6515--691-CUSTOM PACKS

Page 2 of 2 Please see below for answers to questions received regarding solicitation 36C26226Q1325. All other terms and conditions remain unchanged. Clarification of the correct proposal/solicitation response due date Responses are due Friday, September 11, 2026. Clarification and reconciliation of the Period of Performance and initial delivery schedule The period of performance will be for one year Due to the complexity and customization of this product, custom surgical packs shall take no more than 24 weeks to produce, sterilize, and deliver for the initial order after commencement of the forthcoming contract. Confirmation of whether any option periods are identified for this requirement There are no option periods for this requirement. Review and reconsideration of the standard delivery timeline, consistent with industry standard of 2 3 days Pack deliveries shall be made two business days after receipt of an order if placed before 1:00 p.m. PST, and within three (3) calendar days for orders placed after 1:00 p.mAre the two and three days the amount of days they have to ship the items, or the items have to be delivered? The comment was correct that requirement as almost impossible for non-local vendors to meet. They must get adequate processing time for each order. GLA will have to be responsible and take process and shipping times into consideration when placing orders. Keeping it this way greatly reduces competition. . Orders shall be delivered no more than three (3) business days. Consideration of a purchasing commitment of at least 60 days in connection with the three-month inventory requirement The contractor must maintain at least three (3) months completely assembled custom packs onpacks on hand at all times, The government will make no purchasing commitments above the minimum dollar threshold identified in the requirements contract. Clarification or reconsideration of the monthly-in-arrears invoicing structure Per government regulations payment is due 30 days after the latter of receiving a proper invoice or government acceptance of the items. Billing monthly ensures a streamlined and consistent process for managing payments .payments. Inclusion of FAR 52.225-1, Buy American Supplies, consistent with the stated Buy American Act evaluation factor See pages 3-6 for inclusion of FAR 52.225-1, Buy American Supplies and FAR 52.225-2, Buy American Certificate. Additionally, Factor 2 of the Evaluation Factors on page 41 of the RFQ now reads: ii. Factor 2 The Offeror shall identify the percentage of items within the proposed custom surgical and non surgical packs that are manufactured in the United States. The Offeror shall also identify the percentage of items manufactured in each foreign country, clearly listing the countries of origin and the proportion of total components sourced from each location. The Offeror must ensure the percentages provided are accurate and reflect the total composition of each pack. In addition, the Offeror shall complete and submit the Buy American Certificate and Made in America Certificate PPE included in this solicitation. Removal or clarification of the Non-Manufacturer Rule Compliance evaluation factor in light of the standing waiver Per VA regulation, a certification is still required for SDVOSB/VOSB set asides. Evaluation factor #3 will remain in the solicitation unchanged. Clarification on Make PPE in America Act applicability to sterile surgical gowns A waiver for all non-domestic items relevant to this acquisition is under review. Buy American-Supplies (Oct 2022) (a) Definitions. As used in this clause Commercially available off-the-shelf (COTS) item (1) Means any item of supply (including construction material) that is (i) A commercial product (as defined in paragraph (1) of the definition of commercial product at Federal Acquisition Regulation (FAR) 2.101); (ii) Sold in substantial quantities in the commercial marketplace; and (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and (2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Component means an article, material, or supply incorporated directly into an end product. Cost of components means (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or (2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product. Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105 . Domestic end product means (1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both- (i) An unmanufactured end product mined or produced in the United States; (ii) An end product manufactured in the United States, if- (A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or (B) The end product is a COTS item; or (2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of "cost of components". End product means those articles, materials, and supplies to be acquired under the contract for public use. Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws. Foreign end product means an end product other than a domestic end product. Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign. Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners. Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements. United States means the 50 States, the District of Columbia, and outlying areas. (b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for an end product that is a COTS item (see 12.505(a)(1)), except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners. (c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting Officer will treat as domestic for this contract. (d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled "Buy American Certificate." Alternate I (Oct 2022). As prescribed in 25.1101 (a)(1)(ii) substitute the following sentence for the first sentence of paragraph (1)(ii)(A) of the definition of domestic end product in paragraph (a): The cost of its components mined, produced, or manufactured in the United States exceeds 65% percent of the cost of all its components. (End of clause) 52.225-2 Buy American Certificate As prescribed in 25.1101(a)(2), insert the following provision: Buy American Certificate (Oct 2022) (a) (1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component. (2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select no . (3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105). (4) The terms commercially available off-the-shelf (COTS) item, critical component, "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies." (b)Foreign End Products: Line Item No. Country of Origin Exceeds 65% domestic content (yes/no) ______________ _________________ _________________ ______________ _________________ _________________ ______________ _________________ _________________ (b)[List as necessary] (c) Domestic end products containing a critical component: Line Item No. ___ [List as necessary] (d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. (End of provision) 852.225-70 MADE IN AMERICA-PPE ([MAY 2026]) (DEVIATION) (a) Definitions. As used in this clause Component, as applied to an item described in subsection (b) of this clause, means an article, material, or supply incorporated directly into PPE. Domestic PPE, as applied to an item described in subsection (b) of this clause, means PPE, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States