FBODaily.com | FedBizOpps: PRESOL | 66 | Automated DNA Library Preparation System - FDA-15-223-SOL-1146757 with Schedule of Items.PDF

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 23, 2015 FBO #4960
SOLICITATION NOTICE

66 -- Automated DNA Library Preparation System - FDA-15-223-SOL-1146757 with Schedule of Items.PDF

Notice Date: 6/21/2015
Notice Type: Combined Synopsis/Solicitation
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: FDA-15-223-SOL-1146757
Archive Date: 7/22/2015
Point of Contact: Sondea R Blair, Phone: 8705437469
E-Mail Address: sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: FDA-15-223-SOL-1146757 with Schedule of Items.PDF This is a 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. The Government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is FDA-15-223-SOL-1146757 and 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) 2005-82 dated June 08, 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. Contract Type: Commercial Item - Firm Fixed Price. REQUIREMENTS Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), Office for Regulatory Affairs (ORA) Office of Regulatory Science provides guidance to FDA field laboratories on emerging technologies. As such, four of the FDA/ORA field laboratories have expanded their capabilities to identify microorganisms at the genetic level using an Illumina Micro Sequencing (MiSeq) platform for Whole Genome Sequencing and requires an automated DNA library preparation system to be used in tandem with the Illumina MiSeq for a variety of established nucleic acid extraction protocols to genetically identify organisms isolated from regulatory samples, providing consistently reliable DNA extraction for microbial identification, with the elimination of human error due to differences in analyst technique. Instrument should be able to deliver highly reproducible, sequencing-ready libraries with minimal hands-on time (no more than 30 minutes per run), specifically to prepare, quantify, and normalize libraries in a single run without user intervention. Furthermore, the libraries generated should be ready to be prepared for clustering on Illumina MiSeq instruments. Additionally, the library prep workflow should be able to integrate with BaseSpace, the Illumina genomics computing environment for data analysis, storage, and collaboration. Scope: Contractor shall provide four (4) ORA Laboratory locations with a DNA Library Preparation System inclusive of inside delivery, installation, Installation Qualification (IQ), Operational Qualification (IQ) and Performance Qualification (PQ), training, and up to four (4) 1-Year periods for post warranty preventive and corrective maintenance. Part II: Work Requirements A. DNA Library Preparation Systems At a minimum the contractor shall provide: • Four (4) DNA Library Preparation Systems compatible with Illumina next-generation sequencing platforms and BaseSpace, the Illumina genomics computing environment for data analysis, storage, and collaboration. Existing equipment includes Illumina MiSeq Sequencing System (serial numbers: M01444, M01449, M01599R, M01404). • Maximum 115V, 50Hz • Operating temperature range of 19°C to 25°C • 2D barcode scanner • Minimum 16 libraries per run • Minimum of 5 Library preparation kits for each laboratory location inclusive of assays and reagents for DNA and RNA sequencing • Maximum 30 minutes per run • highly reproducible, sequencing-ready libraries • Prepare, quantify, and normalize libraries in a single run without user intervention • Ready to be prepared for clustering on Illumina MiSeq instruments • Windows 7 compatible control computer, with minimum 16GB storage capacity, and preinstalled software • User friendly operation B. Inside Delivery, Installation, IQ/OQ/PQ, and Training • The contractor shall provide inside delivery, installation, and clean-up at each installation site for the entire system with documented IQ/OQ/PQ of the system, and on-site training. • At a minimum, training shall include system operations (including software), calibration, basic and routine preventative maintenance procedures and cleaning requirements for up to six (6) operators. • Installation shall be inclusive of all labor, parts, installation kits, and travel expense. C. Turn-Key System Offerors are expected to provide a turn-key solution which shall include, but not be limited to: • All hardware, components, interfaces, instrument computers, software, installation and installation engineering support, kits, on-site familiarization and operation training required to meet these specifications and the FDA's stated need and intended use for these systems. D. Minimum Service Requirements I. Warranty At a minimum the contractor shall provide: • Minimum 12-month warranty on the entire system, inclusive of hardware and software components. • Warranty shall be inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training. II. System Service Plan: Preventive Maintenance/Corrective Maintenance Service At a minimum, the Contractor shall provide: • One (1) scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense • Include unlimited corrective/remedial maintenance visits within 3 business days of call for service • Include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) • Include unlimited software and firmware updates • All maintenance and repair activities shall be performed by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. • Access for the FDA Contracting Officer's Representative (COR) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument • Services inclusive of labor, travel, replacement parts, components, subassemblies, etc. Part III: Supporting Information A. Place of Performance U.S. Food and Drug Administration Pacific Regional Laboratory South West Richelle Richter/Kyson Chou, Ph. D. FDA/PRL-SW 19701 Fairchild Irvine, CA 92612-2506 U.S. Food and Drug Administration Pacific Regional Laboratory North West Lisa Newberry FDA/PRL-NW 22201 23rd Drive, SE Bothell, WA 98021 U.S. Food and Drug Administration San Francisco District laboratory David Lau FDA/San Francisco Laboratory 1431 Harbor Bay Pkwy Alameda, CA 94502 U.S. Food and Drug Administration Southeast Regional Laboratory Melissa Benjamin FDA/Southeast Regional Laboratory 60 Eighth Street NE Atlanta, GA 30309 B. Period of Performance System delivery, installation, IQ/OQ/PQ and training shall be completed within 90 calendar days (or sooner) from receipt of award. Schedule of Items * See attached PDF file idenitified as FDA-15-223-SOL-1146757 with Schedule of Items.PDF Solicitation Provisions 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 The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (April 2014), applies to this solicitation. The following addenda apply: Prices shall be inclusive of shipping and handling (inside-delivery required) and shall be quoted FOB Destination. Prices shall be firm through September 30, 2015. Offerors shall submit sufficient technical information necessary for the Government to conclusively determine that the offered system and post warranty services meet all of the work requirements identified herein. The period of performance for the option periods in any resultant award will be estimated based on the date of award. If/when Option Period 1 is exercised, the periods of performance for all options will be firmed via bilateral modification. Note: This solicitation is being issued under the premise that the Contractor will certify that the service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as Wage Determination: WD 05-2047 (Rev.-16) http://www.wdol.gov/wdol/scafiles/std/05-2047.txt?v=16 WD 02-2563 (Rev-17) http://www.wdol.gov/wdol/scafiles/std/05-2563.txt?v=17 WD 02-20151 (Rev.-15) http://www.wdol.gov/wdol/scafiles/std/05-2051.txt?v=15 WD 05-2133 (Rev.-14) http://www.wdol.gov/wdol/scafiles/std/05-2133.txt?v=14 FAR Provision Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification (Feb 2009) (a) The offeror shall check the following certification: CERTIFICATION The offeror [ ] does [ ] does not certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c) (3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. The provision at FAR 52.212-2 (Oct 2014),Evaluation-Commercial Items is applicable to this solicitation. (a) The Government will award a contract resulting from this solicitation to the lowest priced, technically acceptable responsible offeror. 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. (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 (March 2015), Offeror's Representations and Certifications - Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. The clause at 52.212-4 (May 2015), Contract Terms and Conditions - Commercial Items applies to this acquisition. The following addenda apply: This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the applicable dates are affected per Federal Acquisition Circular (FAC) 2005-82 dated June 08, 2015 and the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html FAR Clause 52.217-9 Option to Extend the Term of the Contract (a)... within 1 day of contract expiration;.... at least 10 days before the contract expires... (c)...shall not exceed 5 years. FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights; FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper; FAR Clause 52.223-6 Drug-Free Workplace; FAR Clause 52.225-8 Duty-Free Entry FAR Clause 52.232-40 Providing Accelerated Payment to Small Business Subcontractors; FAR Clause 52.242-13 Bankruptcy HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR Clause 352.223-70 Safety and Health HHSAR Clause 352.231-71 Pricing of Adjustments HHSAR Clause 352.242-71 Tobacco Free Facilities Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Service Records and Reports The Contractor shall, with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. 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) Companys 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: Sondea Blair 3900 NCTR Road Building 50, Rm 421 Jefferson, AR 72079 An electronic invoice can be emailed to the following address: sondea.blair@fda.hhs.gov III. One copy to the Contracting Officer' Technical Representative (COTR) 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 <img style="position: static !important; margin: 0px; width: 16px; bottom: 0px; display: inline; white-space: nowrap; float: none; height: 16px; vertical-align: middle; overflow: hidden; cursor: hand; right: 0px; top: 0px; left: 0px;" title="Call: (870) 543-7446" src="data:image/png;base64,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" alt="" /> or (870) 543-7042 <img style="position: static !important; margin: 0px; width: 16px; bottom: 0px; display: inline; white-space: nowrap; float: none; height: 16px; vertical-align: middle; overflow: hidden; cursor: hand; right: 0px; top: 0px; left: 0px;" title="Call: (870) 543-7042" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAIGNIUk0AAHolAACAgwAA+f8AAIDpAAB1MAAA6mAAADqYAAAXb5JfxUYAAAKLSURBVHjadJPfS5NhFMe/21xvuhXRyJAZroiSrJnbRdT7vrAf5HBaK5RABmEEwQIvkpZ/QRcWXdSFw5soKaF0F7qZeLO13mGBDpQsf5CoxVKHOt0Pctp2uvEdrzG/V+c553w/54HnPDIiQiGpPMETABoB2AAYd9MRAMMAvGmX+RcAyAoBVJ7gZQDtABworH4AHWmX+bOMZdkjCoXiUzabvcAwzPSsob5p/VTNY9GcdpnxdmYZ9wJThSCtCr1e/4XjuNPd3d1KjUZzaGbI27ysqzGQoggAsLa1A7ehArrDxfDNr0oBlQB+wmKxbJFEL968SxoamsjkHaPU9l9piUo6A0RE1DG2QCWdASrpDAzJM5kMI8XecdjVxfEl+K9dxFgsgUvvR6HyBKHyBAEATyKLeGSsENuNcqk5kUjEGm7fzcYqr0ClVODl99+YXEvl6+c1amjVe+ahiGGYaUEQKnmeh91uL43rqheixjpdmzCL11er0PcjhrTLvMfUJsyKYUSeyWQ6enp6tgCgrKxsfbP8bB8AdE1G89cOReMAgOv+Cag8QXRNRkXAsDwcDr+am5tLCYKA3t7eo2dG+1vVK/MfpRPtA+MIReMYaKj+/xm9MiICx3EmpVL5wefzFavValis1u1vvHMkdfykCQC0kSGUTo+Ajmnx1dSC7IGD+UUCEYGIwLKsyWazrSeTSSIiMpnNf7Ttz5+ec96fr7/VnE0mk+QfHMzV3WjcKH/4rEr05QGFIA6HY4llWRLPRER+v3/HYrFMFQSIkNra2tVQKJSlfcSyLO0LECFWq3XF6XRGA4HAptTsdrsXeZ6fEHtl+31nAOA4rkUulz/I5XL63dQGgHEAN8Ph8AYA/BsAt4ube4GblQIAAAAASUVORK5CYII=" alt="" /> or electronically at nctrinvoices@fda.hhs.gov Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. As prescribed in 12.301(b)(4), insert the following clause: Contract Terms and Conditions Required to Implement Statutes 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, 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: ___ (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 (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 (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). _X_ (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (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. _X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (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 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-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for 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 (Feb 1999). _X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X_ (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). _X_ (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). _X_ (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 Television (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). __ (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). __ (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. _X_ (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 (Jun 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). ___ (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: ___ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). _X_ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). ___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). ___ (10) 52.222-55, Minimum Wages Under Executive Order 13658 Dec 2014)(Executive Order 13658). (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 (1) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (viii) 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. (ix) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (x) _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 E.O. 13627). (xi) 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.) (xii) 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) (xiii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiv) 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). (xv) 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. (xvi) 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. (xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014)(Executive Order 13658). (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) All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-15-223-SOL-1146757. The offers are due in person, by postal mail or email to the point of contact listed below on or before July 7, 2015 before 9:00 am (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Building 50, Room 421, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in Part III Supporting Information section above. For information regarding this solicitation, please contact Sondea Blair by e-mail at sondea.blair@fda.hhs.gov. Questions regarding this solicitation, will be accepted only via email and shall be submitted no later than 9:00 AM CT on July 3, 2015.
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Place of Performance: Address: U.S. Food and Drug Administration, *Multiple OA Filed Locations Per Solicitaion, Irvine, California, 92612, United States; Zip Code: 92612
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