FedBizOpps Combined Synopsis/Solicitation Notice * * * * * * * CLASSIFICATION CODE SUBJECT CONTRACTING OFFICE'S ZIP-CODE SOLICITATION NUMBER RESPONSE DATE (MM-DD-YYYY) ARCHIVE DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS SET-ASIDE NAICS CODE CONTRACTING OFFICE ADDRESS POINT OF CONTACT (POC Information Automatically Filled from User Profile Unless Entered) DESCRIPTION * See Attachment AGENCY'S URL URL DESCRIPTION AGENCY CONTACT'S EMAIL ADDRESS EMAIL DESCRIPTION ADDRESS POSTAL CODE COUNTRY ADDITIONAL INFORMATION GENERAL INFORMATION PLACE OF PERFORMANCE * = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 65 Pharm Bottles 85014 VA258-17-Q-0461 05-31-2017 5 N 14 339112 Department of Veterans Affairs VISN/18PHX 777 E. Missouri, Suite 300 Phoenix AZ 85014 Shawnta Butler Ignacio [email protected] VA Cooperative Studies Program ATTN: CSP Warehouse (P-2002) 2401 Centre Avenue, SE Albuquerque, NM 87106 [email protected] [email protected] Page 12 of 12 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Solicitation is issued as a Request for Quotes (RFQ). This solicitation is being conducted under FAR Part 13 Simplified Acquisition Procedures (SAP). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89 effective July 14, 2016. This requirement is a Firm Fixed Price 100% Service-Disabled Veteran Owned Small Business set-aside and only qualified respondents may submit quotes. Only quotes from firms that are certified to meet Small business size standard will be considered. You may contact your local U.S. Small Business Administration (SBA) office (federal, not state office) for more information on the small business program. Your local SBA office's contact information may be found by accessing the SBA website www.sba.gov or the Vendor Information Pages at www.vip.vetbiz.gov Questions Due Date: 5/30/2017 4:00 PM EST Quote Due Date: 6/2/2017 4:00 PM EST This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-89 issued and effective July 14, 2016. This solicitation VA258-17-Q-0461 is issued as a request for quote (RFQ). The North American Industry Classification System Code (NAICS) for this procurement is 339112 Surgical and Medical Instrument Manufacturing. This RFQ is being issued as a Small business set a-side under NAICS Code 339112 Surgical and Medical Instrument Manufacturing., with a small business standard of 1,000 employees. Any Award Made as a Result of this Solicitation will be made on an All or Nothing Basis based on Lowest Price Technically Acceptable. Vendors must submit quotes in accordance with the solicitation shown here as an attachment and all associated documents. FOB Destination is in accordance with FAR 52.247-49 And VAAR SAM Requirement: This solicitation requires registration with the System for Award Management (SAM), pursuant to applicable regulations and guidelines. Registration must be complete by end date/time of solicitation or vendor may be found unresponsive, information can be found at www.sam.gov Additionally, all Service Disabled Veteran Owned Businesses who respond to this solicitation must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov by the end date/time of this solicitation. The full text of the referenced FAR clauses may be accessed electronically at https://www.acquisition.gov/far/ The following VAAR clauses are to be incorporated by reference: 852.203-70, Commercial Advertising; 852.232-72, Electronic Submission of Payment Requests; 852.246-71, Inspection; The full text of the referenced VAAR clauses may be accessed electronically at http://www.va.gov/oal/library/vaar/. In addition, the following information is required for your quote to be considered: Estimated delivery time (ARO): Complete company name and address: Company Point of Contact: Email -Phone Number: DUNS Number: Please Add your name/company to interested vendors for this solicitation Submission of Quotes: Submit quotation and all supporting documentation to Theresa Hamilton by email [email protected] no later than 4:00pm Eastern Standard Time June 2, 2017. Only requests submitted electronically to the above address will be considered. Mailed in or physically submitted documents will not be accepted for this solicitation. Please feel free to contact by email if you have any questions 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: 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

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