FDA-RFP-1238397 TTIMS LRCC Solicitation 8 22 2021 7 04 PM.pdf

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Solicitation #: FDA-RFP-1238397 for

Transfusion-Transmissible Infections Monitoring System (TTIMS)

Laboratory & Risk Factor Database Coordinating Center (LRCC)

Issued: 08/22/2021

1. NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items/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. NOTICE OF REQUEST FOR PROPOSALS (RFP)

This solicitation, identified as FDA-RFP-1238397, is issued as a request for proposals (RFP) in accordance with the requirements of FAR Part 12 and 13.5.

The Government anticipates awarding a Firm-Fixed Price (FFP) contract from this solicitation. The total contract period of performance is 48 months (notwithstanding any extension under the FAR 52.217-8 clause) and consists of a one (1) year base year and four possible one-year options.

3. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-06, effective July 12, 2021.

FAR provisions and clauses referenced in this RFP can be found on the following website:

https://www.acquisition.gov/browse/index/far

HHSAR provisions and clauses referenced in this RFP can be found on the following website:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

4. NOTICE OF NAICS/SET-ASIDE

The associated North American Industry Classification System (NAICS) Code is 541990 – All Other Professional, Scientific, and Technical Services, with a small business size standard of $16.5 million.

This requirement is being solicited as full and open competition.

5. DESCRIPTION OF CONTRACT REQUIREMENTS

The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), has a requirement for a Transfusion-Transmissible Infection (TTI) Monitoring System (TTIMS) Laboratory and Risk Factor Database Coordinating Center (LRCC). See Attachment 1 – Statement of Work (SOW) for the full scope of this requirement.

https://www.acquisition.gov/content/part-12-acquisition-commercial-items#i1112616 https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

6. SCHEDULE OF SUPPLIES OR SERVICES AND PRICES/COSTS.

Contract Line Item

(CLIN)

Description QTY Unit Unit Price Extended Price

1 TTIMS-LRCC duties to be performed including all labor, facilities, materials and travel in accordance with requirements as identified in Attachment 1, Laboratory and Risk Factor Database (LRCC) Statement of Work (SOW) (11 Pages) and appendices thereto. Base Year Period of Performance

(POP) 09/25/2021 – 9/24/2022.

1 EA

The below items are optional and may be exercised in accordance with the applicable FAR Clause 52.217-9.

Option Item (FAR 52.217-9) Contract

Line Item

(CLIN)

Description Est

QTY

Unit Unit Price Extended Price

2 Option Year 1 - Same as Item 1 description.

POP 09/25/2022 – 9/24/2023

3 Option Year 2 - Same as Item 1 description.

POP 09/25/2023 – 09/24/2024

4 Option Year 3 - Same as Item 1 description.

POP 09/25/2024 – 9/24/2025

7. PERFORMANCE AND ACCEPTANCE INFORMATION

7.1. Period Of Performance

The anticipated performance periods for the base contract plus four (4) one-year option years are as follows:

Base Year: 09/25/2021 – 9/24/2022 Option Year 1: 09/25/2022 – 9/24/2023 Option Year 2: 09/25/2023 – 9/24/2024 Option Year 3: 09/25/2024 – 9/24/2025

7.2. Place Of Performance

Work will be performed at the contractor’s location but will support the FDA’s Center for Biologics, Evaluation and Research (CBER) located at:

US FDA/CBER

10903 New Hampshire Ave.

Silver Spring MD 20993

7.3. Observance of Federal Holidays & Other Government Closings

No services or deliveries shall be performed at federal sites on federal legal holidays or during other federal closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Juneteenth Thanksgiving Day Independence Day Christmas Day

7.4. Inspection and Acceptance

Services and/or supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer’s Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office.

If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

7.5. Service Contract Labor Statutes

Unless determined otherwise, work performed under a contract resulting from this solicitation is subject to the Service Contract Labor Standards statute; however, the place of performance is not yet known. Wage Determination(s) will be incorporated into any resultant contract as a separate attachment.

Wage Determinations – Offerors shall provide wage determination numbers for all locations of work to be performed by any non-exempt SCA employees. Offeror shall provide any Collective Bargaining Agreements in place, if applicable. Attachment 2 is reserved for Wage Determinations which will be attached and incorporated into any resultant contract awarded from this solicitation.

8. INSTRUCTIONS TO OFFERORS

The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items (July 2021), applies to this acquisition.

Addendum to FAR Provision 52.212-1 – the following paragraphs are modified or added to the provision:

Proposals must be prepared in accordance with the General Instructions, Technical Proposal Instructions, Past Performance Instructions and Business Proposal Instructions outlined in this section. These instructions establish the acceptable minimum requirements for the format and content of proposals. Special attention is directed to the requirements for the technical and business proposals, and the past performance information to be submitted in accordance with these instructions.

Paragraph (b) Submission of Offers. – Modified Submit signed and dated offers to the office specified in this solicitation on or before the exact date and time specified in this solicitation. Offers may be submitted on company letterhead stationery.

The government is not responsible for locating or securing any information which is not identified in the Offeror’s Proposal. Your Proposal must include the following information on the title/cover page of each volume submitted:

• The name, address, telephone and fax number of the Offeror, as well as the following information:

o The solicitation number and title;

o The date and time specified in the solicitation for receipt of offers;

o Tax identification number (TIN);

o Dun & Bradstreet Number (DUNS) o Contact Name o Contact Phone o Contact Fax Number o Contact email address

Offerors shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

8.1 General Information

Proposals must be prepared in accordance with the General Instructions, Technical Proposal Instructions, Past Performance Instructions and Business Proposal Instructions outlined in this section. These instructions establish the acceptable minimum requirements for the format and content of proposals. Special attention is directed to the requirements for the technical and business proposals, and the past performance information to be submitted in accordance with these instructions.

Proposal Volumes. Offerors’ proposals shall consist of three separate Volumes (see format instructions below):

• Volume 1 – Technical Proposal

• Volume 2 – Past Performance

• Volume 3 – Business/Pricing

The Government will evaluate proposals in accordance with the technical evaluation factors as described in Section 9 – Basis of Award & Evaluation.

8.2. Volume Preparation Instructions (Format)

Each volume shall be complete and separate from other volumes, signed by an official authorized to bind the Offeror. To permit a thorough and effective evaluation, each volume should be precise and complete, while as brief as possible. It is essential that the Offeror present information in sufficient detail so as to permit the Government to make an evaluation without further information being required from the Offeror.

All Volumes shall be formatted for standard letter-size (8.5 x 11 inch) paper with standard one-inch margins on each border, single spaced using a minimum of 11-point body text font size (table and graph font may be smaller, but must be clearly legible), using Times New Roman font.

All Volumes shall include:

• Cover Page (include the RFP title, RFP number and Company name)

• Table of Contents.

Electronic copies shall be submitted as follows:

• Using Microsoft Office programs (Word, Excel). If using Excel, do not hide formulas and do not protect cells.

• Adobe PDF:

o Combine individual files (if applicable) into a single PDF per Volume, i.e. Volume 1

– Technical Capability shall be submitted with the original Word documents and also with all Word files consolidated (if applicable) into a single pdf file. Submit Volume 2 and 3 in the same manner.

o PDF must be unlocked, unprotected, and fully searchable for specific text (i.e. not a scanned document with non-renderable text that will not allow word search functions).

8.3. Proposal Instructions (Content)

Volume 1 – Technical Volume. Factor 1: Technical Capability

The Technical Proposal shall not contain any reference to cost or price.

The Technical Proposal shall not exceed 25 pages. The Cover Page and Table of Contents are not included in the page limit.

Offerors must provide a narrative description which is aligned to the Statement of Work (SOW) and includes sufficient technical information necessary for the Government to conclusively determine that the offered services meet or exceed each of the requirements identified therein. Proposals shall thoroughly address at a minimum, the technical approach, program/project management, resources (i.e., facilities, hubs, staff, subcontractors, etc.), quality control, communications and outreach that will be utilized to satisfy all of the SOW requirements; detail; how the approach will further ensure the overall program objective(s) will be achieved. Identify personnel key to the success of the proposed approach, which at a minimum shall include program/project manager(s) and principal investigators/co-principal investigators, discuss their roles and responsibilities as well as their experience in performing same or near-same services. Provide resumes/curriculum vitae and signed letter of commitment (See Attachment 3 for Sample Letter of Commitment) for each key personnel.

The Offeror shall demonstrate their understanding of the requirements as set forth in the SOW and the Offeror’s methods, procedures and approach to performing the work.

Volume 2. Factor 2: Past Performance

The purpose of this Past Performance section is for the Offeror to demonstrate/discuss how well the Offeror performed and how well the offered services met the requirement on similar contracts/projects; therefore, the Offeror shall submit recent and relevant past performance information on currently ongoing or completed contracts within the last three (3) years. A Sample Client Authorization Letter is included at Attachment 4 as a cover letter for Attachment 5 – Past Performance Evaluation Questionnaire for you to send to each of your clients notifying them that you have identified them as a reference related to past performance and notifies them that the questionnaires be returned to Howard Yablon, at the email addresses set forth in the Sample Client Authorization Letter. Offerors shall include a copy of the completed Past Performance Evaluation Questionnaire and the formal Sample Client Authorization Letter sent to each of the Clients with their proposal. Offerors are responsible for completing the “Contract Identification” information in Paragraph 1 of the Past Performance Questionnaire before sending the client letter and questionnaire to the client for their completion. If an Offeror has records in CPARS, CPARS may be submitted in lieu of the past Performance Questionnaire (PPQ); however, Offerors must fill out Section 1 of the PPQ and submit that with the Proposal.

Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Recent is defined as within the last three (3) years. Relevant is defined as work similar in terms of type, scope, complexity, and size of the work described in the

SOW.

Past Performance information will be used to determine the likelihood of success in meeting the FDA’s requirements as indicated by the Offeror’s record of past performance.

Volume 3. Factor 3: Business/Pricing

The price proposal shall consist of the following elements:

a. In addition to completing the pricing table provided herein in Section B, Offerors shall provide an in-depth cost proposal, in excel format as well as a pdf version, which shall include:

proposed labor categories with number of FTEs proposed, labor category descriptions, fixed or estimated labor hours, fully-burdened hourly rates and a breakdown of the price build-up for those rates. Fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative and profit, as well as any proposed management fees and a list of and proposed costs for equipment and materials. Offerors may use any spreadsheet format that provides the rate build-up for the Base Year and each Option Year.

b. Your proposal must stipulate that it is predicated upon all the terms and conditions of this RFP. In addition, it must contain a statement to the effect that pricing is valid through September 30, 2021.

c. A statement acknowledging any formal Amendments issued to the solicitation.

d. A narrative detailing any assumptions not addressed elsewhere in the proposal.

e. A completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items, as specified in Article 10, below.

f. Any other completed provisions with required fill-in information presented in the list of provisions and clauses herein.

Small Business Subcontracting Plan – Integral to any award decision and pursuant to FAR Clause 52.219-9, and as otherwise set forth herein, the Offeror shall submit with its proposal, a small business subcontracting plan containing at a minimum the content required by FAR Clause 52.219(d) and using the Attachment 6, HHS Small Business Subcontracting Plan template attached to this solicitation. If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Failure to submit and then negotiate an acceptable subcontracting plan within 10 calendar days of the date the Contracting Officer notifies the offeror of issues and concerns with the subcontracting plan will render the offeror, notwithstanding any tradeoff decision above, ineligible for award. The resulting subcontracting plan will be made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(I). Small businesses are exempt from this requirement.

The government is not responsible for locating or securing any information which is not identified in the proposal; however, the Government reserves the right to obtain information for use in the evaluation from all sources including sources outside of the Government.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) beta.sam.gov, Contract Opportunities for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Proprietary and/or confidential information shall be clearly marked.

9. EVALUATION CRITERIA & BASIS OF AWARD

The provision at FAR 52.212-2, Evaluation—Commercial Items (OCT 2014), applies to this acquisition. The provision is tailored to include evaluation factors as follows:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The Government will make award to the Offeror whose proposal represents the best value to the Government as determined by using tradeoffs among the technical, past performance, and price evaluation factors. Offerors are placed on notice that any proposals which are not minimally responsive to all the technical factors cited herein will be deemed reflective of an inherent lack of technical competence and may be grounds for the rejection of the proposal(s).

Offerors shall ensure that any relevant prior experience to be considered is documented within the proposal.

The following factors shall be used to evaluate offers:

1. Technical Capability

2. Past Performance

3. Price

Technical Capability and recent/relevant Past Performance are relatively equal, but when combined are significantly more important than price when determining the best overall value to the Government though price remains an important factor. If the Government determines non-price factors to be essentially equal among competing offerors, price becomes more important as a discriminating factor. The Government is more concerned with obtaining superior performance capability rather than lowest overall price. However, the Government will not make an award at a significantly higher overall price to achieve only slightly superior performance.

The Small Business Subcontracting Plan (N/A for Small Business Offerors) is not part of the best value trade-off decision but rather if the Government and offeror can negotiate an acceptable plan.

The plan is rated on an acceptable/unacceptable level. It will be evaluated based on the Offeror’s proposed subcontracting plan related to this effort. Evaluation will reflect the extent to which the contractor has committed to utilizing small businesses. Failure to submit and negotiate an acceptable subcontracting plan by the time of award or other time specified may render the Offeror ineligible for award of a contract. The subcontracting plan will become part of the contract. An Offeror must clearly document circumstances where no small business subcontracting opportunities exist which may be considered acceptable to the Government based on the information submitted.

Offerors are advised that the Government intends to evaluate proposals and make award without discussions; however, the Government reserves the right to request additional information or conduct discussions at any time.

Wage Determinations are not an evaluation factor for award of a contract resulting from this solicitation.

Offerors without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably but will be given a “neutral” rating. Favorable past performance is considered higher than neutral past performance.

Offerors are cautioned that an unrealistically low price or unbalanced pricing of Line Items or Option Years, as proposed initially or subsequently, may be grounds for eliminating a proposal from further consideration, either on the basis that the Offeror does not understand the requirement or has made an imprudent offer. The Government may evaluate the realism and reasonableness of the proposed prices and hourly rate(s).

Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

The Government will evaluate FAR 52.217-8 Option to Extend Services as if the extension of service clause is exercised for the maximum six (6) months, using the exact same rates and terms as the last option period being extended. Evaluation of this Option to Extend shall not obligate the Government to exercise the option; however if the option is exercised, a modification will extend the period of performance of the affected CLINs by up to six months.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

10. The Provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items (FEB 2021) applies to this acquisition.

(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. 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;

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_528902107 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title6-section395&num=0&edition=prelim

(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.

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 concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned 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.

(2) Service-disabled veteran 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).

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

Small disadvantaged business concern, consistent with 13 CFR 124.1002, 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 at 13 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 $750,000 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 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 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.

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 least 51 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.

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(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 Items, 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 will be performed in the United States or its outlying areas.

Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.

(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) Service-disabled veteran-owned small business 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 as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.

(4) 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 CFR124.1002.

(5) 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.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-

(i) It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter http://www.sam.gov/ https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1060550 https://www.acquisition.gov/content/part-4-administrative-and-information-matters#i1121876 the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: .] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

[Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that-

(i) It [ ] is, [ ] is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: .] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) 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.

(9) 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:

(10) 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, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: .] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order 11246-

(1) Previous contracts and compliance. The offeror represents that-

(i) It [ ] has, [ ] has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It [ ] has, [ ] has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that-

(i) It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or

(ii) It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(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) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item” “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:.

Line Item No. Country of Origin

[List as necessary]

(3) The Government will evaluate offers in accordance with the policies and procedures of

FAR Part 25.

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(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) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,” “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 Bahrainian, 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 Bahrainian, 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, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.”

Other Foreign End Products:

(iv) 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 I. If Alternate I 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:

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

Canadian End Products:

(3) 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 Canadian end products or Israeli end products as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-Israeli Trade Act”:

Canadian or Israeli End Products:

(4) 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 paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, 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 Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(5) 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)(5)(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.”

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(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 $3,500 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. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability.

Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(C) The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159.

The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. §362 (the Bankruptcy Code).

(i) Certification Regarding Knowledge of Child Labor for…