FDA-FY22-SOL-1257739.pdf

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

PART 1 – Description

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subparts 12.6 and 13.5 and as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; a quote is being requested and a written solicitation will not be issued. The government contemplates a Firm-Fixed Price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-07 dated August 10, 2022.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing; the small business size standard is 500 employees.

PART 2 – Supplies or Services and Prices/Costs

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) requires a Direct Imaging Particle Analyzer System with Delivery Installation and Training. The Division of Product Quality Research (DPQR) conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to conduct research on assessing the impact of manufacturing process and process analytical technologies (PAT) on performance, quality, and safety of solid oral drug products. These studies are critical in assessing the novel PAT for process control of continuous manufacturing processes. To support this function, DPQR is requesting a laboratory direct imaging particle analyzer (DIPA), to facilitate research and development of in-line PAT for particle size and shape analysis. This PAT can be used on various manufacturing processes, e.g., fluid bed coating, fluid bed granulation, twin screw granulation.

Continuous monitoring of processes critical quality attributes (CQAs) delivers sufficient understanding to devise a data-driven control strategy. The study findings by using this instrument will provide valuable information regarding quality of solid oral drug products and support CDER’s critical missions.

The requested equipment shall be based on non-product contact measurement methods, and it is desired to be operable in both in-line and at-line mode, enabling future research of this PAT in a continuous manufacturing platform. The direct imaging particle analyzer system (DIPA) shall be able to measure a wide particle size distributions with excellent repeatability. It is also desired that the system, with necessary adopters, can be installed into different manufacturing unit operations for particle size and shape measurement.

Pricing Table:

Line Item

Description

Qty.

Price

1 Direct Imaging Particle Analyzer System

1 $

2 Training 1 $

3 Installation 1 $

4 Shipping and Inside Delivery 1 $

TOTAL $

PART 3 -Technical Requirements/Salient Characteristics

The Direct Imaging Particle Analyzer System shall “meet or exceed” the following salient characteristics/specifications.

Offerors shall include a technical brochure or otherwise reference the specific equipment, capabilities and characteristics referenced below. All of the following are minimum requirements. Equivalent requirements that differ from the below

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training requirements must be justified by the proposing vendor and evaluated prior to award. The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

The system shall include and/or meet the following components:

Item 1: the direct imaging particle analyzer system

• The instrument shall be work in real-time conditions with particle size distribution and shape data updated shorter than every 10 sec time intervals

• It shall have a particle size measurement range cover 75 - 5000 μm

• For particle size measurement, it shall report D10, D25, D50, D75, D90 in numeric and volumetric with Mean and Median values all trended in real time with live histogram and S-curve results

• For particle shape measurement, it shall report Eccentricity Average, Eccentricity RSD

• For data exportation, it shall report the data in PDF report, in CVS file with raw data, in JPEG for captured images.

• The object material speed can be measured shall be higher than 5 m/sec

• The image resolution shall be higher than 1023x1023 pixel

Item 2: Accessories The following accessories shall be included with the base equipment:

• The system shall come with necessary assemblies include but not limited to: adopters to connect it to fluid bed and other unit operations

• Cables and power supply for hardware interface

• Hard plastic case for transportation and storage

• All other assemblies needed for inline particle analysis

Item 3: Delivery, Installation, and On-site training The vendor will cover all costs associated with the following:

• System crating, shipping, and delivery.

• Full system installation.

• On-site training.

Delivery, Installation, and On-site training The vendor must cover all costs associated with the following:

• System crating, shipping, and delivery.

• Full system installation.

• On-site hardware training.

Warranty The contractor shall provide a full manufacturer’s warranty for coverage on all non-consumable items and parts including on-site service visits for warranty repairs, factory-certified replacement parts, and labor and travel costs for a certified technician for a 12-month (one year) period after date of award at no additional cost to the government.

PART 4 – Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All equipment shall be new not used or refurbished.

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

PART 5 – Inspection and Acceptance

The Contracting Officer’s Representative (COR), to be provided at time of award, will perform inspection and acceptance of equipment to be provided. For the purpose of this Part the COR is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the location identified in part 6.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 60 days of receipt. The instrument shall not be accepted until specifications herein have been confirmed.

PART 6 – Deliveries or Performance

Satisfactory performance of this contract shall be deemed to occur upon delivery and confirmation of specifications described in Part 3 of this RFQ and upon acceptance by the Contracting Officer, or the COR, of these products. Deliveries required by the contractor shall be made F.O.B. destination within 60 days from receipt of the award of order to the addresses/addressees listed below:

Delivery Location:

The equipment shall be delivered and installed to the location listed below:

Food and Drug Administration 5901 Ammendale Road; Suite D and G Beltsville, MD 20705

Delivery must occur during regular business hours (Monday-Friday) between 8:30 AM and 4:00 PM, excluding Federal holidays (See Part 9) and weather-related closures in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Delivery staff must have photo ID to enter building. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to delivery.

Period of Performance The equipment shall be delivered 60 days from contract award unless the government approves a different delivery schedule. The manufacture warranty shall begin at the date of award.

PART 7 – Contract Administration Data

Contracting Officers Representative (COR) The COR, to be determined upon contract award, will represent the Government for the purpose of this contract.

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.

Contracting Officer (CO) The Contracting Officer is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

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

Contracting Officer:

Linda Troutman 60 8th Street, NE Atlanta, GA 30309 Linda.Troutman@fda.hhs.gov 404-253-1258 mailto:Linda.Troutman@fda.hhs.gov

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

PART 8 - FAR and HHSAR CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulation (FAR) System, 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: http://farsite.hill.af.mil/.

52.212-1 Instructions to Offerors – Commercial Items applies with the following addenda: Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2022.

52.212-2 Evaluation – Commercial Items (Oct 2014) 52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov . If an offeror has not completed the annual representations and certifications electronically at the System for Award

Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision

FAR Clauses in Full Text

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2022)

(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 products and commercial services:

(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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

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

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

[Contracting Officer check as appropriate.] http://farsite.hill.af.mil/ http://www.acquisition.gov/ https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 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.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-

282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

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

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L.

111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 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) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (SEP 2021) ( 15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (13) [Reserved]

__ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15)

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

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

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

__ (17)

(i) 52.219-9, Small Business Subcontracting Plan (NOV 2021) ( 15 U.S.C. 637(d)(4)).

https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (18)

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

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (SEP 2021) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (SEP 2021) ( 15 U.S.C. 657f).

__ (22)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2021) ( 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 (SEP 2021) ( 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 (SEP 2021) ( 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 (SEP 2021) ( 15U.S.C. 637(a)(17)).

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

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2022) (E.O.13126).

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

__ (30)

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

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

__ (31) https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

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

__ (32)

(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

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

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

13496).

__ (35)

(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 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 (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 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 (Jun2014) of 52.223-14.

https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/22.1803#FAR_22_1803 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

__ (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.

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

13513).

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

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47)

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

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

__ (48) 52.225-1, Buy American-Supplies (NOV 2021) ( 41 U.S.C. chapter 83).

__ (49)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2021) ( 41 U.S.C.chapter83, 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 (JAN 2021) of 52.225-3.

__ (iii) Alternate II (JAN 2021) of 52.225-3.

__ (iv) Alternate III (JAN 2021) 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).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (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. 2302Note).

__ (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 (Nov2007) ( 42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

https://www.acquisition.gov/far/52.223-15#FAR_52_223_15 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-18#FAR_52_223_18 https://www.acquisition.gov/far/52.223-20#FAR_52_223_20 https://www.acquisition.gov/far/52.223-21#FAR_52_223_21 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/far/52.225-13#FAR_52_225_13 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.226-4#FAR_52_226_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.226-5#FAR_52_226_5 https://www.acquisition.gov/far/52.229-12#FAR_52_229_12

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Products and Commercial Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT2018) ( 31 U.S.C. 3332).

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

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

__ (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) ( 5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ( 15 U.S.C. 637(d)(13)).

__ (63)

(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C.

55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (NOV 2021) 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 products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) ( 41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) ( 41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

https://www.acquisition.gov/far/52.232-29#FAR_52_232_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.232-30#FAR_52_232_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.232-36#FAR_52_232_36 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.239-1#FAR_52_239_1 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/far/52.242-5#FAR_52_242_5 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-42#FAR_52_222_42 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-43#FAR_52_222_43 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-44#FAR_52_222_44 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-51#FAR_52_222_51 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-53#FAR_52_222_53 https://www.acquisition.gov/far/52.222-55#FAR_52_222_55

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products or commercial services. 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 (NOV 2021) ( 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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(vii) 52.222-26, Equal Opportunity (SEP 2015) (E.O.11246).

https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/2.101#FAR_2_101 https://www.acquisition.gov/far/52.215-2#FAR_52_215_2 https://www.acquisition.gov/far/subpart-4.7#FAR_Subpart_4_7 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/19.702#FAR_19_702 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

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

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

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter 67).

(xiii)

(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O 13627).

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

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) ( 41 U.S.C. chapter 67).

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

(xvi) 52.222-54, Employment Eligibility Verification (MAY 2022) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(xix)

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

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

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

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) ( 42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C.

55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-51#FAR_52_222_51 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-53#FAR_52_222_53 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/52.222-55#FAR_52_222_55 https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

Alternate I (FEB 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to "paragraphs (a), (b), (c), or (d) of this clause" in the redesignated paragraph (d) to read "paragraphs (a), (b), and (c) of this clause".

Alternate II (MAY 2022). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8 G of the Inspector General Act of 1978 ( 5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial products or commercial services, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(D) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(E) 52.219-8, Utilization of Small Business Concerns (OCT 2018) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(G) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(H) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

(I) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

(J) 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.

https://www.acquisition.gov/far/12.301#FAR_12_301 https://www.acquisition.gov/far/12.301#FAR_12_301 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/19.702#FAR_19_702 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40

FDA-FY22-SOL-1257739 Direct Imaging Particle Analyzer System with Delivery Installation and Training

(K) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter 67).

(L) ___ (1) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O 13627).

___ (2) Alternate I (MAR 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

(M) 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).

(N) 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).

(O) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989).

(P) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(Q) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(R) (1) 52.224-3, Privacy Training (JAN 2017) ( 5 U.S.C. 552a).

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

(S) 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).

(T) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (JUN 2020) ( 42 U.S.C. 1792).

Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(U) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C.

55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(End of clause)

HHSAR Clauses HHSAR clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm 352.203-70 Anti-Lobbying (Dec 2015) 352.208-70 Printing and Duplication (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015) https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-51#FAR_52_222_51 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-53#FAR_52_222_53 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/52.222-55#FAR_52_222_55 https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 http://uscode.house.