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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 30, 2015 FBO #5089
DOCUMENT

65 -- 583-16-1-081-0014 Medication - Justification and Approval (J&A)

Notice Date

10/28/2015
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veteran Affairs;VISN 11 CSC Michigan (90VC);5500 Armstrong Rd.;Battle Creek MI 49037
 

ZIP Code

49037
 

Archive Date

11/26/2016
 

Point of Contact

brooke.hansen@va.gov
 

Small Business Set-Aside

N/A
 

Award Number

V797P2140D VA251-16-F-0048
 

Award Date

10/27/2016
 

Description

LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6 Acquisition Plan Action ID: VA251-16-AP-0075 This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: Baxalta US Inc Manufacturer/Contractor POC & phone number: Heather O'Brien 800-423-2090 Mfgr/Contractor Address: One Baxter Parkway Deerfield, IL 60015-4625 Dealer/Rep address/phone number: Heather O'Brien 800-423-2090 1 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY:Department of Veterans Affairs Indianapolis VAMC _________________ 1481 West Tenth Street ____________ Indianapolis, IN 46202 VISN:11 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: A Limited Source Justification (LSJ) for a Firm-Fixed Price Purchase Order on/against FSS Contract V797P-2140D to Baxalta US, Inc. (3)(a)A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: This acquisition is for 1200 vials of Glassia 1000mg/vial. Glassia (Alpha1-Proteinase Inhibitor -Human) is used as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin (AAT) deficiency (b)ESTIMATED DOLLAR VALUE: $276,000.00 (c)REQUIRED DELIVERY DATE: Date of award through the end of the fiscal year ending September 30, 2016. (4)IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) 1Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. Glassia, which is marketed in the U.S. through a strategic partnership by Baxter International Inc., is the first and only ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) approved by the FDA and is indicated as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin deficiency (AATD, or Inherited Emphysema). 1A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) The company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived proteins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company's flagship product is Glassia ®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. 0These are "direct replacements" parts/components for existing equipment. ____________________________________________________________________________ ____________________________________________________________________________ 0The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. 0The 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. 0An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Baxalta US, Inc is on a mandatory NAC schedule (Pharmaceuticals and Drugs, Category 42-2A) contract number V797P-2140D. Glassia (Alpha1-Proteinase Inhibitor -Human) is the first and only ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin (AAT) deficiency. There are no other treatments for adults with alpha-1 antitrypsin (AAT) deficiency without this medication these patients will go without treatment. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: Market Research was conducted via the internet, GSA Advantage!, and the National Acquisition Center (NAC). No other schedule holders were found that could provide the requirement. Glassia is only distributed by Baxalta US, Inc. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: None. (8) 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: The Pharmacy Service will continue to monitor the availability of this medication and watch for generics or additional drugs that can be used for this disorder. Competition will be sought when there are other offerors of this drug. (9) 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/a3c94aededc1d6a813f31003b6c62379)
 

Document(s)

Justification and Approval (J&A)
 

File Name: V797P2140D VA251-16-F-0048 V797P2140D VA251-16-F-0048_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2390897&FileName=V797P2140D-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2390897&FileName=V797P2140D-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03932635-W 20151030/151028234629-a3c94aededc1d6a813f31003b6c62379 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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