Combined_Synopsis_Solicitation_OC-2025-130285.docx

1. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

2. The solicitation number is: OC-2025-130285 and is issued as a request for quotation (RFQ).

3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03.

4. This requirement is being solicited as a total small business set-aside.

a. The NAICS for this requirement is: 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing

b. The SB size standard for the NAICS code is: 1,250 employees (as of latest SBA Table).

c. The PSC for this requirement is: 6515 – Medical and Surgical Instruments, Equipment, and Supplies

5. The following list of line items:

The following Contract Line-Item Numbers (CLINs) are identified in Attachment C – Pricing Schedule. Offerors shall complete and submit Attachment C in full. Do not alter CLIN numbering or quantities.

6. Description of requirement The U.S. Food and Drug Administration (FDA), Office of Occupational Safety and Health (OOSH), requires the procurement, delivery, installation, maintenance, and support of Automated External Defibrillator (AED) units and associated components for its nationwide Public Access Defibrillation (PAD) Program. The Contractor shall provide FDA-approved biphasic escalating waveform AED units with real-time CPR feedback and self-diagnostic capabilities, along with integrated PAD PAK cartridges, responder kits, storage cabinets, signage, and inspection tags. The requirement includes a phased replacement of approximately 400 AED units and related components over fiscal years 2025 and 2026, as well as ongoing preventive maintenance and monitoring. The Contractor shall also provide CPR/AED training and certification for up to 500 FDA personnel annually, in accordance with American Heart Association (AHA) or American Red Cross (ARC) standards. Additional requirements include 24/7 technical support, post-event data retrieval services, and transition support at contract closeout. All equipment and services must comply with applicable FDA, OSHA, DOT, and AHA standards.

7. Delivery information.

a. Acceptance shall be performed at the delivery locations.

b. The FOB point is DESTINATION.

c. The period of performance will be a 12-month base period and two 12-month option periods.

d. Place of performance: Various FDA locations across 87 cities in 34 states and U.S. territories.

e. Delivery point of contact: To be identified at time of award.

8. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision is provided.

a. Addendum to FAR 52.212-1:

1. The quote validity period is to be 90 calendar days from date of quotation deadline.

2. Question Deadline: The deadline for receipt of questions is Wednesday, September 17, 2025 at 12:00PM ET (Eastern Time). Submit questions using Attachment D (Pre-Proposal Questions Form)

3. Quotation Deadline: The deadline for receipt of quotations is Wednesday September 24, at 12:00 PM ET. Quotation submissions shall be submitted electronically to the primary and secondary POCs identified.

4. Quotation Submission Instructions:

i. The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables. Quotes shall be for all the deliverables requested.

ii. Formatting Instructions for Proposal Submission

· Font Type and Size:

· Use Times New Roman or Arial, 12-point font for all narrative text.

· Tables, charts, and graphics may use 10-point font minimum as long as they remain legible.

· Line Spacing:

· Use single spacing within paragraphs.

· Leave a blank line between paragraphs and sections for readability.

· Margins:

· Use 1-inch margins on all sides (top, bottom, left, right).

· Page numbers should appear in the footer, centered or right-aligned.

· Page Layout:

· Use 8.5 x 11-inch pages, portrait orientation, unless otherwise specified.

· Fold-out pages for large graphics/charts are permitted if clearly labeled.

· Other Formatting:

· Headings and subheadings may be bolded for clarity.

· Do not use compressed spacing, narrow fonts, or other devices to exceed page limits.

· Ensure all text, figures, and tables are clear, legible, and printable in black and white.

iii. Submit two separate volumes:

a. Volume I – Technical: Must exclude pricing. Page limits include all coversheets, table of contents, etc. Must address the following:

i. Technical Capability. Page limit: 25. Offerors shall submit a Technical Proposal that clearly demonstrates their ability to meet all requirements of the PWS. The proposal shall include documentation showing that the proposed AED units conform to all specifications and configurations. Offerors shall provide a detailed plan for delivery and installation at all designated locations identified in Appendix A, addressing staffing, resources, schedule, and risk mitigation.

The proposal shall describe the preventive maintenance and remote monitoring program, including methods for inspecting 20–30% of devices each quarter to ensure 100% annual completion, and the systems or processes that will be used to track and document device readiness. Offerors shall also explain their approach to technical and program management support, including administration of the AED Site Coordinator list, data governance, continuous technical assistance with defined service levels and escalation paths, and procedures for post-event data retrieval, analysis, and reporting.

Finally, proposals shall identify qualified staff and the tools and systems that will be used to accomplish the work. Offerors shall describe their quality assurance methods, performance metrics, and monitoring processes to demonstrate how they will ensure consistent, compliant performance throughout the period of performance.

ii. Corporate Experience. Page limit: 10. Offerors shall provide a minimum of three (3) and no more than five (5) examples of projects performed within the last five (5) years that demonstrate relevant experience of similar size, scope, and complexity to this AED Program. Each example shall identify the client, contract or order number, period of performance, contract value, locations covered, scope of work, roles performed, and outcomes achieved.

Experience must clearly show the ability to support AED devices across a wide geographic area comparable to the locations identified in the PWS. Offerors shall also provide current references or points of contact with telephone numbers and email addresses for each example.

iii. Management Approach. Page limit: 10. Offerors shall describe their approach to staffing, managing, and controlling performance in accordance with PWS §4.0. The proposal shall include an implementation plan that addresses phasing, schedule, logistics for distributed sites, key dependencies, and acceptance procedures. Offerors shall identify Key Personnel, demonstrate their qualifications and availability, and describe the approach to managing any subcontractors. Proposals shall also outline risk-mitigation strategies and present a quality-control framework with measurable performance indicators to ensure consistent, compliant performance.

b. Volume II – Price: No page limit. Include completed pricing schedule, Attachment C, and cost breakdown and clearly state all assumptions. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

iv. Quotes shall clearly reference the RFQ number and include:

a. Date of quotation

b. Company Name

c. Company Point of Contact name, email address and phone number

d. System for Award Management Unique Entity ID (UEI)

e. Quotation validity of at least 90 days after RFQ due date and time

v. The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

9. FAR 52.212-2 - Evaluation—Commercial Products and Commercial Services

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation and is determined to be the most advantageous to the Government, considering price and non-price factors.

Factor 1 – Technical Capability The Government will evaluate the Offeror’s demonstrated ability to meet all technical requirements, including conformity with AED specifications and configurations; a realistic, adequately resourced plan to deliver and install at all designated locations identified in Appendix A of the PWS; and a preventive-maintenance and remote-monitoring program that inspects approximately 20–30% of devices each quarter to ensure 100% completion annually. The evaluation will also consider the Offeror’s Technical and Program Management Support, including administration of the AED Site Coordinator list and related data governance, provision of continuous technical assistance with defined service levels and escalation paths, and end-to-end post-event data retrieval, analysis, and reporting with timely, accurate deliverables. Assessment will focus on the clarity and feasibility of methods, staffing and qualifications, tools and systems, schedule realism, risk identification and mitigation, and the proposed quality controls and performance metrics to ensure consistent, compliant performance.

Factor 2 – Corporate Experience The Government will assess the extent to which the Offeror demonstrates recent, relevant experience performing projects of similar size, scope, and complexity to this AED Program (e.g., multi-site AED deployment, maintenance/monitoring, training, and support), and the degree to which that experience supports confidence in successful performance. Experience should clearly show supporting devices across a wide geographic area like the locations provided.

Factor 3 – Management Approach The Government will evaluate the soundness and feasibility of the Offeror’s plan to staff, manage, and control performance in accordance with PWS §4.0 (and applicable subsections), including a coherent implementation plan (phasing/schedule, logistics for distributed sites, dependencies, and acceptance), qualified and available Key Personnel, credible subcontractor management, practical risk-mitigation strategies, and a quality-control framework with measurable performance indicators.

Factor 4 – Price The Government will evaluate price for internal consistency and completeness relative to the solicitation/IDIQ/TO structure and PWS deliverables; for market reasonableness (e.g., comparison to current prices paid, IGCE, competition, and other data); and for the absence of duplicative or improper charges and any indication of unbalanced pricing, to determine whether the overall price is fair and reasonable.

10. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION FEB 2025), with their offer.

11. The clause 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Addenda to the clause is attached to this clause.

12. The clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Nov 2021) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) 52.219-28, Post-Award Small Business Program Representation (Sep 2021) 52.222-1, Notice to the Government of Labor Disputes (Feb 1997) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Dec 2023) 52.222-50, Combating Trafficking in Persons (Nov 2021) 52.225-1, Buy American—Supplies (Oct 2022) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) 52.232-33, Payment by Electronic Funds Transfer – System for Award Management (Oct 2018) 52.247-34 – FOB Destination 52.246-2 – Inspection of Supplies—Fixed-Price

13. The following additional contract requirement(s) or terms and conditions apply:

a. HHS and FDA Special Invoicing instructions

b. Provision 52.204-29, Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures (Dec 2023)

14. This acquisition is NOT rated under the Defense Priorities and Allocations System (DPAS).

CLAUSES

29.2 Federal Excise Taxes (July 2025) (DEVIATION)

In accordance with FAR Subpart 29.2, the Government is generally exempt from Federal Excise Taxes. Accordingly, offerors shall submit pricing on a tax-exclusive basis, unless a specific exemption does not apply. The Contracting Officer may request documentation to support any claimed exemptions. Tax matters are under IRS jurisdiction and not subject to contract dispute.

52.217-8 Option to Extend Services (Nov 1999) (DEVIATION)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time prior to contract expiration.

52.217-9 Option to Extend the Term of the Contract (Mar 2000) (DEVIATION)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36 months.

HHSAR 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

FDA Electronic Invoicing and Payment Requirements – Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted.

(ii.) corresponding payment amount & date received.

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that’s needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

14. This acquisition is NOT rated under the Defense Priorities and Allocations System (DPAS).

15. Offers are to be submitted via email to the primary and secondary points of contact by the date and time listed on the SAM.gov notice.

16. The name and email of the primary and secondary points of contact are as listed in the SAM.gov notice.

FAR 52.212-3 Offeror Representations and Certifications – Commercial Products and Commercial Services (May 2024) (DEVIATION FEB 2025)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— Covered telecommunications equipment or services has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended. “Sensitive technology"— Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business (SDVOSB) concern means a small business concern— (1)

(i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that—

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

Service-disabled veteran-owned small business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties’ control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with 13 CFR 124.1001, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding the threshold at 13 CFR 124.104(c)(2) after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned and controlled by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300.

(b)

(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM.

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs __.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that—

(i) It □ is, □ is not a small business concern; or

(ii) It □ is, □ is not a small business joint venture that complies with the requirements of 13 CFR 121.103(h) and 13 CFR 125.8(a) and (b). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) SDVOSB concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents that it □ is, □ is not an SDVOSB concern.

(4) SDVOSB concern joint venture eligible under the SDVOSB Program. The offeror represents that it □ is, □ is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [Complete only if the offeror represented itself as an SDVOSB concern in paragraph (c)(3) of this provision.] [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(5) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR 124.1001.

(6) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(7) WOSB joint venture eligible under the WOSB Program. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(8) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.] Note to paragraphs (c)(9) and (10): Complete paragraphs (c)(9) and (10) only if this solicitation is expected to exceed the simplified acquisition threshold.

(9) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(10) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________

(11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, as having been certified by SBA as a HUBZone small business concern in the Dynamic Small Business Search and SAM, and will attempt to maintain an employment rate of HUBZone residents of 35 percent of its employees during performance of a HUBZone contract (see 13 CFR 126.200(e)(1)); and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ______.] Each HUBZone small business concern participating in the HUBZone joint venture shall provide representation of its HUBZone status.

(d) [Reserved]

(e) Certification Regarding Payments to Influence Federal Transactions (31 http://uscode.house.gov/ U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American-Supplies, is included in this solicitation.)

(1)

(i) The Offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that each domestic end product listed in paragraph (f)(3) of this provision contains a critical component.

(ii) 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”.

(iii) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(iv) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” “domestic end product,” "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(2) Foreign End Products:

[List as necessary]

(3) Domestic end products containing a critical component:

Line Item No. ___ [List as necessary]

(4) The Government will evaluate offers in accordance with the policies and procedures of FAR part 25.

(g)

(1) Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act, is included in this solicitation.)

(i)

(A) The Offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (iii) of this provision, is a domestic end product and that each domestic end product listed in paragraph (g)(1)(iv) of this provision contains a critical component.

(B) The terms "Bahraini, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "critical component," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act."

(ii) The Offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahraini, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act."

Free Trade Agreement Country End Products (Other than Bahraini, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(iii) The Offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The Offeror shall list as other 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”.

Other Foreign End Products:

(iv) The Offeror shall list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

Line Item No. ___ [List as necessary]

(v) The Government will evaluate offers in accordance with the policies and procedures of FAR part 25.

(2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Israeli End Products:

Line Item No.

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraphs (g)(1)(i)(B) and (g)(1)(ii) for paragraphs (g)(1)(i)(B) and (g)(1)(ii) of the basic provision:

(g)(1)(i)(B) The terms “Korean end product”, “commercially available off-the-shelf (COTS) item,” “critical component,” “domestic end product,” “end product,” “foreign end product,” “Free Trade Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act.”

(g)(1)(ii) The Offeror certifies that the following supplies are Korean end products or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Korean End Products or Israeli End Products:

(4) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(4)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements."

(ii) The offeror shall list as other end products those end products that are not U.S.-made or designated country end products.

Other End Products:

(iii) The Government will evaluate offers in accordance with the policies and procedures of FAR part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation.

(h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals–

(1) □ Are, □ are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(2) □ Have, □ have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property;

(3) □ Are, □ are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and

(4) □ Have, □ have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds the threshold at 9.104-5(a)(2) for which the liability remains unsatisfied.

(i) Taxes are considered delinquent if both of the following criteria apply:

(A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(ii) Examples.

(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency.