combined_synopsis-solicitation_high_resolution_imaging_assay_1151961.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 1151961. 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 August 3, 2015.

The associated North American Industry Classification System (NAICS) Code is- 541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $15 million. This RFQ is issued as full and open competition.

Schedule of items (shipping and handling included)

Line item Description Quantity Unit Price Extended Price

High resolution image analysis of calcium transient and action potential of induced pluripotent stem cell-derived human cardiomyocytes (iPSC-CMs, from both male and female donors)to be cultured in monolayer and analyzed by the Contractor as specified herein.

Samples

(including positive and vehicle controls)

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires the Contractor to analyze iPSC-CMs using high-resolution imaging assays to survey for compound effects against the full complement of cardiac ion channels in a physiologically relevant model.

Part I: General Introduction

The US FDA Office of Women’s Health (OWH) has funded NCTR in establishing in vitro (cell culture) screening assays to study gender differences in drug-induced arrhythmia. As part of the study, NCTR will use high-resolution imaging assay services to evaluate gender differences in the proarrhythmic response of a pair of iPSC-hCMs cell lines, male and female, to three compounds for which there exist extensive animal and human data and for which their mechanisms of action are well understood.

A. Background QT interval (the space between the start of the Q wave and the end of the T wave) prolongation at surface electrocardiogram ECG is a biomarker for assessing the risk of torsade de pointes (TdP). Although, in general, torsadogenic potential is correlated with the extent of QT prolongation, it is not always true for some drugs. Many of the risk factors, including sex, need to be considered in risk assessments of drug-induced TdP. Besides, TdP is not always initiated by blocking Herg (the human Ether-à-go-go-Related Gene) channel, the simultaneous effects on other ion channels may compensate the Herg blocking effects.

Recently, iPSC-hCMs have become a popular model because they largely resemble the electrophysiological behavior of human ventricular myocytes. However, iPSC-hCMs are derived from individuals with diverse genetic backgrounds, no single line is optimal for detecting all arrhythmogenic mechanisms. It would thus be critical to understand the particular characteristics, such as gender difference, of any lines NCTR would routinely use for characterizing compounds.

B. Scope

When observed at the cellular level contraction of the heart is a three step process where: 1) Currents generated by the intrinsic pacemaker tissues of the heart stimulate an action potential in the cell; 2) The action potential stimulates the generation of the cardiac calcium transient, a rapid rise and fall of intracellular calcium levels which 3) regulates the activity of the contractile machinery of the cell. Compounds altering the activity of any of the steps mentioned above may in turn induce arrhythmias. Thus, analyzing compound induced alterations in both the action potential and calcium transients of stem cell derived cardiomyocytes using high-resolution imaging assays provides an integrated assay to survey for compound effects against the full complement of cardiac ion channels in a physiologically relevant model.

Part II: Work Requirements A. Technical Requirements for Contractor:

• Contractor shall be required to culture male and female hiPSC iCell® cardiomyocytes produced by Cellular Dynamics International in monolayer for two weeks then switch the CDI normal culture medium to a hormone-free medium (These cells and media shall be provided by NCTR)

• The Contractor shall be requested to apply one physiological concentration of testosterone (5α-dihydrotestosterone, DHT) on male cells and one physiological concentration of 17β-estradiol (E2) on female cells

• Contractor shall be required to perform a calcium transient assay and an action potential (e.g. integrated membrane potential) assay under conditions with /without electrical stimulation (1Hz or as discussed with NCTR Technical Representative). The measured data will include transient/action potential duration at 25%, 50% ,75% , and 90% of full transient/action potential duration, changes in transient/action potential shape (triangulation or T75-25), amplitude, maximal upstroke and decay/contraction and relaxation velocity, ensemble average of Ca-transient /action potential profiles, and occurrence of proarrhythmia such as early after depolarization (EAD).

• The Contractor shall measure the effects of three compounds (four concentrations each), which will be provided in stock solution form by researchers at NCTR. Names of compounds will not be provided as the contractor will perform a blinded study.

• Two reference compounds and a negative control also will be run on the same plate for quality assurance purposes. Fluorescent markers, reference compounds, imaging solutions, DMSO, and compound dose preparation shall be provided by the Contractor.

• The Contractor shall compare baseline measurements and response (30 min post drug addition, or specified duration discussed with NCTR Technical Representative) to chemical treatment between male and female cardiomyocytes with/without hormone treatment in four replicates wells.

B. US Government Laboratory will conduct the following during this study:

• Researchers at NCTR will ship four (4) vials (>4 millions cells/vial) of cells from each gender to the contractor for processing and data analysis. The cells, hormones, and compounds will be shipped to the Contractor within three (3) months after contract award.

An additional vial of cells can be provided within four (4) months after contract award if needed.

C. Deliverables

• The contractor shall update Technical Representative (TR) (to be identified at award) each month on the status of the project and discuss the result with the TR. A full data report in PDF format shall be provided to the TR. This report shall be completed within 3 months of receiving the biological samples from the FDA. Contractor shall send a draft final report for TR review/comments prior to submission of the final full data report. Contractor shall incorporate TR comments or make appropriate changes as required to the final data report.

The data report shall contain effects of different culture conditions, gender of cells studied and drug effects on action potential duration, maximum rate of rise and fall, Ensemble average of action potential profiles, and changes in calcium release and re-uptake, such as Ca-transient duration, amplitude, maximal upstroke velocity, and maximal decay velocity and ensemble average of Ca-transient profiles.

D. Place of Performance:

• Biological samples analysis shall be conducted at the Contractor’s laboratory.

Laboratory shall be equipped to perform high-resolution imaging analysis.

• The Contractor will receive the payment for the service after FDA/NCTR receives and accepts the final report.

• Biological samples will be shipped from the NCTR laboratory address listed below to the contractor.

Dr. to be identified at time of award

FDA/NCTR

3900 NCTR Rd.

Bldg.__, Room ___ Jefferson, AR 72079

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Period of Performance Delivery of final report shall be within 3 months of receipt of government furnished samples.

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):

Technical acceptability: 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 services meet or exceed the technical requirements identified above. Offerors shall provide sufficient information to demonstrate the capability to perform the proposed work. The response should include who, what, when and how the requirement will be accomplished. Such documentation should also include technical information necessary for the Government to conclusively determine that the respondent and their technical staff is qualified and capable to perform the services and experience with high resolution image analysis of calcium transient and action potential on induced pluripotent stem cell-derived human cardiomyocytes (iPSC- CMs) and otherwise able to meet all the performance requirements herein. The Offeror shall identify any assumptions associated with the services to be performed for this contract.

Price: Provide a detailed price quote for each item proposed to meet the minimum performance requirements outlined above. Include the firm’s DUNS number with quote.

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

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 to the lowest priced technically acceptable offer. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined. The Government reserves the right to request additional information or conduct discussions at any time.

(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.

FAR clause 52.222-49 Service Contract Act—Place of Performance Unknown. (May 1989) shall also be incorporated with the following fill-in text.

(a) “None” …” 10AM Central Time, August 12, 2015.”

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 2015), applies to this acquisition. The following addenda apply:

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

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

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:

mailto:nick.sartain@fda.hhs.gov

(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. 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 Contracting Officer Representative (COR) 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

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).

mailto:nctrinvoices@fda.gov mailto:nctrinvoices@fda.hhs.gov 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/

__ (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.

__ (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.

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 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 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#wp1135970 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136004 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#wp1136017 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#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 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#wp1136058 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#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058

__ (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).

__ (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).

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__ (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).

__ (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).

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__ (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).

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

X (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).

Employee Class: Monetary Wage/ Fringe Benefits

GS-2210/9-11 $23.19-$36.48/36.25%

GS-0340/9-11 $23.19-$36.48/36.25%

__ (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 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 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 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 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#wp1153423 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148260 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148274 http://uscode.house.gov/ 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#wp1163027 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_233_240.html#wp1120023 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 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_215.html#wp1144470 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).

(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).

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%204_7.html#wp1082800 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_217_221.html#wp1136032 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147656 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147711 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

(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 1151961. The offers are due in person, by postal mail or email to the point of contact listed below on or before August 17, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX

(870) 543-7990 or email nick.sartain@fda.hhs.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…