Sol_RFQ Attachment_75F40124Q00128.pdf

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 and FAR Part 13 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular

(FAC) 2024-03.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40124Q00128 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1,000 employees. This requirement is being solicited as a full and open competition. Prospective quoters are responsible for downloading the solicitation and any amendments from SAM.gov. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial quote is providing the Best Value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) has a requirement for the purchase on a BRAND-NAME ONLY basis for an Illumina NextSeq 2000 High Throughput Next-Generation Sequencing System in accordance with the Statement of Work (SOW) provided below. The acquisition is for a complete system and includes a trade-in of an existing instrument;

one (1) Illumina NextSeq 500. The following shall also be included: training, warranty, and a preventative maintenance (PM) agreement.

1. SITE VISIT: A site visit is scheduled for prospective quoters to gain any pertinent information that will assist with the development of a proper quotation. Quoters will be able to review the instrument being traded-in along with the proposed new instrument location to ensure the quotation includes all components required for the proposed system and to ensure the proposed system will work in the location. Attendance is not mandatory but is encouraged in order to confirm the proposed space is appropriate for the instrument system and in order to avoid a delay in system installation, acceptance, and payment.

a. Site visit date and time:

Wednesday, March 13, 2024 at 11:00 AM Eastern Time (ET, Local)

b. Site visit location:

U.S. Food and Drug Administration Center for Veterinary Medicine Bldg MOD2 8401 Muirkirk Rd Laurel, MD 20708

c. RSVPs:

RSVPs for attending the site visit shall be submitted and confirmed with the Contracting Office Point of Contact (POC) below via email only and not later than Monday, March 11, 2024 @ 10AM ET:

Name: Benjamin Dorgan Email: benjamin.dorgan@fda.hhs.gov

Clearly indicate in the email subject line “Site Visit Attendees for RFQ 75F40124Q00128: NextSeq 2000 System”.

d. The FDA designated POC will meet all site visit attendees. Proper identification is required for the site visit (e.g., Drivers License, State ID, etc.).

e. The site visit coordinator will escort attendees to allow for any pertinent questions related to site, instrument, etc.

f. Prospective quoters shall plan to attend during the time period designated for the site visit. Appointments outside of the specified timeframe will not be permitted.

g. Please be advised that reimbursement for travel, per diem, and all other costs associated with submitting a quotation and/or attending the site visit will not be considered.

mailto:benjamin.dorgan@fda.hhs.gov

2. QUESTION DEADLINE: Interested quoters shall submit all questions concerning the solicitation and site visit at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Contracting Officer Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: Thursday, March 14, 2024 at 5:00 PM ET may not be considered.

3. QUOTATION DEADLINE: The deadline for receipt of quotations for this requirement is: Tuesday, March 19, 2024 at 5:00 PM ET. Quotation submissions shall be submitted by email only to Contracting Officer Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. Subject line of the email should be titled: “Quotation Submission:

75F40124Q00128_NextSeq 2000 System”.

4. QUOTATION SUBMISSION INSTRUCTIONS:

4.1 The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables.

4.2 The Contractor shall include and complete the pricing chart below. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

Line Item Description Quantity Unit Unit

Price Extended Price

NextSeq 2000 Sequencing System (Incorporates all System Requirements including System Trade-In Credit, Installation, Training and

Initial Warranty)

Dollars $

2 Shipping and Handling Dollars $

3 Option Period 1 (12 Months Maintenance) Dollars $

4 Option Period 2 (12 Months Maintenance) Dollars $

5 Option Period 3 (12 Months Maintenance) Dollars $

6 Option Period 4 (12 Months Maintenance) Dollars $

Total $

4.3 Quotes shall be in two volumes: Volume I shall be Technical and Volume II shall be Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I. This volume shall provide the equipment description including specs, proposed work breakdown schedule for completion, warranty, delivery timeframe, etc. and not exceed 10 pages in length.

4.4 Site Preparation Information: Quoters shall include in their quotation any, and all site-preparation information required for proper system operation and maintenance, including physical space, ventilation, and IT/network requirements.

4.5 The quoter shall demonstrate that they are an authorized reseller/distributor. Only new, unaltered items shall be provided (i.e., No gray market supplies or equipment shall be provided).

4.6 A quoter must submit sufficient information for a technical evaluation to be made by the Government to determine if the quoter's quotation meets the minimum requirements of the SOW. The Contracting Officer is not responsible for acquiring any additional information. If description/technical data/specifications are not sufficient to make a technical acceptance decision, the quotation may be determined technically unacceptable.

4.7 Quotes shall clearly reference the solicitation, date of quotation, company quoting and point of contact.

4.8 The Contractor’s current address and System for Award Management Unique Entity ID (UEI) shall be included in the quote.

4.9 Quotes shall be for all the deliverables requested.

4.10 Quotes shall be valid for at least 90 days after close of solicitation.

4.11 The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

5. AWARD CRITERIA:

Quotations that do not respond to all requirements in the solicitation may be considered non-responsive without further evaluation, deliberation, or discussion. The Government reserves the right to award without discussions.

The Government contemplates award of a Firm-Fixed-Price Purchase Order resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government and whose quote is the Lowest Priced Technically Acceptable (LPTA).

FAR 52.212-2 EVALUATION -- COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

Lowest Priced, Technically Acceptable (LPTA)

(End of provision)

STATEMENT OF WORK (SOW)

U.S. Food and Drug Administration (FDA)

BRAND NAME ONLY Illumina NextSeq 2000

A. Background:

The Office of Applied Science conducts applied research in support of current and evolving FDA regulatory issues and work to provide research solutions that ensure the safety of animal derived food and animal health products. The Division of Emerging Tecnologies (DET) in the Center for Veterinary Medicine, Office of Applied Science (CVM/OAS), investigate antimicrobial resistance and genetic mechanisms that confer multidrug resistance in foodborne pathogens. In order to advance these efforts, DET conduct routine whole-genome, shotgun metagenomics, and total RNA sequencing, and require an advanced, efficient, cost-effective, and high-throughput next-generation sequencer, brand-name only to the Illumina NextSeq 2000, to contribute to DET research.

B. Scope of Work:

This requirement is for the purchase of a modernized next generation sequencing system, BRAND NAME ONLY to the Illumina NextSeq 2000. This system shall be capable of automated generation of DNA clonal clusters, nucleic acid sequencing by synthesis, and automated local analysis of DNA sequences.

The acquisition is for a complete system to include, but not limited to a touchscreen monitor, integrated computer, control software, and secondary analysis pipelines. This acquisition includes a trade-in of an existing instrument; one (1) Illumina NextSeq 500. The following shall also be included: training, warranty, and a preventative maintenance (PM) agreement as outlined in the sections below.

Minimum Illumina NextSeq 2000 Salient Characteristics:

1) Shall provide a newly manufactured unit, not used or refurbished, or previously used for demonstration.

2) Shall be capable of whole-genome sequencing; metagenome sequencing, targeted sequencing, including, but not limited to:

a) Exome panels and custom enrichment panels (100s kb–Mbs)

b) Whole-genome de novo sequencing

c) Metagenome sequencing

d) Sequencing of bisulfite-treated DNA (Methyl-Seq)

e) RNA sequencing (RNA-Seq), including, but not limited to:

i) mRNA sequencing and total RNA sequencing (coding and noncoding)

ii) genotyping by sequencing (GBS) and nucleosome positioning and chromatin structure studies.

3) Shall provide a complete system to include, but not limited to:

a) Touchscreen monitor

b) Integrated computer

c) Control software (and licenses if required by manufacturer), and secondary analysis pipelines.

4) Shall be compatible with FDA validated Illumina library preparation kits.

5) Shall have the ability to generate data with a minimum of > 75% of bases with Q-scores ≥ 30 at 2 x 150 bp read length.

6) Shall allow user to choose between two flow cell types (P2 and P3).

7) Shall allow selection of read length kit configurations (from 50 to 300 bp) for associated flow cells.

8) Shall deliver a minimum of 300 Gb of sequences per run to support 48 shotgun metagenomics samples (@50 million reads per sample); 40 whole exomes (@50X mean target coverage); or 25 single-cell samples (~4000 cells, 10,000 reads per cell).

9) Shall provide tunable metrics to enable researchers to adjust throughput to maximize deliverable data per cost for mission critical projects with limited funding.

10) Shall Provide the following Optical specifications:

a) Two lasers for excitation of fluorophores with wavelengths at 449 nm (2.0 Watt maximum power) and 523 nm

(1.2 Watt maximum power).

b) A third laser at 820 nm for focus tracking with dual, high-throughput CMOS cameras for rapid imaging of flow cells.

11) Shall provide the following reagents and operation specifications:

a) Support ready-to-use cartridges (with all the reaagents and fluidics within the cartridge) for amplification and sequencing. These integrated cartridges shall contain all fluidic handling components necessary for amplification and sequencing to reduce run to run contamination.

b) Fluid waste shall be purged back into reagent cartridges for easy and safe disposal for the instrument user.

12) Shall provide the following Chemistry Specifications:

a) The instrument shall support Illumina SBS chemistry which uses reversible terminators and highly efficient DNA polymerase modified to accept reversible terminator nucleotides.

b) Reversible terminator chemistry allows only one base addition at every cycle, almost eliminating homopolymer errors.

13) Shall provide the following consumables (reagents) to operate the instrument:

a) Shall be available in environmentally friendly packaging for environmental considerations and user safety.

b) Self-contained plastic components of the instrument’s reagent cartridges may be separated from chemical waste for recycling.

14) Shall provide the following Physical Specifications:

a) Fit on a bench, occupying the following dimensions: (W x D x H): 60 cm x 65 cm x 60 cm (24 in x 26 in x 24 in)

15) Shall provide consumables including the following sequencing reagents at the minimum:

a) P3 Reagents (300 Cycles) – Quantity 4

b) Unique indexes, tagmentation (96 indexes/samples) – Quantity 1

16) Shall provide consumables including the following reagents at the minimum:

a) Illumina Total Stranded RNA Prep, Ligation with Ribo-Zero Plus (96 Samples), Cat#20040529

b) Illumina® RNA UD Indexes Set A, Ligation (96 Indexes, 96 Samples), Cat#20091655

c) NextSeq 2000 P3 Reagents (300 Cycles), Cat#20040561

17) The system shall conform to FDA IT Security requirements and be approved by FDA IT prior to award. FDA/IT Specific requirements:

a) Card Readers. The Contractor (and/or any subcontractor) shall include Federal Information Processing

Standard (FIPS) 201-compliant smart card (access card) readers (referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

b) Offeror’s proposal shall provide any system specific IT information including computer information, software names, version numbers, licensing requirements, and any requirements for exclusion from automatic/push updates, and internet/network connectivity requirements.

18) System shall meet the following requirements for 508 Compliance: Must meet WCAG 2.0 A and AA

a) E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

b) E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

c) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

d) E205 Electronic Content (Appendix A, Application and Scoping Requirements)

e) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

f) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical

Requirements)

g) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

h) Electronic content must be accessible to HHS acceptance criteria.

i) E206 Hardware (Appendix A, Application and Scoping Requirements)

j) Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements)

C. Minimum Training Requirements:

1) Shall include installation, basic applications and 1-2 days on-site training for five (5) to ten (10) users.

2) Shall include any reagents or consumables required for the training

3) Shall provide training taught by manufacturer trained and certified individual https://www.idmanagement.gov/approved-products-list) https://www.idmanagement.gov/approved-products-list) https://www.idmanagement.gov/approved-products-list)

4) Shall provide training covering (at a minimum) system operation, routine maintenance of the system, and utilization of the system with custom workflows or programs.

5) Shall be scheduled by the Technical Point of Contact (TPOC) after installation is deemed by the TPOC to be operationally acceptable. Training may not occur on the day of system installation, weekends, or Federal holidays.

6) Additionally shall provide a virtual introductory presentation training for half day or less for fifteen (15) users covering an overview of the technology and the data output potential of the sequencer for OAS Principle Investigators.

a) Training to occur during the warranty period.

D. Minimum Warranty Requirements:

1) Shall include one (1) year warranty for parts and labor from the date of acceptance

2) Shall provide remote Technical Support through telephone and web services during business hours (8 to 5 pm

EST)

3) Shall include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

4) Service calls shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument.

5) Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

a) The Technical Point of Contact (TPOC) or their designee shall have access to the manufacturer’s technical assistance call center during regular business hours (10am to 8pm EST).

b) The technical assistance call center shall be staffed by engineers who provide a high level of expertise for troubleshooting the instrument.

6) Shall guarantee that a service engineer will be able to work on site within three (3) business days of receiving a call from the End User(s).

a) Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement.

b) If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs.

i) Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government, specifically the Contracting Officer, has given the vendor proper authorization to proceed

c) Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed five (5) business days (120 hours).

7) Shall provide all software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

8) Shall include all shipping, installation, travel, labor, and parts required at no additional cost to the government.

E. Minimum Preventative Maintenance (PM) Agreement Requirements:

1) Shall provide an option year PM agreement covering maintenance of the instrument for four, one-year option periods.

2) Shall cover the same requirements as the warranty requirements with the addition of an annual PM service meeting the following:

a) Shall provide one(1) scheduled PM visit per year over the term of the contract

b) Shall include all travel, labor, parts at no additional cost to the government

c) Shall include routine PM of the instrument, calibration, electrical safety testing, and any other PM measures deemed necessary by the manufacturer.

F. Trade-in Requirements and Information:

As part of this acquisition, the contractor shall accept one (1) (Illumina NextSeq Model 500, Serial # NS500253. This instrument is currently in good condition and has been properly maintained under a full-service agreement since the instrument has been purchased; currently covered under a separate existing contract until 3/23/24

1) The contractor shall be responsible for disassembly, packaging, and shipping at no additional cost to the Government outside of what is included in the quote.

2) The contractor shall complete the removal process of the trade-in prior to installation of the new instrument due to space restrictions.

G. Inspection and Acceptance:

Prior to final acceptance, the vendor shall:

1) Demonstrate upon installation that the item will meet all performance specifications by the manufacturer using supplied controls.

2) Conduct a verification run will be conducted to assess data generation capability and data quality using prepared research samples.

H. International Work/Data Transfer Restriction

The Contractor shall ensure that all work/data under this requirement remain inside the United States. Transfer of work/data outside of the United States is not permitted.

I. Period of Performance

Delivery and installation shall be made within 60 days of award. A one-year warranty shall be provided beginning from the date of acceptance. Four 12-month option periods for preventative maintenance purposes shall also be provided.

J. Delivery Address:

The vendor shall be responsible for installation and setup of the instrument. Any necessary shipping shall be on a FOB Destination basis. Delivery hours are 10:00 am – 4:00 pm (Local, Eastern Time), Monday – Friday, excluding Federal holidays and weekends. Installation shall be performed by a currently trained technician, certified by the manufacturer.

All installation costs shall be included in the proposal including, but not limited to: delivery, uncrating, placement, and setup of the instrument in the installation location, and provision of required installation kits. The complete installation should be scheduled within thirty (30) days of delivery of all necessary components. The vendor shall provide any predefined specifications or requirements for the installation as part of the proposal information.

The items shall be delivered to the Technical Point of Contact, (name to be provided at award) at:

FDA/CVM

Bldg MOD2 8401 Muirkirk Rd Laurel, MD 20708 Note: Loading dock delivery is acceptable.

K. POINTS OF CONTACT (POCs)

1) Technical Point of Contact:

To Be Provided at Award

2) Contracting Officer (CO):

Benjamin Dorgan U.S. Food and Drug Administration Office of Acquisitions and Grants Services

Tel: (301) 796-6542 Benjamin.Dorgan@fda.hhs.gov mailto:Benjamin.Dorgan@fda.hhs.gov

CONTRACT CLAUSES

I. FEDERAL ACQUISITION REGULATION (48 CHAPTER 1) CLAUSES

I.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at these addresses: www.acquisition.gov AND www.acquisition.gov/hhsar

I.2 52.212-4 CONTRACT TERMS AND CONDITIONS -- COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2023)

I.3 52.247-34 F.O.B. DESTINATION (NOV 1991)

I.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

(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 Covered Entities (Dec 2023) (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:

[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) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111- 117, section 743 of Div. C).

http://www.acquisition.gov/ http://www.acquisition.gov/hhsar

_X_ (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L.

117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

__ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204–30.

_X_ (12) 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).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C.

2313).

__ (14) [Reserved].

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

_X_ (16) 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).

__ (17) [Reserved] __ (18) (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.

__ (19) (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.

_X_ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 15 U.S.C. 637(d)(2) and (3)).

__ (21) (i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) ( 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 2023) of 52.219-9.

__ (22) (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.

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) ( 15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024) ( 15 U.S.C. 632(a)(2)).

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

__ (27) 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)).

__ (28) 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)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

_X_ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

_X_ (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

_X_ (35) (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_ (36) (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_ (37) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_X_ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (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).

__ (40) 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.)

__ (41) (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.)

__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (44) (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.

__ (45) (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.

__ (46) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) ( 42 U.S.C. 8259b).

__ (47) (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_ (48) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (49) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (50) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (51) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

__ (52) (i) 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

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

__ (53) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 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 (NOV 2023) of 52.225-3.

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

_X_ (54) 52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (55) 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).

__ (56) 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).

__ (57) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150).

__ (58) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (59) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (60) 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).

__ (61) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C.

4505, 10 U.S.C. 3805).

_X_ (62) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C.

3332).

__ (63) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (64) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (65) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (66) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (67) (i) 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).

__ (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.]

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 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).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

_X_ (5) 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).

__ (6) 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).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 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, 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-

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

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii) 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)).

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 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).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117- 328).

(vii) (A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

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

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

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

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

(xiv) 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.

(xv) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xvi) (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).

(xvii) 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).

(xviii) 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).

(xix) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

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

(xxi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii) (A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

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

(xxiii) 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).

(xxiv) 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.

(xxv) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi) 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)

I.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

I.6 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 at least 0 days 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.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years and 6 months.

Health and Human Services Acquisition Regulation (HHSAR) and U.S. Food and Drug Administration (FDA) Clauses:

I.13 HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS

I.14 HHSAR 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(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.

(c) 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.

(d) 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.

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

I.15 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 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.

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

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 documentation to substantiate costs incurred.

1. 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;

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

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

4. 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;

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

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

7. 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:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) 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 Delivery 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.