HLA Class II Generation Sequencing

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13. The solicitation number is FDA_SOL_1214032. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2019-02 dated May 06, 2019. The associated North American Industry Classification System (NAICS) Code is 541380- Testing Laboratories; Small Business Size standards $15.0 million. This requirement is solicited as a Full and Open competition. Requirement The FDA/CBER requires HLA Typing to support hemophilia genetic project at CBER. HLA typing is performed as a routing service in CBER clinical laboratories. For our research we require high resolution, gene-based HLA typing of 1,000 patient samples. There are several HLA loci on the human gene; we require HLA Class II DRB1; DRB 3, 4 & 5; DQB1 and DPB1 to be typed for all 1,000 samples Technical Specifications: DNA samples from de-identified hemophilia A patients have been collected by MLOF under appropriate IRB approvals from consented patients. These have been provided to the FDA and we will ship them to the selected clinical laboratory for high-resolution HLA typing. It is required that the vendor perform HLA typing of the following loci: - HLA Class II DRB1 - HLA Class II DRB 3, 4 & 5 - HLA Class II DQB1 - HLA Class II DPB1 Schedule of Supplies or Services and Prices/Costs (inclusive of delivery) 0001 HLA Class II Generation Sequencing DRB1, DBRB345, DQB1, DPB1, per the minimum requirements. Quantity: 1,000 Each Unit Price: ____________________________ Extended Price: ____________________________ GSA Contract Number (if applicable): ____________________________ Deliverables acceptance criteria: All items shall include shipping, handling and in-side delivery to the destination identified herein. The contractor will deliver the data within 60 days after receipt of order of DNA samples being provided by FDA. If there are technical difficulties the vendor shall notify the FDA and provide alternate dates for delivery. The FDA COR/TPOC will inspect and make acceptance decisions for all materials, documents, and services provided under this contract. The COR/TPOC shall monitor the Contractor's performance, evaluate the quality of services and perform the final inspection and acceptance of all deliverables. The Contractor is prohibited from any use of the data. The data is solely owned by the FDA. TPOC will verify sample data received and acceptable within 60 days to review. If data is not acceptable, the experiment should be repeated to generate acceptable data and provided to the FDA investigator within 60 days. Delivery Address (*FOB Destination): US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) 10903 New Hampshire Ave. Building 52/72, Room number 4120 Silver Spring, MD, 20993 Contract Type: Commercial Item-Firm Fixed Price Period of Performance: Delivery expected within 60 days of DNA samples being provided by FDA. If there are technical difficulties the vendor shall notify the FDA and provide alternate dates for delivery. All questions shall be received via email to Roosevelt Walker at contact@example.gov before 1:00 P.M. (Central Prevailing Time) on June 11, 2019. Solicitation Provisions 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition and can be obtained at https://www.acquisition.gov/far/ and http://farsite.hill.af.mil/VFHHSAR1.htm FAR Provisions 52.204-7 System for Award Management (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting. (Jul 2016) 52.204-17 Ownership or Control of Offeror (Jul 2016) 52.204-20 Predecessor of Offeror (Jul 2016) The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (Oct 2018) applies to this solicitation. The following addenda apply: Microsoft Suite Documents Containing Macros The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicants responsibility to ensure all electronic documents are submitted without the use of macros. It is the offeror's responsibility to monitor the Government Point of Entry (GPE) FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Price: Provide detailed price quote for each item proposed to meet the Schedule of Items. Include the firm's DUNS number with quote. The option year periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly. Technical Capability: Will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered supplies meet or exceed the technical requirements identified above, the quality of the work to be performed and the ability of the offeror to accomplish what is proposed. Offerors shall specifically address the performance specifications and support same with submitted technical specifications, descriptive material, literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered solution at meeting or exceeding the stated needs of the FDA. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA's stated need. All Offerors shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only service records and reports and invoices to be applicable to the requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. The price proposed shall represent the offeror's response to the schedule of supplies/services above. The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The following addenda apply: (i) Technical Capability (See FAR Provision 52.212-1 and addenda thereto) (ii) Price (See FAR Provision 52.212-1 and addenda thereto) The government intends to award a firm?fixed?price order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous or best value to the government; price and other non-price factors considered. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018), applies to this acquisition. 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) website 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- "Administrative merits determination" means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance. "Arbitral award or decision" means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance. "Civil judgment" means- (1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction. (2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance. "DOL Guidance" means the Department of Labor (DOL) Guidance entitled: "Guidance for Executive Order 13673, - Fair Pay and Safe Workplaces'". The DOL Guidance was initially published in the Federal Register on August 25, 2016, and significant revisions will be published for public comment in the Federal Register. The DOL Guidance and subsequent versions can be obtained from www.dol.gov/fairpayandsafeworkplaces. "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. "Enforcement agency" means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13673 are- (1) Department of Labor Wage and Hour Division (WHD) for- (i) The Fair Labor Standards Act; (ii) The Migrant and Seasonal Agricultural Worker Protection Act; (iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act; (iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act; (v) The Family and Medical Leave Act; and (vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors); (2) Department of Labor Occupational Safety and Health Administration (OSHA) for- (i) The Occupational Safety and Health Act of 1970; and (ii) OSHA-approved State Plans; (3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for- (i) Section 503 of the Rehabilitation Act of 1973; (ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974; and (iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity); (4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and (5) Equal Employment Opportunity Commission (EEOC) for- (i) Title VII of the Civil Rights Act of 1964; (ii) The Americans with Disabilities Act of 1990; (iii) The Age Discrimination in Employment Act of 1967; and (iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act). "Forced or indentured child labor" means all work or service- (6) 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 (7) 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). "Labor compliance agreement" means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters. "Labor laws" means the following labor laws and E.O.s: (1) The Fair Labor Standards Act. (2) The Occupational Safety and Health Act (OSHA) of 1970. (3) The Migrant and Seasonal Agricultural Worker Protection Act. (4) The National Labor Relations Act. (5) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act. (6) 41 U.S.C. chapter 67, formerly known as the Service Contract Act. (7) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity). (8) Section 503 of the Rehabilitation Act of 1973. (9) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974. (10) The Family and Medical Leave Act. (11) Title VII of the Civil Rights Act of 1964. (12) The Americans with Disabilities Act of 1990. (13) The Age Discrimination in Employment Act of 1967. (14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors). (15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html). "Labor law decision" means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of "labor laws". "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. "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. "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. "Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern- (1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and (2) Whose management and daily business operations are controlled by one or more women. "Women-owned small business (WOSB) concern eligible under the WOSB Program" (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. Note to paragraph (a): By a court order issued on October 24, 2016, the following definitions in this paragraph (a) are enjoined indefinitely as of the date of the order: "Administrative merits determination", "Arbitral award or decision", paragraph (2) of "Civil judgment", "DOL Guidance", "Enforcement agency", "Labor compliance agreement", "Labor laws", and "Labor law decision". The enjoined definitions will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction. (b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website. (2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through http://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 (t) 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) Representations required to implement provis...