FDA-SOL-75F40123Q00187.docx

REQUEST FOR QUOTE

Schrodinger software, LiveDesign Suite License, and IT Service Support

FDA-75F40123Q00187

Date Posted: April 13, 2023

Response Date: April 28, 2023, 1 PM ET

Classification Code: D319 - IT and Telecom – Annual Software Maintenance Service Plans NAICS Code: 513210 – Software Publishers

SECTION 1 – PRODUCT LIST AND DELIVERY INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.

The solicitation number is FDA-SOL-75F40123Q00187. This solicitation is issued as a Request for Quote (RFQ). This is a total Small Business Set aside.

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2023-01, effective 15 January 2023. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.acquisition.gov/browse/index/far

1.1 PRODUCT SPECIFICATIONS

The contractor shall provide the brand name or equal Schrodinger software, LiveDesign Suite License and IT Service Support for Center for Tobacco Products (CTP) to test the proof of concept for setting up a new server in the FDA/CTP cloud environment to use a new Schrodinger LiveDesign Cloud Platform that offers host seats and host “floating” seats software licenses. LiveDesign is a browser-based enterprise platform to enable collaborative review amongst computational scientists. This modern web-based interface provides an intuitive user experience for generating, exploring and managing ideas alongside other project data. The commercially available services shall include the following Supplies/Services below:

Page

Base Year: 05/07/2023 thru 05/06/2024

LiveDesign User License

12 months

Option Year 1: 05/07/2024 thru 05/06/2025

Option Year 2: 05/07/2025 thru 05/06/2026

Option Year 3: 05/07/2026 thru 05/06/2027

Option Year 4: 05/07/2027 thru 05/06/2028

1.2 The specific salient characteristics / brand name or equal requirements. The Contractor shall be capable to provide the following:

1. The Contractor shall deliver the software license electronically via secure e-mail with license activation code or via direct download from the vendor.

2. The FDA/CTP LiveDesign installation must be implemented, supported, and maintained on an FDA-approved cloud environment as determined by the contracting officer’s representative (COR) and project team.

3. The Contractor is expected to work with other FDA employees and contractors as related to FDA policies and procedures including the CTP Customer Service Center, Modernization team and OMIT processes must be followed. Bug fixes, minor enhancements, and licenses must be compatible with FDA/CTP’s current implementation.

4. The Contractor shall provide IT project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. The Contractor shall also provide supporting documents for Capital Planning and Investment Control (CPIC) and other Agency project monitoring programs.

5. The Contractor shall consult with the FDA Project Manager to clarify the documentation requirements. The Contractor shall coordinate and participate in all applicable Stage Gate reviews for the application as per Enterprise Performance Life Cycle (EPLC) standard processes.

6. The Contractor shall store and track documentation using FDA established tools that are accessible to the FDA Project Manager.

7. Provide automated creation and validation of quantitative structure-activity relationship (QSAR) models using automatic computation of descriptors and chemical fingerprints with multiple machine learning methods of kernel-based partial least squares, naïve bayes, and ensemble-based recursive partitioning, and the ability to automatically create hundreds of QSAR models and rank the best generated predictive QSAR models for prediction accuracy.

8. Ability to rapidly develop, validate, and deploy computational predictive QSAR models.

9. Provide a user-friendly graphic interface for model building and evaluation with easy access to chemical structures and properties stored in an expandable relational database

10. Provide fast substructure searching based on multiple fingerprinting methods including clustering and substructural analysis with a separate storage scheme for each chemical feature

11. Automatically explore various chemical descriptor and model fitting methodologies and put forth the best combination for a dataset

12. Create and organize chemical scaffolds in a hierarchical tree to visualize the data and chemotypes as well as highlight active compounds with heat maps.

13. Allow users to calculate and analyze fingerprints and properties, and ability to assess how ligand’s electrostatic, hydrophobic, and steric fields affect biological activity or inactivity.

14. Perform fingerprint-based similarity searching and substructure matching

15. Convert 2D chemical structures to 3D chemical structures

16. Provide structure clustering and R-group analysis by similarity based on fingerprints or chemical properties

17. Construct a model for the relationship between known pharmacological/toxicological activity and 3D structural characteristics of a set of chemicals, such as electrostatic, and hydrophobic fields using multi-step computational workflows

18. Provide technical training and scientific support on use, and interpretation of computational function and abilities by the software programs.

19. Ability to assess the 3D shape of chemical molecules and handle very large (millions of compounds) libraries.

20. Ability to enumerate ligand protonation states

21. Ability to identify and computationally analyze pharmacophores and calculate quantum mechanical properties of chemicals.

22. Ability to perform high-performance ligand-receptor computational docking including analyze the energy and properties of a ligand protein interaction.

23. Provide a protein structure prediction functionality

24. Offer a cloud-based data and project management cheminformatics platform to enable collaboration with all users that is not available with single machine seat-based installations

25. Ability for multiple users to share and work on the same computational data projects, results, and reports at the same time in a web-based cloud environment to all users instantly without having to recalculate assessments.

26. Ability to search existing compound databases using chemical fingerprints.

27. Compatibility: The computational models of the software to be purchased should be compatible to in- house data for custom- model building.

28. 12-month standard maintenance is included with upgrades and maintenance of the instance and software.

1.3 DELIVERY REQUIREMENTS

10 seats to LiveDesign includes 5 concurrent licenses to the floating calculation tools. 120 hours IT Technical Services

LiveDesign License Seats

*** 10 Seats to LiveDesign allows 10 users to access the instance simultaneously. Each user will be provided with their own login information. The 10 licenses seats provide 5 additional licenses of each tool for calculations on the instance. ***

The above items shall be delivered according to the below Period of Performance in Section 1.7. The vendor shall deliver all software as detailed in Section 1.1 of this delivery order as follows:

1.4 Period of Performance

The period of performance is for a base period and four option years, as follows:

1.8 Contract Type

This order is a firm-fixed-price order.

SECTION 2 – CONTRACT ADMINISTRATION

2.1 Contract Management

Contracting Officer (CO): Roosevelt Walker Email: roosevelt.walker@fda.hhs.gov

Contracting Specialist (CS): Robert Waite Email: robert.waite@fda.hhs.gov

Contracting Officer’s Representative (COR): (To be entered at time of award)

2.2 Contracting Officer’s Authority

The Contracting Officer (CO) 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 RFQ;

(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. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. 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 award. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (COR) 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 contract 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.

2.3 Interpretations of Modifications

No oral or written statement of any person and no written statement of anyone other than the CO shall modify or otherwise affect the terms and conditions of this contract. Requests for interpretations, modifications or changes must be made in writing to the CO. The technical point of contact can only respond to technical matters that do not result in a change of scope to this contract.

2.4 IPP Invoice Requirements

(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) 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.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866) 973-3131. 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.

(2) 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.

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

(4) If the Contractors 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.

(1) At a minimum the following cost information shall be included, in addition to supporting 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 Indirect)-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–amountasallowableinaccordancewiththeScheduleandFAR52.216- 8ifapplicable.

(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:

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted-corresponding payment amount &date received -totalamountofallpaymentsreceivedtodateunderthesubjectcontractororder-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.

2.5 Payment Terms

Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

SECTION 3 – INSPECTION & ACCEPTANCE

Inspection and acceptance will be at destination in accordance with FAR clause 52.212-4(a). In accordance with FAR 52.212-4(a), the Government has the right either to reject or to require correction of nonconforming supplies. Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with contract requirements. The Government may reject nonconforming supplies with or without disposition instructions.

The COR will perform inspection and acceptance of all products and services. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed above and within the established Period of Performance.

Inspection and acceptance will occur at the place of delivery. Inspection will include verifying all parts were received and warranties and services are in place. The Government will accept goods and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

All quoter’s shall be Authorized reseller and/or servicing agent shall identify and/or provide documentation to confirm their claim as an authorized reseller and/or servicing agent.

All Offerors quote shall clearly state license number, product description, quantity, price, and period of performance for each product. The quotation shall include and match license number, product description, quantity, and period of performance. Offerors are advised that should their quotation conflict with or does not clearly reflect the specified product and requirement of this solicitation, their quotation may be deemed as technically unacceptable and may not be considered for award.

Price: Provide a detailed quote for each item/component proposed to the schedule of items. Discounts are highly encouraged.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

SECTION 4 – FAR /HHSAR CLAUSES

4.1. The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (Oct 2018) applies to this solicitation. The following addenda apply:

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicants responsibility to ensure all electronic documents are submitted without the use of macros.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) Sam.gov for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only deliverables/reports and invoices to be applicable to the requirement.

Paragraph (b)(4): Technical Capability: Will be determined by review of information submitted by the offeror which shall provide sufficient technical information for the Government to conclusively determine that the offered supply items meets or exceeds the technical requirements identified above. In addition to identifying brand, item name, and item number of offered products, it is incumbent of offerors that they unequivocally demonstrate that offered products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered instrument. Offerors shall address the technical requirements identified above, as well as detailed information on the items in the solicitation. The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

Price: Provide detailed price quote for each item proposed to meet the Schedule of Items. Include the firm’s Unique Entity Identifier (UEI) number with quote. The option year periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly.

Pricing shall be valid through September 30, 2023

4.2. The The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The following addenda apply:

The government intends to award a firm‐fixed‐price order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be best value to the Government as Lowest Price Technically Acceptable (LPTA).

4.3. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (DEC 2019), applies to this acquisition.

4.4. The The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018). The following addenda apply:

Solicitation Clauses:

FAR Provision 52.252-1 Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be Completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Provision:

HHSAR Provision:

HHSAR 352.239-73 Electronic and Information Technology Accessibility (Dec 2015)

FAR Clause:

FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the contract expires. Delivery of added items shall continue at the same rate that like items are called for under the contract unless the parties otherwise agree.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract (option period and optional item/service) by written notice to the Contractor any time before the contract expires. The option periods must be exercised any time before the contract expires. Optional Items/Service may be exercised at any time during the contract period of performance. Any 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.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

HHSAR Clause:

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 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)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items. (DEC 2022)

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) 52.233-3, 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 products and commercial services:

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.)

(Oct 2022) (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 52.219-6.

(15) (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.

(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.

(18) (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.

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

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

X (31) (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 (32) (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.

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

X (36) 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.)

(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.)

(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 (Jun2014) of 52.223-14.

(ii) Alternate I (Jun 2014) of 52.223-16.

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

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

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

(49) (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.

(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.

(50) 52.225-5, Trade Agreements (Dec 2022) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (51) 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).

(Nov2007) ( 42 U.S.C. 5150).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (Nov 2021) 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 products and commercial services:

[Contracting Officer check as appropriate.]

( 41 U.S.C. chapter 67).

(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, as defined in FAR 2.101, on the date of award of this contract, 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 products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

that offer subcontracting opportunities.

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

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

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

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

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 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 (Nov 2021) ( 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 (May 2022) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (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. Subtitle A, Part V, Subpart G Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 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 (Nov 2021) ( 46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause)

5. Questions & Time Submission

All questions in response to this solicitation shall be submitted on or before April 19, 2023, 12:00 noon Washington DC Local Time. All questions shall be submitted via email to Robert Waite, Contracting Specialist, robert.waite@fda.hhs.gov

All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-75F40123Q00187. The quotes are due by email only to the point of contact listed below on or before April 28, 2023, by 1:00 pm (CT).

For information regarding this solicitation, please contact Robert Waite email: robert.waite@fda.hhs.gov image1.png