FDA_SOL_1229155.pdf

Solicitation No. FDA_SOL_1229155 Date: July 22, 2020

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020‐07.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION

WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA_SOL_1229155 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516‐ Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. The requirement will be awarded as Firm‐Fixed Price and 100% small business set‐ aside. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Beta.Sam.Gov. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government intends to issue a Firm‐Fixed Priced Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure one integrated genomic sequencing system BRAND NAME OR EQUAL TO the Illumina NextSeq 2000 Sequencing System, Plus, a Preventative Maintenance Agreement for Four (4), One Year Option Periods.

**************************BRAND NAME OR EQUAL*******************************

Background and Overview The Division of Microbiology in the Office of Regulatory Science is currently working on microbial metagenomics for use in epidemiology of food borne illness associated with agricultural commodities, growing conditions, agricultural and processing practices and all environments where it is possible for contamination to take place on the path of fresh fruits and vegetables as they travel from the farm to the consumers table. Exploration of entire microbial environments associated with the paths of fresh produce to market, has revealed numerous opportunities for contamination and spread of disease. With inexpensive and reliable sequence information, FDA will produce high resolution characterization of all biological risks associated with various growing and production pipelines. This information will guide the development of improved management practices for safe agricultural production and safe processing of fresh produce for American consumption. This newly sequencing platform has much better performance with increased accuracy in array‐based sequencing technologies.

The Division requires a sequencing system that can perform real‐time analysis to improve laboratory efficiency for metagenomics study analysis. The new system enhancement with Real‐time analysis software using two‐channel chemistry performs base calling, filtering and quality scoring in about six minutes per cycle. Once primary analysis is complete secondary analysis is initiated to generate FASTQ files and utilizing the DRAGEN Bio‐IT platform provides tasks such as structural variant calling, mapping, and gene fusion detection.

Statement of Work The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

The vendor shall provide (1 ea) one integrated genomic sequencing system with the following technical specifications:

1. Scalability enable data output ranging up to 300 Gb per run to support a broad range of applications and study sizes

2. Flexibility to switch between data output of up to 120 Gb per run or larger capacity runs of up to 300 Gb per run

3. 48 hour runs including data Bio‐IT platform integrated analysis

4. High accuracy of consensus sequencing system >99.9999%

5. Analysis software capable of generating readable and convertible printable reports into commonly used formats through open web‐based platforms such as Galaxy or other commercially available software (CLC bio).

6. Shall assist the Division scientists with sequencing studies of food products to define microbial communities and to evaluate products for the presence of pathogens and virulence markers, pathogen subtyping and source tracking

7. Multiple flow cell configurations enable sequencing of up to 300 Gb per run, providing adjustable output based on project needs including large, complex application and experiment types

8. Streamlined workflows, automated onboard cluster generation, including automated exclusion amplification (ExAmp) chemistry ensure consistent, reproducible run performance

9. RFID‐encoded consumables and load‐and‐go reagent cartridges for user‐friendly experience;

reliability of matching run configurations with the proper flow cell and consumable kit minimizes potential incompatibilities

10. Intuitive software and instrument operation for streamlined run setup and data analysis on premise or in the cloud

11. First instance of on‐board DRAGEN™ Bio‐IT platform integrated into the sequencer enabling user access to hardware accelerated pipelines via FPGA

Warranty Shall include a minimum of one (1) year comprehensive warranty from the date of installation.

Four (4) One Year Option Periods Maintenance Agreement

a) Service contract coverage shall include trouble‐shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

b) Access to the manufacturer’s call center during regular business hours (8 am to 5 pm EST) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument. Access to the manufacturer’s support center via e‐mail.

c) The Vendor shall be able to guarantee that a service engineer will be able to work on‐site within five business days of receiving a call from CFSAN if on‐site service is required.

d) The Vendor shall provide annual in‐house training and preventative maintenance inspection during the 12‐month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the manufacturer.

e) The Vendor shall provide all major and minor software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

f) The Vendor shall respond to requests for emergency on‐site service and/or non‐emergency requests (Monday‐Friday, excluding Federal holidays) within 3 business days and engineer onsite within 5 business days (120 hours).

g) Upon the on‐site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non‐emergency on‐ site visit to completion of repairs shall not exceed 5 business days (120 hours).

h) For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card.

i) For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs.

j) Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization.

k) One‐year warranty on all parts and labor, including shipping and travel. Parts shall be covered against manufacturing defects and failures occurring during normal usage of the system.

l) Service Records and Reports:

The vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the 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, on‐ site hours expended and parts/components replaced.

Delivery and Installation Center for Food Safety and Nutrition 5001 Campus Drive

TBD

College Park, MD 20740

The Vendor shall deliver and install the system 120 days after receipt of order (DARO)

The vendor shall deliver, unpacked, and installed the item in the laboratory. The sequencer shall be verified and operating before disconnecting and removing the trade‐in equipment NextSeq 500 (SNNS500296) located in room 4EL‐018. The Property Custodians shall be contacted, and appropriate paperwork shall be filed to remove the NextSeq 500 from the CFSAN assets.

*****NOTE: Coordination on the delivery and installation must be agreed upon by FDA TPOC before item is shipped. *****

Acceptance Criteria FOB: Destination Inspection/Acceptance: Destination

Period of Performance

120 DARO plus 12‐month warranty (Base Period) January 28, 2022 – January 27, 2023 (Option Period 1) January 28, 2023 – January 27, 2024 (Option Period 2) January 28, 2024 – January 27, 2025 (Option Period 3) January 28, 2025 – January 27, 2026 (Option Period 4)

Line Items and Prices

The Contractor shall provide the following deliverables:

NOTE: The Contractor shall complete the pricing table below.

Line Item

Description Qty. Unit Price

Total Price

1 Integrated genomic sequencing system BRAND NAME OR EQUAL TO the Illumina NextSeq 2000 Sequencing System (Base Period)

1 EA $

De‐Installation remove NextSeq 500 (SNNS500296) (Base Period)

Trade‐In Value for NextSeq 500 (SNNS500296) (Base Period)

2 Shipping/Delivery (Base Period) 1 EA $ 2 Installation (Base Period) 1 EA $ 3 Preventative Maintenance ‐ Option Period 1 1 EA $ 4 Preventative Maintenance ‐ Option Period 2 1 EA $ 5 Preventative Maintenance ‐ Option Period 3 1 EA $ 6 Preventative Maintenance ‐ Option Period 4 1 EA $

TOTAL $

Provide a fixed price quote in accordance with the Statement of Work identified above

Instruction to Vendors

1. Responses shall be submitted to the Contract Specialist’s email below.

2. Deadline for questions and answers: Interested offerors shall submit questions electronically to

Heather.Kinsey@fda.hhs.gov no later than July 24, 2020, @10am Eastern Time (ET).

a. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

b. No Phone Calls Please.

3. Quotes Due Date shall be no later than: July 31, 2020 at 10:00 am ET

a. Quotes shall be in two volumes: Volume I Technical and Volume II Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I. Volume I shall discuss offeror plans to accomplish the scope of work and not exceed 10 pages.

4. Quotes shall clearly reference the solicitation, date of offer, organization proposing and point of contact.

5. Quotes shall be valid through September 30, 2020.

Evaluation Method The Government will evaluate quotes received in response to this RFQ on a lowest price, technically acceptable (LPTA) basis. A technically acceptable quote is one that can provide all the items listed above.

mailto:Heather.Kinsey@fda.hhs.gov mailto:Heather.Kinsey@fda.hhs.gov

General Information Contracting Point of Contact

Heather Kinsey Contract Specialist Email: heather.kinsey@fda.hhs.gov

Government Holidays

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around‐the‐clock or emergency operations, Contractor personnel will not be able to perform on‐site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

Provisions and Clauses FAR 52.252‐2 Solicitation Provisions 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.acquisition.gov/hhsar.

mailto:heather.kinsey@fda.hhs.gov mailto:heather.kinsey@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/far https://www.acquisition.gov/hhsar https://www.acquisition.gov/hhsar

The Following Provisions and clauses apply:

HHSAR Clauses 352.203‐70 Anti‐Lobbying (Dec 2015) 352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223‐70 Safety and Health (Dec 2015)

FAR 52.212‐2 Evaluation‐Commercial Items (OCT 2014) FAR 52.212‐3, Offeror Representations and Certifications‐Commercial Items (Mar 2020) FAR 52.212‐4 Contract Terms and Conditions‐Commercial Items (Oct 2018) FAR 52.212‐5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders‐ Commercial Items (Jun 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) (31U.S.C.3553).

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

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

[Contracting Officer check as appropriate.] ___ (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).

_X__ (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 (June 2010) (Section 1553 of Pub. L. 111‐5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204‐10, Reporting Executive Compensation and First‐Tier Subcontract Awards (Oct 2018) (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 (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.

___ (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] _X_ (14) (i) 52.219‐6, Notice of Total Small Business Set‐Aside (Mar 2020) (15 U.S.C.644).

___ (ii) Alternate I (Mar 2020).

___ (iii) Alternate II (Nov 2011).

___ (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.

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

_X__ (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 (Mar 2020) (15 U.S.C. 637(d)(4)) ___ (ii) Alternate I (Jan 2017) of 52.219‐9.

___ (iii) Alternate II (Nov 2016) of 52.219‐9.

___ (iv) Alternate III (Mar 2020) of 52.219‐9.

___ (v) Alternate IV (Aug 2018) 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 (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 (Mar 2020) (15 U.S.C. 657f).

_X_ (22) 52.219‐28, Post Award Small Business Program Rerepresentation (May 2020) (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 (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 (June 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 (Sept 2016) (E.O.11246).

___ (ii) Alternate I (Feb 1999) of 52.222‐26.

_X_ (31) (i) 52.222‐35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222‐35.

_X_ (32) (i) 52.222‐36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

___ (ii) Alternate I (July 2014) of 52.222‐36.

_X__ (33) 52.222‐37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

_X__ (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‐ theshelf 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 (Jun2016) (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 (May 2020) (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 (Aug 2011) (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.

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

___ (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.

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

___ (56) 52.232‐30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_X_ (57) 52.232‐33, Payment by Electronic Funds Transfer‐System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (58) 52.232‐34, Payment by Electronic Funds Transfer‐Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

___ (59) 52.232‐36, Payment by Third Party (May 2014) (31 U.S.C.3332).

_X_ (60) 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).

___ (61) 52.239‐1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (62) 52.242‐5, Payments to Small Business Subcontractors (May 2019) (15 U.S.C. 637(d)(13)).

___ (63) (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) 52.222‐17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

___ (2) 52.222‐41, Service Contract Labor Standards (Aug 2018) (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) (Aug 2018) (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).

_X_ (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).

___ (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).

(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) 52.204‐23, 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 $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.

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

(vii) 52.222‐21, Prohibition of Segregated Facilities (Apr 2015).

(viii) 52.222‐26, Equal Opportunity (Sept 2015) (E.O.11246).

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

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

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

(xii) 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.

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

(xiv) (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).

(xv) 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).

(xvi) 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).

(xvii) 52.222‐54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xviii) 52.222‐55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xix) 52.222‐62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

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

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

(xxi) 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).

(xxii) 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.

(xxiii) 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.

FAR 52.217‐5 Evaluation of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

FAR 52.217‐8 Option to Extend Services (Nov 1999)

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

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

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

FAR 52.232‐8 Subject to Availability of Funds (Apr 1984) FAR 52.232‐40 Providing Accelerated Payments 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.

FDA Invoice Submission Instructions

FDA Three‐Way Match Invoicing Procedures

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.gov *** Acceptable methods of delivery include: E‐mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC) identified above.

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.

***NOTE TO VENDOR***

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212‐3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract.

You may register by going to www.sam.gov.

http://www.sam.gov/ http://www.sam.gov/