FDA-18-RFQ-1199548.pdf

FDA-18-RFQ-1199548

Request for Quote (RFQ) Number: FDA-18-RFQ-1199548

Subject: Inverted Type Fluorescence Phase-Contract Microscope.

PART 1 – DESCRIPTION

The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has a need for an inverted type fluorescence phase-contract microscope.

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

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-99-1. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing.

THIS SOLICITATION IS A TOTAL SMALL BUSINESS SET ASIDE

PART 2 – SERVICES AND SUPPLIES AND PRICES

2.1 CONTRACT TYPE: FIRM-FIXED-PRICE

2.2 Pricing Table

Contract Line Item Number

(CLIN)

Service and Supply Description Quantity Unit Price

Total Firm- Fixed-Price*

Fluorescence Microscope, Software, Delivery, Training and Support.

1 EA $

TOTAL MAXIMUM POTENTIAL FIRM-FIXED-PRICE $

*The firm-fixed-prices are inclusive of all costs, such as shipping, parts, installation, training, labor, travel, and any other warranty and service maintenance costs. Payment is only authorized for the respective firm-fixed-prices upon successful completion of the respective CLIN, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR), and upon submission of a proper invoice.

Proper invoice submission includes following the invoice instructions below.

PART 3 – DESCRIPTION/SPECIFICATIONS

3.1 Background

The purpose of this acquisition is to obtain an inverted fluorescence phase-contrast microscope equipped with image analysis capabilities capable of capturing high-resolution images of in vitro cell tissue cultures, cultured within a microphysiological/organ on a chip testing platform. Cell numbers, cell morphology, cell-cell interactions, and cellular components to name a few must be imaged easily and accurately. Conventional methods for determining these critical details of cells are time consuming and come with a degree of human error. An inverted fluorescence phase-contrast microscope equipped with image analysis capabilities will speed up the time it takes to take and analyze pictures.

Under this project it is necessary to image the both layers of a bi layer in vitro organ on a chip testing platform in order to accurately determine cell coverage as well as view both layers in the system. With conventional methods, one would have to take multiple overlapping images on a confocal microscope and then manually stitch the pictures together. This process can take days just to complete imaging, followed by several more days of analysis and image stitching. An inverted fluorescence phase-contrast microscope equipped with image analysis capabilities that can image both layers of a bi layer in vitro cell culture system while taking a series of z stack images and stitching all the images together in minutes will greatly increase the speed at which experiments can be completed. Additionally, instead of relying on an individual to determine the best focus to create an image, the instrument shall use real time z stack imaging to find the best plane for each cell to image thereby reducing blur observed from cells not being exactly flat. This creates better images than can be obtained from traditional methods.

Additionally, this microscope has the capability to perform accurate quantification of cells, which will be useful in determining cell density and cell numbers. What would take weeks to count by hand with a high degree of human error, will take minutes with this system with much less user error.

The 3D Module component shall increase the FDA’s understanding of the Microphysiological/organ on a chip test system. Again, because the cell cultures are grown in bi layers, it is impossible to view both layers at the same time. The 3D module component of the Fluorescence Microscope can take multiple z stack images of the in vitro bi layer cell culture test system in order to facilitate an understanding of cell to cell interactions across the in vitro bi layer. This purchase of this instrument for the organ chip project will assist the FDA by significantly decreasing the amount of time needed to complete experiments and analysis and greatly increase the accuracy of the analysis of the images between experiments.

3.2 Salient Characteristics of the Required Instrument.

3.2.1 Fluorescence Microscope

The system provided, shall be brand name or equal to the Keyence Corporation of America [BZ- X710] BZX ALL-IN-ONE Fluorescence Microscope, meeting or exceeding the following salient characteristics.

The offered instrument shall be a fully enclosed inverted type fluorescence phase-contrast microscope.

The instrument shall be portable and able to fit on a laboratory benchtop; due to space restrictions the offered system shall be no more than 24” x 24” X 24 “ The instrument shall have fully digital output.

The instrument shall have objective lens switching: Six-mount electronic revolver The instruments’ objective shall be high quality (laboratory grade) objectives, capable of 2

-100x magnification.

The instrument shall have a fully automated XY stage.

The instrument shall have an electronic Z stage: 8mm stroke, 0.1 µm pitch minimum The instrument shall have an electronic filter turret: Four filters mounted, automatic excitation shutdown during filter replacement The instrument shall have fluorescent incident illumination using a rod fiber optical system The instrument shall have fluorescence dimming mechanism

The instrument shall have a 80W Metal Halide lamp with 2000 average lifetime or better.

The instrument’s stage shall be contained in a built-in darkroom The instruments image pick-up element shall be 2/3 inch, 2.83 million pixel monochrome

CCD, or better.

The instrument’s output signal, gradations: 14-bit monochrome, 8-bit monochrome, and 8-bit RGB The instrument shall have on chip binning The number of number of pixels in recorded image shall be 4,080 x 3,060 max (12.5 million pixels, high quality interpolation) or better.

The instrument shall have a cooling system.

The instrument’s electronic shutter shall be from 1/12,000 sec to 60 seconds.

The instruments shall have electronic revolver control driver software (controlled via mouse) The instrument shall have electronic stage control driver software (controlled via mouse) The instrument shall have moving image recording software enabled The instrument shall have multi-color capturing software, auto overlay The instrument shall have multipoint image capturing software The instrument shall have an Anti-Photo Bleaching Mode The instrument’s image stitching software requires up to 50,000 x 50,000pixel image The instrument’s Real Time Quick Z-stacking software The instrument shall have Automatic cell counting software The instrument shall have meMeasurement software The instrument shall have a PC interface USB The instrument shall have lLive cell incubation

3.2.2 System Software

The contractor shall provide software to accompany the system above, at a minimum the software shall perform the following functions:

1. The analysis software shall allow for cell counting and measurement.

2. The software shall be intuitive allowing users to analyze large amounts of data in minimal time.

The instrument shall have a sensitivity that allows for rapid capture and analysis of high quality images with minutes.

3. The software shall allow for high throughput image capture and analysis.

4. The software shall allow for cell counting to quickly count cells as well as to quantify the area of certain points of interest on samples. This feature shall provide for “cell separation”, to distinguish between two distinct cells if they are touching.

5. The software shall allow multiple analytical methods inclusive of;

a. Shall have Black/White balance, level correction, digital filters, multi-color merging, etc.

i. Low photobleach mode- The ability to reduce this will provide better more accurate pictures.

b. Shall allow for reconstructs stitched images, flattens z-stacks, assembles time-lapse

i. Real time image overlay- This will allow the FDA to overlay images from 3 fluorescent stains which will facilitate data analysis of the cell culture testing platform and expedite image capture.

ii. Image stitching- The microscope shall take multiple pictures of the of the in vitro cell culture surface are within the organ chip and then stitch the images together to make one composite picture instantly.

c. Shall capture images into .avi files

d. Shall have Haze Reduction (image sharpening algorithm)

i. Haze reduction reduction-fluorescence can be blurry. Blurry pictures make it hard to analyze. This will correct for the “background” stain that always causes so many problems.

e. Shall have the ability to capture and analyze multiple locations in a 96 well plate in minutes i.e., Programmable system whereby the user can create/program conditions which will allow the instrument to quantify cell shape, size and brightness in order to facilitate high throughput screening/data analysis;

f. Shall have 3D analysis – The FDA requires this because the cells on the bi layer in vitro cell culture testing platform are not always on the same plane. Therefore, when one cell is in focus other cells in the image may not be in focus. It is important the microscope has the technology to automatically focus the image so all the cells are in focus. (Z stacks).

Additionally, with respect to the 3D Module- the FDA’s test system is 3D and with this 3D module we can create modules showing the interactions between the top and bottom layer of cells along the entire length of the testing platform due to the image stitching capabilities

i. Create 3D models with Z-stacks

ii. Creates rotatable 3D models,

iii. 3 plane (XYZ) max projections,

iv. orthogonal views

v. Generate 3D rotational video files (.avi format)

g. Shall have the ability to measure length, angles, radii, areas, RGB brightness quantification presented as line profiling or a histogram.

h. Shall provide Cell Count-

i. Shall macro cell count-batch count lots of images ie lots of chips in minutes.

A analysis software access key shall be provided for each one (1) laboratory.

3.3.2 System Support

For the hardware and software of the instrument provided, the contractor shall provide the following services for a five (5) year duration.

1. Application support, Monday’s through Fridays.

2. On-Site Consulting, Monday through Friday. For these occurrences, the Government will provide advanced notice.

3. Included repair service for the offered instrument. Should the instrument need repairs, the quoter shall provide a temporary replacement unit (inclusive of shipping) at no cost to the Government while the repairs are made.

3.3 Delivery, Installation, and Training.

The instrument shall be delivered to the FDA Facility, located at 8301 Muirkirk Rd- MOD 1 Laurel, MD 20708 within 30 days of award. FOB Destination

Following installation, the contractor shall provide instrument training and familiarization with in one

(1) month of delivery for approximately ten (10) CFSAN users in no more than two (2) sessions. The specific location and time of this training shall be coordinated with the COR following award.

3.4 Security Requirements

• During installation, the contractor personnel will be checked through FDA security and escorted by a designated FDA employee.

• All of the software accompanied by the instrument shall be approved on FDA’s Master Approved Technology (MAT) list and comply with OIMT requirements. Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award.

PART 4- INSPECTION AND ACCEPTANCE

For the purpose of this PART, COR- [TBD, upon contract award] is the authorized representative of the Contracting Officer.

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials, documents and services to be provided.

PART 5- CONTRACT ADMINISTRATION

Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this order: [TBD]

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Christopher R. McGucken U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville, MD 20857 Christopher.McGucken@fda.hhs.gov

(240) 402-7566

The contact information for the Contractor is the following: [TBD]

PART 6- PAYMENT

The Government will pay the Contractor only each respective firm-fixed-price delineated in the pricing table in Subpart 2.2 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

PART 7- INVOICING INSTRUCTIONS

FDA Three-Way Match Invoicing Procedures (Sep 2016)

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

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;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

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

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

mailto:FDAVendorPaymentsTeam@fda.hhs.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (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 FDA Payment Office at the e-mail address provided above in Section A.

PART 8- CONTRACT CLAUSES

The following clauses are hereby incorporated by reference, upon request the Contracting Officer shall make the full text available.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL ITEMS (SEP 2017)

(IAW FAR 12.301(b)(4))

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19,Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

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

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

[Contracting Officer check as appropriate.] __ __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 2006), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).

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

__ __ (3) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__X __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved] __ __ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct

2016) (Pub. L. 111-117, section 743 of Div. C).

__X __ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

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

____ (10) [Reserved} __ __ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011)(15 U.S.C.

657a).

__ __ (11) (ii) Alternate I (Nov 2011) of 52.219-3.

__X __ (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).

__ _ (12) (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).

__ __ (14) (ii) Alternate I (Nov 2011).

__ __ (14) (iii) Alternate II (Nov 2011).

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

__ __ (15) (ii) Alternate I (Oct 1995) of 52.219-7.

__ __ (15) (iii) Alternate II (Mar 2004) of 52.219-7.

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

__ __ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ __ (17) (ii) Alternate I (Nov 2016) of 52.219-9.

__ __ (17) (iii) Alternate II (Nov 2016) of 52.219-9.

__ __ (17) (iv) Alternate III (Nov 2016) of 52.219-9.

____ (17) (v) Alternate IV (Nov 2016) of 52.219-9.

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

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

__ __ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

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

__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) (1 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).

__ __ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O.

13126).

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

__X __ (28) 52.222-26, Equal Opportunity (Sept 2016)(E.O. 11246).

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

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

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

__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 (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ __ (33) (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ __ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ __ (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.)

__ _ (37) (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 (June 2016) (E.O. 13693).

__ __ (39) 52.223-12, Maintenance, Service, repair, or Disposal of Refrigeration Equipment and Air Conditioners (June 2016) (E.O.13693).

__ _ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ _ (40) (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).

__ _ (41) (ii) Alternate I (Jun 2014) of 52.223-14.

__ __ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42.U.S.C.

8259b).

__ __ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ _ (43) (ii) Alternate I (Oct 2015) of 52.223-16.

__X __ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O.13513).

__ __ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693) __ __ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__X __ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (47) (ii) Alternate I, (Jan 2017) of 52.244-3.

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

__ __ (49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

__ _ (49) (ii) Alternate I (May 2014) of 52.225-3.

__ _ (49) (iii) Alternate II (May 2014) of 52.225-3.

__ _ (49) (iv) Alternate III (May 2014) of 52.225-3.

__ __ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__X __ (51) 52.225-13, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury).

__ __ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ __ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007)(42 U.S.C. 5150).

__ __ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007)(42 U.S.C. 5150).

__ __ (55) 52.232-29, Terms for financing of Purchases of Commercial Items (Feb 2002)(41 U.S.C.

4505, 10 U.S.C. 2307(f)).

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

__ __ (57) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)(31.U.S.C. 3332).

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

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

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

__ __ (61) 52.242-5, Payment to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

__ __ (62) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ _ (62) (ii) Alternate I (Apr 2003) of 52.247-64.

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

[Contracting Officer check as appropriate.] __ __ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).

Page 10 of

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

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

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

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

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

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

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

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

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

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

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

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

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

Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

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

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in paragraphs (e)(1) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

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

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

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

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

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

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

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

(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

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

(xii) __X __ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

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

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

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

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

Note to paragraph (e)(1)(xvii): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

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

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

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

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

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

(xxiii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

ADDENDUM TO CLAUSE 52.212-4

352.201-70 PAPERWORK REDUCTION ACT (JAN 2006)

52.203-3 GRATUITIES (APR 1984)

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO

INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)

352.203-70 ANTI-LOBBYING (JAN 2006)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS

(DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS

(JUN 2016)

52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS (JAN 2017)

THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(12):

52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZone SMALL BUSINESS

CONCERNS (JAN 2011)

(c) Waiver of evaluation preference.

__ Offeror elects to waive the evaluation preference.

THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(22):

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

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352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (JAN 2010)

52.247-34 F.O.B. DESTINATION (NOV 1991)

352.223-70 SAFETY AND HEALTH (JAN 2006)

352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006)

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS

(DEC 2013)

PART 9 – INSTRUCTIONS TO QUOTERS

Cover Page

Quoters shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2), estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Quoters shall ensure the solicitation number is visible in the header of the email transmission of their quote. In addition, all offers must indicate if any of the proposed items are open market. Faxed quotes will not be accepted.

Quoter’s submissions shall contain all necessary product descriptions/literature required to determine if the instrument and services offered meet or exceed the requirements of section 3. Quotes submitted shall not simply state “meet/exceeds”, supporting documentation must be provided.

Quotes must be valid through September 30, 2018.

Quoters Response Date and Time

All quotes and revisions shall be submitted via email to Christopher.Mcgucken@fda.hhs.gov on or before 3:00 PM Eastern Time on August 1st, 2018.

NOTE: LATE QUOTES WILL NOT BE EVALUATED.

THE FDA WILL EVALUATE QUOTES AND MAKE AN AWARD DECISION BASED ON THE

LOWEST EVALUATED PRICED QUOTATION MEETING OR EXCEEDING THE

TECHNICAL ACCEPTABILITY STANDARDS DELINEATED ABOVE.

FAR PROVISIONS INCORPORATED BY REFERENCE

FAR 52.252-1, SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

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(FEBRUARY 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov/far/

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS

(JAN 2017)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs

(c) through (u) of this provision.

(a) Definitions. As used in this provision— “Civil Judgement” means

(1) In paragraph (h) of this provision: A judgement or finding or a civil offense by any court of competent jurisdiction.

“Economically disadvantage women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127.

It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Enforcement Agency” means any agency granted authority to enforce the Federal Labor Laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and health Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations board. It also means a state agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13637 are—

(1) Department of Labor Wage and Hour Division (WHD) for--

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for--

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for--

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for--

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service--

(1) Extracted from any person under the age of 18 under the menace of penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

http://www.acquisition.gov/far/ https://www.sam.gov/portal

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“Inverted domestic corporation” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Labor Compliance Agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor Laws” means the following labor laws and E.O.’s:

(1)The Fair Labor Standards Act.

(2)The Occupational Safety and Health Act (OSHA) of 1970.

(3)The Migrant and Seasonal Agricultural Worker Protection Act.

(4)The National Labor Relations Act.

(5)40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6)41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7)E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8)Section 503 of the Rehabilitation Act of 1973.

(9)The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974.

(10)The Family and Medical Leave Act.

(11)Title VII of the Civil Rights Act of 1964.

(12)The Americans with Disabilities Act of 1990.

(13)The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15)Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

“Manufactured end product” means any end product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service--disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) “Service-disabled veteran” means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part http://www.osha.gov/dcsp/osp/approved_state_plans.html

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121 and size standards in this solicitation.

“Small disadvantaged business concern, consistent with 13 CFR 124.1002,” means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidia…