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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 08, 2017 FBO #5676
DOCUMENT

Q -- Metformin 500 MG XR Tablets extended release for the Albuquerque New Mexico VA. - Attachment

Notice Date

6/6/2017
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

VA24017Q0156
 

Response Due

6/12/2017
 

Archive Date

6/14/2017
 

Point of Contact

Linda Buccigrossi, Contracting Officer
 

Small Business Set-Aside

N/A
 

Description

SOURCES SOUGHT (Metformin) The Albuquerque VA Medical Center at The VA Cooperative Studies Program (CSP) Clinical Manufacturing Section (CMS) has a requirement to purchase the estimated quantity of 19,045,800 Metformin 500 mg XR tablets to support VA CSP Clinical Study CSP2002, Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT). This notice is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Monday, June 12, 2017, 12:00 Noon, EST. Interest/capability statements may be sent to Linda Buccigrossi at linda.buccigrossi@va.gov and should include company name, address, point of contact, socio-economic status and business size, and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement. ***Email responses should include in the subject line Metformin 500 mg XR Deliver to: VA Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue SE Albuquerque, NM 87106 U.S.A. Period of Peformance: Period of Performance 8/1/ 2017 to 7/31/2018 8/1/ 2018 to 7/31/2019 8/1/ 2019 to 7/31/2020 8/1/ 2020 to 7/31/2021 8/1/ 2021 to 7/31/2022 Type of Contract: Firm Fixed Price, Indefinite Delivery/Indefinite quantity See following for Statement of Work (SOW)/description of requirement Statement of Work (SOW) CONTRACT TITLE CSP2002, Metformin BACKGROUND The Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) is planning a clinical trial (CSP #2002) Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT). SCOPE The study will last a minimum of 102- months and is composed of two phases: A 12-month pilot recruitment phase which has a target sample size of estimated 1,200 participants and a full scale recruitment phase with a target sample size of estimated 6,668 participants. Enrollment will take place over 6.5 years or until estimated 1,360 primary end point events occur. This requirement is for the provision of the estimated quantity of 19,045,800 Metformin 500 mg XR tablets. Metformin 500 mg XR tablets must be extended release tablets. The tablets will need to be shipped to the CSPCRPCC in bulk and the CSPCRPCC will package these bulk tablets in bottles based on the prescription written by the study Local Site Investigator. The Vendor will perform stability testing and release testing as specified in the tasks. Stability testing data must be provided to the CSPCRPCC within 5 business days of their release. For stability testing background, CSPCRPCC s distribution plan is as follows: Required Shelf-Life is a minimum of 22- months to meet the distribution plan described in Section 3 above Shipments to CSPCRPCC will be consistent with the recommended storage conditions The CSPCRPCC will mail study drug via two-day shipping to participants home address on file using vendor recommended storage/shipment conditions. SCHEDULE OF SERVICES AND/OR SUPPLIES NOTE: Unit of Issue (UI) is Tablet. This may be multiple bottles. Below are the estimated quantities and period of performance. The VA is contemplating a base period, plus 4 option period (for a total of 5 years). Base Year 12-Month Pilot 8/01/2017 7/31/2018 Line Item Description Estimated Qty UI 0001 Metformin Hydrochloride 500 mg XR Tablets Active 652,500 Tablet Option Year One (1) 8/01/2018 7/31/2019 Line Item Description Estimated Qty UI 1001 Metformin Hydrochloride 500 mg XR Tablets Active 2,257,900 Tablet Option Year Two (2) 8/01/2019 7/31/2020 Line Item Description Estimated Qty UI 2001 Metformin Hydrochloride 500 mg XR Tablets Active 4,648,000 Tablet Option Year Three (3) 8/01/2020 7/31/2021 Line Item Description Estimated Qty UI 3001 Metformin Hydrochloride 500 mg XR Tablets Active 5,743,700 Tablet Option Year Four (4) 8/01/2021 7/31/2022 Line Item Description Estimated Qty UI 4001 Metformin Hydrochloride 500 mg XR Tablets Active 5,743,700 Tablet ***ALL QUANTITIES ARE ESIMATES. DELIVERY SCHEDULE BEGINNING IN OPTION YEAR 2 MAY BE MULTIPLE DELIVERY DATES. CORWILL ESTABLISH DELIVERY SCHEDULE WITH THE VENDOR.*** SPECIFIC TASKS The successful performance of this Statement of Work requires the Vendor to be in compliance with current Good Manufacturing Practices (cGMP) as detailed in 21 CFR, Chapter 1, Subchapter C, Parts 210-211. Vendor is to supply the CSPCRPCC with active Metformin 500 mg XR tablets that are FDA-approved with a therapeutic equivalence evaluation. Therapeutic equivalency requires that the active Metformin XR tablets be classified as a pharmaceutical equivalent expected to have the same clinical effect and safety profile when administered to study participants under the conditions specified in the official prescribing information. Production estimate is 19,045,800 tablets (across the life of the awarded contract) of Metformin 500 mg XR. The quantities required by year are listed above in the Schedule of Services/or Supplies Active Metformin tablets will contain identical amounts (500 mg) of the same active pharmaceutical ingredient in the same dosage form (extended release formulation) as the reference listed drug (21 CFR 314.94(a)(3)). Active Metformin tablets will meet compendial or other applicable standards of strength, quality, purity, and identity. Active Metformin tablets will be bioequivalent to the reference listed drug and meet all acceptable in-vitro standards. Tablets also must meet all necessary bioequivalence requirements and have a therapeutic equivalence code of at least AB. Supplier must have and must provide the CSPCRPCC with tracer documentation proving the pedigree of Metformin 500 mg XR active pharmaceutical ingredient and Trade Agreement Act (TAA) compliance. Vendor will ship active drug in appropriately sealed bulk containers. Vendor must perform release testing and stability testing and provide data (Certificates of Analysis and Stability Reports) to CSPCRPCC by lot number no later than 5 business days prior to shipping. Certificates of Analysis and Stability Reports may be provided to the CSPCRPCCC by fax or e-mail. CSPCRPCC will provide contact information. Stability testing must include testing at vendor recommended storage conditions for time points to specified durations or expiration of product. Certificates of Analysis: Vendor will provide industry standard Certificates of Analysis for each lot of product contained in a shipment regardless of whether or not portions of the lot have previously been sent. Shipments to CSPCRPCC will occur according to the Schedule of Services. This schedule may change based on actual expiration of product during the life of the study. Vendor is responsible for shipping costs of Metformin 500 mg XR to the CSPCRPCC. The CSPCRPCC will perform acceptance inspections of shipments, ensure Certificates of Analysis and Packing Lists are included and complete, containers are properly labeled, and containers are properly sealed. Failure of a Lot, Shipment, or Container to meet contract requirements may result in a rejection of the Lot, Shipment, or Container. Vendor will label bulk packages consistent with all applicable Code of Federal Regulations (CFR) rules. Labeling will clearly identify the content of each sealed container. Each shipment must be accompanied with a packing list that describes the product and quantity shipped, lot number and expiration date that clearly identifies the product shipped. MISSING DOCUMENT/INFORMATION CAN RESULT IN REJECTION OF A SHIPMENT. Remediation for damaged/unacceptable lots, shipments: Vendor will replace any identified unacceptable lots, shipments and/or bottles at vendor expense. Examples (but not limited to these) include broken tablets, incorrect/improper labeling, damaged containers, and/or missing documentation. Vendor will provide the CSPCRPCC with up-to-date, FDA-approved, official prescribing information. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS Packaging, Packing and Shipping Instructions.  Product delivery will take place according to the delivery schedule for a 60-month duration.  This schedule may change based on actual expiration of product during the life of the study.  Shipments will be made using vendor recommended storage/shipment procedures. Inspection and Acceptance Criteria. Delivered product must contain the specified lot number and stability testing information.  Product must arrive at CSPCRPCC in qualified, sealed containers. RISK CONTROL Metformin 500mg XR formulation, manufacturing, etc. must be performed under current Good Manufacturing Practices (cGMP) in a TAA-compliant country to ensure the product is safe for study participants use.  The vendor must provide documentation demonstrating use of cGMP in the production of the product. Due to the nature of the product, it is also critical shipping processes protect the product from damage. The CSPCRPCC reserves the right to visit the production facility to ensure cGMP policies/procedures are followed for the production of Metformin XR 500 mg tablets. PLACE OF PERFORMANCE Metformin 500 mg XR product will be produced by the vendor and then shipped to the CSPCRPCC as established in the contract.  CSPCRPCC shipping address is: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Attention  : Donna W. Cain, BA CSP 2002 2401 Centre Avenue, SE Albuquerque, NM  87106 ESTIMATE OF DELIVERY SCHEDULE Product delivery is expected to occur over a period of 60 months and according to the below schedule. Study duration and study sample size may need to be adjusted based on actual study events such as the cumulative event rate, enrollment changes, actual product expiration results, contract award date, etc. NOTE: Order Dates are based on the idea that as soon as contract documents are complete, an order will be placed. Planned Delivery Date Quantity of Active (Doses) Base Year Pilot Phase Order Date: 8/01/2017 Delivery No Later Than 30 days after Order Date 652,500 Option Year One Order Date: 8/01/2018 Delivery No Later Than 30 days after Order Date unless user/COR/Vendor accept later date 2,257,900 Option Year Two Order Date: 8/01/2019 Order Date: 12/01/2019 Delivery No Later Than 30 days after Order Date unless user/COR/Vendor accept later date 2,324,000 2,324,000 Option Year Three Order Date: 8/01/2020 Order Date: 12/01/2020 Delivery No Later Than 30 days after Order Date unless user/COR/Vendor accept later date 2,871,850 2,871,850 Option Year Four Order Date: 8/01/2021 Order Date: 12/01/2021 Delivery No Later Than 30 days after Order Date unless user/COR/Vendor accept later date 2,871,850 2,871,850
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/06bc760cc6ee8f45fe2340109db21ea6)
 

Document(s)

Attachment
 

File Name: VA240-17-Q-0156 VA240-17-Q-0156.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3553273&FileName=VA240-17-Q-0156-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3553273&FileName=VA240-17-Q-0156-000.docx

 

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

Place of Performance

Address: Albuquerque NM VA;Clinical Research Pharmacy Coordinating Center;2401 Centre Ave SE;Albuquerque, NM

Zip Code: 87106
 

Record

SN04534764-W 20170608/170607000155-06bc760cc6ee8f45fe2340109db21ea6 (fbodaily.com)
 

Source

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

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