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VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification ... VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021 VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021 VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID:__36C770-21-AP-0985______ Contracting Activity: Department of Veterans Affairs, RPO Central Contracting CMOP Station 765 NCO 15 CMOP 5th & Roosevelt, Bldg 6-37, NW Dock 18 34520 S. 4th Street Hines, IL. 69141-3030 Leavenworth, Ks. 66048 2237#-765-21-4-800-0274 Description of Action: This acquisition is conducted under the authority of the MultipleAward Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). NDC#/UPC Description Qty Unit of Measure Valbenazine 80MG Oral Cap, 30Count 75 Bottles Valbenazine 40MG Oral Cap, 30Count 75 Bottles Order against: FSS Contract Number: ___36C79718D0414__________ Name of Proposed Contractor: Neurocrine Biosciences, Inc. Street Address: 12780 El Camino Real City, State, Zip: San Diego, CA 92130 2042 Phone: 858.617.7568 Description of Supplies or Services: x The estimated value of the proposed action is $ 677,821.50 x The items above support Veterans Patient s prescriptions. x This order is to be delivered in 3 days ARO. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; x 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 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. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: x No competition exists for these drugs, and the NAC CO has determined the price to be fair and reasonable. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted x This item is packaged by Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc. has this item on a NAC contract (36F79718D0414). Because they are the only vendor to sell this item, the Rule-of-Two was not met, therefore, this will be a sole-source procurement. Any Other Facts Supporting the Justification: A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: x On going Market Research will be conducted to determine any available sources or Authorized Distributors 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) 422091 Carlos Araghi Digitally signed by Carlos Araghi 422091 Date: 2021.09.30 05:20:40 -05'00' _____ SIGNATURE DATE NAME TITLE SERVICE LINE/SECTION FACILITY (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Larry M. Zaritz Digitally signed by Larry M. Zaritz 184054 Date: 2021.09.30 07:09:09 184054 -05'00' _____ CONTRACTING OFFICER/DESIGNEE S SIGNATURE DATE Larry Zaritz, Contracting Officer NCO 15 Contracing__________________ NAME AND TITLE FACILITY/NCO/PCO One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. CHRISTY PENDLAY Digitally signed by CHRISTY PENDLAY Date: 2021.09.30 08:01:53 -05'00'_____ SIGNATURE DATE NAME: Christy Pendlay NCO 15 CMOP Branch Chief HIGHER LEVEL APPROVAL (Required for orders over $750,000): VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. _____ NAME DATE VHA Head of Contracting Activity (HCA) Senior Procurement Executive Approval (over $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. Angela Billups, Ph.D. DATE Deputy Assistant Secretary Office of Acquisition and Logistics Senior Procurement Executive (SPE)