FDA-RFQ-1228426 Tapestation RFQ.pdf

FDA-RFQ-1228426

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-1228426

Posted Date: Monday, June 22, 2020

Response Date: Tuesday June 30, 2020 12:00 PM CT

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

Classification Code: 6640 – Laboratory Equipment and Supplies

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079

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. The solicitation is being issued in conjunction with FAR Part 13 - Simplified Acquisition Procedures and FAR 13.5 Simplified Procedures for Certain Commercial Items. The solicitation number is FDA-RFQ-1228426. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-06 effective June 5, 2020.

The associated North American Industry Classification System (NAICS) Code is 334516 – Analytical Laboratory Instrument Manufacturing; SB Size status: 1,000 employees. This requirement is solicited as full and open competition.

Requirement The U.S. Food and Drug Administration’s (FDA), Center for Biologics Evaluation and Research (CBER)’s laboratory in Silver Spring MD is characterizing virus stocks to be used as reference materials for next generation sequencing studies. This project requires the extraction of genetic material from the viruses and the preparation of many next generation sequencing libraries. For this reason, the lab requires a 4150 Tapestation, specifically an Agilent 4150 Tapestation System or equal instrument with laptop and accessories, to analyze the quantity, size and integrity of DNA and RNA samples and sequencing libraries. The instrument will also require three (3) years of post-warranty maintenance, “Crosslab Silver,” or equal service plan.

This RFQ is for a Brand Name or Equal solution. Proposed equal needs to meet all the salient characteristics listed below to be deemed technically acceptable.

Schedule of Supplies or Services and Prices/Costs. Pricing shall be inclusive of shipping and installation to the Center for Biologics Evaluation and Research (CBER) at 10903 New Hampshire Ave, BLDG 52 Loading dock, building 52/72, room 1238, Silver Spring MD, 20993.

Line Item 1: 4150 Tapestation instrument, or equal, including software, vortexer, accessories, plastic consumables, user information. Does not include Screen Tape consumables and reagents.

Also includes TapeStation Software Laptop Bundle:

Quantity: 1 Unit: EA

Price: _____________________

Line Item 2: Post-Warranty Maintenance/Service Agreement (“Crosslab Silver” or equal), Option Year 1.

Line Item 3: Post-Warranty Maintenance/Service Agreement (“Crosslab Silver” or equal), Option Year 2.

Line Item 4: Post-Warranty Maintenance/Service Agreement (“Crosslab Silver” or equal), Option Year 3.

Total Price (System + 3 years of Post-Warranty Maintenance/Service Agreement): _____________

Salient Characteristics/Specifiations required of the “Brand Name or Equal” 4150 Tapestation System with laptop and accessories:

1. System shall be able to provide quantitative results of RNA and DNA integrity, size and quantity.

2. System shall determine size and quantification of DNA ranging in size from 35 base pairs up to 60 kilo base pairs (high molecular weight DNA) in as little as 5 pg/µl up to 100 ng/ul. The instrument shall be compatible with the use of high molecular weight gDNA and cell free

DNA.

3. System shall provide a quantitative unambiguous measure of DNA integrity in the form of a DIN (DNA integrity number).

4. System shall determine size and quantification of RNA ranging in size from 100 nucleotides up to 6000 nucleotides in as little as 100 pg/µl up to 500 ng/µl sample concentration.

5. System shall provide a quantitative unambiguous assessment of RNA integrity in the form of a RIN (RNA integrity number) or equivalent measure.

6. The system shall be able to process any number between 1- 16 samples in one run to avoid reagent waste.

7. Shall use only minimal amount of sample input (1-2 µl of sample per assay)

8. Shall have an integrated pipette to handle sample transfers

9. Shall be compatible with downstream analysis of samples with Illumina and Oxford Nanopore technologies sequencers.

10. Vendor shall install the instrument and provide a scheduled training session. Date of installation and training to be agreed upon after system purchase.

11. Vendor shall provide a maintenance agreement that includes preventive maintenance visits as per the below requirements and repairs using OEM parts and manufacturer trained technicians

Installation, Training and Warranty Requirements

• The instrument and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall conduct an onsite training session to provide a thorough demonstration of all system/solution functions, maintenance, data acquisition and analysis, basic troubleshooting and hardware/software operation.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Post Warranty Maintenance Requirements, Agilent Crosslab Silver or equal. Service includes:

• At a minimum, one (1) Agilent CrossLab Preventive Maintenance visit per year.

• Agilent Remote Advisor is also included (upon availability).

• On-site hardware troubleshooting and repair with standard response time (in this area, “standard response time” is 3-6 days after the call is logged)

• All labor, travel costs, and service parts, including consumable parts required for repair

• Telephone support to isolate and resolve hardware and software problems

• Service center repair: Includes diagnosis and correction of product malfunctions and failures at local Agilent Service Centers. Agilent may install engineering improvement modifications, when applicable, and perform services such as cleaning, adjusting, lubricating, inspecting, or testing. Repaired products are re-tested and certified to verify proper operation. All required labor, parts, and materials are included. Replaced parts become the property of Agilent.

Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed

Contract Type: Commercial Item-Firm Fixed Price

Period(s) of Performance for Service/Maintenance Plan. Base Year plus three (2) one-year Option Years.

Manufacturer’s Warranty: 12 consecutive months from installation and training (anticipated on/about Sept 16, 2020 – Sept 15, 2021);

Option Year 1: anticipated on/about Sept 16, 2021 – Sept 15, 2022 Option Year 2: anticipated on/about Sept 16, 2022 – Sept 15, 2023 Option Year 3: anticipated on/about Sept 16, 2023 – Sept 15, 2024

The period of performance for the Option years in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. If/when Option Year 1 Post-Warranty Service/maintenance is exercised, the periods of performance for all post-warranty Options will be firmed via bilateral modification.

Delivery Terms Within 30 days after contract award, contractor shall be responsible for delivery, installation and training of personnel on the system at the following address:

Delivery Address FDA Center for Biologics Evaluation and Research (CBER) 10903 New Hampshire Ave.

Building 52/72, Room 1238 Silver Spring, MD 20993 POC: Will be provided at time of award

Contract 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 and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) applies to this acquisition. The following addenda apply:

FAR Clauses 52.204-13 System for Award Management and Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) “…any time before the contract expires; ...any timebefore the contract expires…”

(c) “…shall not exceed three (3) years” 52.232-18 Availability of Funds (Apr 1984)

HHSAR Clauses 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

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

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

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

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

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

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

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

https://www.acquisition.gov/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Contract Administration Contracting Officer The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract;

or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Name: Suzanne Martella Email: suzanne.martella@fda.hhs.gov Phone: (870) 543-7540 The TPOC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

Technical Point of Contact (TPOC) The following Technical Point of Contact (TPOC) will represent the Government for this contract (to be provided upon contract award):

Name:

Email:

Phone:

Payment terms Net 30 days after government acceptance of a proper invoice. No advance payment will be made.

Invoice Submission

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

(301) 827-3742 E-mail: FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. *** Provide a courtesy copy to the Technical Point of Contact (TPOC) identified above at (to be included at contract award).

mailto:FDAVendorPaymentsTeam@fda.hhs.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in

(i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jun 2020) (Deviation Apr 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108- 78 (19 U.S.C. 3805note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020), with Alternate

I (OCT 1995)

(41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101note).

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

__ (10) [Reserved].

__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C.657a).

__ (ii) Alternate I (MAR 2020) of 52.219-3.

X (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C.

657a).

__ (ii) Alternate I (MAR 2020) of 52.219-4.

__ (13) [Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C.644).

__ (ii) Alternate I (MAR 2020).

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

__ (ii) Alternate I (MAR 2020) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (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 (JUN 2020) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C.637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

X (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (MAR 2020) (15 U.S.C.

632(a)(2)).

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

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (MAR 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C.

644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

X (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2020) (E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

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

__ (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.

__ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

X (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (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).

__ (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

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

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

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

__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

X (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (MAY 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub.

L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

X (ii) Alternate I (MAY 2014) of 52.225-3.

__ (iii) Alternate II (MAY 2014) of 52.225-3.

__ (iv) Alternate III (MAY 2014) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

X (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT 2018) (31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

__ (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C.3332).

X (61) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)(DEVIATION APR 2020)(31 U.S.C. 3903 and 10 U.S.C. 2307).

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

__ (63) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) (15 U.S.C. 637(d)(13)).

__ (64) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (APR 2003) of 52.247-64.

__ (iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

__ (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) (29 U.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 Under Executive Order 13658 (DEC 2015).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (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 items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds 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.

(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 (JAN 2019) (22 U.S.C. chapter 78 and E.O 13627).

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

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C.

chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

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

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

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (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 (FEB 2006) (46 U.S.C.

Appx.1241(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

Solicitation 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/these address(es): https://www.acquisition.gov/browse/index/far and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (June 2020) applies to this solicitation. The following addenda apply:

https://www.acquisition.gov/browse/index/far

Paragraph (b)(4). 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 acceptability of the offered supplies/services.

To be considered for award, quotes of “equal” products, including “equal” products of the brand name manufacturer shall meet the salient physical, functional, or performance characteristic specified in this solicitation; clearly identify the item by brand name, if any; and make or model number. “Equal” quotes shall include a narrative describing how the offer meets each salient characteristic as well as an explanation of how each salient characteristic is fully met. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need.

Technical acceptability will be determined and evaluated by review of information submitted by the offeror, which must provide sufficient technical information necessary for the Government to conclusively determine that the offered product(s) and/or services meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.

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.

The price proposed shall represent the offeror’s response to the schedule of supplies/services above.

Price shall be detailed and supported by a breakdown of all items required for system operation.

(Offerors shall fill in the schedule above with the total system price and provide a detailed quote in their own format.)

Proprietary and/or confidential information shall be clearly marked. Respondent’s DUNS number shall be included with quote.

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 all sources including sources outside of the Government.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc.

Note: The solicitation is being issued under the premise that the Offeror certifies that the service it will propose to fulfill this requirement are exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). Based on this premise that the Offeror certifies that its proposed services are exempt under the terms and conditions of 52.222-48, FAR clause 52.222-51- Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements will be applicable to the resulting order. In the event that an Offeror determines its proposed services do not meet the exemption, they are to expressly notify the Contracting Officer in their quotation and the traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 2015-5121 (Rev. 10) Revision date: 07/16/2019. The applicable wage determination can be located here: https://beta.sam.gov/wage-determination/2015-5121/10/document

The Contractor’s quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48.

The provision at FAR 52.222-48 Exemption from Application of the Service Contract to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) applies as follows:

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that-

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act-

(1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-- Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision-https://beta.sam.gov/wage-determination/2015-5121/10/document

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, will not be included in any resultant contract awarded to this offeror; and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

Addendum Paragraph (c) Period for Acceptance of Offerors. The offer agrees to hold the prices in its offer firm through September 30, 2020.

Microsoft Suite Documents Containing Macros The offeror or applicant shall submit all electronic documents created by 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 offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation.

The specific evaluation criteria to be included in paragraphs (a) through (c) of that provision are as follows:

(a) The Government intends to award a contract resulting from this solicitation to the lowest priced technically acceptable responsible offeror. Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (June 2020), applies to this acquisition.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision.

(a) Definitions. As used in this provision— “Covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_528902107 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are…