FDA-SOL-1149894.doc

FDA-SOL-1149894 – The Application of an Assay for the Identification of Phosphopeptide Presented in Heart Cells

PART 1 – GENERAL INTRODUCTION

This is a solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals being requested and a written solicitation will not be issued. The Government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is FDA-SOL-1149157 and this solicitation issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-82 dated June 08, 2015.

The associated North American Industry Classification System (NAICS) Code is 541711- Research and Development in Biotechnology; Small Business Size Standard is 15 million dollars. This RFQ issued as a set-aside for small business.

Contract Type: Commercial Item - Firm Fixed Price

PART 2 – SUPPLIES OR SERVICES AND PRICES/COST

The U.S. Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR), Jefferson, AR requires services for assessing protein expression changes in cell cultures using Gel-Mass Spectrometry Services. The human cell pellet samples obtained from government research lab. Ultimately, the cellular expression changes of the various proteins used as biomarkers of toxicity. Protein Mass Spectrometry approach is well-established approach in proteomics field, it is required to us 20 fractions approach (http://en.wikipedia.org/wiki/protein_massspectrometry) and it should profile ~ 3000 proteins for each sample. The post-translational modification of proteins-phosphorylation can be analyzed by iron immobilized metal ion affinity chromatography (Fe-IMAC) columns. Fifty-four (54) samples (cell pellets shall be analyzed, so that FDA can compare the effect of drugs on the cellular expression of the proteins. Ultimately, the cellular expression changes of the various proteins used as biomarker to predict the adverse effects.

PRICING TABLE:

4x50mm Fe-IMAC column

Total Cost

PART 3 - STATEMENT OF WORK

Background

Drug-induced cardiotoxicity is a leading cause for the withdrawal of marketed drugs in the US and the failure of investigational drugs in clinical trials. The limited number of biomarkers available today has yet to offer a comprehensive measure of valid scientific prediction of adverse outcomes. Therefore, there is a need to develop new biomarkers, especially phosphopeptide.

Scope

Omics technologies (proteomics) have shown promise of not only discovering new biomarkers of harm to various types of products (e.g., drugs and general chemicals), but also providing more sensitive indicators of cellular injury. Various protein changes in a target tissue or cell often occur before clear phenotypic signs of injury observed. In summary, omics analyses should be able to detect subtle changes in cellular function in response to the compounds.

The study, for which this SOW is prepared, is being conducted for in vitro cell lines with or without drug exposure. The Protein Mass Spectrometry (label-free) approach will be used to directly assess protein expression level in the cells. The major goal is to identify biomarkers of harm by comparing the protein changes after the treatment.

Work Requirements A. Technical Requirements for Perspective Vendor are as follows:

Vendor shall use cell pellets supplied by FDA.

Sample digestion- cell pellet samples shall be processed followed by in-solution trypsin digestion.

Fractionation- 20 fractions approach shall be used for all samples.

LC/MS/MS- After sample fractionation, each fraction shall run on LC/MS/MS.

Phosphopeptide enrichment- Comprehensive and reproducible phosphopeptide enrichment using iron immobilized metal ion affinity chromatography (Fe-IMAC) columns.

Data analysis- Alignment of chromatographic peaks for each m/z feature, normalization, integration and statistical analysis Will be performed for peptide identification.

Report generation -PDF report and Excel. Data rationalized and presented to ensure clarity and client side ability to understand the results.

US Government Laboratory will conduct the following during this study:

Will obtain chemical treated cells Will ship samples to selected vendor for processing and data analysis. A total of 54 samples will be shipped to the respective vendor within 12 months.

Place of Performance:

Biological sample analysis should be conducted at the perspective vendor's laboratory. Laboratory should be equipped to identify the peptide sequence via mass spectrophotometer. The altered phosphopeptide shall be analyzed by the vendor.

Biological samples shallbe shipped from the FDA Office, listed below.

US FDA NCTR

3900 NCTR Road Jefferson, AR 72079

POC: TBD

Phone: TBD

E-mail: TBD Period of Performance: 08/03/2015 – 08/02/2016 PART 4 – Packaging, Marking, and Shipping

4.1 Marking Instructions for Reports

All deliverables required under this contract shall be packaged, marked, and shipped with the organizations name and contract number. As appropriate, note on the face page of the report and when feasible on the binding: (1)”one volume only” or (2) “volume 1 of 2, volume 2 of 2” etc.

PART 5 – Inspection and Acceptance

5.1 The Contracting Officer or the duly authorized Contracting Officers Representative (COR) will perform inspection and acceptance of materials and services to be provided.

5.1.1 For the purpose of this SECTION, (The Contracting Officer’s Representative (COR) – to be named in separate correspondence is the authorized representative of the Contracting Officer and is responsible for inspection and acceptance of all items to be delivered under this contract.

5.1.2 Inspection and acceptance will be performed at 3900 NCTR Road, Jefferson, AR 72079. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized COR within 30 days of receipt.

5.1.3 The contract incorporate the following clause by reference, with the same force and effect as if it were given in full text. FAR clauses are also available on the Internet at: http://farsite.hill.af.mil/. Upon request, the Contracting Officer will make its full text available.

5.1.4 FAR Clause 52.246-2, Inspection of Supplies –Fixed-Price (August 1996).

PART 6 – Deliveries or Performance

Deliverables A full data report will be provided to the Systems Biology Division (FDA/NCTR). The report will be completed within three-months of receiving last biological samples from the FDA. The total period of performance of this research study should last no more than eight-months, once the contract has been award and the process is initiated, beginning when the first batch of samples shipped from NCTR to the selected vendor.

The data report will contain for, each sample, identification and quantification of peptides by mass spectrometry.

The final report should describe the methodologies, summary and overall findings, interim report is not necessary. The vendor should provide final reports on portable hard drive to hold all the data which shall include: raw data and tab-delimited file containing normalized signals of each protein.

PART 7 – Contract Administration Data

7.1 Contracting Officer Representative (COR)

The following COR will represent the Government for the purpose of this contract: (To be determined upon contract award)

7.1.1 The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

COR contact information shall be provided at time of award.

7.2 Contract Administration

7.2.1 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Linda Troutman

Contract Officer

Linda.Troutman@fda.hhs.gov 404-253-1258

7.2.2 CONTRACTOR REPRESENTATIVE

The Contractor's representative shall be responsible for all contract administration issues and shall act as the central point of contact with the FDA. The representative shall have full authority to act for the Contractor in all contractual matters.

Name:

Shall be provided at time of award

Email:

Telephone:

7.2.3 PAYMENT TERMS

A. Progress payment paid on a monthly basis with the receipt, review, and approval of information in Part 2, pricing table. Including the receipt of a proper invoice and a description of services delivered during the invoice period.

B. After completion of the work, and prior to final payment, the Contractor shall furnish to the Contracting Officer a release of claims against the United States arising out of the Contractor, other than claims specifically excepted from the operation of the release.

7.2.4 INVOICING SUBMISSION

In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration no later than 14 days prior to submission of the first invoice:

A. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Officer:

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

ATTN: Linda Troutman, Contracting Officer

60 8th street, NE

Room 116

Atlanta, GA 30309

E-mail: Linda.Troutman@fda.hhs.gov *** Acceptable methods of delivery include: mail, hand delivery and email***

(II)

One copy to the contracting officer representative (COR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration

ATTN: COR

Email:

*** Acceptable methods of delivery include: mail, hand delivery and email***

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt payment) AND 52.232-33 (Payment by electronic funds transfer – Central Contractor Registration) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase order/award number;

(IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) Period of performance for high costs claimed;

(b) Itemized travel costs, including origin and destination;

(c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped to Government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order/award, or in a proper notice of assignment);

(VIII) Name, title, and phone number of the person to notify in the event of a defective invoice;

(IX) Taxpayer identification number (TIN);

(X) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR), as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is □ is not □ 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:

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

(1) Invoice number, amount, and date submitted

(2) Corresponding payment amount and date received

(b) Total amount of all payments received to date under the subject contract or order

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

C. An electronic invoice is acceptable if in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

FDA Payment Services

ATTN: Vendor payment, OFS FDA

10903 New Hampshire Avenue

Bldg. 32, Rm 2162, Mail Hub 2145

Silver Spring, MD 20993-0002

301.827.3742 OR 866.807.3742

OFS/paymentservices@fda.hhs.gov

7.2.4.1 Final payments will occur upon verification by the FDA COR, noting acceptance of the work.

7.2.4.2 Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in Pricing Terms.

7.2.4.3. Payment will be made on the basis in accordance with the pricing matrix.

PART 8 - SPECIAL CONTRACT REQUIREMENTS

8.1 Security and Privacy

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems.

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval from the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the COR, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

SEQ CHAPTER \h \r 1 Each contractor/subcontractor employee who may have access to non-public Department information and/or sensitive information under this contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COR or designee prior to performing any work under the contract. The COR or designee will inform the contractor of the forms and training that are required. However, it is the responsibility of the Contractor to assure that such forms have been signed.

8.2 FDA 1338 Individual Conflict of Interest

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contacting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

8.3 Conflict of Interest Screening

An individual offeror/contractor submitting a proposal in response to this solicitation must submit the following information (if no relevant information exists, please provide a statement to that effect, limited to only those projects or financial holdings where the contractor believes there is or may be a potential for conflict).

1. Any contracts, grants, or cooperative research and development assignments that you are working on or have under negotiation;

2. Any other relevant information concerning any past, present, or planned interest that may have a bearing on the responsibilities described in the Statement of Work

The Contracting Officer’s Representative shall conduct a review of the information submitted and determine if a conflict of interest exist prior to forwarding any documents to the contractor. Prior to submitting new work assignment, the Contracting Officer’s Representative will follow-up with the contractor to determine if any changes to his/her financial interest have occurred.

8.4 Conflict of Interest Agreement

In executing this contract, the individual contractor agrees:

1. To report to the proper authority within the FDA (the Contracting Officer), any situation or event that may constitute a conflict of interest, whether actual or potential.

2. To act impartially and not give preferential treatment to any individual or organization which has submitted applications, information, and or data.

3. Not to solicit any gift or other item, nor accept any gift or other item, of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with or conducting activities related to the evaluations and work performed under this contract. Aggregate market value of individual gifts should not exceed $50.00 in a calendar year.

4. Not to participate in any matter involving specific parties who are likely to or can directly affect the financial interest of a member of his household or a relative with whom they have a close personal relationship; and

5. To disqualify himself from participating in particular matters involving former employees or their representatives, with whom they have worked within the past one (3) years and who might represent a conflict of interest.

8. 5 Organizational Conflict of Interest

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities.–1, and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested

8.6 Personnel Security Clearance Requirements

FDA 1335 Personnel Security Clearance Requirements (12/2010)

1. BACKGROUND

The office of the Assistant Secretary of Management and Budget of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information undergo a background investigation or some type.

Contractor employee who will be in DHHS-owned or lease space for less than thirty (30) days, are exempted from the background investigation requirement. The contractor employees must be escorted at all time while in DHHS-owned or leased space.

PART 9

CONTRACT CLAUSES

9. 1 52.252-2 FAR Clauses Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

https://acquisition.gov/far/

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which is incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

52.212-2 – Evaluation – Commercial Items (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

[Contracting Officer shall insert the significant evaluation factors, such as

(i) technical capability of the item offered to meet the Government requirement;

(ii) price;

(iii) past performance (see FAR 15.304);

Technical and past performance, when combined, are __________ [Contracting Officer state, in accordance with FAR 15.304, the relative importance of all other evaluation factors, when combined, when compared to price.]

(b) 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).

(c) 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)

52.212-3- Offeror Representations and Certifications -- Commercial Items (Mar 2015)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision--

“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;

(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.

“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—

(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 CFR 124.104(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.

“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 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 the 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 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.

“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.

(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 posted on the SAMwebsite.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation 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 applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ____________. [Offeror to identify the applicable paragraphs at (c) through (p) 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 to 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 CFR 124.1002.

(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.

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

(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 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.

(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 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:

[List as necessary]

(3) 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) 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…