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Artificial Intelligence Technical Expert Combined Synopsis Solicitation
FDA-CSS-1238254
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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.
The solicitation number is FDA-CSS-1238254. 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 2021-05 dated March 10, 2021.
The appropriate NAICS code for the acquisition is 541690 – Other Scientific and Technical Consulting Services; Small Business Size standards – $16.5 MIL. This requirement is being competed Unrestricted/Full and Open Competition.
Background:
The FDA, NCTR, Division of Bioinformatics and Biostatistics (DBB) requires a Technical Expert in Artificial Intelligence for digital pathology and clinical image analysis; an experienced individual with written and oral presentation skills, and a thorough understanding of bioinformatics with specific knowledge in Artificial Intelligence (AI) for digital pathology and clinical image analysis with respect to reproducibility, interpretability and transparency. One of the essential roles of the Division of Bioinformatics and Biostatistics (DBB) at the National Center for Toxicological Research (NCTR) is to deal with the rapid growth of biomedical data present in the public domain and generated within the Food and Drug Administration (FDA), and to develop state-of-art bioinformatics and biostatistics methodologies to translate these burgeoning data to knowledge to be used in the FDA. One area of this research is artificial intelligence (AI) for digital pathology and clinical image analysis. Specifically, the goal is to evaluate, develop and employ the AI methodologies with a specific emphasis on its reproducibility, transparency and interpretability. This will aid in the efforts in the FDA to (1) develop the policy in regulation for the products that contain AI and (2) improve the agency’s operation by incorporating AI methods in regulatory science.
Objective:
It is critical for the DBB to develop and coordinate informatics capabilities within NCTR, across FDA Centers, and in the larger community. It is important for these capabilities to be communicated in an effective manner with the research community and the FDA. This requires an experienced individual with written and oral presentation skills, a thorough understanding of bioinformatics with specific knowledge in AI for digital pathology and clinical image analysis with respect to reproducibility, interpretability and transparency.
Scope of Work:
FDA seeks a contractor with demonstrated expertise in working with Artificial Intelligence (AI) for digital pathology and clinical image analysis the contractor will support the FDA/DBB to develop and coordinate informatics capabilities within NCTR and FDA Centers. The contractor shall have a thorough understanding of bioinformatics with specific knowledge in Artificial Intelligence for digital pathology and clinical image analysis with respect to reproducibility, interpretability and transparency. The contractor shall work in close coordination with the DBB at NCTR in Jefferson, Arkansas, and shall assist in the formulation of innovative ideas/approaches to address the current needs in AI development, to advise bioinformatics staff in the appropriate methods of writing papers and protocols, and to provide support in the generation of manuscripts and other documentation. This shall require periodic visits to the NCTR Campus and communication with the DBB staff via other electronic means, including video conferencing. Specifically, the contractor shall communicate via e-mail, phone calls and video conferences to make recommendations as appropriate, and to schedule visits to the NCTR campus, with the Technical Point of Contact (TPOC).
Minimum Performance Requirements:
1. The contractor shall conduct Manuscript Review/Protocol Development at the contractor’s facility and shall not exceed four hours per week. The contractor shall review draft manuscripts related to AI; conduct independent AI data analysis, as needed, to verify results in manuscript;
provide recommendations for revisions to manuscript to prepare for publication (shall follow the standard practices in the scientific community for conducting manuscript writing); and assist in the development of research protocols to further the research.
The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.
2. The contractor shall visit NCTR one time per year with each visit being for a period of at least 5 business days. The purpose of the visit is to train DBB junior scientists and to assist the DBB in the writing of manuscripts and research protocols related to AI. Visits shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of AI. The contractor shall perform needed literature assessment, etc., therefore, shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR shall provide access to guest Wi-Fi and projection equipment if needed for presentations.
If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).
3. Contractor shall participate in one or two video and/or teleconference meetings per month (meetings approximately 1 hour each).
Minimum Position Requirements & Qualifications:
Education and Experience:
1. Shall have in-depth knowledge of current issues in the field of Artificial Intelligence (AI) for digital pathology and clinical image analysis.
2. Shall have presented at one or more international conferences about Artificial Intelligence (AI).
3. Shall have extensive experience with reproducibility, transparency and interpretability in developing and applying Artificial Intelligence (AI).
4. Shall have extensive experience in instructing research professionals.
5. Shall have extensive experience in technical writing and editing.
6. Shall have experience in supervising graduate students and postdoctoral fellows.
7. Shall have verifiable records of publications in peer reviewed scientific journals and publications.
8. Shall have a minimum 15-20 years’ experience in the field of (AI).
Deliverables and Milestones:
Deliverables Task Due Date
1. Manuscript Review/Protocol Development
Shall review draft manuscripts related to AI;
conduct independent AI data analysis, as necessary, to verify results in manuscript;
provide recommendations for revisions to prepare manuscript for publication (shall follow the standard practice in the scientific community for conducting manuscript writing) and assist in the development of research protocols to further the research.
(The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.)
Annually – not to exceed 4 hours per week
2. Visit NCTR one time per year (at least 5 business days)
Visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of artificial intelligence. Assist the DBB in the writing of manuscripts and research protocols related to artificial intelligence.
*If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).
Annually
3. Attend meetings Participate in monthly video and/or teleconference meetings
Once or twice per month (approximately 1 hour each)
4. Quarterly Reports
Status reports to include a summary of work completed.
Quarterly or Semi-annually
All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA (i.e., MS 2016) and are 508 compliant. Quarterly reports shall be provided by e-mail from the Contractor.
The Contractor shall deliver all products to the TPOC/COR. The COR or other technical staff will notify the Contractor of deliverable acceptance regarding overall compliance with the guideline’s requirements of the task. The Quarterly report shall also be submitted to the Contract Specialist/Contracting Officer.
The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the contractor at no additional cost to the Government. Unless specified otherwise, the TPOC/COR will review and approve all deliverables.
Unless specified otherwise, the Contractor shall provide a copy of each deliverable listed in DELIVERABLES section to the TPOC/COR for review. The Government will review the deliverable and suggest any changes. If changes are required, unless specified otherwise, the Contractor shall resubmit the revised deliverable to the TPOC/COR five (5) business days after receiving the Government’s input, unless otherwise agreed to in advance.
Deliverable products shall be reviewed, validated, and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements, and quality measures. In the event of the rejection of any deliverable, the Contractor shall be notified in writing by the TPOC/Contracting Officer’s Representative (COR), giving the specific reason(s) for rejection. The Contractor shall have ten (10) business days to respond to the rejected deliverable and return it to the COR.
Section 508:
• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.
Schedule of Supplies or Services and Prices/Costs:
Line Item Description Quantity Unit of
Issue Unit Price Extended Price
Artificial Intelligence Technical Expert for digital pathology and clinical image analysis in accordance the Minimum Performance Requirements and Minimum Position Requirements & Qualifications set forth above and herein.
GSA Contract #, if applicable__________
Months
Option Period 1 - Artificial Intelligence Technical Expert for digital pathology and clinical image analysis
Same as item 0001 description http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html
Option Period 2 - Artificial Intelligence and clinical image analysis
Option Period 3 - Artificial Intelligence and clinical image analysis
Option Period 4 - Artificial Intelligence and clinical image analysis
Total Amount for CLIN 0001 - 0005 $ ________
Period of Performance: Base + 4 Option Years
Base Period: August 3, 2021 – August 2, 2022 Option Period 1: August 3, 2022 – August 2, 2023 Option Period 2: August 3, 2023 – August 2, 2024 Option Period 3: August 3, 2024 – August 2, 2025 Option Period 4: August 3, 2025 – August 2, 2026
Place of Delivery/Performance:
At the contractor’s location. However, the contractor shall be required to travel to NCTR one time per year to meet with junior staff and the Project Officer to review materials and conduct training:
US Food and Drug Administration- NCTR 3900 NCTR Rd.
Jefferson, AR. 72079
Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) During site visits the contractor shall perform needed literature assessment, etc., therefore, the contractor shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR will provide access to guest Wi-Fi and projection equipment if needed for presentations.
Security and Privacy The Contractor shall be responsible for determining that the individuals provided to perform under this contract will not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.
Due to the possible sensitive nature of the information discussed, contractor personnel shall be required to sign a Commitment to Protect Non-Public Information form 3398, which will be included as an attachment to any resultant contract.
The Contractor must assure the protection of the information and data it receives in performance of this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions.
Solicitation Clauses:
FAR 52.212-4 Contract Terms and Conditions—Commercial Items (Oct 2018)
The following addenda apply:
The following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained at:
https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
Service Contract Act Exemption This solicitation is being issued as exempt from the Service Contract Act per FAR 22.1903 (b) (2) (ii) (c) for bona fide professional services.
FAR Clause:
52.204-13 System for Award Management and Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)
52.217‐9 Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.
52.222-49 Service Contract Labor Standards-Place of Performance Unknown (May 2014)
For the purposes of this clause the blank(s) is/are completed as follows:
“(a)…none.”; “within 10 days of the issuance of this solicitation.”
HHSAR Clause:
352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) Paragraph (c). The Section 508 standards applicable to this contract are:
• Must meet WCAG 2.0 A and AA
• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)
• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)
• E204 Functional Performance Criteria (Appendix A, Application and Scoping
Requirements)
• E205 Electronic Content (Appendix A, Application and Scoping Requirements)
• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)
• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.
• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)
352.237-75 Key Personnel (DEC 2015)
The key personnel specified in the contract are considered to be essential to work performance. At least30 days prior to the contract voluntarily diverting any of the specified individuals to other programs or contract the Contractor shall notify the Contracting Officer and shall submit justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the requirements of the contact (including, when applicable, Human Subjects Testing requirements). If the employee of the contract is terminated for cause or separates from the contract voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to the key personnel with the written consent of the Contracting Officer. The contract will be modified to added or delete key personnel as necessary to reflect the agreement of parties.
(End of Clause)
Inspection/Acceptance:
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments 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.
http://508.hhs.gov/
The TPOC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements;
(3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
The following Technical Point of Contact (TPOC) will represent the Government for the purpose of this contract (To be provided upon contract award):
Name:
Email address:
Phone:
The contact information for the Contracting Administrator:
Name: Jennifer L. Johnson Email Address: jennifer.johnson3@fda.hhs.gov Phone: (870) 543-7830
Payments:
Payment terms net 30 days after government acceptance of the supplies/service. Payment shall not be made more frequently than monthly in arrears.
FDA Three-Way Invoicing Procedures:
A. The contractor shall submit all invoices to:
Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor
MAIL HUB 2145
Silver Spring, MD 20993-0002 Attn: Vendor Payments
301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov
*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.
Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is:
To be provided upon contract award.
B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award mailto:jennifer.johnson3@fda.hhs.gov mailto:fdavendorpaymentsteam@fda.gov
Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:
(i) Name and address of the contractor;
(ii) Invoice date and invoice number;
(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite- Quantity Contracts or Blanket Purchase Agreements);
(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:
(a) period of performance for which costs are claimed;
(b) itemized travel costs, including origin and destination;
(c) any other supporting information necessary to clarify questionable expenditures;
(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;
(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);
(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)
(viii) Name, title, and phone number of person to notify in event of defective invoice;
(ix) Taxpayer Identification Number (TIN);
(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;
(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;
(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:
(a) list of all invoices submitted to date under the subject award, including the following:
(1) invoice number, amount, & date submitted
(2) corresponding payment amount & date received
(b) total amount of all payments received to date under the subject contract or order
(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;
(xiii) Any other information or documentation required by the award.
C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.
D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.
Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.
mailto:ERIC@fda.hhs.gov
52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2021) (Deviation 2017-02) (Deviation Apr 2020) and (Deviation 2020-05 Oct 2020).
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (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)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C.3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C.4704 and 10 U.S.C.2402).
__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).
__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)
_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).
__ (5) [Reserved].
__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).
__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).
__ (10) [Reserved].
__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).
__ (ii) Alternate I (Mar 2020) of 52.219-3.
_X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
__ (ii) Alternate I (Mar 2020) of 52.219-4.
__ (13) [Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate I (Mar 2020).
__ (iii) Alternate II (Nov 2011).
__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate I (Mar 2020) of 52.219-7.
https://www.acquisition.gov/content/52204-25-prohibition-contracting-certain-telecommunications-and-video-surveillance-services#id1989I600I4C
__ (iii) Alternate II (Mar 2004) of 52.219-7.
__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Mar 2020) (15 U.S.C. 637(d)(4)) __ (ii) Alternate I (Jan 2017) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
__ (iv) Alternate III (Mar 2020) of 52.219-9.
__ (v) Alternate IV (Aug 2018) of 52.219-9 __ (18) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
__ (19) 52.219-14, Limitations on Subcontracting (J Mar 2020) (15 U.S.C. 637(a)(14)).
__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f).
_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2020) (15 U.S.C.
632(a)(2)).
_ (ii) Alternate I (Mar 2020) of 52.219-28.
__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).
__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C.
644(r)).
__ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).
_X_ (27) 52.222-3, Convict Labor (June 2003) (E.O.11755).
_X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020 Oct 2020) (E.O.13126).
_X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
_X_ (30) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).
__ (ii) Alternate I (Feb 1999) of 52.222-26.
_X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
__ (ii) Alternate I (July 2014) of 52.222-35.
_X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
__ (ii) Alternate I (July 2014) of 52.222-36.
_X_ (33) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).
__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
_X_ (35) (i) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O.
13627).
__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter78 and E.O. 13627).
__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)
__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).
__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).
__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).
https://www.acquisition.gov/content/52222-3-convict-labor#i1055332 https://www.acquisition.gov/content/52222-19-child-labor-cooperation-authorities-and-remedies#i1055664 https://www.acquisition.gov/content/52222-21-prohibition-segregated-facilities#i1055713 https://www.acquisition.gov/content/52222-26-equal-opportunity#i1055793 https://www.acquisition.gov/content/52222-26-equal-opportunity#i1055793 https://www.acquisition.gov/content/52222-35-equal-opportunity-veterans#i1056230 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/52222-35-equal-opportunity-veterans#i1056230 https://www.acquisition.gov/content/52222-36-equal-opportunity-workers-disabilities#i1056250 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/content/52222-36-equal-opportunity-workers-disabilities#i1056250 https://www.acquisition.gov/content/52222-37-employment-reports-veterans#i1056265 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/52222-40-notification-employee-rights-under-national-labor-relations-act#i1056304 https://www.acquisition.gov/content/52222-50-combating-trafficking-persons#i1056535 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52222-50-combating-trafficking-persons#i1056535 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52222-54-employment-eligibility-verification#i1056753 https://www.acquisition.gov/content/221803-contract-clause#i1095479 https://www.acquisition.gov/content/52223-9-estimate-percentage-recovered-material-content-epa-designated-items#i1053138 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52223-9-estimate-percentage-recovered-material-content-epa-designated-items#i1053138 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52223-11-ozone-depleting-substances-and-high-global-warming-potential-hydrofluorocarbons#i1053180 https://www.acquisition.gov/content/52223-12-maintenance-service-repair-or-disposal-refrigeration-equipment-and-air-conditioners#i1053196 https://www.acquisition.gov/content/52223-13-acquisition-epeat%C2%AE%E2%80%93registered-imaging-equipment#i1053207
__ (ii) Alternate I (Oct 2015) of 52.223-13.
__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).
__ (ii) Alternate I (Jun 2014) of 52.223-14.
__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).
__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).
__ (ii) Alternate I (Jun 2014) of 52.223-16.
_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).
__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).
__ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).
__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).
__ (ii) Alternate I (Jan 2017) of 52.224-3.
__ (48) 52.225-1, Buy American-Supplies (Jan 2021) (41 U.S.C. chapter 83).
_X_ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014 Jan 2021) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, [19 U.S.C. chapter 29 (sections 4501- 4732),] Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
__ (ii) Alternate I (May 2014) of 52.225-3.
__ (iii) Alternate II (May 2014 Jan 2021) of 52.225-3.
__ (i[ii] v) Alternate III (May 2014 Jan 2021) of 52.225-3.
__ (50) 52.225-5, Trade Agreements (Oct 2019 2020) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;
10 U.S.C. 2302 Note).
__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
__ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).
__ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).
_X_ (57) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).
__ (58) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).
__ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).
__ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
_X_ (61) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) (DEVIATION APR 2020) (31 U.S.C. 3903 and 10 U.S.C. 2307).
__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
__ (ii) Alternate I (Apr 2003) of 52.247-64.
__ (iii) Alternate II (Feb 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
__ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).
https://www.acquisition.gov/content/52223-13-acquisition-epeat%C2%AE%E2%80%93registered-imaging-equipment#i1053207 https://www.acquisition.gov/content/52223-14-acquisition-epeat%C2%AE-registered-televisions#i1053232 https://www.acquisition.gov/content/52223-14-acquisition-epeat%C2%AE-registered-televisions#i1053232 https://www.acquisition.gov/content/52223-15-energy-efficiency-energy-consuming-products#i1053246 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52223-16-acquisition-epeat%C2%AE-registered-personal-computer-products#i1053274 https://www.acquisition.gov/content/52223-16-acquisition-epeat%C2%AE-registered-personal-computer-products#i1053274 https://www.acquisition.gov/content/52223-18-encouraging-contractor-policies-ban-text-messaging-while-driving#i1053316 https://www.acquisition.gov/content/52223-20-aerosols#i52_223_20 https://www.acquisition.gov/content/52223-21-foams#id1668D08086F https://www.acquisition.gov/content/52224-3-privacy-training#i52_224_3 https://www.acquisition.gov/content/52224-3-privacy-training#i52_224_3 https://www.acquisition.gov/content/52225-1-buy-american-supplies#i1053372 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52225-3-buy-american-free-trade-agreements-israeli-trade-act#i1053446 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/content/52225-3-buy-american-free-trade-agreements-israeli-trade-act#i1053446 https://www.acquisition.gov/content/52225-3-buy-american-free-trade-agreements-israeli-trade-act#i1053446 https://www.acquisition.gov/content/52225-3-buy-american-free-trade-agreements-israeli-trade-act#i1053446 https://www.acquisition.gov/content/52225-5-trade-agreements#i1053648 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/content/52225-13-restrictions-certain-foreign-purchases#i1054249 https://www.acquisition.gov/content/52225-26-contractors-performing-private-security-functions-outside-united-states#i1054921 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52226-4-notice-disaster-or-emergency-area-set-aside#i1055038 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52226-5-restrictions-subcontracting-outside-disaster-or-emergency-area#i1055048 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52232-29-terms-financing-purchases-commercial-items#i1050508 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52232-30-installment-payments-commercial-items#i1050540 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52232-33-payment-electronic-funds-transfer-system-award-management#i1050674 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/content/52232-34-payment-electronic-funds-transfer-other-system-award-management#i1050705 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52232-36-payment-third-party#i1050789 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52239-1-privacy-or-security-safeguards#i1049272 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/content/52242-5-payments-small-business-subcontractors#i52_242-5 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52247-64-preference-privately-owned-us-flag-commercial-vessels#i1046560 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52247-64-preference-privately-owned-us-flag-commercial-vessels#i1046560 https://www.acquisition.gov/content/52247-64-preference-privately-owned-us-flag-commercial-vessels#i1046560
__ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).
__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
__ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C.
1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement.
Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items.
Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (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)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(v) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627).
(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xix)(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.
2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C.
1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.
Appx.1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
Full Text of Deviated Clauses:
52.222-19 Child Labor—Cooperation with Authorities and Remedies. (JAN 2020) (DEVIATION 2020-05) (Oct 2020)
(a) Applicability. This clause does not apply to the extent that the Contractor is supplying end products mined, produced, or manufactured in—
(1) Canada, and the anticipated value of the acquisition is $25,000 or more;
(2) Israel, and the anticipated value of the acquisition is $50,000 or more;
(3[2]) Mexico, and the anticipated value of the acquisition is $83,099 or more; or (4[3]) Armenia, Aruba, Australia, Austria, Belgium, Bulgaria, [Canada,] Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Taiwan, Ukraine, or the United Kingdom and the anticipated value of the acquisition is $182,000 or more.
(b) Cooperation with Authorities. To enforce the laws prohibiting the manufacture…
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