Office of Procurement, Acquisition and Logistics (OPAL)
Trade Agreements Act (TAA)
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Non-Availability Determinations under 65 I B
Under 19 USC 2501 Trade Agreements Act agencies may only acquire US-made or designated country end products or US or designated country services. Products/services offered under the VA Schedule Program that are end products/services of countries other than the United States or identified designated countries will not be considered for award.
For more information about the Trade Agreements Act:
The following list of designated countries is current, accurate, and complete as of October 31, 2016.
TAA — Non-Availability Determinations under 65 I B
Effective April 15, 2017, the Department of Veteran Affairs started modifying all of the Federal Supply Schedule contracts to expand the non-availability determinations of NON-TAA covered drugs under SIN 42-2A to include all eligible ordering facilities. Agencies should follow their own procurement policies as it relates to ordering items. Please see Attachment A that lists all the products that have been added to the VA Federal Supply Schedule contracts and available to all eligible ordering facilities. This attachment will be updated periodically. Pricing for the products listed on Attachment A can be found in the NAC Pharmaceutical Pricing File.
Public Law (PL) 102-585, Section 603 requires covered drug manufacturers to make all covered drugs available for purchase under the 65 I B Schedule program at a not to exceed price as a condition for receiving payment from certain entities and to have a VA Schedule contract. Under 19 USC 2501 Trade Agreements Act, the VA Schedules Program has previously required that all offered products be U.S.-made or substantially transformed designated country end products. We are now requiring that all covered drugs, regardless of county of substantial transformation, be available on a 65 I B FSS contract. In other words, we now accept covered drugs that were formally excluded due to their “TAA non-compliant” nature. For those covered drug manufacturers who do not currently have a 65 I B FSS contract in place, you will need to begin with establishing an Interim Agreement (IA) which serves to bridge the gap while negotiating a VA Schedule contract. Please visit our Public Law webpage for information on the Interim Agreement process, including establishing a Master Agreement and Pharmaceutical Pricing Agreement. You can read more about the Trade Agreements Act on our Compliance and TAA Designated Countries webpages.
TAA — Non-Availability Determination
Special Item Number (SIN) 42-2A product items that are not U.S.-made or designated country end products must be offered for sale to the Government under an FSS 65 I B contract and must be listed as other end products, as required by Federal Acquisition Regulation (FAR) 52.212-3(g)(5)(ii). In accordance with FAR 25.403(c) & 25.103(b)(2), the decision has been made that the Contracting Officer may make an individual non-availability determination pursuant to 1) information provided by the offeror that neither the offered 42-2A product items nor similar or like items are mined, produced, or manufactured in the United States or a designated country in sufficient quantity to fulfill the requirements, and 2) in light of the requirement set forth in 38 U.S.C. Section 8126(a)(1) that manufacturers shall make available for procurement on the Federal Supply Schedule of the General Services Administration each covered drug of the manufacturer. Below outlines the process for offering these items to the Government under an FSS 65 I B contract via modification or via an Interim Agreement (IA), as applicable.