75F40124R00054.pdf

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Accreditation of CBER’s Laboratory Quality System and Reference Materials Production
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FDARFP75F40124R00054
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About this file

This document is a Request for Proposal (RFP) issued by the Food and Drug Administration (FDA) for the accreditation of the FDA's Center for Biologics Evaluation and Research (CBER) Laboratory Quality System and Reference Materials Production.

The key details are:

  • The FDA is seeking to renew accreditation of CBER's pharmaceutical testing and reference material production activities to ISO 17025 and ISO 17034 standards.
  • The contract will be a Cost-Plus-Fixed-Fee order for a base period of 12 months and three 12-month option periods.
  • The North American Industry Classification System (NAICS) code is 541380, Testing Laboratories.
  • Proposals are due by April 19, 2024, 2:30PM Eastern Time.
  • The technical proposal is limited to 25 pages and the business/pricing proposal is limited to 10 pages.
  • The government intends to utilize a Quality Assurance Surveillance Plan to monitor the contractor's performance.

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Accreditation of CBER’s Laboratory Quality System and Reference Materials Production

PART 1- Description

Solicitation number FDA-RFP - 75F40124R00054 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13 and included in this notice.

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-03. The North American Industrial Classification System (NAICS) code for this procurement is 541380, Testing Laboratories.

Type of Contract

The Government intends to award a Cost-Plus-Fixed-Fee order for a base period of twelve (12) months and three (3) twelve (12) months option periods.

PART 2- SUPPLIES OR SERVICES AND PRICES/COSTS

Description of Services and Supplies:

See attached CLIN pricing to be completed

PART 3 - DESCRIPTIONS/SPECIFICATIONS/STATEMENT OF WORK

BACKGROUND

FDA’s Center for Biologics Evaluation and Research’s (CBER) mission is to protect and advance public health by ensuring the safety and efficacy of biological products used in medicine. To support this mission, the Quality Assurance Staff (QAS) team under the Office of the Director (OD) provides oversight and management of the quality systems and laboratory accreditation activities for the Center’s laboratory functions that are integral to the regulatory process of post-licensure confirmatory testing of CBER products.

QAS manages CBER’s third party ISO (International Standards Organization) accreditation. The fully implemented and accredited Laboratory Quality System (LQS) has been accredited to two external International Standards; ISO 17025 for testing activities, and ISO 17034 for Reference Material Producers. QAS staff are directly engaged in both building and maintaining quality elements in CBER’s regulatory laboratories and in the promotion of a quality culture for the Center, to include education, contributions to IT systems development and maintenance, and Quality Systems design/implementation planning.

When an organization pursues accreditation of its laboratory activities, the first step is to establish a quality management program (apply good business practices to the organization), then select which test methods are of interest, select an accrediting body (AB) to perform the assessment, send the AB all requested documentation, schedule an on-site assessment, receive a report of findings, respond to the findings. The AB reviews all information received and makes a determination on accreditation. Accreditation, if granted, is effective for a specified length of time. Depending on the activities under consideration, there may be a need for multiple assessors with differing areas of expertise to conduct the assessment(s).

QAS needs Accreditation of CBER’s Laboratory Quality System and Reference Materials Production Services from an accreditation program in biological and chemical testing, and in biological reference material production. The accrediting bodies shall possess an in-depth knowledge of CBER’s specific regulatory practices and must be accredited by International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC) and/or Inter-American Accreditation Cooperation (IAAC).

OBJECTIVES:

The objective of this SOW is to renew accreditation of CBER’s pharmaceutical testing and reference material production activities to international standard ISO 17025 “General requirements for the competence of testing and calibration laboratories” and ISO 17034 “General requirements for the competence of reference material producers”. After accreditation is granted, an alternating schedule of biennial on-site assessments and alternating year document reviews is required.

SCOPE:

Independently, and not as an agent of the Government, the Contractor shall assess CBER’s 17025 and 17034 Quality System and LQS including previously accredited biological, microbiological, and chemical test methods (currently 21) with no additional new test methods being put forward for the base year but CBER reserves the right to expand its scope in the upcoming option years (approximately 10 per year) along with approximately 30 reference materials. These activities are conducted at only one location in Silver Spring, Maryland. No off-site or mobile testing is performed. Methods are conducted by approximately 38 technicians and scientists. The following task areas are outlined in the task section (2.1 Requirements/ Task Areas) of this statement of work

(SOW).

1) Assessment Activities

2) Analysis and Reports

3) Communication and Collaboration

4) Task Management.

REQUIREMENTS/ TASKS AREAS:

TASK 1: Assessment Activities:

Contractor shall conduct all business under this agreement in compliance with international standards. As accreditation facilitates global commerce, regulation, and mutual recognition, these accreditations shall be recognized by the widest possible international community.

i.ISO 17011 “Conformity assessment – General Requirements for Accreditation Bodies accrediting conformity assessment bodies” ii.ISO 19011 “Guidelines for quality and or environmental management systems auditing”

• All contract employees shall sign Form FDA 3398, Contractor’s Commitment to Protect Non-Public Information Agreement prior to the release of nonpublic information.

• Contractor shall be accredited by International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC) and/or InterAmerican Accreditation Cooperation (IAAC)

• Contractor shall be a Mutual Recognition Arrangement (MRA) Signatory for both ISO17025 and

ISO17034

• Contractor shall assess against the current version of the international standard ISO 17025 “General requirements for the competence of testing and calibration laboratories” the CBER Laboratory Quality System’s (LQS) ability to conduct conformity assessments of biological pharmaceuticals using both biological/microbiological and chemical testing methods for the purposes of renewing and expanding accreditation of the CBER LQS to ISO 17025.

o The Contractor shall perform the pre-review of the CBER Lab Quality System Documentation according to ISO 17011 section 7.6.

o Contractor shall perform an assessment of CBER 17025 Lab Quality System documentation including approximately 30 test methods prior to performing the on-site assessment.

o Contractor shall determine accreditation for CBER 17025 Quality System and approximately 30 test methods, if applicable, and provide an ISO 17025 certificate for accredited activities.

• Contractor shall assess against the current version of the international standard ISO 17034 “General requirements for the competence of reference material producers” the CBER 17034 Quality System’s ability to produce biological reference materials for the purposes of renewing accreditation of the CBER 17034 Quality System to ISO 17034.

o Contractor shall perform an assessment of the CBER 17034 Quality System documentation including approximately 10 reference materials prior to performing the on-site assessment.

o Contractor shall determine accreditation for CBER 17034 Quality System and approximately 30 reference materials, if applicable, and provide an ISO 17034 certificate for accredited activities.

• Contractor shall conduct, prepare and present the assessment in compliance with International Standards as applicable:

o ISO 17011 “Conformity assessment – General Requirements for Accreditation Bodies accrediting conformity assessment bodies” section 7.6, 7.7, & 7.8 o ISO 19011 “Guidelines for quality and or environmental management systems auditing” section 7.9 & 7.10

• Contractor shall perform assessments of CBER’s Lab Quality System and Quality System operations at one on-site location

• Contractor shall provide an accounting of all Non-Public Information and documents obtained to perform the assessment

TASK 2: Accreditation Certification and Reports:

• The Contractor shall work, prepare and present the assessment reports in compliance with International

Standards as applicable:

o ISO 17011 “Conformity assessment – General Requirements for Accreditation Bodies accrediting conformity assessment bodies” section 7.6, 7.7, & 7.8 o ISO 19011 “Guidelines for quality and or environmental management systems auditing” section 7.9 & 7.10

• Contractor shall prepare assessment reports and provide reports to the FDA within 10 business days after on-site assessment

• The contractor shall coordinate with FDA to review and accept the reports.

• The Contractor shall prepare and present accreditation certifications in compliance with International Standards as applicable:

o ISO 17011 “Conformity assessment – General Requirements for Accreditation Bodies conformity assessment bodies” section 7.9, and 7.10

• The contractor shall determine accreditation for CBER Lab Quality System and approximately 20 new test methods, if applicable, and provide an ISO 17025 certificate for accredited activities.

• The contractor shall determine accreditation for CBER 17034 Quality System and approximately 30 reference materials, if applicable, and provide an ISO 17034 certificate for accredited activities.

• The contractor shall coordinate with FDA to review accreditation certification prior to contract initiation and throughout the contract. The contractor shall provide FDA with processes and procedures for how the accreditation shall be transferred between Accrediting Bodies, should this event happen. The contractor shall provide a risk-based approach plan for potential lapses in FDA accreditation.

• The contractor shall coordinate with FDA to review accreditation certification for accuracy prior to issuance.

• Contractor shall provide the FDA with processes and procedures for the accreditation including how to appeal assessors' findings during the contract initiation meeting and anytime these documents are updated during the life of the contract.

• Contractor shall be responsible for facilitating ISO 17025 & ISO 17034 Accreditation and Annual

Certification Fees.

• Contractor shall include a Security Plan, which reflects security and operational policies which safeguard the confidentially of non-public information that would be released to the contractor under the performance of the contract. The plan shall address procedures for the issuance, reproduction, transmittal, storage, and return or disposal, etc. of non-public information collected during the performance of this contract.

• The Contractor shall return all Non-Public Information and documents to the FDA and comply with FDA

NDA agreements at the end of each on-site assessment.

TASK 3: Communication and Collaboration:

The Contractor shall ensure that oral and written forms of communication are consistent with CBER’s specific regulatory practices. In order to perform this task effectively, the Contractor shall:

1) Draft correspondence that is clear, logical, and within the required deadline.

2) Proactively resolve issues independently beginning with email communication, phone calls, and/or in-person meetings before escalating to senior management and maintains documents as proof of efforts made to resolve issues.

3) Completes assigned tasks and delivers quality work within the scope of the project and is in compliance with milestones and deadlines.

4) Provides oral and written progress updates and final reports that meet the requirements as defined by the objectives.

TASK 4: Task Management:

The Contractor shall coordinate as necessary with the CBER/QAS management and COR to ensure that the task is managed consistently with overall contract requirements. The Contractor shall work with the COR, CBER/QAS, and Subject Matter Experts (SMEs) to ensure that tasks stay on track and important milestones are met.

Special Consideration/Descriptions/Minimum:

Once accredited, CBER may at any time put forward additional test methods and reference materials for accreditation. Depending on the documentation supplied by CBER to the AB and the expertise of the assessor, an on-site assessment may be required. Depending on timing of this request, this on-site assessment may occur outside of the routine bi-annual assessment schedule.

Typically, CBER requests for accreditation of additional test methods and reference materials are timed to take advantage of the review efforts and travel schedules of the routine assessment schedule. With no additional new test methods being put forward for the base year, CBER reserves the right to expand its scope in the upcoming option years (approximately 10 per year) along with approximately 30 reference materials. Test methods are conducted by approximately 38 technicians and scientists.

PART 4 –INSPECTION AND ACCEPTANCE:

The Contractor shall deliver all products to the COR, CBER/QAS management and other technical customers, as appropriate per CBER/FDA’s policy and/or agreed upon when assigned. Electronic transmission, via e-mail, will be the primary delivery mechanism; however, hard copies shall be provided as requested. All work under this task order is subject to inspection and final acceptance by the COR. The Contractor shall ensure that the deliverables comply with the requirements in the SOW and the following quality standards:

• Accuracy: Work products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Technical Soundness: Work products, especially digital work products, shall exhibit minimal technical flaws.

• Clarity: Work products shall be clear and concise.

• Consistency to Requirements: All work products must satisfy the requirements of the statement of work.

• Timeliness: Work products shall be submitted by the due date specified in this statement of work or submitted in accordance with a later scheduled date determined by the Government.

• File Editing: All text and diagrammatic files shall be editable by the Government.

• Format: Work products shall be submitted electronically and, in the format, mutually agreed upon prior to submission.

PART 5 – DELIVERABLES

Deliverables are specified in Table 1. The Contractor shall deliver all products to the COR, various programmatic staff and/or Contracting Officer (CO) where applicable.

Table 1. Deliverables / Schedule

Task Area Type Quantity / Frequency Due Date

2.1.4 Kick-Off Meeting One-time Within ten (10)

business days after order award

2.1.1 Assessment

Activities

Routine As Assigned

2.1.2 Accreditation

Certification and Reports

Routine As Assigned

2.1.3 Communication/Col

laboration Support

Routine As Assigned

PART 6 - PERIOD OF PERFORMANCE

The anticipated period of performance shall be as follows:

Base Period: April 30, 2024, April 29, 2025 Option Period 1: April 30, 2025, April 29, 2026 Option Period 2: April 30, 2026, April 29, 2027 Option Period 3: April 30, 2027, April 29, 2028

PART 7- CONTRACT ADMINISTRATION DATA

PLACE OF PERFORMANCE: (On-Site Assessments)

These activities are conducted at only one location in Silver Spring, Maryland. No off-site or mobile testing is performed. If at any point work designations change, the Contractor shall be able to perform work on the Government sites within the Washington DC Metro Area at the following location:

U.S. Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Ave

Silver Spring, MD 20993

Work shall be performed Monday through Friday during normal hours of operation. Contractor must obtain permission to work beyond their regular hours. If permission is not provided, Contractor works at its own risk.

QUALITY ASSURANCE SURVEILLANCE PLAN

The Government will develop a Quality Assurance Surveillance Plan (QASP) that describes how the contractor’s performance will be measured against specific objective performance standards related to the requirements of the task order. The criteria for each of the performance standards will be defined and discussed with the contractor prior to the start of the task or subtask but no later than 30 days after the start of the task order. In general, the QASP will be used to evaluate in terms of how well the requirements of the task order are satisfied, the extent to which the work performed follows the approach found in the contractor’s technical quote, clarity of documentation, and timeliness of scheduled task accomplishment.

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the contractor’s performance. The QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Contractor Performance and Assessment Report (CPARS). The QASP will be finalized immediately following award and a copy provided to the Contractor after award.

The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process as to:

• What will be monitored.

• How monitoring will take place.

• Who will conduct the monitoring.

• How monitoring efforts and results will be documented.

The QASP is not part of the contract, nor is it intended to duplicate the contractor’s quality control plan.

Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

The main purpose of the QASP is to ensure early identification and resolution of performance issues to minimize impact on mission performance.

The QASP is a living document and may be updated by the Government as necessary.

The methods of surveillance listed below are used in the administration of performance measurement supporting this Order:

Description Performance Standard Acceptable Quality Level

Surveillance Method and Assessment

Task Management

Management of task resources and budget to ensure the requirements are met.

Project activities are completed as specified in the SOW and approved by the

COR.

100% inspection by COR

Quality and Timeliness of Deliverables

Deliverables are on time per the Government approved PMP.

Deliverables are delivered to the COR in the COR approved template by the specified date in the approved PMP

100% inspection by COR

Timeliness of revisions to deliverables

Deliverables are updated and maintained in a timely manner.

Appropriate deliverables are updated and delivered to COR by the specified date in the approved PMP

100% inspection by COR

GOVERNMENT FURNISHED EQUIPMENT (GFE):

Government furnished property (materials, equipment, and/or information) is to be provided in conjunction with required performance under this contract as determined by mutual agreement between FDA and the Contractor.

The Government will provide FDA Laptops to all Contractor personnel working on this task order.

The Contractor shall maintain an inventory of all FDA accountable property and ensure the return of the property upon completion of all work. Further, all Contractor staff assigned to this contract must provide verification of completion of all mandatory FDA training, including Annual Security Awareness Training if assigned an FDA laptop that allows for FDA network access.

At the written request of the Government, the Contractor will immediately return any property provided by FDA for the Contractor’s use to complete the work required in this task order. If not requested, the Contractor will continue to abide by FAR Part 45 until completion of the contract.

A list of GFE will be developed and agreed to during the kickoff meetings.

Contracting Officer Representative

The following COR will represent the Government for the purpose of this contract: (COR To be determined at the time of contract award)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including The surveillance and assessment of performance and recommending changes in requirements to the Contracting Officer; (2) interpreting the Statement of Work and any and all other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance of the contract. The Government may unilaterally change its COR designation.

The contact information for the Contracting Specialist is:

Sheila Brown

OFBA/OO/OAGS

4041 Powder Mill Road Calverton, MD 20705 E-Mail: Sheila.Brown1@fda.hhs.gov Phone: (301) 796-0827

The contact information for the Contracting Officer is:

Ian Weiss -OFBA/OO/OAGS 4041 Powder Mill Road Calverton, MD 20705 Phone: (301) 796-5782 Email: Ian.Weiss@fda.hhs.gov

INVOICE SUBMISSION

1. The following clauses are incorporated into the contract:

a. 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

mailto:Sheila.Brown1@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov http://www.ipp.gov/

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

b. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c. (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re-register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

At a minimum the following cost information shall be included, in addition to supporting http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA 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.

(END OF CLAUSE)

mailto:ERIC@fda.hhs.gov

PART 8- CONTRACT CLAUSES

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Jun 2023)

(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 products and commercial services:

(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 (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115- 232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov

2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31

U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 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 products and commercial services:

https://www.acquisition.gov/far/12.301#FAR_12_301 https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 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 (Jun 2020) (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) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

X (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

X (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

(11) [Reserved].

(12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

(13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(14) [Reserved] https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.204-27#FAR_52_204_27 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4

(15)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

(16)(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-7.

(17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C.

637(d)(2) and (3)).

(18)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (15 U.S.C.

637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Jun 2020) of 52.219-9.

(v) Alternate IV (Sep 2021) of 52.219-9.

(19)(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

(ii) Alternate I (Mar 2020) of 52.219-13.

(20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

(21) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

637(d)(4)(F)(i)).

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Oct 2022) (15 U.S.C. 657f).

(23)(i) 52.219-28, Post Award Small Business Program Representation (Mar 2023)(15 U.S.C. 632(a)(2)).

(ii) Alternate I (Mar 2020) of 52.219-28.

(24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

(25) 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 (Oct 2022) (15 U.S.C. 637(m)).

X (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32

2020) (15 U.S.C. 644(r)).

X (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

X (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (31)(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

X (32)(i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(ii) Alternate I (Jul 2014) of 52.222-35.

X (33)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (Jul 2014) of 52.222-36.

X (34) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(36)(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

(38)(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 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title29-section793&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/22.1803#FAR_22_1803 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 acquisition of commercially available off-the-shelf items.)

(39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

(40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

(41)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(42)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun2014) of 52.223-14.

(43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C.

8259b).

(44)(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 (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

(46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

(47) 52.223-21, Foams (Jun2016) (E.O. 13693).

X (48)(i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

(ii) Alternate I (Jan 2017) of 52.224-3.

(49)(i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

(ii) Alternate I (Oct 2022) of 52.225-1.

(50)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (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), Public Law 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.

https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-15#FAR_52_223_15 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-18#FAR_52_223_18 https://www.acquisition.gov/far/52.223-20#FAR_52_223_20 https://www.acquisition.gov/far/52.223-21#FAR_52_223_21 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/2112 https://www.govinfo.gov/link/uscode/19/3805 https://www.govinfo.gov/link/uscode/19/4001 https://www.govinfo.gov/link/uscode/19/4001

(ii) Alternate I [Reserved].

(iii) Alternate II (Dec 2022) of 52.225-3.

(iv) Alternate III (Jan 2021) of 52.225-3.

(v) Alternate IV (Oct 2022) of 52.225-3.

(51) 52.225-5, Trade Agreements (Dec 2022) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

X (52) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(53) 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. Subtitle A, Part V, Subpart G Note).

(54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

(55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

(56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

(57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

(58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

(59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

(60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management

(Jul 2013) (31 U.S.C. 3332).

(61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(62) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section3301&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/far/52.225-13#FAR_52_225_13 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 https://www.acquisition.gov/far/52.226-4#FAR_52_226_4 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.226-5#FAR_52_226_5 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.229-12#FAR_52_229_12 https://www.acquisition.gov/far/52.232-29#FAR_52_232_29 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/3805 https://www.acquisition.gov/far/52.232-30#FAR_52_232_30 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/3805 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3…

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