36F79718D0414 36C77021N0218_1.docx

SUBJECT*

VALBENAZINE

GENERAL INFORMATION

SOLICITATION NUMBER*

BASE NOTICE TYPE

NCO 15 Contracting Ofc - CMOP 3450 S. 4th St. Trafficway

Leavenworth KS 66048-5012

POINT OF CONTACT*

Contract Specialist Keon Muldrow Keon.Muldrow@va.gov 913.946.1996

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

LIMITEDSOURCESJUSTIFICATION

ORDER >SATFARPART8.405-6

AcquisitionPlanActionID:36C770-21-AP-0946

(1) ContractingActivity:DepartmentofVeteransAffairs,NCO15Contracting,HinesCMOP2237#765-21-4-800-0266

(2) DescriptionofAction:Thisisanindividualbrand-namejustificationtosupporttheprocurementofthefollowingitems:

Item #

CAP

TheHines,ILCMOPfacilityrequirestheaboveitemstobeprocuredwiththesupportoftheinstant justification and approval for other than full and open competition. The proposedprocurementactionwillbeafirmfixed-pricecontractawardforthesupplies.

3)DescriptionofSuppliesorServices:

The estimated value of the proposed action is $677,821.50The items above support Veterans Patient’s prescriptions.Thisorderistobedeliveredin3daysARO.

(4) Identify the Authority and Supporting Rationale(see below and if applicable, ademonstrationoftheproposedcontractor’s uniquequalificationstoprovidetherequiredsupplyorservice.

VHAPM

Part 808.405-6 Limiting Sources Attachment 2:

Request for Limited Sources Justification Format

>SAT

VHAPM

Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision Eff Date:

03/18/2021 Page of

FAR8.405-6(a)(1)(A):Anurgentandcompellingneedexistsandfollowingtheorderingprocedureswouldresult inunacceptabledelays:

FAR 8.405-6(a)(1)(B):Only one source is capable of providing the supplies or servicesrequired at the level of quality required because the supplies or services are unique or highlyspecialized; Products have been prescribed for patients by VA Physicians. Pharmacy employeesdo 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 NationalDrug 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 “brandspecific” products in the VA PRINT NAME. This is not always inclusive where a particular NDChas been determined to be “formulation specific” by clinical evaluation performed by the PBMor in the case where only one product in the marketplace has been identified to contain thespecificingredientstomatchtheproductcode.

FAR8.405-6(a)(1)(C):Intheinterestofeconomyandefficiency,thenewworkisalogical follow-on to an original Federal Supply Schedule order provided that the original orderwasplacedinaccordancewiththeapplicableFederalSupplyScheduleorderingprocedures.Theoriginal order must not have been previously issued under sole source or limited sourceprocedures.

FAR8.405-6(b):Itemspeculiartoonemanufacturer:

Apatent,copyrightorproprietarydatalimitscompetition.Theproprietarydata is:

Theseare“directreplacements”parts/componentsforexistingequipment.

Thematerial/servicemustbecompatible inallaspects(form,fitandfunction)withexistingsystemspresentlyinstalled/performing.

(5) Describe Why You Believe the Order Represents the Best Value Consistent with FAR8.404(d) to aid the contracting officer in making this best value determination:No competitionexistsforthesedrugs,andtheNACCOhasdeterminedthepricetobefairandreasonable.

(6) Describe the Market Research ConductedThis item is packaged by Neurocrine Biosciences,Inc. Neurocrine Biosciences, Inc. has this item on a NAC contract (36F79718D0414). Becausethey are the only vendor to sell this item, the Rule-of-Two was not met, therefore, this will be asole-sourceprocurement.

(7) AnyOtherFactsSupportingtheJustification:N/A

(8) A Statement of the Actions,if any, the agency may take to remove or overcome anybarriersthatledtotherestrictedconsiderationbeforeanysubsequentacquisitionforthesuppliesorservicesismade:N/A

(9) Requirements Certification:I certify that the requirement outlined in this justification is aBona Fide Need of the Department of Veterans Affairs and that the supporting data under mycognizance, which are included in the justification, are accurate and complete to the best of myknowledge.I understand that processing of this limited sources justification restrictsconsideration of Federal Supply Schedule contractors to fewer than the number required byFARSubpart8.4.(Thissignatureistherequestor’ssupervisor,fundcontrolpointofficial,chiefofserviceorsomeonewithresponsibilityandaccountability.)

Carlos Araghi Digitally signed by 422091 Carlos Araghi 422091 Date:

2021.09.08 06:32:54 -05'00' CarlosAraghi Date InventoryManagementSpecialistHinesCMOP

(10) ApprovalsinaccordancewiththeVHAPMPart806.3OFOCSOP:

a. ContractingOfficer’sCertification(required):Icertifythattheforegoingjustificationisaccurateandcomplete tothebestofmyknowledgeandbelief.

Larry M.

Digitally signed by Larry M. Zaritz 184054 Zaritz 184054 Date:

2021.09.09 14:47:57 -05'00' LarryZaritz Date ContractingOfficer

b. OneLevelAbovetheContractingOfficer(RequiredovertheSATbutnotexceeding$750K):

Icertifythejustificationmeetsrequirementsforotherthanfullandopencompetition.

CHRISTY

PENDLAY

Digitally signed by

CHRISTY

PENDLAY

Date:

2021.09.09 16:04:19 -05'00' ChristyPendlay Date SupervisoryContractOfficer image1.png