SOURCES SOUGHT (PROSOLV EASYtab SP/brand name or equal) The Albuquerque VA Medical Center at The VA Cooperative Studies Program (CSP) Clinical Manufacturing Section (CMS) has a requirement to purchase The Brand Name or Equal PROSOLV® EASYtab SP (Product) to make approximately 24,250,000 placebo tablets to support VA Cooperative Studies Program (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
[email protected] 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 PROSOLV® EASYtab SP Type of Contract: Firm Fixed Price, Indefinite Delivery/Indefinite quantity Deliver to: Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) VA CSPCRPCC 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 See following for Statement of Work (SOW)/description of requirement STATEMENT OF WORK (SOW) PROSOLV®EASYtab SP (Brand name or equal) CONTRACT TITLE. PROSOLV®EASYtab SP BACKGROUND. The VA Cooperative Studies Program (CSP) Clinical Manufacturing Section (CMS) needs to make approximately 24,250,000 placebo tablets to support VA Cooperative Studies Program (CSP) Clinical Study CSP2002, Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT) . The placebo tablet for CSP2002 must have essentially identical physical characteristics to the 500 mg extended release Metformin tablet we are matching for this clinical research study. We made pilot batches (i.e. conducted experiments) with a pre-blended product and with excipients the CMS would need to blend together appropriate for meeting the placebo tablet specifications of: Weight, Hardness (how difficult it is to break), and Thickness. The PROSOLV® EASYtab SP brand name or equal (Product) was chosen because the pilot batches showed that placebo tablets made with the product meet the specifications for weight, hardness and thickness and because use of the Product eliminates the 10,106 personnel hours required for CMS to blend excipients resulting in a significant cost saving to the government. SCOPE. The CSP Clinical Research Pharmacy Coordinating Center (CRPCC) is contemplating a firm fixed price, Indiefinate Delivery/Indefinate Quantity (IDIQ) contract of a base year plus 4 option year periods. The IDIQ allows flexibility in the quantity of drums of Prosolv purchased each year based upon the projected study enrollment. The range for the minimum to maximum amount of Product expected to be purchased each year is defined in this notice. The Product must: Have a minimum expiration/re-evaluation date remaining of 2.5 years upon receipt, Have a Certificate of Analysis supplied for each lot of product received by the CSP CRPCC, and The manufacturer must have an active Drug Master File filed with the United States Food and Drug Administration for PROSOLV®EASYtab SP. The Product must be Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) free. REQUIREMENT: Prosolv Easytab SP (Brand Name or Equal) Sodium Starch Glycolate, Sodium Stearly Fumarate ESTIMATED SCHEDULE OF SUPPLIES. Product Est Min Qty Est Max Qty Period of Performance Base Year PROSOLV®EASYtab SP 150 KG 750 KG 8/1/ 2017 to 7/31/2018 Option Year 1 PROSOLV®EASYtab SP 150 KG 1650 KG 8/1/ 2018 to 7/31/2019 Option Year 2 PROSOLV®EASYtab SP 150 KG 3750 KG 8/1/ 2019 to 7/31/2020 Option Year 3 PROSOLV®EASYtab SP 150 KG 3750 KG 8/1/ 2020 to 7/31/2021 Option Year 4 PROSOLV®EASYtab SP 150 KG 6000 KG 8/1/ 2021 to 7/31/2022 SPECIFIC TASKS. Task 1 Product Provide the amount of Product designated yearly which shall not be less than the minimum or more than the maximum amounts stated in Item #3 above, Schedule of Supplies required by the CSP CRPCC. The Product will be provided in 25 Kg drums. Where possible, each shipment shall consist of one lot or batch of product. Subtask 1 Expiration Dating The Product shall have a minimum expiration/re-evaluation date of two and one-half years (2.5) years upon receipt by the CSP/CRPCC. Subtask 2 - Certificate of Analysis The vendor shall assure that the product contains the following ingredients in the amounts indicated. Ingredient Function Content Regulatory Requirement Microcrystalline Cellulose CAS No. 9004-34-6 Binder/ Filler 95 - 98% NF, Ph. Eur., JP Sodium Starch Glycolate CAS No. 9063-38-1 Superdisintegrant 1.2% NF, Ph. Eur., JP Colloidal Silicon Dioxide CAS No. 112945-52-5 Glidant 1.5 2.5% NF, Ph. Eur., JP Sodium Stearyl Fumarate CAS No. 4070-80-8 Lubricant 0.3 1.0% NF, Ph. Eur., JP The vendor shall provide a Certificate of Analysis showing the Product meets its specifications for each lot or batch of Product delivered to the CSP CRPCC. Parameter Acceptance Criterial Reference Identification I Microcrystalline cellulose Violet Blue Color NF, Ph. Eur., JP Identification II Microcrystalline cellulose Stable suspension JP Identification III Microcrystalline cellulose Degree of polymerization #60 mesh sieve (250 µm) > #200 mesh sieve (75 µm) Max. 8% 45 80% JRS Method Particle size (laser diffraction) D10 D50 D90 25 50 µm 90 150 µm 190 300 µm JRS Method Powder Flow - Angle of Repose (°) Max. 38° JRS Method The raw materials, manufacturing process and product shall not contain any of the solvents listed in the Residual Solvents (USP , Ph. Eur. ) except toluene, ethanol and acetone. Residual Class 2 solvents toluene and ethanol shall be below Option 1 limit and residual Class 3 solvent acetone shall be below 0.5 per cent. Subtask 3 - Drug Master File The vendor must have an active Drug Master File (28461) filed with the United States Food and Drug Administration for PROSOLV®EASYtab SP. The vendor will provide the CSP CRPCC with notifications of changes to the manufacturing process that may impact the Product. Subtask 4 - TSE/BSE Free The Product must be Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) free. PERFORMANCE MONITORING. The CSP CRPCC will monitor performance upon product delivery by: Statements Standards/AQLs Inspections Methods Identification testing on each lot of product received FT-IR: The sample is positive for microcrystalline cellulose if the software matches it to microcrystalline cellulose Or FT-NIR: Positive for Microcrystalline Cellulose if the match value is 90.00 or greater Laboratory Analysis FT-IR FT-NIR Reviewing each Certificate of Analysis (CofA) to assure the product meets the vendor s specifications See the attached example of a JRS Pharma CofA for Product Review CofA Direct Observation OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. Identification of Possible Follow-on Work. CSP2002 is expected to last a minimum of seven years. Because of the large tablet requirement, we will need to continue ordering the same Product to supply tablets for the length of the study. Information on the clinical study is reported to the Food and Drug Administration (FDA). FDA expects the CSP CRPCC to use the same Product for the life of the study because changing the Product might influence the outcome of the trial. Identification of Potential Conflicts of Interest (COI). No organizational COI exists. Identification of Non-Disclosure Requirements. The contractor will not have access to sensitive or proprietary information. Packaging, Packing and Shipping Instructions. Product shall be shipped from the vendor to the attention of: Jan Hickey VA CSPCRPCC 2401 Centre Avenue SE Albuquerque, NM 87106 U.S.A. Product shall be shipped in appropriate containers to prevent contamination, degradation or shipping damage. Inspection and Acceptance Criteria. The CSP CRPCC will: Inspect each shipment for damage upon receipt, Sample each shipment and conduct identification testing to assure the appropriate Product is received. Review the Certificate of Analysis to assure the Product meets its specifications. RISK CONTROL. The CSPCRPCC will minimize risk to Veteran patients taking placebo tablets manufactured using the Product by: Testing each lot of placebo tablets manufactured using this product to assure it meets the in-process and finished placebo tablet specifications. Entering all process and product deviations, out of specification results, etc. into our Corrective and Preventive Action (CAPA) system, reviewing and correcting these items, documenting all changes appropriately and completing other actions as required to assure the Product is safe. DELIVERY SCHEDULE. Deliverable Title Format Number Calendar Days After Start PROSOLV® EASYtab SP 25 kg drums, 6 drums to a pallet Minimum 3 year retest/ expiration Each lot of Product shall have a Certificate of Analysis Varies 24