Ambrisentan Tablets   3

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79721R0006 for an unrestrictive procurement for Ambrisentan Tablets, for the Department of Veterans Affairs (VA) and Bureau of Prisons (BOP). This product is a specialty drug that requires pharmacies enroll in the Ambrisentan Shared System Risk Evaluation and Mitigation Strategy (REMS) Program. Therefore, the awardee must meet all Ambrisentan Shared System REMS program requirements and will be required to sponsor Government pharmacies as authorized outpatient pharmacies in the Ambrisentan REMS Program (inpatient pharmacies will not require sponsorship under Ambrisentan REMS program). As such, to be eligible for award, the offeror must be an Ambrisentan REMS Consortium member with the ability to sponsor outpatient pharmacies to serve as certified Ambrisentan REMS Outpatient Pharmacies. Only NDA/ANDA holders listed on the FDA Ambrisentan REMS Shared System are authorized to become sponsors under the program. Furthermore, The Ambrisentan Shared System REMS Program does not allow for distributors to provide products to other distributors/wholesales (such as the Pharmaceutical Prime Vendor(s)). As this solicitation requires that all products be shipped and orders made via the Pharmaceutical Prime Vendor(s) to be eligible for award, the offeror must be an NDA/ANDA holder listed on the FDA Ambrisentan REMS Shared System site. Additionally, the offeror shall understand distribution and REMS fees that the offeror may incur if awarded a contract, as well as the PPV s role and in the REMS program prior to submitting an offer. The VA will award one contract to the responsible offeror who will be able to provide an uninterrupted source of supply for the contracted items. The contract period will be for one year plus four pre-priced one-year option periods. The contract items will be distributed through the VA s Prime Vendor Program. Offerors must state the exact name (name that appears on label) by which the drug will be supplied and have a unique NDC number. Solicitation #36E79721R0006 will be electronically issued in commercial item format in accordance with FAR Part 12 on or about November 12, 2020 with a tentative closing date of November 30, 2020. The NAICS code for this procurement is 325412. Any future amendments and other miscellaneous documents will be available electronically for download at the following URL: https://beta.sam.gov/. No paper copies of the solicitation will be available, and no telephone requests for paper copies of the solicitation will be accepted. Interested offerors are advised to continuously check this URL for any changes to this solicitation. All responsible sources may submit an offer that if timely received, will be considered. The point of contact for this procurement is Deborah Fassl. Questions can be e-mailed to: Deborah.Fassl@va.gov. The estimated annual requirements are as follows: Item Description Size Estimated Annual Requirements (Bottles or Blister Packs) AMBRISENTAN 5MG TABLETS 30 561 AMBRISENTAN 10MG TABLETS 30 1,201