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 or 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:
[email protected]. It is anticipated that a Request for Quotes will be issued in November 2019. Award of a firm fixed price contract is contemplated by January 2020. This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), capable of performing the requirements to warrant a socio-economic set-aside or full & open competition. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance (3) intentions of subcontracting program to include set-asides if any; (4) proof of registration in the VA Vet Biz or SBA websites or intention of registration prior to submission of offers to a solicitation; (5) If you are a distributor a statement from the manufacturer that your company is an authorized distributor; (6) a statement to inform the government if you are a manufacturer or distributor; (7) any information regarding FSS Schedule availability; (8) SAM Registration (9) any other pertinent company documentation. The response date to this Sources Sought notice is November 20, 2019 at 2:00 pm AZ time. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or full & open competition, or a sole-source procurement is appropriate. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable via
[email protected], and are highly preferred. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. ALL FIRMS ARE INSTRUCTED NOT TO CALL THE INDIVIDUAL VA MEDICAL CENTERS REQUESTING MORE INFORMATION. This procurement is for NEW Equipment ONLY; no remanufactured or "gray market" items. Vendor shall be an Original Equipment Manufacturer, OEM authorized dealer, authorized distributor or authorized reseller for the proposed equipment such that OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with any equipment shall be in accordance with the OEM terms and conditions. All Equipment must be covered by the manufacturer warranty. The quote MUST include evidence of authorized distributor status for the manufacturer being quoted. Salient Characteristics: Vendor is to supply the CSPCRPCC with active Pentoxifylline (PTX) Extended Release (ER) 400 mg tablets (4,212,541 tablets across the life of the contract) from a Manufacturer that is FDA-approved with a therapeutic equivalence evaluation. Therapeutic equivalency requires that the active Pentoxifylline (PTX) Extended Release (ER) 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. Active Pentoxifylline tablets will contain identical amounts (400 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 Pentoxifylline tablets will meet compendia or other applicable standards of strength, quality, purity, and identity. Active Pentoxifylline 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 Pentoxifylline 400 mg ER active pharmaceutical ingredient and Trade Agreement Act (TAA) compliance. If exempted for any reason, provide documentation attesting to this fact. Vendor will ship active drug in appropriately sealed bulk containers for repackaging. The vendor will provide and ship Pentoxifylline (PTX) Extended Release (ER) 400 mg tablets in bulk containers to the CSPCRPCC and will provide a Certificate of Analysis for each lot of pentoxifylline supplied. Required Shelf-Life is a minimum of 18- months at time of receipt to CSPCRPCC. Same lot bulk shipment up to 1.26 million tablets for research testing. Deliverables: The vendor must obtain and forward the Manufacturer s evidence of performed release testing and stability testing (industry standard Certificates of Analysis and Stability Reports) to CSPCRPCC by lot number (regardless of whether portions of the lot have previously been sent) 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. Shipments to CSPCRPCC will occur after receiving an order. Orders will be placed as a single order during contract period of performance to allow for adjustments to study performance date. Vendor is responsible for shipping costs of Pentoxifylline 400 mg ER to the CSPCRPCC. The CSPCRPCC will perform acceptance inspections of shipments, ensure Certificates of Analysis and Packing Lists are included and complete, and containers are properly labeled and sealed. Failure of a Lot, Shipment, or Container to meet contract requirements may result in a rejection of the Lot, Shipment, or 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 containers 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. Schedule of Services and/or Supplies: Orders will be shipped as a single order during the contract period of performance. Packaging, Packing, and Shipping Instructions: Product will be packaged in bulk containers and shipped using manufacturer 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. FOB Destination (ShipTo): VA Cooperative Studies Program 2401 Centre Avenue, SE Albuquerque, NM 87106 52.217-4 EVALUATION OF OPTIONS EXERCISED AT TIME OF CONTRACT AWARD (JUN 1988) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate the total price for the basic requirement together with any option(s) exercised at the time of award. 52.217-5 EVALUATION OF OPTIONS (JUL 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).