SOW final.docx

U. S. Food and Drug Administration CFSAN Statement of Work (SOW) Template

Purchase of GridION Software License or equal and Device warranty

RFQ-FDA-1245239

1. Background The efforts are required to support FDA’s Next Generation Sequencing (NGS) business needs for genomic data collection and analysis.

Researchers within the CFSANs Office of Applied Research and Safety Assessment are participating in an initiative to build a database of foodborne beneficial microbes and pathogens based on Next Generation Whole Genome Sequencing methods. Also, part of the offices interest is in understanding the transcriptome of these microbes. As part of the initiatives, the laboratories have purchased instrumentation for sequencing. The software license and device warranty for the instrumentation is necessary for the instruments to function accurately. The sequences from the pathogenic bacteria will be included into the GenomeTrakr network. The GenomeTrakr network is the first distributed network of laboratories to utilize whole genome sequencing for pathogen identification. It consists of public health and university laboratories that collect and share genomic and geographic data from foodborne pathogens. The sequences from the beneficial microbes will be made publicly available in NCBI. OARSA research teams using the sequencers will be providing sequences to this database which is also being populated by scientists through the already established network.

2. Purpose:

The purpose of this requirement is to purchase Software Licenses and Device warranties for two (2) Oxford Nanopore Technology’s GridION instruments, S/N 5158326 and S/N 5158324. The GridION instruments are used to support FDA’s Next Generation Sequencing (NGS) business needs for genomic data collection and analysis.

3. Objectives:

The objective of this requirement is to purchase GridIon software license or equal and device warranty.

This includes:

•Software updates upon release •Hardware updates on release •Return and Replace policy

4. Scope:

Purchase of software license and device warranty.

5. Specific Tasks:

The task at hand is to purchase of Software License and Device warranty for two (2) Oxford Nanopore Technology’s GridION machines, serial number 5158326 and serial number 5158324.

Project Milestones/Completion Dates

Milestones Projected Completion Date

6. Deliverables

· Software License and Device warranty for Nanopore Technology’s GridION machines.

· The renewal should be 9/20/2021 but no later than 9/30/2021.

6.1 Deliverable Table

9/22/2021

7. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) No Government-furnished property will be provided to the Contractor.

8. Contractor Provided Special Material Requirements No special materials will be needed for this task.

9. Security If needed, Government will provide escort of the service engineer to install/update the GridION software to the instruments. The engineer will not be provided access to any material that involves Non-Public positions and involves the lowest degree of adverse impact on the efficiency of the Agency. This position does not require a badge or access to FDA’s network.

10. Travel If travel is required, the contractor will cover the expenses.

11. Other Considerations None to disclose.

12. Place of Performance

The task of installation will be performed at FDA, MOD1 8301 Muirkirk Road Laurel, MD 20708.

Work shall be conducted Monday through Friday, excluding federal holidays.

13. Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure (e.g. applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.

14. Period of Performance

9/22/2021 – 9/21/2022

15. Order Type The order type is Firm-Fixed-Price.

16. Point of Contacts

Contracting Specialist Nakita Putty 4041 Powder Mill Rd Beltsville, MD 20705

(301) 796-7104 Email: Nakita.Putty@fda.hhs.gov

Contracting Officer

TBD

Contracting Officer’s Representative (COR

TBD

17. Contracting Officer’s Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price.

The CO shall be the only individual authorized to accept nonconforming work waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer's Representative {COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the delivery order.

18. Authorized Contractor

The Contractor shall be the software Original Equipment Manufacturer (OEM) or an authorized reseller/servicing agent of the software OEM.

The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM.

19. Order of Precedence

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

20. Clauses

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 this/these address(es): https://www.acquisition.gov/far/part-52#FAR_52_215_1

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)

52.204.24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)

52.204-25 – Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)

52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40: Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

352.239-74 – Electronic Information and Technology Accessibility (December 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

· 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)

· 302 Functional Performance Criteria (Appendix C, Application and Scoping

· Requirements)

· Chapter 6 Support Documentation

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508.

If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

21. Provisions

52.252-1 – Solicitation 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 address https://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482

(End of Provision)

52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (Jan 2017)

52.204-24 – Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Dec 2019) 52.204-26 – Covered Telecommunications Equipment or Services-Representation (Dec 2019)

352.239-73: Electronic and Information Technology Accessibility Notice (Dec2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

Special Notice and Agreement regarding Software EULA/TOS

Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government.

Therefore, by submitting a quotation the quoter shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The quoter agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the quoter must agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.

22. Instructions to Quoters

This solicitation is issued under FAR Part 16.5 procedures using NASA SEWP V. The solicitation is issued under Group(s) C. Quoters shall submit quotes via NASA SEWP on or before 9:00 PM EDT on September 16, 2021.

The Quoter shall provide Software license and device warranty. Satisfying the requirements set forth in this solicitation.

Quotes shall be valid for 30 days.

Quoter shall be an Authorized reseller and or servicing agent of the manufacturer.

Quoters shall include serial numbers, as shown in section 5 and 6 of the task and deliverables sections in their quotation.

Quoter shall be meet 508 compliant standards.

Phone calls will not be accepted.

Quoters providing quotations must clearly state the overall cost to the Government.

23. Evaluation of Quotes

FDA will evaluate quotes received in response to this RFQ by using the low-price-technically-acceptable methodology. The quoter’s initial quote should contain the quoter’s best terms from a price standpoint. The government intends to evaluate quotes and award a firm fixed price contract without a dialogue. However, the government reserves the right to conduct a dialogue if later determined by the Contracting Officer to be necessary.

Quotes will be evaluated based on the following:

Technical capability meeting / exceeding salient characteristics.

Quoter demonstration to provide software and device warranty as specified.

Quoter meeting/exceeding section 508 standards.

Quotation Total Price.

24. Award Determination The award will be made to the lowest price offeror that demonstrates they can meet the requirements of this solicitation. Failure to demonstrate meeting the requirements will result in a rating of technically unacceptable and will not be considered for award.

25. Post-Award Administration Completion of all deliverables, quality and timeliness of delivery, as well as incidents and types of defects, will be used to evaluate the Contractor’s progress and suitability.