9_-_Combined_Synopsis_Solicitation_-_Hydro_-_N62645-18-R-0014.docx

N6264518R0014

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 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. The solicitation number is N6264518R0014. The solicitation is issued as a request for proposals (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2005-95 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/ and http://farsite.hill.af.mil/. The NAICS code is 325413, with a small business size of 1,250. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

This RFP is on behalf of the Department of Defense (DoD) Drug Demand Reduction Program (DDRP). This requirement is for an immunoassay test reagent for the detection of Hydrocodone and Hydromorphone in urine.

Proposal Submission Proposals are due no later than 20 July 2018 by 02:00 PM Local Time. Proposals shall be submitted in accordance with the Addendum to 52.212-1 Instructions to Offerors.

Each

Hydrocodone & Hydromorphone Reagent Kits

FFP

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).

Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

PURCHASE REQUEST NUMBER: N6264518RC3D001

PSC CD: 6640

NET AMT

Each

FFP

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).

Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

NET AMT

Each

FFP

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).

Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

NET AMT

Each

FFP

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).

Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

NET AMT

Each

FFP

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).

Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

31-AUG-2019

SEE DO/TO

SEE DELIVERY/TASK ORDERS

FOR SHIP TO/ PAYMENT INSTRUCTIONS

SEE DO/TO MD

SEE ORDER

FOB: Destination N62645

31-AUG-2020

N62645

31-AUG-2021

N62645

31-AUG-2022

N62645

31-AUG-2023

N62645

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

(a) Definitions. As used in this clause-- Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015, (Pub. L. 113-235), and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

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:

The proposals will be evaluated under the following factors:

Volume I: Technical Approach Proposal Evaluation Factor A: FDA and ISO Certification Evaluation Factor B: Reagent Preparation and Calibration Information Evaluation Factor C: Performance Test – Minimum Requirements Evaluation Factor D: Performance Test – Enhancing Factors Volume II: Past Performance Proposal Evaluation Factor E: Past Performance Volume III: Small Business Participation Plan and Subcontracting Plan Proposal Evaluation Factor F: Small Business Participation Plan and Subcontracting Plan Volume IV: Business Proposal Evaluation Factor G: Price

Relative Importance of Factors. The relative importance of each factor is as follows:

Evaluation Factor A and Evaluation Factor B will be evaluated individually on a pass/fail basis. If an offeror's technical proposal is judged to have failed under Evaluation Factors A or B, either initially or following discussions if they are conducted, the firm's offer will receive no further consideration for award unless there are no other technically compliant proposals. If an offeror’s technical proposal is judged to have passed both Evaluation Factors A and B, then the offeror will subsequently be notified of Evaluation Factor C (Performance Test of their reagent), to determine compliance. If an offeror’s technical proposal is judged to have failed under Evaluation Factor C, the firm’s offer will receive no further consideration for award unless there are no other technically compliant proposals. If an offeror is judged to have passed under all Evaluation Factor A, B, and C minimum requirements, then the firm’s offer will be further evaluated on a tradeoff basis. Thus, Evaluation Factors D-G will be taken into consideration. In doing so, Evaluation Factor D (Performance Test – Enhancing Factors) is more important than Evaluation Factor E (Past Performance). The combination of Evaluation Factors D and E will be more important than Evaluation Factor F (Small Business Participation Plan and Subcontracting Plan). The combination of Evaluation Factors D, E and F will be more important than Evaluation Factor G (Price).

Tradeoff Evaluation Factor Ratings:

Evaluation Factor D: Performance Test – Enhancing Factors

Evaluation Factor E: Past Performance

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Certification of Food and Drug Administration (FDA) approval/authorization for the proposed HYDROCODONE/HYDROMORPHONE Immunoassay Reagent. Documentation of FDA approval/authorization for use of the HYDROCODONE/HYDROMORPHONE Immunoassay Reagent shall be provided with the offeror’s' proposal. Documentation of current certification compliance with applicable International Standards Organization (ISO) Standards (in the form of a copy of the applicable certificate(s)) or documentation of compliance with SOW Sections 4.1 through 4.5.6 shall be provided with the offeror’s’ proposal.

Evaluation Factor B: Reagent Preparation and Calibration Information. Package-insert with complete, accurate and verifiable information shall contain the following:

(1) Explanation and principles of the testing procedure.

(2) Description of each reagent composition of the reagents for use on the Beckman Coulter AU5800 Series Analyzer in the processing of samples.

(3) Instructions for reagent handling, mixing, and storage.

(4) Reagent stability and storage requirement for both unopened and opened working reagent.

(5) Calibration AND Parameter settings for use on the Beckman Coulter AU5800 Series Analyzer. The reagent calibrator and positive controls shall be recommended by the reagent kit manufacturer, and shall be either hydrocodone or hydromorphone.

(6) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the principal analyte(s).

(7) Table of cross reactivity and specificity of the assay, with regards to commonly encountered scheduled compounds, common over-the-counter medications, and other principal drugs of abuse.

Shelf-Life: In accordance with the SOW paragraph 1.5, the offeror shall provide reagent kits with a minimum shelf life of at least 180 days from date of delivery at the drug testing laboratory for any unopened component of the assay. Once kit container seals are broken and the component opened, the shelf-life shall be at least 14 days. The offeror shall specifically address shelf-life capabilities.

Evaluation Factor C: Performance Test – Minimum Requirements. If the offeror passes Evaluation Factors A and B, the Government shall conduct an evaluation of the vendor’s reagent at one of the five DoD military drug screening laboratories located within the continental United States (CONUS). The test shall be conducted in accordance with the established protocol cited below. Upon request, the offeror shall ship a SUFFICIENT number of reagent kits to perform at least five thousand (5,000) tests, plus enough reagent for instrument start up, calibration, quality control checks, and shut down. These reagents shall be shipped, at no cost to the Government, to one of the four DoD military drug-screening laboratories located within the continental United States (CONUS).

Performance Test – Minimum Requirements

Data obtained will be analyzed as to the HYDROCODONE/HYDROMORPHONE test reagent’s ability to meet the solicitation requirements, as described below.

The Calibrator (CAL) shall be a target concentration of 300 ng/mL. Quality Control (QC) samples containing the calibrator analyte at target concentrations of 0%, 50-75%, and 150-200% of the CAL concentration shall be analyzed with each batch of specimens. Data obtained will be evaluated to determine the vendor’s HYDROCODONE/HYDROMORPHONE test reagent’s ability to meet minimum requirements. The absorbance is normalized so that 100 indicates a positive result (results less than 100 are negative, results 100 or above are positive).

1. Previously confirmed and archived Hydrocodone and Hydromorphone positive specimens that are authorized for disposal will be re-confirmed as positive (Hydrocodone and Hydromorphone above 300 ng/mL, individually or in combination) and analyzed by immunoassay. At least twenty (20), but no more than one hundred (100), positive specimens will be analyzed with water blanks between each specimen.

1.1. The minimum requirement is met if at least 95% of the specimens are correctly identified as positive by the offeror’s immunoassay reagent for the presence of Hydrocodone and Hydromorphone, utilizing the DoD initial screen cutoff concentration of 300 ng/mL.

2. Routinely submitted military specimens will be analyzed by immunoassay. The military specimens are screened with an initial immunoassay kit (not the kit being solicited) to identify specimens that are presumptively positive for opioids which are subject to adjunct testing (using the kit identified in this solicitation). Approximately fifteen to twenty (15-20) adjunct batches containing opioid presumptive positive specimens will be analyzed.

2.1. The minimum requirement is met if 100% of the 0% QC samples screen negative and provide values less than the mean of the 50-75% QC samples both within runs and between runs.

2.2. The minimum requirement is met if at least 95% of the 50-75% QC samples screen negative.

2.3. The minimum requirement is met if 100% of the 150-200% QC samples screen positive.

3. Precision/accuracy, linearity, and calibration stability of the HYDROCODONE/HYDROMORPHONE reagent will be evaluated based on analysis of 20 replicates of QC samples at target concentrations of 0%, 50%, 75%, 100%, 125%, 150%, and 200% of the CAL analyzed at 0 hours, 4 hours, and 8 hours after calibration.

3.1. The minimum requirement is met if there is a positive correlation for the slopes (i.e., increasing concentrations result in increasing values) of the lines drawn between the mean replicate values of the 0% through 150% concentrations.

3.2. The minimum requirement is met if individual replicates at 0%, 50%, 100%, and 150% demonstrate a distinctive range of values with no overlap with adjacent concentrations.

3.3. The minimum requirement is met if the coefficients of variation (CVs) of the 20 replicate values at 75%, 100%, 125%, 150%, and 200% of the CAL are less than 10% within each run.

3.4. The minimum requirement is met if the CVs of the 60 replicate values at 75%, 100%, 125%, 150%, and 200% of the CAL are less than 15% within the three timed runs.

4. Cross reactivity to the non-target analyte will be evaluated based on analysis of 10 replicates of QC samples spiked with the non-target analyte at target concentrations of 100% and 125% of the cutoff concentration. The analyte used to calibrate the kit is the target analyte. Other analytes that are to be detected by the kit are the non-target analytes (i.e. Hydromorphone is the non-target analyte when the calibrator contains Hydrocodone).

4.1 The minimum requirement is met if the average response of the QC specimens, spiked with the non-target analyte, demonstrate at least 80% cross reactivity.

4.1.1. For the 125% non-analyte QC sample replicates, the average normalized response of the 10 replicates must be greater than or equal to 100.

4.1.2. For the 125% non-analyte QC sample replicates, 90% of the normalized responses must be greater than or equal to 100.

Evaluation Factor D: Performance Test – Enhancing Factors. Reagents meeting the minimum requirements of the Performance Test will then be evaluated by the government on the following factors:

(1) Linearity: A correlation coefficient which is closer to +1, as determined by linear regression analysis of data from Evaluation Factor C, 3. (0%, 50%, 75%, 100%, 125%, 150% and 200% of the CAL), will increase the value of the reagent.

(2) Sensitivity/Positive and Negative Predictive Rates: The specimens analyzed in the Minimum Requirements section 2 will be analyzed to evaluate the reagent’s ability to distinguish between specimens containing Hydrocodone and Hydromorphone at or above the 300 ng/mL screening cutoff and specimens that contain less than 300 ng/mL of Hydrocodone and Hydromorphone. Confirmation results will be compared to immunoassay results. Samples that yield a positive HYDROCODONE/HYDROMORPHONE initial screen result and samples that give a HYDROCODONE/HYDROMORPHONE screening index value greater than/equal to 75 (current kit and kit(s) being evaluated) will be confirmed by GC/MS or LC/MS/MS. Greater sensitivity (ability to discriminate between negative samples with Hydrocodone and/or Hydromorphone with concentrations below 300 ng/mL and positive samples with Hydrocodone and/or Hydromorphone with concentrations above 300 ng/mL) and predictive rates (fewer false positives and fewer false negatives) will increase the value of the kit.

(3) Specificity: The effect/interference of endogenous matrix components, commonly encountered compounds, and compounds that are structurally similar to the analytes of interest on the immunoassay response will be evaluated. Assessment will be performed by spiking drug-free urine with high concentrations of potentially interfering analytes. Cross reactivity will be evaluated with individual specimens containing 10 µg/mL of compounds such as fentanyl, norfentanyl, methadone, tramadol, meperidine, naloxone, and naltrexone. Individual specimens containing 10 µg/mL of the compounds on the current DoD testing panel (refer to SOW 1.2) shall also be evaluated. Cross reactivity will be measured by comparing response values to values for calibrators containing 300 ng/mL of the vendor’s recommended calibrator. Better specificity (lower/negative response values for non-analyte of interest specimens) will increase the value of the kit.

(4) Ease of preparation will be evaluated as an enhancing factor. Ready-to-use reagents with no additional mixing will be evaluated as an enhancing factor. Any additional required preparation will reduce the value of the kit.

Volume II: Past Performance Proposal

Evaluation Factor E - Past Performance. The Past Performance evaluation will result in an assessment of the offeror’s probability of meeting the solicitation requirements. The Government is likely to randomly select references provided for contact and does not commit to contacting every reference.

The Government will evaluate past performance for:

(a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection

(b) Quality: total number of rejected or returned reagents, with reasons for rejection or return, and total number of kits replaced

(c) Responsiveness: vendor's compliance with established delivery schedules and ability to provide timely replacement reagents due to recall or return.

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact (POCs) are verified and accurate. In the case of an offeror 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 on past performance (FAR 15.305(a)(2)(iv)). The offeror will receive a neutral rating.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2017)

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

“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”--

(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.

“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 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 stock of which 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 its stock is owned by one or more women; or

(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 electronically on the SAM website.

(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 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 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 (u) 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 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.

(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.

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) Certifications and 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 either to the Equal Opportunity clause of this solicitation, the 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 Subparts 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:

[List as necessary]

(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 Act-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I (Jan 2004). 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:

(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:

Line Item No.

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II (Jan 2004). 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 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 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''.

(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…