RFQ_-_3D_microscope.pdf

FDA-19-RFQ-1214122 Page 1 of 17 Optical 3D Surface Measurement System

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.5 as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing 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 2019-02 dated May 6, 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is 333314 – Optical Instrument and Lens Manufacturing, with an associated size standard of 500 employees. This requirement is being solicited as a total small business set-aside.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

Contract

Line Item

Number (CLIN) Description Price

One (1) complete optical 3D Surface Measurement System with all accessories to meet requirements in Part 3

2 Shipping to FDA FCC in Cincinnati, OH 45237 $

3 Onsite training for up to 4 users $

TOTAL PRICE $

PART 3 – DESCRIPTION OF REQUIREMENT

Background The Forensic Chemistry Center (FCC) in The Office of Regulatory Affairs/Office of Regulatory Science/Medical Products, Tobacco and Specialty Labs (ORA/ORS/OMPTSLO) requires the purchase of one (1) 3D optical 3D surface measurement system in support of the combating the opioid epidemic by the analysis of opioid related products submitted through criminal cases package. The requested

FDA-19-RFQ-1214122 Page 2 of 17 instrument will provide the capable to analysis/source opioid counterfeit tablet debossing/punches.

Purpose FCC has provided counterfeit detection support to FDA/Office of Criminal Investigations (OCI) in the analysis of opioid drugs as well as other solid dosage forms using the Alicona InfiniteFocus Microscope (IFM) Gf4 system for the last several years. Using this system, FCC has developed methods capable of detecting counterfeit opioid drugs such as the analysis of tablet compared to authentic and suspect tablets to suspect tablet punch tips sourcing and the methods are transferable to other laboratory who may possess similar instrumentation. The FCC has used the IFM Gf4 successfully to source tablets to TPT and has determined this system to be a way to aid OCI in the determination of possible counterfeit as well as many other illicit drugs. The IFM Gf4 is suitable for this purpose. A new system is in dire need as the current system, while still functioning well, has begun showing glitches from time to time, possibly signs of near future system failure. The purpose of this acquisition is to procure an additional system to continue the analysis of opioid related products submitted through criminal cases packages.

Scope The Forensic Chemistry Center (ORA/ORS/MPTSLO/FCC) requires the purchase of one (1) Alicona InfiniteFocus system, or equivalent.

Requirements

Technical Specifications:

The Contractor shall provide one (1) optical 3D surface measurement system equivalent to an Alicona InfiniteFocus system. This requirement is being solicited in accordance with FAR 52.211-6, Brand Name or Equal. Equivalent specifications that differ from the minimum requirements shall be justified by the proposing vendor. The system shall meet or exceed the following salient functional characteristics:

1) The microscope system shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Data communication compatible to current profilometer database salient characteristics

i) The profilometer shall be compatible with the current profilometer database, Alicona InfiniteFocus Microscope (IFM) system Gf4

b) Compatibility of 3D file generated datasets salient characteristics

i) The profilometer must use the same IFM Gf4 generated files called datasets to characterize measurements and compare to currently developed huge 3D dataset of authentic library

c) Measurements modules salient characteristics

i) Capable of performing the following measurements:

(1) Profile roughness measurements

(2) Surface texture measurements

(3) Difference measurements

(4) Profile form measurements

(5) 3D form measurements

(6) Contour measurements

(7) 2D image measurements

(8) Volume measurements

(9) automated measurement inspection

(10) difference measurements (automated measurements inspection)

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(11) Polyworks (various measurement tools)

ii) Shall be able to also perform automated Geometric Dimensioning and Tolerancing (GD&T) measurements (CAD file measurements)

iii) Automatically perform and create 3D datasets and automatically perform the analysis on the datasets.

iv) Measurements analysis report generator

d) Profilometer stage salient characteristics:

i) Sturdiness of the frame’s architecture/design for instrument vertical tower for turret stability of the microscope;

ii) Stage base with breadboard design;

iii) Illumination features such as co-axial and ring lighting capability;

iv) Motorized stage with stitching capability allowing to create datasets of 500 Million datapoints or greater;

v) 200 by 200 mm of x-y travel motorized stage with a 2 micrometer accuracy over a 20 mm movement, and a vertical dynamic range of 100 mm

vi) Capable of holding heavy samples, greater than 10Lb.

e) 3D rotation attachment for stage salient characteristics:

i) Perform 3D technology capable of automated measurements 360 degrees around the rotational axis

ii) Tilting capability with programable measurement procedures

f) Profilometer sensor salient characteristics

i) Must utilize the same Focus Variation as the current IFM Gf4, capable of measuring (X, Y, Z) coordinates

ii) Must be able to present the dataset in RGB registered true color values and estimated repeatability for every measured point

iii) Measure steep slopes of up to 87 degrees from the vertical axis

g) Profilometer hardware connections units salient characteristics

i) Must support a 3D fixture unit that can connect to a 5-axis rotation unit capable of measuring a surface from in 5-axis to give various perspectives and merging them into a full 3D dataset

ii) Measurement speed of 1.7 million data points per second

h) Profilometer salient sensor hardware characteristics:

i) Up to 3 million datapoints measured per field of view

ii) Obj. Lens: continuous 10nm resolution over 3mm height step measurement (100x objective with 4.5mm working distance); continuous 50nm resolution over 15mm height step (20x objective with 19mm working distance)

iii) Snap-on/removable ring light with 24 segment; include both ring light and co-axial illumination for more capabilities for various surfaces/samples

iv) Use of focus variation and not image stacking to create datasets of higher resolution

v) Z movement accuracy for 1mm step height should be no greater than 0.5um and a standard deviation of 0.1micrometer

vi) Roughness measurement accuracy for roughness with Ra 0.1um should be no greater than

0.025um and a standard deviation of 0.003um

vii) Roughness measurement accuracy for roughness with Ra 0.5um should be no greater than

0.04um and a standard deviation of 0.004um.

i) Traceable profilometer calibrations salient characteristics

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i) Calibrations and calibration tools must be fully traceable to Physikalisch-Technische Bundesanstalt (PTB) for all form and roughness measurements

ii) Include a traceable calibration tool for use prior to using the profilometer

2) Profilometer objective lens and illumination salient characteristics:

a) Must have a maximum vertical resolution of 10 nm using the 100x objective

b) Objectives with very high working distances such as 5x with 23.5 mm WD (working distance);

20x with 19 mm WD; 50x with 11 mm WD; 100x with 4.5 mm WD

c) Must have the following objective lens:

i) 2.5x obj. lens with:

(1) Coaxial light capable

(2) 0.075 numerical aperture

(3) 8.8 mm working distance

(4) 8 mm maximum measurable height

ii) 5 x obj. lens with:

(1) Adaptive ring light illumination capable

(2) Coaxial light capable

(3) 0.15 numerical aperture

(4) 23.5 mm working distance

(5) 22.5 mm maximum measurable height

iii) 10 x obj. lens with:

(1) Adaptive ring light illumination capable

(2) Coaxial light capable

(3) 0.3 numerical aperture

(4) 17.5 mm working distance

(5) 16.5 mm maximum measurable height

iv) 20 x obj. lens with:

(1) Adaptive ring light illumination capable

(2) Coaxial light capable

(3) 0.4 numerical aperture

(4) 19 mm working distance

(5) 18 mm maximum measurable height

v) 50 x obj. lens with:

(1) Adaptive ring light illumination capable

(2) Coaxial light capable

(3) 0.6 numerical aperture

(4) 11 mm working distance

(5) 10 mm maximum measurable height

vi) 100 x obj. lens with:

(1) Coaxial light capable

(2) 0.8 numerical aperture

(3) 4.5 mm working distance

(4) 4 mm maximum measurable height

vii) Illumination in the sensor uses modulated light of varying intensities to measure different surface materials

3) Software salient characteristics:

FDA-19-RFQ-1214122 Page 5 of 17

a) Allow having multiple users and main storage for measured datasets

b) All analysis contained in one suite / location

c) Profile settings maintained, modifiable and stored within the given measurement module

d) Shall be able to perform real 3D data fusion that combines a dataset to a larger dataset (surface measurements or 360 degree measurements)

e) Shall be able to measure and compare deviations between two 3D datasets; either two measured datasets from two different samples and/or measuring deviation of a sample with its GD/T CAD model/s

f) Shall be able to measure 3D dataset for parameters such as angle, step height, edge radius, radius, etc.

g) Shall be able to measure 3D dataset for roughness Ra measurement value (the average of a set of individual measurements of a surfaces peaks and valleys)

h) Shall be able to measure 3D dataset for surface texture (Sa) which is roughness in an area

i) Shall not require an internet connection to function properly

j) Shall be able to use the current profilometer generated files and the current 3D authentic dosage form dataset library / profiles in the databases

k) Shall be able to analyze current profilometer generated datasets and perform difference measurement analysis using the current profilometer scripting

l) Shall include volumetric (depth) in pseudo-coloring to allow for reveal and convey obvious differences / similarities in surface morphology using the wire-frame model mode

m) Shall allow profilometer customizable settings

n) Shall allow to store stage parameter profiles, operate a motorized stage, operate a motorized rotation objective lens turret, operate the profilometer illumination

o) Shall include database searchable capabilities of current profilometer generated dataset database

p) Shall be able to export wire-frame models in various image formats including but not limited to

3D rendered images

q) Shall be able to have capability to automate data acquisition and analysis to increase throughput

(allowing the system to be automated completely and aid in creating consistent measurement procedure)

r) Shall be able to have capability to individually select LED on the 24 ring light segments for illumination required on some samples due to surface reflectivity

s) Shall be able to perform areal surface roughness measurements according DIN ISO 25178 including filtering of Roughness and Waviness data according to the ISO standard

t) Shall be able to perform measurement of 3D forms like spheres, cylinders, cones and GD&T measurement like flatness, straightness, parallelism, concentricity, etc.

u) Shall be able to perform CAD comparison capabilities (overlay of CAD blueprint model with measured dataset); scripting capabilities with .net Framework to create customized measurement procedures.

4) Computer/workstation computer (PC) equipped with an Intel Core i7 3.20GHz with 12GB RAM running Windows 7 (64 bit):

a) PC shall have all components necessary to operate the profilometer with the following specifications:

a. Processor salient characteristics

i. Intel® Xeon® E5-2640 v4 (10 core, 2.5 GHz, 25MB Cache, 90W) Processor

b. Memory salient characteristics

FDA-19-RFQ-1214122 Page 6 of 17

i. 32GB Memory total

ii. Sixteen (16) DIMM slots

c. System salient characterizes

i. Tower configuration

ii. Power cord(s)

iii. 900W AC 240V DC Redundant Power Supply

iv. 6 PCle Gen 3.0 slots

v. Operating Temperature Range: 50 to 95 degrees F

d. Network salient characteristics

i. 1GB Ethernet

e. Storage salient characteristics

i. 2TB or greater hard drive

ii. SATA DVD-Rom with optional enablement kit, if necessary

f. Management Features

i. Advanced License, with 24/7 technical support for 1 year

g. Operating System Compatibility

i. Compatible with Windows Servers

h. Warranty

i. Parts/labor warranty for one year from date of delivery

Trade and Service Requirements:

• The system shall be newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

• A minimum of a one-year warranty is required with the purchase and shall include, at a minimum, coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories.

• FOB Point destination of the equipment and training. An on-site 4-hour training class for up to four users shall be provided within 60 days of delivery such that operators may independently operate the instrument and increase familiarity and proficiency. The training shall include manuals and consumables to be used during training.

Deliverables

Description of Deliverable Due Date

1 One (1) optical 3D surface measurement system

To be delivered no later than 10 weeks after award unless otherwise agreed upon with the Technical POC.

2 On-site training

Shall be scheduled with the Technical POC and scheduled no later than 60 days after delivery of the equipment.

PART 4 - PACKAGING, MARKING and SHIPPING

FDA-19-RFQ-1214122 Page 7 of 17

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 delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.

PART 5 – INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within five (5) business days from the time the Government notifies the Contractor of any rejected deliverables. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan.

PART 6 – DELIVERIES OR PERFORMANCE

Deliveries and Place of Performance Satisfactory performance of this contract shall be deemed to occur upon delivery of equipment described above and/or upon acceptance by the Contracting Officer or the Technical Representative of these products and services. Deliveries required by the contractor shall be made F.O.B. destination.

Deliverables shall be shipped to:

US Food and Drug Administration Forensic Chemistry Center (FCC) 6751 Steger Dr.

Cincinnati, OH 45237 POC: To be identified at award

The POC for the laboratory will be identified at the time of award. The Contractor shall contact the Government POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries, installation and trainings shall occur at the Place of performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time)). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Period of Performance The required equipment shall be delivered no later than ten (10) weeks after award unless the Government approves an alternate delivery schedule. Training shall be coordinated with the Technical POC and shall occur within 60 days after delivery. The required warranty shall not begin until delivery, installation and acceptance of the equipment has occurred.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Representative:

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To be determined upon contract award

The Technical Representative 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): Contract Specialist (CS):

Gary Klaff Robin Goon 4041 Powder Mill Road 4041 Powder Mill Road Beltsville, MD 20705 Beltsville, MD 20705 Gary.Klaff@fda.hhs.gov Robin.Goon@fda.hhs.gov Tel: (240) 402-7555 Tel: (301) 348-1923

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

Payment Schedule:

The Contractor shall submit invoices subsequent to the delivery and training of the required equipment.

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 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

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;

mailto:Gary.Klaff@fda.hhs.gov mailto:FDAVendorPaymentsTeam@fda.hhs.gov

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(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 award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

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

(vi) Terms of any discount for prompt payment offered (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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(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 Inspections, 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 (xiii) 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.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) mailto:ERIC@fda.hhs.gov

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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://acquisition.gov/far/ (End of clause)

FAR 52.204-13 – System for Award Management Maintenance (Oct 2018) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) FAR 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (May 2019)

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

(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(5) 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:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (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. 6101 note).

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

https://acquisition.gov/far/ https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://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://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://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://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://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://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

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___ (10) [Reserved].

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

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

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

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

___ (13) [Reserved] _X_ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

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

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

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

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (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 (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9 ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

_X_ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).

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

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

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

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

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

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

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

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

_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

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

_X_ (29) (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_ (30) (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_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

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

_X_ (33) (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).

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FDA-19-RFQ-1214122 Page 12 of 17

___ (34) 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.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

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

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Oct 2015) of 52.223-13.

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

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

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

___ (41) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

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

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).

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

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

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

___ (47) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 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).

___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;

10 U.S.C. 2302 Note).

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

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

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

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

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

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

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

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

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

___ (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:

___ (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 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

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

___ (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 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050540 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050674 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050705 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050789 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_242-5 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://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://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055581 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_222_41 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056410 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056443 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056463 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056685 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056732 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056818 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_222_62 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055065 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1059150…