P03_SingleSourceJustification_MPT-SAT.09.01.20 Signed.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:___36C262-20-AP-5002____

1. Contracting Activity: Department of Veterans Affairs, VISN 22, Long Beach 600 Medical Center VA

Long Beach 600. PR 605-21-1-059-0001.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Ga 68 Dotatate injection is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in patients. Ga 68 Dotatate Injection is a radioactive diagnostic agent for intravenous administration. Ga 68 Dotatate Injection is a sterile, pyrogen free, clear, colorless, buffered solution, with a pH between 4 to 8. Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable Zinc (Zn 6). The somatostatin is a naturally occurring hormone that acts by binding to Somatostatin Receptor (SSTR), a receptor that is overexpressed on most Neuroendocrine Tumors (NET) CI is Conventional Imaging. NET is Neuroendocrine Tumor. Ga 68 Dotatate distributes to all Somatostatin Receptor 2 (sstr2)-expressing organs such as pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands.

Imaging Service/Nuclear Medicine at VALLHCS will use this radioactive probe for diagnosing and staging to find Neuroendocrine tumors (NET) throughout the body. This radioactive nuclide attached to tumor cells that express somatostatin receptors including malignant cells, which overexpress Somatostatin Receptor 2 (sstr2) receptors.

Estimated amount for FY2021: $133,000.00 for 38 doses.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Pursuant FAR 13.I06-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

On June 16, 2020, the U.S. Food and Drug Administration approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs). FDA noted that Netspot is manufactured by one company/source. https://www.fda.gov/news-events/press-announcements/fda-approves-new-diagnostic-imaging-agent-detect-rare-neuroendocrine-tumors https://www.acquisition.gov/?q=/browse/far/13 https://www.fda.gov/news-events/press-announcements/fda-approves-new-diagnostic-imaging-agent-detect-rare-neuroendocrine-tumors https://www.fda.gov/news-events/press-announcements/fda-approves-new-diagnostic-imaging-agent-detect-rare-neuroendocrine-tumors https://www.fda.gov/news-events/press-announcements/fda-approves-new-diagnostic-imaging-agent-detect-rare-neuroendocrine-tumors

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

Additionally, Advanced Accelerator Applications USA, Inc., is a Large Business provided an Exclusive Licensing Letter on September 1, 2020 which explains this vendor is the Original Equipment Manufacturer (OEM) and only distributor for the Gallium Ga 68 Dotatate.

Based on this research, the unique characteristics of this radioactive diagnostic agent to only one source for positron emission tomography (PET) imaging limits availability. Dotatate is the only PET agent available to LLVAHCS and no other supply or service is available to be used.

4. Description of market research conducted and results or statement why it was not conducted:

The end user conducted market research by using the internet for the market research of the gallium Ga 68 dotatate. Found one source/company manufacturing Dotatate as noted by FDA.

Found one source/company manufacturing Dotatate per market research. Unable to find other sources approved by FDA to make Dotatate per research on Internet. A market research quote was received from FDA approved manufacturer of Dotatate.

Furthermore, the Contract Specialist conducted Market Research as follows:

a. FPDS under previous contract 36C26220P0006 in the amount of $133,000.00.

b. GSA Advantage which did not show any schedules for these products.

c. Mandatory contracts under the National Strategic Source Listing (SAC) which did not show any mandatory contracts for these products.

d. The National Acquisition Center (NAC) which also did not show any contracts for these products.

e. Ability One website which does not offer these products.

f. Unicor which also does not offer these products

g. A request for Information was posted in BetaSam on 08/24/2020 and it closed on 08/27/2020. 1 response was received from a Large Business, Advanced Accelerator Applications USA, Inc., which is the Original Equipment Manufacturer (OEM) and sole distributor for these products.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466