36C24825Q0021 0001 01_28_2025.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 14

0001 01-28-2025

None

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

To all Offerors/Bidders

36C24825Q0021

12-26-2024

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 02-14-2025 15:00 EST

See CONTINUATION Page

X 1

The purpose of this Amendment is to extend the offer due date, answer questions and add/update the clauses and provisions listed in the Amendment. As a result;

a. The offer due date is hereby EXTENDED from 02/05/2025 at 3:00 PM EST to 02/14/2025 at 3:00 PM EST.

b. Answers to participant questions are referenced beginning on page 2.

c. The question and answer period is hereby closed. No further questions shall be accepted.

d. Offers are due NLT 02/14/2025 at 3:00 PM EST.

36C24825Q0021 0001

CONTINUATION PAGE

QUESTIONS AND ANSWERS

Q1. SDVOSB is checked, but the Nonmanufacturer Rule is not checked.

A1. NAICS 339112 does not have a Nonmanufacturer Class Waiver for Surgical and Medical Instrument Manufacturing.

Q2. Buy American is checked 52.225-1 (domestic) (further reading starts on page 45) – suggest TAA 52.225-3 to be used instead.

A2. Offeror must complete FAR 52.225-2 BUY AMERICAN CERTIFICATE (p. 69) to list both foreign and domestic end products.

Q3. Is the quantity listed each pack or case?

A3. Quantity is per pack as referenced in Section B.2 Price/Cost Schedule.

Q4. We are looking at the estimates as yearly. Please confirm these are annual and not monthly estimates.

A4. Please reference Period of Performance in Section B.2.

Q5. Angio Cath Pack – this pack contains a Custom Angio Kit, P/N Q-121777. Please provide the exact items with manufacturer name in order to properly quote this kit or a schematic of the kit.

A5. The contents of the Cath Angio Kit are as follows (BRAND NAME OR EQUAL):

Manufacturer Item No. Description Medline 112126 TUBING HIGH PRESS 20IN M/F ROT Medline 118547 MANIFOLD 3-PORT 250PSI ON Medline 120184 SYRINGE CNTRL 10ML SKINNY ROTATING Medline 123751 SET CONTRAST MGR DYEPOD Medline 126459 GUIDEWIRE .035X210CM PTFE 3MMJ Medline 127235 TUBING HIGH PRESS 72IN M/F ROT Medline 14143 TUBING PRESS MONITOR 72IN M/F Medline 26128 POUCH PEEL 6X10 2ML Medline 83560 SYRINGE 10ML LUER LOK PC BLUE Medline 83562 SYRINGE 10ML LUER LOK PC RED Medline 83593 SYRINGE 20ML LUER LOK PC YELLOW Medline 91629 STOPCOCK 3-WAY RA 1050PSI OFF Medline 92025 BAG RECLOSABLE 4X6 2ML VNT Medline 92025TW BAG RECLOSABLE 4X6 2ML VNT Medline 92700 CAP MALE NONVENTED WHITE ABS Medline 94412 ADAPTER M/MW/ROTAROR 1200PSI Medline 98975 BAG WASTE W/DRIP CHMB FILT Medline 99049 TRANSDUCER 1-WAY 3WAY SC

Q6. Invoicing - Standard practice is to submit invoices when orders are shipped as orders are placed on separate PO’s. Please confirm invoices should be processed in accordance with Tungsten standard operating procedures.

A6. In accordance with the Statement of Work, all orders shall be placed through Delivery Orders and payment(s) shall be rendered monthly in arrears. It is the responsibility of the contractor to maintain accurate invoice records.

Q7. Same Day Emergency orders are not common unless a distribution center is located in the same area. Please confirm 24hour/Overnight delivery for Emergency Orders is acceptable.

A7. If necessary, the VA will accept overnight delivery for emergency orders.

Q8. Standard industry practice is 45-60 days for custom pack changes after facility sign-off for pack changes. Please confirm 45-60 days for component changes.

A8. Please reference Section V in the Statement of Work. There will be no change to outlined specifics in this section.

Q9. Standard industry practice for custom packs is 45-60 days or until supply is depleted due to unique components that may be in the pack. Please confirm minimum of 45 days will be accepted.

A9. See Question 8.

Q10. Are appointments required before for said deliveries within the dock hours or can their deliveries just be brought in within the dock hours no appointment needed?

A10. No appointments are required for dock deliveries. All deliveries shall be made during the days and times outlined in Section VIII of the Statement of Work.

Q11. RFQ states – Expiration dating of all custom sterile procedure packs delivered shall have a minimum shelf life of 12 months remaining upon delivery to the Government. Due to supply chain issues this past year, suppliers are shipping components as available. Please confirm ability to receive packs with 6-month minimum shelf life when shipped to facility.

A11. The VA will accept packs with a 6-month minimum shelf life.

Q12. Our facility is certified to ISO 13485.2016 and FDA 21 CFR Part 820 standards, which encompass rigorous quality management and compliance protocols. Would adherence to these internationally recognized standards fulfill the intent of the solicitation's requirement for compliance with IAHCSMM and AAMI/ANSI standards?

A12. ISO 13485 Certification and MDSAP Certification shall be required.

Q13. The solicitation references compliance with IAHCSMM attire guidelines. Our facility maintains strict gowning protocols aligned with ISO 14644-1.2015 standards for cleanrooms, including the use of gowns, hair coverings, and shoe covers to access controlled environments. Will this approach satisfy the attire requirements outlined in the solicitation, or is specific compliance with IAHCSMM guidelines mandatory?

A13. Attire shall be certified to meet ISO 14644-1:2015 Class 8 requirements.

Q14. We do not alter pack pricing. Please confirm if receiving replacement or credit for shorted component is acceptable.

A14. Please reference Section XVII in the Statement of Work. There will be no change to outlined specifics in this section.

Q15. We follow ISO 13485.2016 and 21 CFR Part 820 for quality management and product compliance in medical device manufacturing. Can you confirm whether compliance with AAMI and AORN guidelines is strictly required, or if adherence to ISO 13485.2016 would be sufficient for meeting these standards.

A15. All pack manufacturing, production and assembly shall occur in environmentally controlled rooms (ECRs, or cleanrooms) certified to meet ISO 14644-1:2015 Class 8 requirements.

Q16. Are there any limitations for the pack components?

A16. In accordance with the Statement of Work, all components are Brand Name or Equal. Compatibility notes are listed in the Salient Characteristics.

Q17. Are there any BAA/TAA compliant companies to provide components?

A17. The contractor is responsible for identifying companies and sourcing components in compliance with FAR 52.225-1 and FAR 52.225-2 which are attached to this document.

Q18. Are there any limitations or requirements for pack components brands?

A18. See Question 16.

Q19. Is the awarded contract for full items or partial?

A19. Please reference the Statement of Work and Section B.2 Price/Cost Schedule.

Q20. If partial award, will there be multiple contractors awarded?

A20. See Question 19.

Q21. On PG. 27 – INVOICES: we see that the Contractor shall submit one monthly invoice for all items delivered during the month. However, on PG. 24 – SERVICES TO BE PROVIDED: the Orlando, FL VAMC plans to order these packs on an “as-needed” basis. With this being said, if the Orlando, FL VAMC places multiple orders within the month can you please confirm if we can submit more than one invoice? Or is one invoice expected to be submitted at the end of the month for multiple orders?

A21. See Question 6.

Q22. On PG. 39 - Clause 52.225-1, Buy American – Supplies (OCT 2022) (41 U.S.C chapter 83) has been marked. Can you please confirm if the Packs we submit are required to be BAA compliant to respond?

A22. See Question 2.

Q23. On PG. 39 - Clause 52.223-23, Sustainable Products and Services (MAY 2024) (E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, AND 42 U.S.C. 76711) has been marked. We can confirm that Custom Surgical Packs are manufactured for one time use and do not fall under any of the product/material categories covered in this clause. Can you please confirm if this clause would still be applicable to this Solicitation?

A23. The prescription at FAR 23.109 references materials that are manufactured sustainably. It does not restrict single-use products. There will be no change to outlined specifics in this section.

Q24. On PG. 51 - VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON

SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS

(SEP 2021) (DEVIATION) has been included and the below has already been marked.

We are a nonmanufacturer that would be supplying the product of a Large Business manufacturer and would not be able to certify the above, can you please advise if we are permitted to proceed with providing a copy of our authorized distributor letter from the original large business manufacturer?

A24. Please reference C.11 VAAR 852.212-71(c) for information about authorized distributors.

Regarding VAAR 852.219-76, Section 2(i) was checked in error. All offerors shall complete the updated clause at VAAR 852.219-76 attached to this document.

Q25. Do the kits need to be assembled and stocked before an order is placed?

A25. Please reference Section V of the Statement of Work.

Q26. What is the lead time from the moment an order is received?

A26. Please reference Section III of the Statement of Work.

Q27. Do you have any historical data on the usage of the requested kits?

A27. The VA retains historical usage data on all kits. Listed in the Solicitation is the estimated annual usage based on historical requirements.

Q28. Will there be a minimum quantity requirement for this opportunity?

A28. Please reference Section C.4 FAR 52.216-19(a).

Q29. What can we expect for each surgical pack?

A29. Please reference the attached Salient Characteristics in the posting on SAM.gov.

Q30. Will the NMR rule be waived in this case?

A30. See Question 1.

Q31. Would it be acceptable to fulfill some custom surgical packs immediately and others at a later stage?

A31. Please reference Section II of the Statement of Work.

Q32. Could you share the contact information of the suppliers you have worked with in the past?

A32. The VA does not have direct contact with individual suppliers.

Q33. In the Pacemaker Pack, can you please provide more detailed information for Part # QPL394, which is a custom drape?

A33. Manufacturer Part Number has been updated. Reference row 17 of the PACEMAKER PACK sheet in the Salient Characteristics (highlighted in yellow).

Q34. In the Cath Angio Pack, Part # Q121777 lists a custom kit, with vague description, can we get a complete detailed list of the items that are included in that kit?

A34. See Question 5.

Q35. Can you please confirm if the “Estimated Quantity” requested starting on page 6 is by each individual pack or by the case?

A35. See Question 3.

Q36. Is there a specific country of origin requirement?

A36. See Question 2.

Q37. Can we substitute different products in the BOMs?

A37. Please reference Sections V and VII of the Statement of Work.

Q38. Beginning on page 6, each of the packs has an estimated quantity, but doesn’t specify if that’s monthly, quarterly, annual usage etc. Can you please confirm?

A38. See Question 4.

Q39. In our responses to the solicitation, is there a requirement to provide a breakdown of each item for each pack with images of the components?

A39. See adjusted Addendum to FAR 52.212-1 below.

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

ELIGIBILITY:

This RFQ is limited to responsible parties (see FAR Part 9) with the ability to provide service/product(s) for Orlando Veterans Affairs Healthcare System located in Orlando, Florida.

Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 120 calendar days from the date specified for receipt of offers.

CONTRACTING OFFICER’S SPECIAL INSTRUCTIONS AS FOLLOWS:

In order to maintain integrity of this solicitation and subsequent award date, all quoters are advised that any questions must be submitted in written form via e-mail to chelsea.adams@va.gov shall be received no later than JANUARY 22, 2025 AT 12:00 PM EASTERN STANDARD TIME (EST). Questions will not be entertained after JANUARY 22, 2025 AT 12:00 PM EST.

The Contracting Specialist will issue a consolidated response via solicitation amendment.

CONTRACTOR’S SIGNATURE:

In accordance with Federal Acquisition Regulation Part 4, contractual documents (e.g. bids, proposals, awards, modifications, etc.) shall be completed and signed by the Contractor as follows:

(a) Individuals. Signed by the individual.

(b) Individual doing business as a firm. Signed by that individual, and the signature shall be followed by the individual’s typed, stamped, or printed name and the words, “an individual doing business as (insert name of firm).”

(c) Partnership. Signed in the partnership name. Prior to award, provide a list of all partners and designate which partners have authority to bind the partnership.

(d) Corporations. Signed in the corporate name followed by the work “by” and the signature, and title of the person authorized to sign. Prior to award, provide a list of individuals who have authority to bind the corporation.

(e) Joint Ventures. Signed by each participant in the joint venture in the manner prescribed in (a) through (d) above.

(f) Agents. When an agent is to sign the contract, other than as stated in paragraph (a) through (e) above, the agent’s authorization to bind the principal must be established by evidence satisfactory to the Contracting Officer.

QUOTE PREPARATION AND SUBMISSION INSTRUCTIONS:

Quotes are due by the date and time set for the receipt of offers shown in Block 8 of the SF 1449 (page 1 of this document). One electronic copy of all items requested below shall be submitted via email to the following:

Contracting Officer: Susan M. Rodriguez-Perez, susan.rodriguez-perez@va.gov Contract Specialist: Benjamin Amato, benjamin.amato@va.gov Contract Specialist: Chelsea Adams, chelsea.adams@va.gov.

The subject line of the email must read: 36C24825Q0021 – Custom Surgical Packs for Orlando.

Emails with attachments may not exceed 5mb. If your submission is larger than 5mb, you may send multiple emails – please add the following label to the email’s subject line, e.g., ‘1 of 3’, ‘2 of 3’, and so

on. (NOTE: Faxed quotes are NOT permitted under any circumstances.)

The following items must be submitted:

a. All commitments made in the quote may become a part of the resultant contract. The data submitted with each quote should be complete and concise, but not overly elaborate. Excessive reliance on promotional brochures is discouraged.

b. Electronic Copy: Provide one (1) electronic copy of the complete proposal. Electronic copies must be in Microsoft Word or Adobe Acrobat format, and virus checked prior to submission.

Volume 1 (PRICING):

1. SF1449 - fill-in blocks 17a, 30b, 30c and sign 30a.

2. Completed Section B.1(1)(a) titled Contract Administration. (Include Contractor address and point of contact information)

3. Signed Amendment(s) (SF 30) OR completed ACKNOWLEDGEMENT OF AMENDMENTS –

(if applicable).

4. Completed Section B.2 SCHEDULE OF SUPPLIES & PRICING.

5. Quoter shall describe their firm’s ability to provide the products required in accordance with the

SOW.

6. Quoter shall provide line items in the same format as Section B.2.

7. Quoter shall complete and sign VAAR 852.219-76 VA Notice of Limitations on

Subcontracting—Certificate of Compliance for Supplies and Products in Section C.

VOLUME 2 (TECHNICAL INFORMATION):

1. Manufacturer’s Product Specification or brochures.

2. Submission of Custom Surgical Pack Components with images and Salient Characteristics.

3. Item breakdown of consumables, materials and equipment (do not include prices in volume 2).

4. Authorization letter from manufacturer to distribute or resell equipment.

5. Warranty Information

The Technical volume should include necessary information regarding the offeror’s ability to perform all requirements outlined in the solicitation. Failure to provide a Technical information in accordance with the solicitation instructions may render a quote incomplete and ineligible for award.

Quoters, at the discretion of the Government, may be asked to provide information for clarification purposes regarding their proposals. Requests for clarification information do not constitute discussions.

The Quoters shall be held responsible for the validity of all information supplied in his/her quote, including information provided by potential subcontractors. Should subsequent investigation disclose that the fact and conditions were not as stated, the quote may be rejected and receive no further consideration.

clearly marked. The use of hyperlinks in quotes is prohibited. Late quotes will not be accepted for evaluation. The contractor is responsible for confirming the Government’s receipt of the contractor’s quote.

If revised quotes are requested, the number of revised copies to be submitted shall be the same as those of initial proposals.

Submissions can be sent in multiple emails to avoid computer system email size limitation, to CO. Quotes submitted by any other method will not be considered. All proprietary information must be clearly marked.

NOTE: Quoters who fail to submit required documentation may be considered ineligible for award.

(End of Addendum)

FAR 52.225-1 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): (A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components.

(End of Clause)

FAR 52.225-2 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 55% domestic content (yes/no)

[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)

VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE

OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (NOV 2022)

(a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows:

(i) [ ] In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIPlisted SDVOSBs as set forth in 852.219–73 or VOSBs as set forth in 852.219–74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fillin—check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

(i) [] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer.

[ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) [ ] The offeror certifies that it will supply the end item of a small business manufacturer, processor, or producer made in the United States, unless a waiver as provided in 13 CFR 121.406(b)(5) has been issued by SBA. [Contracting Officer fill-in or removal (see 13 CFR 121.1205). This requirement must be included for a single end item. However, if SBA has issued an applicable waiver of the nonmanufacturer rule for the end item, this requirement must be removed in the final solicitation or contract.] or [Contracting officer tailor clause to remove one or other block under subparagraph (iii).] b If this is a multiple item acquisition, the offeror certifies that at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns. [Contracting Officer fill-in or removal. See 13 CFR 121.406(d) for multiple end items. If SBA has issued an applicable nonmanufacturer rule waiver, this requirement must be removed in the final solicitation or contract.]

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/ VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following: (i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and (iii) Prosecution for violating section 1001 of title 18. (b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement.

Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification

I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee: ___________

Printed Title of Signee: _____________

Signature: ____________

Date: ______________

Company Name and Address: _______________

(End of Clause)

End of Document