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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 30, 2017 FBO #5637
DOCUMENT

65 -- Pharmaceutical Bottles - Attachment

Notice Date

4/28/2017
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25817N0399
 

Response Due

5/5/2017
 

Archive Date

5/8/2017
 

Point of Contact

Shawnta butler Ignacio
 

E-Mail Address

SHAWNTA.BUTLERIGNACIO@VA.GOV
(shawnta.butlerignacio@va.gov)
 

Small Business Set-Aside

N/A
 

Description

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Please advise if you carry this product are a suitable or equal. Also include company socio/Economic status and size. If you have any questions or concerns in reference to the Parts listing please provide as well. EMAIL INFORMATION TO : shawnta.butlerignacio@va.gov STATEMENT OF WORK (SOW) As of 02/07/2017 Contract Number: Task Order Number: IFCAP Tracking Number: 501-17-3-137-0134 Follow-on to Contract and Task Order Number: CONTRACTING OFFICER S REPRESENTATIVE (COR). (Identify the individual(s) who will act as the COR.) Name: Frank Lueddeke Section: Chief, Clinical Materials Management Section Address: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106-4180 Phone: (505) 265-1711 x6354 Cell Phone: (505) 975-8103 Fax: (505) 248-3205 Email Address: Frank.lueddeke@va.gov SUBJECT MATTER EXPER (SME). Name: Mark Valdez Section: Clinical Materials Management Section Address: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106-4180 Phone: (505) 265-1711 x6309 Cell Phone: (505) 218-2246 Fax: (505) 248-3205 Email Address: Mark.valdez2@va.gov SCHEDULE OF SERVICES AND/OR SUPPLIES. BASE YEAR POP: 08/29/2017 to 08/28/2018 # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 200S38W CLIN 1 - 200cc white, HDPE, 38-400 round packer 120 CS TOTAL ESTIMATED COST OPTION PERIOD 1 POP: 08/29/2018 to 08/28/2019 # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 200S38W CLIN 1 - 200cc white, HDPE, 38-400 round packer 150 CS 2 CR38400NXJT CLIN 2 - Child Resistant 38-400 induction sealed enclosures 57 CS TOTAL ESTIMATED COST OPTION PERIOD 2 POP: 08/29/2019 to 08/28/2020 # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 200S38W CLIN 1 - 200cc white, HDPE, 38-400 round packer 195 CS 2 CR38400NXJT CLIN 2 - Child Resistant 38-400 induction sealed enclosures 56 CS TOTAL ESTIMATED COST OPTION PERIOD 3 POP: 08/29/2020 to 08/28/2021 # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 200S38W CLIN 1 - 200cc white, HDPE, 38-400 round packer 314 CS 2 CR38400NXJT CLIN 2 - Child Resistant 38-400 induction sealed enclosures 56 CS TOTAL ESTIMATED COST OPTION PERIOD 4 POP: 08/29/2021 to 08/28/2022 # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 200S38W CLIN 1 - 200cc white, HDPE, 38-400 round packer 323 CS 2 CR38400NXJT CLIN 2 - Child Resistant 38-400 induction sealed enclosures 56 CS TOTAL ESTIMATED COST CONTRACT TITLE. CSP2002, Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles and Berry Plastic s PN# CR38400NXJT, 38-400 induction sealed enclosures 5. BACKGROUND. The Department of Veteran Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) has a requirement to purchase Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles and Berry Plastic s PN# CR38400NXJT, child resistant 38-400 induction sealed enclosures under an Indefinite Delivery, Indefinite Quantity (IDIQ) base year contract, with four (4) additional option years. The Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) is planning a clinical trial (CSP #2002) to determine if metformin extended release, compared with placebo, decreases the time to first occurrence of death or non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization. A sample size of 7,868 participants will be followed until the accrual of 1,360 primary end point events occurs. The sample size may be increased during the study if the primary endpoint event rate is lower than anticipated. The minimum quantity of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles required to meet study needs per base year and additional option years are listed within the table below. Base YR/Option YR Period of Service 200cc Btl Quantity Base Year: 08/29/2017 to 08/28/2018 40,200 Option 1: 08/29/2018 to 08/28/2019 50,250 Option 2: 08/29/2019 to 08/28/2020 65,325 Option 3: 08/29/2020 to 08/28/2021 105,190 Option 4: 08/29/2021 to 08/28/2022 108,205 The minimum quantity and delivery of Berry Plastic s PN# CR38400NXJT, Child Resistant 38-400 induction sealed enclosures would begin during option year one (1), up to option year four (4) as listed within the table below. Base YR/Option YR Period of Service 38-400 Enclosures Option 1: 08/29/2018 to 08/28/2019 96,900 Option 2: 08/29/2019 to 08/28/2020 95,200 Option 3: 08/29/2020 to 08/28/2021 95,200 Option 4: 08/29/2021 to 08/28/2022 95,200 6. SCOPE. The study will last a minimum of 102- months and is composed of two phases: An 18-month pilot recruitment phase which has a target sample size of 1,200 participants and a full scale recruitment phase with a target sample size of 6,668 participants. Enrollment will take place over 6.5 years or until 1,360 primary end point events occur. This requirement is for the provision of 20,447,300 metformin 500 mg XR tablets plus 1,022,000 contingency tablets and 20,447,300 matching placebo tablets plus 1,022,000 contingency tablets. Metformin 500 mg 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 200cc white, HDPE, 38-400 round packer pharmaceutical bottles based on the prescription written by the study Local Site Investigator. The bottles will be sealed and enclosed with a 38-400 induction sealed child resistant cap. 7. SPECIFIC TASKS. 7.1 Task 1 Base Year Delivery of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles: Deliver 200cc white, HDPE, 38-400 round packer pharmaceutical bottles in amounts specified by VACSP personnel via E-mail, which will total a quantity of 40,000 bottles during the base year contract period. Delivery on site should be within a three to four week time period upon being contacted by the purchaser via E-mail 7.2 Task 2 Option Year One (1) delivery of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles: Deliver 200cc white, HDPE, 38-400 round packer pharmaceutical bottles in amounts specified by VACSP personnel via E-mail which will total a quantity of 50,000 bottles during option year one (1) contract period. Delivery on site should be within a three to four week time period upon being contacted via E-mail 7.2.1 Subtask 2 Option Year One (1) deliver Berry Plastic s PN# CR38400NXJT, Child Resistant 38-400 induction sealed enclosures: Deliver 87,500 induction sealed enclosures with a size of 38-400 in amounts specified by VACSP personnel via E-mail during option year one (1) contract period. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.3 Task 3 Option Year Two (2) delivery of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles: Deliver 200cc white, HDPE, 38-400 round packer pharmaceutical bottles in amounts specified by VACSP personnel via E-mail which will total a quantity of 65,000 bottles during option year two (2) contract periods. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.3.1 Subtask 3 Option Year Two (2) deliver Berry Plastic s PN# CR38400NXJT, Child Resistant 38-400 induction sealed enclosures: Deliver 87,500 induction sealed enclosures with a size of 38-400 in amounts specified by VACSP personnel via E-mail during option year two (2) contract period. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.4 Task 4 Option Year Three (3) delivery of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles: Deliver 200cc white, HDPE, 38-400 round packer pharmaceutical bottles in amounts specified by VACSP personnel via E-mail which will total a quantity of 93,000 bottles during option year three (3) contract periods. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.4.1 Subtask 4 Option Year Three (3) deliver Berry Plastic s PN# CR38400NXJT, Child Resistant 38-400 induction sealed enclosures: Deliver 87,500 induction sealed enclosures with a size of 38-400 in amounts specified by VACSP personnel via E-mail during option year three (3) contract periods. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.5 Task 4 Option Year Four (4) delivery of Alpha PN# 200S38W, 200cc white, HDPE, 38-400 round packer pharmaceutical bottles: Deliver 200cc white, HDPE, 38-400 round packer pharmaceutical bottles in amounts specified by VACSP personnel via E-mail which will total a quantity of 102,000 bottles during option year four (4) contract periods. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 7.5.1 Subtask 4 Option Year four (4) deliver Berry Plastic s PN# CR38400NXJT, Child Resistant 38-400 induction sealed enclosures: Deliver 87,500 induction sealed enclosures with a size of 38-400 in amounts specified by VACSP personnel via E-mail during option year four (4) contract periods. Delivery on site should be within a three to four week time period upon being contacted via E-mail. 8. PERFORMANCE MONITORING. Task Standard Acceptable Quality Level Surveillance Method 7.1 - Delivery of 40,000; 200cc, White, HDPE, 38-400 Round Packer Pharmaceutical Bottles during base year of service contract 200cc bottles to be delivered in specified amounts via E-mail request to vendor during base year of service contract Specified amount of 200cc bottles delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.2 - Delivery of 50,000; 200cc, White, HDPE, 38-400 Round Packer Pharmaceutical Bottles during option year one of service contract 200cc bottles to be delivered in specified amounts via E-mail request to vendor during option year one of service contract Specified amount of 200cc bottles delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.2.1 - Delivery of 87,500 Child resistant, 38-400 induction sealed enclosures during option year one of service contract Child resistant, 38-400 induction sealed enclosures to be delivered in specified amounts via E-mail request to vendor during option year one of service contract Specified amount of Child resistant, 38-400 induction sealed enclosures delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.3 - Delivery of 65,000; 200cc, White, HDPE, 38-400 Round Packer Pharmaceutical Bottles during option year two of service contract 200cc bottles to be delivered in specified amounts via E-mail request to vendor during option year two of service contract Specified amount of 200cc bottles delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.3.1 - Delivery of 87,500 Child resistant, 38-400 induction sealed enclosures during option year two of service contract Child resistant, 38-400 induction sealed enclosures to be delivered in specified amounts via E-mail request to vendor during option year two of service contract Specified amount of Child resistant, 38-400 induction sealed enclosures delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.4 - Delivery of 93,000; 200cc, White, HDPE, 38-400 Round Packer Pharmaceutical Bottles during option year three of service contract 200cc bottles to be delivered in specified amounts via E-mail request to vendor during option year three of service contract Specified amount of 200cc bottles delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.4.1 - Delivery of 87,500 Child resistant, 38-400 induction sealed enclosures during option year three of service contract Child resistant, 38-400 induction sealed enclosures to be delivered in specified amounts via E-mail request to vendor during option year three of service contract Specified amount of Child resistant, 38-400 induction sealed enclosures delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct observation, Review of detailed Packing Slip provided with shipment 7.5 - Delivery of 102,000; 200cc, White, HDPE, 38-400 Round Packer Pharmaceutical Bottles during option year four of service contract 200cc bottles to be delivered in specified amounts via E-mail request to vendor during option year four of service contract Specified amount of 200cc bottles delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 7.5.1 - Delivery of 87,500 Child resistant, 38-400 induction sealed enclosures during option year four of service contract Child resistant, 38-400 induction sealed enclosures to be delivered in specified amounts via E-mail request to vendor during option year four of service contract Specified amount of Child resistant, 38-400 induction sealed enclosures delivered within three to four weeks from E-mail request -Detailed packing slip provided with shipment Direct Observation Review of detailed Packing Slip provided with shipment 9. SECURITY REQUIREMENTS. Not Applicable 10. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). Not Applicable 11. SECURITY REQUIREMENTS. The CSPCRPCC is a secure facility. All contractor(s) visiting the CSPCRPCC will be required to present a valid ID (driver s license or Government issued ID) to Security Officer(s) in order to be physically checked in and given a visitor s badge. Contractor(s) must wear their visitor s badge and will be escorted by a CSPCRPCC staff member at all times while within the facility. The contractor will not have access to any IT networks or patient information. The C&A requirements do not apply and a Security Accreditation Package is not required. 12. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. Identification of Possible Follow-on Work. Future follow on services may be utilized if study 2002 is extended beyond it scheduled life cycle. Identification of Potential Conflicts of Interest (COI). Not Applicable Identification of Non-Disclosure Requirements. Not Applicable Packaging, Packing and Shipping Instructions. Vendor shall palletize and ship all 49 cases of 100cc bottles in the appropriate shipping boxes to prevent damage, with proper shipping documentation securely attached to the inside or outside of shipping box to Cooperative Studies Program loading dock, located at 2401 Centre SE, Albuquerque, NM 87106. Inspection and Acceptance Criteria. General quality measures shall be applied to the work product received from the contractor under this SOW. 13. RISK CONTROL. General quality measures shall be applied to the work product received from the contractor under this SOW. 14. PLACE OF PERFORMANCE. 200cc, White, HDPE, 38-400 Round Packer and Child resistant, 38-400 induction sealed enclosures shall be procured and readied for shipment at the contractor s sight. Final delivery of 200cc white, HDPE, 38-400 round packer pharmaceutical bottles and the Child resistant, 38-400 induction sealed enclosures will be delivered to VA Cooperative Studies Program 2401 Centre Avenue, SE ATTN: CSP Warehouse (P-2002) Albuquerque, NM 87106-4180 15. PERIOD OF PERFORMACE. The service period slated for this contract will consist of a base year and four additional option years for the procurement and delivery of 200cc white, HDPE, 38-400 round packer pharmaceutical bottles and the Child resistant, 38-400 induction sealed enclosures required to meet study needs as shown within the table below. Base YR/Option YR Period of Service Base Year: 08/29/2017 to 08/28/2018 Option 1: 08/29/2018 to 08/28/2019 Option 2: 08/29/2019 to 08/28/2020 Option 3: 08/29/2020 to 08/28/2021 Option 4: 08/29/2021 to 08/28/2022 16. DELIVERY SCHEDULE. SOW Task # Deliverable Title Format Number Calendar Days After CO Start 7.1 / 7.2 / 7.3 / 7.4 / 7.5 200cc, White, HDPE, 38-400 Round Packer Government Supply Technician 1 copy to warehouse, 1 copy to Supply Technician Monthly 7.2.1 / 7.3.1 / 7.4.1 / 7.5.1 Child resistant, 38-400 induction sealed enclosures Government Supply Technician 1 copy to warehouse, 1 copy to Supply Technician Monthly *Standard Distribution: One copy of the transmittal letter without the deliverable to the Contracting Officer shall be emailed. 17. ACRONYMS. CO Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. COTR Contracting Officer s Technical Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. CSPCRPCC Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. VAMC Department of Veterans Affairs Medical Center NMAHCS New Mexico Veterans Affairs Healthcare System
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25817N0399/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-17-N-0399 VA258-17-N-0399_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3456286&FileName=VA258-17-N-0399-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3456286&FileName=VA258-17-N-0399-000.docx

 

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

Record

SN04489317-W 20170430/170428234028-6f83454f1354fe3015daf9f5d615541e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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