RFQ_for_Next_Gen_Sequencing_System.doc

Subject: Brand Name or Equal for NovaSeq 6000 Sequencing System and Reagent Kit Solicitation Number: FDA-18-RFQ-1197544 Part 1 – Description 1.1This is a Request for Quotation (RFQ) for Brand Name or Equal for NovaSeq 6000 Sequencing System and Reagent Kit. This requirement will be posted as a full and open competition.

1.2 The associated North American Industrial Classification System (NAICS) code for this procurement is 334516.

Part 2 – Supplies or services and Prices/Costs

2.1 Description of Equipment/Services

CLIN

Part 3 – Description/Specifications/Work Statement

3.1 Background:

The Office of Hematology and Oncology Products (OHOP/OND/CDER/FDA) and the Office of Biotechnology Products (OBP/OPQ/CDER/FDA) have jointly established a Next Generation Sequencing (NGS) Laboratory to support post-market surveillance of FDA-regulated biotechnology products with hematology/oncology indications. The lab uses NGS genomics technologies to assess the real-world safety and efficacy of immune-modifying biotechnology agents that are used to the treatment of cancer. Analysis of genetic material contained in these patient samples shall provide answers to key regulatory issues concerning individual products and the rapidly-developing class of immune-oncology agents.

3.2 Statement of Work

The contractor shall provide the FDA, one (1) Brand Name or Equal NovaSeq 6000 Sequencing System and one (1) NovaSeq 6000 S1Reagent Kit, or similar equipment which shall enable the FDA to process invaluable clinical samples, produce results that shall aid review and policy development, and shall lead to more effective and safer use of these agents in care of patients. The instrument shall also be used to train CDER review staff members on NGS technologies, which are increasingly appearing in product applications. Adding capability for cutting-edge scientific expertise in Next Generation Sequencing (NGS) to investigate the genetic origins of adverse events can facilitate the review and enhance the safety and efficacy of biotechnology-derived drug products.

3.3 Specifications ((1)NovaSeq 6000 Sequencing System and (1) S1 Reagent Kit)

(1) NovaSeq 6000 Sequencing System and (1) S1 Reagent Kit, or similar instrument, shall be able to provide automated high-throughput sample analysis at a low price per sample based on sequencing by synthesis chemistry. Specifically:

· The highest output of the instrument must be greater than 18 billion clusters using two flow cells at 150 bp per run

· The instrument must be capable of running at least 3 flow cells types

· The instrument must be capable of running multiple flow cell configurations to adapt to project needs

· Regents must be provided in preconfigured load-and-go cartridges to reduce opportunities to misload reagents

· Throughput must be greater than 3000 Gigabases per day

· The machine operator must have the ability to define read lengths

· The instrument must allow for multiplexing

· Must be able to conduct automated exclusion amplification chemistry

· The instrument must be able to conduct targeted resequencing (including exome panels and custom enrichment panels), RNA-seq (including mRNA-seq and total RNA seq), whole-genome resequencing, methyl-seq, and genotypic experiments

· Must interface with a BaseSpace Sequence Hub

3.4 On-Site Training and Maintenance (NovaSeq 6000 Silver Support Plan) The vendor shall include all activities associated with the following:

· Full-system software and peripheral installation (if applicable).

· On-site hardware and software training for at least two (2) personnel.

· Regular service and maintenance for at least three (2) years, including at least one (1) Primary Maintenance Service (PM) per year.

· Service and maintenance includes full coverage for parts, labor, travel, and reagent replacement.

· Emergency maintenance agreement shall be included.

3.5 Warranty

· Warranty period shall begin after installation/acceptance testing is completed and device is approved/certified as a fully operational system.

· Warranty period shall cover no less than twenty-four (24) months.

Part 4 – Inspection and Acceptance 4.1 The Contracting Officer’s Representative (COR) (see Part 6) will perform inspection and acceptance of materials and services to be provided at location in Part 5.

Part 5 – Deliverables or Performance Deliverables /Place of Performance

5.1 Delivery and Installation

The vendor shall include all activities associated with the following:

· System crating, shipping, and delivery to the laboratory site.

· Setup and connection to support utilities necessary to operate the system.

· All installation/acceptance testing shall be included. The testing protocols shall be agreed upon prior to the evaluation. Tests shall be performed on-site, after installation.

The sequencing instrument shall be delivered within ninety (90) days of contract award to the White Oak Building 52/72 Loading Dock and transported to White Oak Building 52/72, Next Generation Sequencing Lab, for installation.

Delivery Location:

Food and Drug Administration White Oak Campus

10903 New Hampshire Avenue

WO Building 52/72 Loading Dock

Silver Spring, MD 20993

Assembly Location:

Building 52/72; second floor; Next Generation Sequencing Lab; room number TBD 5.2 Period of Performance The period of performance shall begin upon the successful completion of the installation and training on the equipment. The period of performance (warranty and maintenance) is estimated to end after twenty-four (24) months.

Part 6 – Contract Administration Data

6.1 Contracting Officers Representative (COR) The following COR will represent the Government for the purpose of this contract:

(To Be Determined at the Time of Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the 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. The Government may unilaterally change its COR designation.

6.2 Contract Specialist

The contact information for the Contracting Specialist is:

Tara Hobson

5630 Fishers Lane, Room 2042

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov

(240) 402-7586

6.3 Contracting Officer

The contact information for the Contracting Officer is:

Richard Robinson Department of Health and Human Services

Food & Drug Administration, OAGS

5630 Fishers Lane

Rockville, MD 20857

Phone: (301) 796-6508 Richard.Robinson@fda.hhs.gov

6.4 Contractor Point of Contact

The contact information for the Contractor Point of Contact is: (To Be Determined at the Award of the Contract)

Name:

Address:

Phone Number:

Email:

6.5 INVOICE SUBMISSION

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A.

THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW:

Office of Financial Services

Food and Drug Administration

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.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) Purchase order/award number;

(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 number 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;

(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 (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C.

An electronic invoice shall be 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 FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave

WO32 - Second Floor, MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

Phone 301-827-ERIC (3742)

(Amend as necessary)

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 (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

PART 7-CONTRACT CLAUSES

7.1 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: www.acquisition.gov/far/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (Jan 2017) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2018)

(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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

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

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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 items:

_x__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), 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 (Oct 2015) (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 (Oct 2016) (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 (Oct 2015) (31 U.S.C. 6101 note).

___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

_x__ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (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 (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Nov 2016) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (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 (Nov 2011) (15 U.S.C. 657f).

__x_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (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 (Dec 2015) (15 U.S.C. 637(m)).

_x__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__x_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_x__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_x__ (28) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

__x_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

__x_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_x__ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

___ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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).

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 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.)

___ (35) (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.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (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.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

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

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (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_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

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

_x__ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (47) (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).

___ (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.

___ (48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (49) 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).

___ (50) 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).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__x_ (55) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

___ (60) (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.

(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:

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 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).

___ (6) 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).

___ (7) 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).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(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, 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 (Oct 2015) (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) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(vi) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(x) 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.

(xi) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xii) (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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 E.O. 13627).

(xiii) 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.)

(xiv) 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)

(xv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

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

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

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

(xix) 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).

(xx) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxi) 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.

7.3 FAR Clauses in Full Text

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 within the term of the contract.

TC "I.74 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)" \f C \l "2" 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 at any time within the term of the contract.

(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 24 months.

52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

Part 8– Instructions to the Offerors

8.1 FAR provisions Incorporated by Reference

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at (System Award Management) http://sam.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website, the offeror shall complete and submit only paragraphs (c) through (m) of this provision.

FAR Clause

Description

Date

52.212-1

Instructions to Offerors-Commercial Items (Jan 2017) 52.212-3

Offeror Representations

(Nov 2017)

And Certifications-

Commercial Items

RFQ Due Date: All quotes and revisions shall be received via email to tara.hobson@fda.hhs.gov before 12:00 PM (1200) EASTERN TIME on July 31, 2018. Offerors shall ensure the RFQ number is visible in the header of the email.

Fax quotes shall not be accepted.

All Offerors shall be registered in the System Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov.

8.2 Technical Proposal

a) The Offeror shall demonstrate that they can meet all the specifications in Part 3.3.

b) The Offeror shall demonstrate that they can provide installation involving set-up, instructions.

c) The Offeror shall demonstrate that they provide on-site training on hardware and software.

d) The Offeror shall demonstrate that they can provide warranty and maintenance.

e) The Offeror shall demonstrate that they can deliver system within 180 days of award.

8.3 Price Proposal The Offerors shall complete pricing table in Part 2.1.

PART 9 – Evaluation Factors for Award

9.1 Evaluation Factors

The Government will evaluate the quote to ensure that it is technically acceptable in accordance with the requirements in Part 3 and that the price is fair and reasonable. Award will be made lowest price technically acceptable offer (LPTA).

9.2 Technical Capability

a) The Offeror meets the capability that they can provide specifications in Part 3.3.

b) The Offeror shall demonstrate that they can provide installation involving set-up, instructions.

c) The Offeror shall demonstrate that they provide on-site training on hardware and software.

d) The Offeror shall demonstrate that they can provide warranty and maintenance.

e) The Offeror shall demonstrate that they can deliver system within 180 days of award.

9.3 Price

The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

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