development of Integrated Navigation System
Notice Type: Amendment to Combined Synopsis/Solicitation
Posted Date:
Office Address:
Subject: development of Integrated Navigation System
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: HHSNCCOPCCS18-000011
Contact:
Setaside: N/AN/A
Place of Performance (address): 9000 Rockville PikeBethesda, MD
Place of Performance (zipcode): 20892
Place of Performance Country: US
Description:
Clinical Center/
COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: HHSNCCOPC18-000011 Posted Date:
This solicitation is a Request for Quotation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC 2005-96).
The associated North American Industrial Classification System (NAICS) code for this procurement is 541990, with a small business size standard of
The Clinical Center/Radiology & Imaging Sciences has a requirement to develop and validate a cost effective, easy-to-use and fully integrated navigation system for needle placement during image guided cancer diagnosis and treatment. Applications include but are not limited to biopsy, various thermal ablations (e.g. radiofrequency, cryo-, microwave, and laser ablation), and brachytherapy.
Accurate diagnostic and/or therapeutic intervention depends on accurate needle insertion, which may be extremely difficult in certain settings. In standard CT-guided needle placement procedures, translation from a pre-planned needle angle to the actual intra-procedural needle insertion is estimated only with the physician's visuospatial abilities and experience.
The goal of this contract is to improve needle placement in clinical practice. Image-guided needle insertion is a promising method for fulfilling the project goal, but the system must be cost-effective, accurate, and ergonomic to be clinically feasible. The proposed system's hardware includes a compact guidance platform that tracks needle-based interventional instruments, and provides navigation information to the clinician during the procedure. The system will be designed to assist with cancer treatment planning and procedure execution.
The technology will be a compact tracker design that can clip onto needles and provide Micro Electro Mechanical (MEM) inertial-based tracking. The hardware will also have fewer sterility requirements and it will be easier to calibrate compared to existing electromagnetic and optical tracking systems. The calibration step of the device only takes a few seconds, making it practically negligible. The wireless clip design allows the navigation device to be easily attached to and removed from any standard needles, which gives the physician the highly desired freedom to benefit from the navigation while minimizing its impact on the clinical workflow. Our device allows for visual guidance during procedures by providing real-time angulation tracking of needles, catheters, or interventional tools. Visual guidance will improve targeting accuracy, and reduce procedure time and side effects.
Outcome: The product of this contract is a fully integrated needle-guidance system prototype that is ready for human clinical trials. The system will be prototyped and evaluated in a live animal/human study to quantify the targeting accuracy and workflow for CT, Cone Beam CT, and Ultrasound-guided procedures.
Specifications: A2. Engineering Specifications:
A2. Engineering Specifications:
1. Wireless needle tracker
The Government seeks prototypes of wireless needle trackers to address the challenges in needle placement procedures by accurately tracking the needle angular and positional information. The needle tracker design should be compact, wireless, and can be clipped onto any needle instrument (Fig. 1a-d). The system will provide 6 degrees-of-freedom (DOF) sensing at up to 40 Hz. The tracker should be configured to wirelessly stream data via Bluetooth. The system should be ready for calibration and validation.
Sensor Fusion The Government requires a method to combine the use of a gyroscopic sensing and the gravity vector to enhance needle tracking accuracy.
A3. Specific Instrument Descriptions and Deliverables: The contract deliverables include the wireless tracker electronics, mechanical protection cases, calibration docking stations, tracker chargers, and software source code for streaming out the positional information from the tracker.
* 3 prototype Micro Electro Mechanical (MEM) trackers for abdominal biopsy needles * 3 prototype MEM trackers for abdominal ablation catheters * 3 prototype MEM trackers for abdominal ultrasound probes * 3 prototype universal MEM tracking beacons for multiple-propose tracking * 3 prototype MEM trackers for Prototype MRI-guided prostate transperineal focal laser ablation * 3 needle holders integrated with MEM trackers and an MRI visible needle-guide for navigation and registration * 3 prototype 100mmX100mm MRI visible grid fiducial markers for prostate transperineal procedures * 3 prototype electromagnetic tracker needle clips for multiple-propose needle procedures * The tracker cases together with the tracker calibration docking station will be fabricated using 3D printing technology and are made deposable.
D. Period of Performance: 2-year contract with the start date of award and end date of 24 months following
Period of Performance : Base Period- One year (specific dates to be determined) Option Period One: One year( specific dates to be determined)
Delivery Location, Schedule, and Instructions
Security Provisions See attached security clauses Government Furnished Equipment (GFE) There is no government furnished equipment requirements for this order.
Inspection and Acceptance Criteria N/A Award shall be made to the quotation which offers the best value to the government, considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria:
TECHNICAL EVALUATION ELEMENTS
1. Technical Approach (25) The Government will evaluate the offeror's technical approach to satisfy each element in the Statement of Work requirements. 2. Experience(25) The offeror must demonstrate a minimum of two (2) years of experience providing maintenance support services similar to or equivalent to the system that is subject of this procurement.
3. Past Performance (25) The offeror must provide three references from previous customers where the offeror provided maintenance support with similar specifications and complexity.
4. PRICE (25) The price quoted will be evaluated for price reasonableness. A best value analysis will be performed taking into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule.
The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.
The following solicitation provisions apply to this acquisition FAR 52.212-1, "Instructions to Offerors-Commercial Items" 1. FAR 52.212-3, "Offerors Representations and Certifications-Commercial Items" (April2016)
Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, "Offerors Representations and Certifications-Commercial Items." If paragraph (j) of the provision is applicable, a written submission is required.
The following contract clauses apply to this acquisition: * FAR 52.212-4, "Contract Terms and Conditions-Commercial Items" (
The following subparagraphs of FAR 52.212-5 are applicable:
PROVISIONS AND CLAUSES
CLAUSES INCORPORATED BY REFERENCE
52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items
52.203-3 Gratuities
52.232-30 Installment Payments for Commercial Items
52.212-3 Offeror Representations and Certifications -Commercial Items (
52.212-3 Offeror Representations and Certifications-Commercial Items.
Offeror Representations and Certifications-Commercial Items (
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
"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
"Enforcement agency" means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division,
(1)
(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
(2)
(i) The Occupational Safety and Health Act of 1970; and
(ii)
(3)
(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
(4)
(5)
(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
(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
(15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are
"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
(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
(1) Are conducted under contract directly and exclusively with the regional government of southern
(2) Are conducted pursuant to specific authorization from the
(3) Consist of providing goods or services to marginalized populations of
(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
(ii) To disrupt, monitor, or otherwise restrict speech of the people of
(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
(ii) Each individual claiming economic disadvantage has a net worth not exceeding
(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.
"ccessor" 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
Note to paragraph (a): By a court order issued on
(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
(1) Small business concern. The offeror represents as part of its offer that it ____ is, 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
(ii) It ____ is, ____ is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.
(d) Representations required to implement provisions of Executive Order 11246-
(1) Previous contracts and compliance. The offeror represents that-
(i) It ____ has, ____ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and
(ii) It ____ has, ____ has not filed all required compliance reports.
(2) Affirmative Action Compliance. The offeror represents that-
(i) It ____ has developed and has on file, ____ has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 cfr parts 60-1 and 60-2), or
(ii) It ____ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.
(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed
(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1,
(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
(2) Foreign End Products:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.
(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
(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:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[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
Other Foreign End Products:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.
(2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:
(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.
_______________________________________
_______________________________________
_______________________________________
[List as necessary]
(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:
(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade
Agreements-Israeli Trade Act":
Canadian or Israeli End Products:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:
(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act":
Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(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
(ii) The offeror shall list as other end products those end products that are not
Other End Products:
Line Item No.
Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(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
(h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals-
(1) ____ Are, ____ are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;
(2) ____ Have, ____ have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property;
(3) ____ Are, ____ are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and
(4) ____ Have, ____ have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds
(i) Taxes are considered delinquent if both of the following criteria apply:
(A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.
(B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.
(ii) Examples.
(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. [Section]6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.
(B) The
(C) The taxpayer has entered into an installment agreement pursuant to I.R.C. [Section]6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.
(D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. [Section]362 (the Bankruptcy Code).
(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).]
(1) Listed end products.
Listed End Product
Listed Countries of Origin
___________________ ___________________
___________________ ___________________
(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.]
____ (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.
____ (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.
(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-
(1) ____ In
(2) ____ Outside
(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.]
____ (1) Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(1). The offeror ____ does ____ does not certify that-
(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;
(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
(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.
____ (2) Certain services as described in FAR 22.1003-4(d)(1). The offeror ____ does ____ does not certify that-
(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;
(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));
(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
(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.
(3) If paragraph (k)(1) or (k)(2) of this clause applies-
(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
(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.
(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 database to be eligible for award.)
(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
(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
(3) Taxpayer Identification Number (TIN).
____ TIN: ________________________________.
____ TIN has been applied for.
____ TIN is not required because:
____ 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
____ Offeror is an agency or instrumentality of a foreign government;
____ Offeror is an agency or instrumentality of the Federal Government.
(4) Type of organization.
____ Sole proprietorship;
____ Partnership;
____ Corporate entity (not tax-exempt);
____ Corporate entity (tax-exempt);
____ Government entity (Federal, State, or local);
____ Foreign government;
____ International organization per 26 CFR 1.6049-4;
____ Other ________________________________.
(5) Common parent.
____ Offeror is not owned or controlled by a common parent;
____
TIN _________________________________.
(m) Restricted business operations in
(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.
(2) Representation. The Offeror represents that-
(i) It ____ is, ____ is not an inverted domestic corporation; and
(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
(1) The offeror shall e-mail questions concerning sensitive technology to the
(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-
(i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of
(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
(iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds
(3) The representation and certification requirements of paragraph (o)(2) of this provision do not apply if-
(i) This solicitation includes a trade agreements certification (e.g., 52.212-3(g) or a comparable agency provision); and
(ii) The offeror has certified that all the offered products to be supplied are designated country end products.
(p) Ownership or Control of Offeror. (Applies in all solicitations when there is a requirement to be registered in SAM or a requirement to have a unique entity identifier in the solicitation.
(1) The Offeror represents that it ____ has or ____ does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in the joint venture.
(2) If the Offeror indicates "has" in paragraph (p)(1) of this provision, enter the following information:
Immediate owner CAGE code: ____________________.
Immediate owner legal name: _____________________.
(Do not use a "doing business as" name)
Is the immediate owner owned or controlled by another entity: ____ Yes or ____ No.
(3) If the Offeror indicates "yes" in paragraph (p)(2) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:
Highest-level owner CAGE code: __________________.
Highest-level owner legal name: ___________________.
(Do not use a "doing business as" name)
(q) Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law.
(1) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, The Government will not enter into a contract with any corporation that-
(i) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or
(ii) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.
(2) The Offeror represents that-
(i) It is ____ is not ____ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and
(ii) It is ____ is not ____ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.
(r) Predecessor of Offeror. (Applies in all solicitations that include the provision at 52.204-16, Commercial and Government Entity Code Reporting.)
(1) The Offeror represents that it ____ is or ____ is not a successor to a predecessor that held a Federal contract or grant within the last three years.
(2) If the Offeror has indicated "is" in paragraph (r)(1) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):
Predecessor CAGE code: ________ (or mark "Unknown")
Predecessor legal name: _________________________
(Do not use a "doing business as" name)
(s) Representation regarding compliance with labor laws (Executive Order 13673). If the offeror is a joint venture that is not itself a separate legal entity, each concern participating in the joint venture shall separately comply with the requirements of this provision.
(1)(i) For solicitations issued on or after
(ii) For solicitations issued after
(2) If the Offeror checked "does" in paragraph (s)(1)(i) or (ii) of this provision, the Offeror represents to the best of the Offeror's knowledge and belief [Offeror to check appropriate block]:
____ (i) There has been no administrative merits determination, arbitral award or decision, or civil judgment for any labor law violation(s) rendered against the offeror (see definitions in paragraph (a) of this section) during the period beginning on
____ (ii) There has been an administrative merits determination, arbitral award or decision, or civil judgment for any labor law violation(s) rendered against the Offeror during the period beginning on
(3)(i) If the box at paragraph (s)(2)(ii) of this provision is checked and the Contracting Officer has initiated a responsibility determination and has requested additional information, the Offeror shall provide-
(A) The following information for each disclosed labor law decision in the System for Award Management (SAM) at www.sam.gov, unless the information is already current, accurate, and complete in SAM. This information will be publicly available in the Federal Awardee Performance and Integrity Information System (FAPIIS):
(1) The labor law violated.
(2) The case number, inspection number, charge number, docket number, or other unique identification number.
(3) The date rendered.
(4) The name of the court, arbitrator(s), agency, board, or commission that rendered the determination or decision;
(B) The administrative merits determination, arbitral award or decision, or civil judgment document, to the Contracting Officer, if the Contracting Officer requires it;
(C) In SAM, such additional information as the Offeror deems necessary to demonstrate its responsibility, including mitigating factors and remedial measures such as offeror actions taken to address the violations, labor compliance agreements, and other steps taken to achieve compliance with labor laws. Offerors may provide explanatory text and upload documents. This information will not be made public unless the contractor determines that it wants the information to be made public; and
(D) The information in paragraphs (s)(3)(i)(A) and (s)(3)(i)(C) of this provision to the Contracting Officer, if the Offeror meets an exception to SAM registration (see FAR 4.1102(a)).
(ii)(A) The Contracting Officer will consider all information provided under (s)(3)(i) of this provision as part of making a responsibility determination.
(B) A representation that any labor law decision(s) were rendered against the Offeror will not necessarily result in withholding of an award under this solicitation. Failure of the Offeror to furnish a representation or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible.
(C) The representation in paragraph (s)(2) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous representation, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation in accordance with the procedures set forth in FAR 12.403.
(4) The Offeror shall provide immediate written notice to the Contracting Officer if at any time prior to contract award the Offeror learns that its representation at paragraph (s)(2) of this provision is no longer accurate.
(5) The representation in paragraph (s)(2) of this provision will be public information in the Federal Awardee Performance and Integrity Information System (FAPIIS).
Note to paragraph (s): By a court order issued on
(t) Public Disclosure of Greenhouse Gas Emissions and Reduction Goals. Applies in all solicitations that require offerors to register in SAM (52.212-1(k)).
(1) This representation shall be completed if the Offeror received
(2) Representation. [Offeror to check applicable block(s) in paragraph (t)(2)(i) and (ii)].
(i) The Offeror (itself or through its immediate owner or highest-level owner) ____ does, ____ does not publicly disclose greenhouse gas emissions, i.e., makes available on a publicly accessible website the results of a greenhouse gas inventory, performed in accordance with an accounting standard with publicly available and consistently applied criteria, such as the Greenhouse Gas Protocol Corporate Standard.
(ii) The Offeror (itself or through its immediate owner or highest-level owner) ____ does, ____ does not publicly disclose a quantitative greenhouse gas emissions reduction goal, i.e., make available on a publicly accessible website a target to reduce absolute emissions or emissions intensity by a specific quantity or percentage.
(iii) A publicly accessible website includes the Offeror's own website or a recognized, third-party greenhouse gas emissions reporting program.
(3) If the Offeror checked "does" in paragraphs (t)(2)(i) or (t)(2)(ii) of this provision, respectively, the Offeror shall provide the publicly accessible website(s) where greenhouse gas emissions and/or reduction goals are reported:_________________.
(u)(1) 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), Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
(2) The prohibition in paragraph (u)(1) of this provision 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.
(3) Representation. By submission of its offer, the Offeror represents that it will 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
(End of provision)
Alternate I (
(11) (Complete if the offeror has represented itself as disadvantaged in paragraph (c)(4) of this provision.)
____ Black American.
____ Hispanic American.
____ Native American (
____ Asian-Pacific American (persons with origins from
____ Subcontinent Asian (Asian-Indian) American (persons with origins from
____ Individual/concern, other than one of the preceding. 52.213-2 Invoices.
Invoices (
The Contractor's invoices must be submitted before payment can be made. The Contractor will be paid on the basis of the invoice, which must state-
(a) The starting and ending dates of the subscription delivery; and
(b) Either that orders have been placed in effect for the addressees required, or that the orders will be placed in effect upon receipt of payment.
(End of clause)
52.213-3 Notice to Supplier.
Notice to Supplier (
This is a firm order ONLY if your price does not exceed the maximum line item or total price in the Schedule. Submit invoices to the Contracting Officer. If you cannot perform in exact accordance with this order, Withhold Performance, and notify the Contracting Officer immediately, giving your quotation.
(End of clause)
(End of Addendum to 52.212-4) 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (
See Attachment 01- Statement of Work See Attachment 02- Invoice and Payment Provisions
All quoters shall submit a quotation which addresses all elements of the Statement of Work, includes two copies. All quotations shall be forwarded to Contract Specialist
This is an open-market combined synopsis/solicitation for services as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." Submission shall be received not later than
Link/URL: https://www.fbo.gov/spg/HHS/NIH/CCOPC/HHSNCCOPCCS18-000011/listing.html
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