H339462

H339462 May 13, 2025 OT:RR:CTF:VS H339462 AM CATEGORY: Origin Dave Townsend Dorsey & Whitney LLP 50 South Sixth Street Suit 1500 Minneapolis, Minnesota 55402 RE: U.S. Government Procurement; Title III, Trade Agreements Act of 1979 (19 U.S.C. 2511); Subpart B, Part 177, CBP Regulations; Country of Origin of IV Drips Dear Mr. Townsend: This is in response to your request, dated May 16, 2024, on behalf of your client, Wai Medical Technologies (“Wai Medical”) and its affiliate MedSource International LLC (“MedSource”), for a final determination concerning the country of origin of the Biomedix Selec-3 Multiple Drop Intravenous Product (“Selec-3 IV Product”), pursuant to Title III of the Trade Agreements Act of 1979 (“TAA”), as amended (19 U.S.C. 2511 et seq.), and subpart B of Part 177, U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 177.21, et seq.). Your request, submitted as an electronic ruling request, was forwarded to this office from the National Commodity Specialist Division (“NCSD”). Wai Medical is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and 177.23(a) and is therefore entitled to request this final determination. FACTS: The merchandise at issue is the Selec-3 IV Product. The Selec-3 IV Product is an intravenous set made with components from a variety of U.S. and non-U.S. components. The Selec-3 IV Product has a patented selectable drop chamber (“SDC”) that offers three drop settings. These settings allow the user to adjust the drip rate for the fluids administered via the Selec-3 IV Product. By allowing the user to quickly and easily change the drip rate, the Selec-3 IV Product saves time, reduces inventory costs, and minimizes the risk of contamination of fluids administered to patients. The Selec-3 IV Product has the following components: • Check valve and connector: allows opening and closing the polyvinyl chloride (“PVC”) tube for purposes of helping regulate flow of the fluid and allows control of fluid from either the Drop Chamber or one of the Y-sites. 1 • Dust cap: placed on the end of the Selec-3 IV Product to ensure the end remains uncontaminated prior to use. • Pinch Clamp (x2): The pinch clamps can be used to stop and start the flow of liquid through the tubing and to the patient. • PVC Tube (73 Inches): The PVC tube allows the fluid to flow from the bag containing the fluid, through the SDC, and ultimately to the patient. • Roller Clamp: The clamp is a binary control allowing or disallowing flow of fluid into the SDC, and thus to the patient. • SDC: The SDC is a clear plastic tube with a mechanism allowing the user to select one of three drop rates. The SDC is patented and allows unwanted gas to bubble out of the fluid, allowing medical staff to see that fluid is flowing through the IV, and allowing regulation of the flow rate through the patented adjustable SDC. • Spike and Cap: The spike is used to connect the Selec-3 IV Product to the fluid being administered to the patient. The spike is inserted into the bag holding the fluid. The cap is used to ensure the spike is not contaminated prior to use. • Spin Lock: The spin lock allows connection between a device allowing the direct infusion of the fluids into the patient to the Selec-3 IV Product. • Y-Sites (x3): The Y-sites allow the injection of additional treatments or medicines to be administered to the patient, in addition to the fluid connected to the Selec-3 IV Product that runs through the SDC and tubing to the patient. Assembly of the Selec-3 IV Product involves three steps: (1) assembly of the SDC subassembly with the roller clamp and spike, (2) the assembly of the other tubing sub- assemblies, and (3) the final assembly. (1) Assembly of the SDC Assembly of the SDC involves connecting, gluing, and sealing the parts of the SDC, including the tubing and the roller clamp and spike. The plastic tubing is inspected and the tube to the drip-rate selector is aligned and glued. Then, the drop chamber is inspected and cured with ultraviolet light to bind them together. The assembler must apply silicone to the selector, sealing the selector, and adding the selector top. Lastly, the chamber is connected to a short piece of tubing that ends with a roller clamp and spike. The total cost of the SDC sub-assembly components is roughly less than half of the total cost of the Selec-3 IV Product. (2) Assembly of the other tubing sub-assemblies The premanufactured parts are inspected for defects. Assembly continues with three sections of tubing, i.e., the primary tubing, the patient side assembly (top half), and the extension set (bottom half). To assemble each of those three sections, tubing is connected to luers and Y- sites. (3) Final Assembly During the final assembly process, the primary tubing, the patient side assembly, and the extension set are put together with the SDC sub-assembly, and the Selec-3 IV Product is complete. Adhesives are added to ensure lasting connection between certain parts. 2 Set forth below are several sourcing scenarios for components that Wai Medical is contemplating. Wai Medical requests that CBP issue a determination covering all five scenarios below. Scenario 1: All of the Selec-3 IV Product components originate from the United States, are sterilized in the United States, and then are assembled in India prior to being re-imported, and fully assembled in the United States. Scenario 2: The SDC originates from the United States and is assembled into the SDC sub- assembly (including the roller clamp and spike) in the United States. The remaining components originate, are sterilized, and assembled in India. The final assembly takes place in India. Scenario 3: The SDC originates from the United States. The SDC sub-assembly takes place in India. Additionally, remaining components originate, are sterilized, and assembled in India. The final assembly takes place in India. Scenario 4: The SDC originates from Mexico and all components (including SDC) are sterilized and assembled in India. All of the Selec-3 IV Product components, except the SDC, originate and are sterilized in non-TAA eligible countries. The final assembly takes place in India. Scenario 5: The SDC components originate and are assembled into the SDC sub-assembly in Mexico. All other parts of the Selec-3 IV Product originate from China. Sterilization of the entire product occurs in China. The final assembly takes place in India. ISSUE: What is the country of origin of the Biomedix Selec-3 Multiple Drop Intravenous Product for purposes of U.S. Government procurement? LAW & ANALYSIS: CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purpose of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title III, Trade Agreements Act of 1979, as amended (19 U.S.C. 2511- 2518). CBP’s authority to issue advisory rulings and final determinations is set forth in 19 U.S.C. 2515(b)(1), which states: For the purposes of this subchapter, the Secretary of the Treasury shall provide for the prompt issuance of advisory rulings and final determinations on whether, under section 2518(4)(B) of this title, an article is or would be a product of a foreign country or instrumentality designated pursuant to section 2511(b) of this title. 3 Emphasis added. The Secretary of the Treasury’s authority mentioned above, along with other customs revenue functions, are delegated to the Secretary of Homeland Security via Treasury Department Order (TO) 100-20 “Delegation of Customs revenue functions to Homeland Security,” dated October 30, 2024, and are subject to further delegations to CBP (see also 19 CFR Part 177, subpart B). The rule of origin set forth in 19 U.S.C. 2518(4)(B) states: An article is a product of a country or instrum

CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purpose of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title III, Trade Agreements Act of 1979, as amended (19 U.S.C. 2511- 2518). CBP’s authority to issue advisory rulings and final determinations is set forth in 19 U.S.C. 2515(b)(1), which states: For the purposes of this subchapter, the Secretary of the Treasury shall provide for the prompt issuance of advisory rulings and final determinations on whether, under section 2518(4)(B) of this title, an article is or would be a product of a foreign country or instrumentality designated pursuant to section 2511(b) of this title. 3 

 Emphasis added. The Secretary of the Treasury’s authority mentioned above, along with other customs revenue functions, are delegated to the Secretary of Homeland Security via Treasury Department Order (TO) 100-20 “Delegation of Customs revenue functions to Homeland Security,” dated October 30, 2024, and are subject to further delegations to CBP (see also 19 CFR Part 177, subpart B). The rule of origin set forth in 19 U.S.C. 2518(4)(B) states: An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See also 19 CFR 177.22(a). In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of su