combined_synopsis-Solicitation-whole_slide_scanner_1151675.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. The solicitation number is 1151675. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-83 dated July 2, 2015.

The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This RFQ is issued as full and open competition.

Schedule of items

Line item

Description Quantity Unit Unit Price Extended Price

1 Whole slide scanner system as specified herein. 1 EACH $__________ $___________

The Food and Drug Administration (FDA), Center for Biological Evaluation and Research (CBER), Office of Blood Research & Review, Division of Hematology Research & Review, Laboratory of Biochemistry and Vascular Biology requires a stand-alone, easy to use whole slide scanner instrument in order to be able to analyze, catalog, and preserve high quality digital images of the Laboratory’s microscopy experiments.

A major focus of the lab’s research centers on the effects of hemoglobin based oxygen carriers (HBOCs) and microbial pathogens on the vascular endothelium in various organ systems (e.g.

heart, kidney, brain, lung, and liver) and in cell culture systems. Making detailed observations by brightfield and fluorescence microscopy of animal tissue specimens and cells is a vital part of being able to ascertain the safety and/or efficacy of these biological treatments. The current method of analyzing the data involves taking pictures of processed slide samples with the existing microscope camera. The lab now has to image representative sections of the slide and capture a high volume of images to catalog the whole section, which is very time consuming, inefficient, and a potential source of experimental variability. Additionally, when using fluorescence microscopy, the stained slides have a limited shelf life as the fluorescent signal starts to degrade shortly after the experiment ends. The whole slide scanner is an instrument that can take a whole-slide high quality digital image in a very short amount of time. The high quality and resolution of this “virtual slide” allows the lab to zoom in to any area of the section at any desired magnification, effectively replacing the current method of obtaining images with one that takes a fraction of the time. The analysis of these high quality “virtual” slides will also eliminate a significant source of experimental variability and enhance the accuracy of the data.

The whole slide scanner will also allow the lab to capture all the relevant data from a fluorescence experiment before any loss of signal (in the future when the scanner is upgraded to fluorescence capabilities). The slide loader will allow the lab to capture images from an entire experiment quickly and efficiently and without a technician being present to switch every slide.

The “virtual” slides obtained will allow the lab to reexamine the data from slides indefinitely into the future – for example to examine the cortex of a kidney vs. the medulla of a kidney – without having to run a new experiment --- which translates into significant savings of personnel and reagent resources. The laboratory prefers to obtain a stand-alone, easy to use digital slide scanner. The laboratory already has 2 microscopes and prefers to not add another microscope outfitted to scan slides.

In broader terms, this instrument will be used to evaluate the effect of biologics on various animal tissues and cell culture systems. The instrument will be used to characterize the safety of biologics and evaluate the pathogenic mechanisms of bioterrorism threats. This system will support multiple projects within the Laboratory of Biochemistry and Vascular Biology.

Technical Performance requirements:

• Shall be able to accept microscope slides of sizes 1X3” or 2X3”

• Shall be able to automatically load 6 or more slides

• Shall use TDI (Time Delayed Integration), or similar detector technology for extremely high quality image resolution, image fidelity,sensitivity, and continuous scanning.

• Shall NOT form final image data by stitching together adjacent images, instead shall allow for continuous scanning without stopping the stage.

• Shall be able to capture uncompressed raw file formats for quantitation compatible software outputs such as ImageJ (NIH)

• Shall offer magnifications of 20X and 40X without the need to move optical components within the light path (which leads to variability).

• Shall be able to acquire brightfield and multi-channel fluorescence data automatically in the same scanning sequence (which enhances fidelity and reduces variability).

• Shall use software that is icon based and user friendly

• Shall have a Z-stack feature for thick samples

• Shall be upgradable to fluorescence capabilities

• Computer, monitor and cables as required.

• With very limited bench space the instrument (not including computer and monitor) should be 63.7cm (h) X 54cm (w) X 64.2cm (d) or smaller. This is equivalent to 25in X 21.3in X 25.3in respectively.

Installation, Training and Additional System Requirements.

The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The Contractor shall include all costs associated with the shipping and handling of the equipment, and all travel and field engineer expenses associated with install and training (minimum 2 days overall). On-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications in the contract.

Offered system shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year.

FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 60 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave., Building 52/72, Room 4148, Silver Spring, MD 20993.

Solicitation provisions

Contract Type: Commercial Item-Firm Fixed Price.

FAR Provision 52.252-1 Provisions Incorporated by Reference (Feb 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 shall 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/these address(es):

https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (APR 2014) applies to this solicitation. The following addenda have been added to this provision:

Addendum Paragraph (b):

Offerors are afforded the opportunity to inspect the system prior to the date set for receipt of quotes by contacting the Contract Specialist/Contracting Officer identified herein to schedule an appointment. Failure to inspect the system will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Technical capability: will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered instruments, components, and services meet or exceed the technical requirements and provide compatibility with https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html existing systems identified above. Offerors shall specifically address the performance specifications and support same with submitted technical specifications, descriptive material, literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered solution.

Price: Provide detailed price quote for each item proposed to meet the Schedule of Items.

Include the firm’s DUNS number with quote.

The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2015.

The provision at FAR 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

- Technical Capability

- Price

Technical capability is more important than price. However, if the Government determines non-price factors to be essentially equal among competing offerors price becomes more important as a discriminating factor

The Government reserves the right to request additional information or conduct discussions at any time.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (MAR 2015), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov.

One or more of the items under this acquisition is subject to Free Trade Agreement.

Contract clauses-

FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (MAY 2014), applies to this acquisition. The following addenda apply:

FAR Clause 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(DEC 2013)

HHSAR Clause 352.202-1 Definitions JAN 2006 HHSAR Clause 352.203-70 Anti-lobbying JAN 2006 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations JAN 2010 HHSAR Clause 352.223-70 Safety and Health JAN 2006 HHSAR Clause 352.231-71 Pricing of Adjustments JAN 2001 HHSAR Clause 352.242-71 Tobacco-free facilities. JAN 2006

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Representative (TR) specified at award. If the supplies or services are acceptable, the TR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TR shall document the nonconforming items/services and immediately notify the contracting officer.

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer 3900 NCTR Road

HFT-320

Jefferson, AR 72079 Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov http://www.acquisition.gov/ https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf mailto:nick.sartain@fda.hhs.gov

b. Technical Representative (TR) Point of Contact The following TR will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The TR 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.

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 statement of work;

(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.

Payments

Payment terms Net 30 days after government acceptance. Payments shall be made no more frequently than monthly and will be in arrears. No advance payments will be made.

Invoice Submission

Invoices shall be submitted to the address identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.

I. 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) Purchase order/award number;

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

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

(vi) Terms of any discount for prompt payment offered, if applicable;

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

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

(ix) Taxpayer identification number (TIN);

(x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order;

(xii) Company’s DUNS number; and

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

II. An original and two (2) copies shall be submitted to:

FDA/OC/OA/OFO/OFS

Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: 870) 543-7446 Fax: (870)543-7224

An electronic invoice can be emailed to the following address:

nctrinvoices@fda.gov

III. One copy to the Technical Representative (TR) or other program center/office designee, clearly marked “courtesy copy only”:

To be completed at time of award by Government.

IV. Questions regarding invoice payments should be directed to the FDA payment office at

(870) 543-7446 or (870) 543-7042 or electronically at nctrinvoices@fda.hhs.gov mailto:nctrinvoices@fda.gov mailto:nctrinvoices@fda.hhs.gov

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAY 2015)

(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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-

77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the

Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

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

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (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 (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

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

Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (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).

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

https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955

__ (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] __ (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.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Oct 2014) 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 (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcon-tracting 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. 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 Economically Disadvantaged Women-Owned

Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB)

Concerns Eligible Under the WOSB Program (Jul 2013) (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 2014)

(E.O. 13126).

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

X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

__ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).

X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

__ (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

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

__ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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).

__ (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (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)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-13.

__ (37)(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.

__ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN

2014) (E.O.s 13423 and 13514).

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

X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

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

X (42)(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.

X (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.

__ (43) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (44) 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).

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__ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

__ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C.

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

X (50) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (51) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (54)(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.

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

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

__ (2) 52.222-41, Service Contract Labor Standards (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).

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__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014)(E.O. 13658).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014)

(42 U.S.C. 1792).

__ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 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 this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C.

3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 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.

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

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

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(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

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

793).

(viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212)

(ix) 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.

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

(xi)

__(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).

(xii) 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).

(xiii) 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).

(xiv) 52.222-54, Employment Eligibility Verification (AUG 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive

Order 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

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

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

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

(End of clause)

It is the offeror's responsibility to monitor FedBizOpps.Gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 1151675. The offers are due in person, by postal mail or email to the point of contact listed below on or before July 24, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148123 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1155380 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1156645 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1163027 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217

FDA/OO…