FDA-FO-1228659.pdf

FDA-SB-SOL-1228659

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation shall not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-06. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. Business size standard of 1000 number of employees. The solicitation is intended for full and open competition.

SUPPLIES OR SERVICES AND PRICES/COSTS

BACKGROUND

As part of the Color Technology Branch’s mission, it is often necessary for staff to extract impurities from color additives that are listed in 21 CFR, Parts 74 and 82. Once these impurities are extracted and the solvent evaporated, they are subjected to purification and identification for various research purposes and development of analytical methods. These impurities are also used as reference materials to support the mission of the Color Certification Branch, which is to certify color additives for foods, drugs, and cosmetics.

The current approaches to accomplish such extractions involve various repetitive, manual, time-consuming, multi-step procedures, including several evaporation steps. Routine extractions take about 10 hours to complete. New instrumentation would replace those methods with automatized means of extraction and of solvent evaporation and reduce extraction time to about 40 minutes.

SCOPE

Independently, and not as an agent of the Government, the Contractor shall provide an extractor-evaporator system. The system shall include the following unique features:

1. Zirconium alloy (Dionium) extraction cells that permit extractions from samples treated with strong acids or bases.

2. Extractor flasks designed to connect directly to the evaporator, eliminating transfer time and reducing the number of vessels necessary.

3. Extractor flasks that can hold up to 250 ml of extracted solution, designed to attach directly to the evaporator, and to collect the extracted material directly into an LC or GC auto-sampler vial.

PRICE SCHEDULE

CLIN Description Price

0001 Solvent Extractor and Evaporator System

Training/Installation $

Shipping $

1001 Option Year 1 Maintenance $

2001 Option Year 2 Maintenance $

3001 Option Year 3 Maintenance $

4001 Option Year 4 Maintenance $

TOTAL COST $

SPECIFICATIONS

The solvent extractor and evaporator shall meet the following specifications:

1. The automated extractor shall use a combination of solvent(s) under elevated temperature (40 – 200˚C) and pressure conditions to perform rapid and efficient extractions.

2. The automated extractor shall support the processing of up to 24 samples in a sequential manner with unattended operation.

3. The automated extractor shall be compatible with non-polar organic, polar organic, aqueous, and acidic and basic solvents for the extraction of analytes from solid and semi-solid samples.

4. The automated extractor shall work with stainless steel cells in the following volumes: 1, 5, 10, 22, 34, 66, and 100 mL. This system shall also work with zirconium cells when using acids and bases as solvents in the following volumes: 66 and 100 mL. The extraction cells must be of hand closure type that requires no tools or mechanical tightening.

5. The automated extractor shall have an auto-seal actuator which places the extraction cells into the oven and returns the cells to a tray after extraction. This auto-seal actuator will operate in an automated manner that does not require user intervention.

6. The automated extractor shall automatically read the extraction cell size when loaded into the oven without user input into the extraction method.

7. The automated extractor shall be capable of temperature control of +/- 5 ˚C from the setpoint. The temperature gradient over the length of the extraction cell must also be within +/- 5 ˚C.

8. The solvent pump in the automated extractor shall deliver solvent to the extraction cells at a rate of 70 mL/min for rapid extraction. This flowpath shall contain a flow restrictor to prevent any cavitation of solvent.

9. The automated extractor shall provide inline proportioning and mixing for up to three solvents prior to addition to the extraction cell.

10. The automated extractor shall achieve in-line filtration of samples using both cellulose and glass fiber filters within the extraction cells.

11. The extraction cells for the automated extractor shall be compatible with thimble inserts

(cellulose and glass fiber) that prevent samples from adhering to the side of the cell.

12. The automated extractor shall achieve in-line sample cleanup and in-line drying using resins, dispersants, and drying agents that are added to the extraction cell.

13. The automated extractor shall use both 250 mL and 60 mL sample collection vials in both clear and amber formats.

14. The automated extractor shall allow direct transfer of 250 mL and 60 mL sample collection vials to the Genevac Rocket Evaporator without any manual pouring or pipetting of sample.

15. The automated extractor shall allow 60 mL Genevac Rocket Evaporator Flip Flop vials to be added directly to the sample collection carousel to facilitate transfer to the evaporation system once extraction is complete.

16. The automated extractor shall enable an optional rinsing step of the sample flow path in-between samples to prevent cross contamination.

17. The automated extractor shall have front panel control that provides the capability to create and store methods and sequences, displays the extraction run status, and provides access to service diagnostic procedures.

18. The automated extractor shall provide both method and sequence control for the processing of samples. Method control will enable the analyst to enter key parameters to control the extraction method and sequence control will allow the application of multiple methods in one batch of samples. The front panel shall store up to 24 methods and up to 33 extractions per sequence.

19. The automated extractor shall be able to run multiple extractions on one sample and collect extracts in the same vial or multiple collection vials for fraction collection.

20. The automated extractor shall be compatible with Chromeleon 7.2 WE software for integration into the analytical workflow with GC and LC systems and standardization of laboratory software.

21. The automated extractor shall offer optional solvent saver modes in both the front panel and Chromeleon 7.2 WE software to further reduce the amount of solvent required for the extraction.

22. The automated extractor shall have features to ensure safe operation and protection for the laboratory analyst. These features include a pressure relief valve to prevent over pressurization of the extraction cells, a hydrocarbon sensor to detect solvent vapor, leak sensors to detect solvent leaks, automatic shut off, and safety shield for sample collection carousel.

23. The automated extractor shall be an enclosed system that can be operated outside of a fume hood. The system shall have a built-in vapor sensor and the extractor will shut down if vapor levels are detected to be above accepted safety limits.

24. The automated extractor shall be manufactured in a factory that maintains ISO

Certification according to the requirements of ISO 9001:2015.

25. The automated extractor shall meet the requirements of key regulatory methods including U.S. EPA Methods 3545A, 8267, and 6860.

26. The automated extractor shall be covered by a three-year parts warranty from the factory.

27. The automated extractor shall include the cost of installation in the price of the system.

28. The automated extractor shall be supported post-sale by a dedicated service organization who can provide preventative maintenance, instrument trouble shooting and repair, and service agreement options that guarantee onsite support times.

SPECIFICATIONS FOR EVAPORATOR

The evaporator shall meet the following specifications:

1. The evaporation system shall use centrifugation combined with vacuum and temperatures ranging from -20°C to 40°C.

2. The evaporations system shall have precise temperature control for increased precision.

3. The evaporation system shall have a solvent recovery system that will recover 80-90% of solvents.

4. The solvent recovery system shall have a chiller that uses a 2-stage cold trap.

5. The evaporation system must be able to run unattended.

6. The evaporation system must have a minimum of 6-positions for evaporation flasks.

7. The evaporation system shall have the ability to use up to six 250-mL evaporation flasks.

8. The evaporation system shall have the ability to evaporate from a 250 mL flask directly into an auto sampler vial with no transfer.

9. The evaporation system shall accommodate up to 18 60-mL vials.

10. The evaporation system shall have technology that will prevent solvent bumping and cross-contamination by using centrifugal force in combination with a pressure gradient.

11. The evaporation system must have automated end point detection.

TRAINING

The Contractor shall provide onsite training on using the equipment. This training shall be provided during business hours over 2 days.

DELIVERY/INSTALLATION

U.S. Food and Drug Administration 4300 River Road, Room 1090 College Park, MD 20740

PERIOD OF PERFORMANCE

Delivery of the instrument should be within 60 days of contract award. The period of performance shall be 1 year from the date of delivery and installation to ensure proper establishment of the system warranty.

INSPECTION AND ACCEPTANCE CRITERIA

The Government shall have 30 working days to inspect and verify that the equipment and its operational software are functional and demonstrate performance.

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer’s Representative is: TBD

The contact information for the FDA Contracting Officer is: TBD

The contact information for the FDA Contract Specialist is the following: TBD

CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

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

52.202-1 Definitions (November 2013) 52.203-5 Covenant Against Contingent Fees (May 2014) 52.203-7 Anti-Kickback Procedures (May 2014) 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) 52.217-8 Option to Extend Services (NOV 1999) 52.217-9 Option to Extend the Term of the Contract Services (MARCH 2000)

FAR Clauses in Full Text:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (JUNE 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).

http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_1124452424

(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.] 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).

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.)

_X_ (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. 6101note).

_X_ (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] __ (14) X (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.

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419

__ (iii) Alternate II (Mar 2004) 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 (Mar 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 (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 (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).

__ (22) X (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 (June 2003) (E.O.11755).

__ (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).

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

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

__ (31) X (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

__ (ii) Alternate I (July 2014) of 52.222-35.

__ (32) X (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).

__ (35) https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057730 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057758 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057823 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057902 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057947 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055332 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055664 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055713 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056265 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056304

(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. chapter78 and E.O. 13627).

X__ (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 (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) X (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).

__ (49) X (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.

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__ (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)).

__ (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).

__ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

X_ (61) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (62)

(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).

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__ (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).

__ (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)).

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(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 78and 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.

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(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.

(End of clause)

HHSAR Clauses Incorporated by Reference

This order incorporates the following U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) 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 the following website:

http://www.hhs.gov/policies/hhsar/.

HHSAR Clause Description Date 352.203-70 Anti-lobbying (Dec 2015) 352.223-70 Safety and health (Dec2015) 352.233-71 Litigation and claims (Dec 2015)

INSTRUCTIONS TO OFFERORS

COVER PAGE

Offeror shall include a cover page which shall include a point of contact (name, telephone number, and email address). Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the subject line in the email transmission of their quote.

BASIS FOR AWARD

Award will be made to a single responsible party with the lowest priced technically acceptable offer.

OFFERORS RESPONSE DATE AND TIME

All quotes shall be submitted via email to Telisha.Wilson@fda.hhs.gov by or before 10:00 AM Eastern Time on 08/13/2020 with the subject titled “Requisition 1228659”.

Quotes must be valid through September 30, 2020 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 http://www.hhs.gov/policies/hhsar/ http://www.hhs.gov/policies/hhsar/ mailto:Wilson@fda.hhs.gov mailto:Wilson@fda.hhs.gov