before DSUVIA is added to the Tactical Combat Casualty Care clinical practice guideline, the committee wants to see comparative data between DSUVIA and OTFC. There is no point in conducting the study without DSUVIA. Only the brand name DSUVIA is required for USAMMDA’s comparative clinical trial. No brand other than FDA approved DSUVIA will meet USAMMDA’s requirement. NO quantities above what is needed for clinical studies will be purchased under this proposed contract.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201.

A Notice of Intent (NOI) to Sole Source W81XWH-20-R-0091 to BETA.SAM.gov on 16 July 2020 for 15 days; however, after ascertaining from AcelRx Pharmaceuticals, Inc., that AcelRx Pharmaceuticals, Inc., was not the sole source of brand name DSUVIA, the Contract Specialist cancelled the NOI. AcelRx Pharmaceuticals, Inc., is the manufacturer and reseller of brand name DSUVIA and has several resellers for brand name DSUVIA. Therefore, the Contract Specialist changed acquisition strategy to brand name DSUVIA and 100% set aside for small business.

7. Actions to Increase Competition: USAMMDA and USAMRAA conduct online research as part of their periodic market research efforts to locate other available sources that are capable of meeting this requirement in the future. All future requirements will be competed and 100% set aside to small business.

8. Market Research: USAMMDA conducts market research of brand name DSUVIA on an on-going basis and identifies manufacturers capable of providing brand name DSUVIA for research and clinical trial of severe pain requiring an opioid. The Contract Specialist conducted market research on 14, 15, 16, and 17 July 2020 by internet and telephonic searches for brand name DSUVIA providers. The search identified AcelRx Pharmaceuticals, Inc., and DMS Pharmaceutical Group, Inc. These businesses are capable of meeting the Government’s need.

9. Interested Sources: AcelRx Pharmaceuticals, Inc., DMS Pharmaceutical Group, Inc., Cardinal Health, McKesson Corporation, and AmeriSourceBergen. In addition to those sources that have expressed an interest in the acquisition, the proposed contract action will be made available on Beta.SAM.gov in accordance with Federal Acquisition Regulation (FAR) 5.201 in order to improve small business access to acquisition information and enhance competition.

10. Other Facts: Thorough market research was conducted to include a review of USAMRAA’s contracting writing system, Procurement Desktop-Defense (PD2), the USAMRAA Paperless Acquisition System (UPAS), and the Virtual Contracting Enterprise Paperless Contract File (VCE-PCF). The search results identified no previous Purchase Orders issued for brand name

a. Procurement History: Not Applicable.

11. Technical Certification: I certify 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.

Typed Name: Date:

Title: Program Manager Signature:

12. Requirements Certification: I certify 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.

Title: Program Manager Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis IGCE audit: other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of the U.S. Food and Drug Administration (FDA) Sufentanil NanoTab brand name DSUVIA pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Date:

Special Advocate for Competition Signature: