FO SOL .pdf

FDA-FO-22-1257734

Title: Benzene Screening of Drug Products

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation shall not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-05. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541380, Testing Laboratories and Services. This solicitation is intended for full and open competition.

BACKGROUND

To help assure safe and effective drugs are sold in the United States, the Food and Drug Administration (FDA) tests selected drugs in FDA laboratories. This includes active pharmaceutical ingredients (API) used to make the product and the finished drug product sold to consumers. We test using the same standards that are part of the drug approval process for identity, strength, purity, and bioavailability, which is also used to establish bioequivalence.

The FDA is committed to protecting patients from potentially unsafe, non-effective or poor-quality drugs. Postmarket surveillance testing is one way that FDA works to help ensure patients have access to safe, effective, quality drugs.

The FDA has become increasingly aware of the presence of benzene in some drug products.

FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. Benzene is a known human carcinogen that causes leukemia and other blood disorders. Certain hand sanitizers and aerosol drug products have been recalled due to benzene contamination. This contamination may be related to inactive ingredients such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons.

SUPPLIES OR SERVICES AND PRICES/COSTS

Description Quantity Unit Price Price Benzene Samples 200 $ $

TOTAL COST $

CONTRACT TYPE

Firm Fixed Price

OBJECTIVES

Fund an accredited contract laboratory (i.e., to ISO 17025 or equivalent) to help the agency screen various marketed drug products to determine baseline levels of benzene. The analytical methods must be accurate and precise to very low levels (i.e., LOD ~100 ppb or lower). In addition, the contract laboratory must be equipped to handle significant throughput (~200 samples within a 12-month period of performance).

SCOPE

The overall scope of the project is to have a contract laboratory test ~200 drug product samples for benzene, using a validated test method(s). Drug product samples to test will be provided by the FDA, specifically gels and aerosols.

TASK

The FDA is seeking support in screening for benzene in various drug products.

The contracting laboratory shall have an established process for reliable receipt and management/traceability of all drug product samples provided for testing, including:

• Chain of custody

• Acceptable storage conditions

• Lot information

• Expiry information

• Ensure testing is performed within the sample’s expiration date.

• Ensure appropriate analytical test method development

The Contractor shall use methods that have been validated under appropriate quality management system and determined to be fit for purpose which includes the method characteristics given below. The Contractor shall provide FDA with method validation reports along with detailed analytical methodologies which shall include:

• System Suitability

• Specificity

• Accuracy

• Precision

• Robustness

• Limit of detection (LOD)

• Limit of quantitation (LOQ)

• Quality Control

• Range

• Linearity

• Recoveries

• Analytical testing may utilize compendial methods (e.g., FDA Guidance, USP Chapter

<1225>, ICH Guidance). Any exceptions to method validation as outlined in these methods should be justified.

Benzene testing requirements

Method(s) to quantitate benzene in gel and aerosol drug products shall be proposed by the Contractor, based on technical expertise and laboratory capabilities. Note that in this document, the term “gel” could also refer to ointments or creams, and the term “aerosol” could refer to sprays or foams. The FDA published a method for the analysis of benzene contamination in hand sanitizers that can be used as a reference or starting point for contractors needing to conduct full method development and validation of a test method for the analysis of benzene in gel and aerosol-based drug products. Contractors with existing methods for benzene detection should demonstrate existing methods and provide comparable results to the method developed by the FDA and referenced in literature.

Laboratory methods shall include a description of procedures used to determine the level of benzene in drug products. Additionally, the methods shall include a thorough description of how each type (gel or aerosol) of sample will be prepared and how the benzene concentration in each sample will be verified.

The Contractor shall conduct tests to determine benzene content in commercial products (~200) supplied by the FDA. Upon receiving the samples, the Contractor shall record product information, when possible, including full product name, image, manufacturer, lot/batch number (#), product identification number (ID) if any (e.g., UPC code), number of samples, receiving date, manufacturing date (if any), sell-by date (if any), and storage conditions by the laboratory before analysis. The Contractor shall keep a copy or photo of the front of the product package/label for record.

If matrix effects are observed for a sample under investigation, the Contractor shall provide a report on the recovery/efficiency studies performed. The Contractor shall provide this report no later than 30 days from day of discovery.

Provide Final Report to FDA, to include:

• Raw data and tabulated results (means, averages, coefficient of variation, and standard deviations) of all analyses of drug products specifically identified by FDA and for quality control samples.

• The number of documents provided and include representative data, results, and chromatograms with a brief explanation in the appropriate report(s) (e.g., collate chromatograms and insert them into the appropriate sections of the report instead of sending in numerous individual, unidentified data files; label chromatograms/data).

• If the Final Report refers to an internal document, please provide all documents in an appendix or in the report (e.g., if you refer to an internal method/SOP, provide the method/SOP).

Validation reports shall include:

• Full descriptions of analytical test methods used

• Summary of the quality management system under which the test methods were used and validated to complete the analysis

• Running control charts

• Descriptions of any laboratory issues encountered along with their solutions, and any other issues relevant to the study.

• Standard Operating Procedures that were used for the sample management and analysis

• All internal documents that are referenced by the report. These documents can be provided in an appendix or in the report (e.g., if you refer to an internal method/SOP, provide the method/SOP).

Before issuing the Final Report, the Contractor shall provide the template for the draft Final Report to FDA.

The Final report is due to FDA no later than 30 days after completion of testing, or no later than 30 days before the end of the period of performance (whichever is sooner).

DELIVERABLES

Deliverables Due Date Monthly progress reports – documented activities and accomplishments, overall performance compared with goal, and overall summary. These progress reports should include any problems identified along with recommended solutions.

5th working day of each month

Kick-off meeting One calendar week after award date

Established procedure for receipt, storing, and traceability of samples for testing while in the Contractor’s possession (FDA providing all samples to test)

Two calendar weeks after award date

Established procedure(s) to ensure testing is performed on samples within expiry (this may include some prioritization schema)

Two calendar weeks after award date

Validated test method for gels – documented, submitted to FDA 10 weeks after award date

Validated test method for aerosols – documented, submitted to FDA 10 weeks after award date

Test Results/Analytical Worksheets submitted to FDA as part of monthly progress reports

Monthly, starting in January 2023

Draft Report Template, requiring FDA approval Nine months after award date

Final Report, tabulating all relevant activities and results No later than 11 months after award date

CONTRACTOR PERSONNEL

The Contractor shall propose individuals with resumes to fill at least the following, minimum key personnel positions:

• Program/Project Manager

• Analytical Chemist

• Technician

CONTRACTOR PERSONNEL / LABOR CATEGORIES

The Contractor shall propose additional labor categories describing how and where they intend to apply them utilizing the labor categories described in the BPA SOW.

PERIOD OF PERFORMANCE

12 months from date of award

GOVERNMENT ISSUED PROPERTY

Not applicable.

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer’s Representative (COR) is the following: TBD

The contact information for the FDA Contracting Officer (CO) is the following: TBD

The contact information for the FDA Contract Specialist (CS) is the following: TBD

The contact information for the FDA Technical Point of Contact (TPOC) is the following: TBD

CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

52.252-2 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:

www.acquisition.gov/far/index.html

52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.202-1 Definitions (November 2013) 52.203-5 Covenant Against Contingent Fees (May 2014) 52.203-7 Anti-Kickback Procedures (May 2014) 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-3 Offeror Representations and Certifications-Commercial Items

1. As prescribed in 12.301(b)(2), insert the following provision:

2.

3. OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (JAN 2021)

http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194 https://www.acquisition.gov/far/part-12#FAR_12_301

4.

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

6. (a) Definitions. As used in this provision—

7. "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.

8. 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.

9. Forced or indentured child labor means all work or service—

10. (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

11. (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.

12. 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.

13. 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.

14. 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).

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

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

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

18. (3) PSG 88, Live Animals;

19. (4) PSG 89, Subsistence;

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

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

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

23. (8) PSC 9610, Ores;

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

25. (10) PSC 9630, Additive Metal Materials.

https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

26. 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.

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

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

29. 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—

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

31. (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;

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

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

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

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

36. Sensitive technology—

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

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

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

40. (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)).

41. Service-disabled veteran-owned small business concern—

42. (1) Means a small business concern—

43. (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

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

45. (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).

https://www.acquisition.gov/far/part-52#FAR_52_204_25 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

46. Small business concern—

47. (1) 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.

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

49. Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

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

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

52. (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

53. (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.

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

55. (1) Directly by a parent corporation; or

56. (2) Through another subsidiary of a parent corporation

57. 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.

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

59. (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

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

61. 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.

62. Women-owned small business concern means a small business concern—

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

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

(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

65. (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

66. [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.

67. 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.

68. 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.]

69. (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.

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

71. (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.

72. (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.

73. (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.

74. (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.

http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201

75. (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-

76. (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

77. (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.

78. (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-

79. (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

80. (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.

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

82. (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.

83. (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:____________________________________

84. (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–

85. (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

86. (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 Order11246-

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

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

88. (ii) It □ has, □ has not filed all required compliance reports.

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

90. (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

91. (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.

92. (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.

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

(1)

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

94. (ii) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

95. (iii) The terms "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American- Supplies."

96. (2) Foreign End Products:

97. [List as necessary] http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_225_1

98. (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)

(A) The Offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or

(iii) of this provision, is a domestic end product.

99. (B) The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "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."

100. (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."

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

102. [List as necessary]

103. (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.

104. Other Foreign End Products:

105. [List as necessary]

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

107. (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:

108. (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":

109. Canadian End Products:

110. [List as necessary]

111. (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:

https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3

112. (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":

113. Canadian or Israeli End Products:

114. [List as necessary]

115. (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:

116. (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":

117. Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

118. [List as necessary]

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

120. (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."

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

122. Other End Products:

123. [List as necessary]

124. (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.

125. (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–

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

127. (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;

https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_5 https://www.acquisition.gov/far/part-25#FAR_Part_25

128. (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

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

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

131. (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.

132. (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.

133. (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.

134. (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.

135. (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).

136. (i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (i)(1) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, unless excluded at 22.1503(b).]

137. (1) Listed end products.

https://www.acquisition.gov/far/part-9#FAR_9_104_5 https://www.acquisition.gov/far/part-22#FAR_22_1503

138. (2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.]

139. (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product.

140. (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that it has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor.

141. (j) Place of manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly-

142. (1) □ In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or

143. (2) □ Outside the United States.

144. (k) Certificates regarding exemptions from the application of the Service Contract

Labor Standards (Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services.) [The contracting officer is to check a box to indicate if paragraph (k)(1) or (k)(2) applies.]

145. (1) Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(1). The offeror □ does □ does not certify that–

146. (i) The items of equipment to be serviced under this contract are used regularly for other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontract) in substantial quantities to the general public in the course of normal business operations;

147. (ii) The services will be furnished at prices which are, or are based on, established catalog or market prices (see FAR 22.1003-4(c)(2)(ii)) for the maintenance, calibration, or repair of such equipment; and

148. (iii) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract will be the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

149. (2) Certain services as described in FAR 22.1003-4(d)(1). The offeror □ does □ does not certify that-

150. (i) The services under the contract are offered and sold regularly to non- Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations;

https://www.acquisition.gov/far/part-22#FAR_22_1003_4 https://www.acquisition.gov/far/part-22#FAR_22_1003_4 https://www.acquisition.gov/far/part-22#FAR_22_1003_4

151. (ii) The contract services will be furnished at prices that are, or are based on, established catalog or market prices (see FAR 22.1003-4(d)(2)(iii));

152. (iii) Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract;

and

153. (iv) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract is the same as that used for these employees and equivalent employees servicing commercial customers.

154. (3) If paragraph (k)(1) or (k)(2) of this clause applies–

155. (i) If the offeror does not certify to the conditions in paragraph (k)(1) or (k)(2) and the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and

156. (ii) The Contracting Officer may not make an award to the offeror if the offeror fails to execute the certification in paragraph (k)(1) or (k)(2) of this clause or to contact the Contracting Officer as required in paragraph (k)(3)(i) of this clause.

157. (l) Taxpayer Identification Number (TIN) ( 26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable if the offeror is required to provide this information to the SAM to be eligible for award.)

158. (1) All offerors must submit the information required in paragraphs (l)(3) through (l)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS).

159. (2) The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the offeror’s relationship with the Government (31 U.S.C.

7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror’s TIN.

160. (3) Taxpayer Identification Number (TIN).

161. TIN: ________________________________.

162. TIN has been applied for.

163. TIN is not required because:

164. Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States;

165. Offeror is an agency or instrumentality of a foreign government;

166. Offeror is an agency or instrumentality of the Federal Government.

167. (4) Type of organization.

168. Sole proprietorship;

169. Partnership;

https://www.acquisition.gov/far/part-22#FAR_22_1003_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-4#FAR_4_904

170. Corporate entity (not tax-exempt);

171. Corporate entity (tax-exempt);

172. Government entity (Federal, State, or local);

173. Foreign government;

174. International organization per 26 CFR1.6049-4;

175. Other ________________________________.

176. (5) Common parent.

177. Offeror is not owned or controlled by a common parent;

178. Name and TIN of common parent:

179. Name ________________________________.

180. TIN _________________________________.

181. (m) Restricted business operations in Sudan. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan.

(n) Prohibition on Contracting with Inverted Domestic Corporations.

(1) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

182. (2) Representation. The Offeror represents that–

183. (i) It □ is, □ is not an inverted domestic corporation; and

184. (ii) It □ is, □ is not a subsidiary of an inverted domestic corporation.

(o) Prohibition on contracting with entities engaging in certain activities or transactions relating to Iran.

(1) The offeror shall e-mail questions concerning sensitive technology to the Department of State at CISADA106@state.gov.

185. (2) Representation and Certifications. Unless a waiver is granted or an exception applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the offeror-

186. (i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran;

187. (ii) Certifies that the offeror, or any person owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Iran Sanctions Act; and

188. (iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds the threshold at FAR 25.703- 2(a)(2) with Iran’s Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (et seq.) (see OFAC’s Specially Designated Nationals and Blocked Persons List at https://www.treasury.gov/resource-center/sanctions/SDN- List/Pages/default.aspx).

https://www.acquisition.gov/far/part-9#FAR_9_108_2 https://www.acquisition.gov/far/part-9#FAR_9_108_4 mailto:CISADA106@state.gov https://www.acquisition.gov/far/part-25#FAR_25_703_2 https://www.acquisition.gov/far/part-25#FAR_25_703_2…