Department of Health and Human Services, Food and Drug Administration | Published June 30, 2015 - Deadline July 16, 2015
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. 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 1150021 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 effective June 8, 2015.
The associated North American Industry Classification System (NAICS) Code is 334516 ‐ Analytical Laboratory Instrument Manufacturing. FSC Code is 6640. Small Business Size Standard is 500 employees. Acquisition is unrestricted.
Contract Type: Commercial Item-Firm Fixed Price.
Background: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR), Division of Pharmaceutical Analysis (DPA) has a requirement for an on-line UV/vis Spectrophotometer for use with an existing fully automatic dissolution apparatus, Vortex Cetus 840, (Serial No CET840-060) including inside delivery, installation/integration, Installation Qualification/Operation Qualification (IQ/OQ) testing, on-site operator training/familiarization, and optional post-warranty maintenance for up to four (4) 1-year option periods. The system is needed to directly interface with the existing a dissolution apparatus for rapid, sensitive, and specific analysis of drug products during dissolution testing. The current system was install in December of 2014 under Contract No. HHSF223201410215A by Vortex Pharma Group. The system is under warranty until 12/2015.
Current the fully automatic system can only be used to test drug products which require High Performance Liquid Chromatography methods for determination. Many drug products on the market also need on-line UV/vis method for finished analysis, which current system is not capable of testing. The vendor (Vortex), who manufactured our fully automatic dissolution apparatus, also developed an on-line UV/vis program. The addition of an on-line UV/vis, is necessary to expand the FDA's capability to test all drug products on the market.
Minimum General Specifications:
-The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.
-The entire system shall be warranted for parts and labor for 12 months from date of installation acceptance. Installation/Integration of this UV/vis Spectrophotometer to the existing equipment shall not void or have any negative impact on the warranty under Contract No.HHSF223201410215A.
-All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Safety Data Sheets (SDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system.
-The system shall be delivered with all necessary supplies, equipment, components, adapters, software, accessories, etc. required to seamlessly install/integrate, IQ/OQ test and train; Contractor is responsible for a turnkey solution.
Minimum System Requirements:
UV-Vis Spectrophotometer shall include:
-Software Integration (all software for data acquisition, interpretation and analysis, etc.) with the existing Cetus 840 fully automatic dissolution apparatus.
-Driver (compatible to existing Cetus 840 operation system)
- UV-Vis spectral acquisition and analysis in less than 1 second
-a multi-cell transport
-Set of 10 mm cuvettes
Minimum Installation/Integration, IQ/OQ testing and on-site operator training/familiarization
The Contractor shall provide all labor, travel, and tools to install/integrate the equipment at the address provided below, to include inside delivery. Equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The vendor shall demonstrate upon installation and testing that the item meets all performance specifications with IQ/OQ testing UV document set provided upon completion. The Contractor shall provide onsite system training for users.
Minimum Post-Warranty Service Requirements:
• Shall include at least one (1) planned, onsite preventative maintenance visit per contract year.
• Shall include unlimited technical support (e.g., telephone-based, email-based, website-based, etc.) and unlimited corrective/remedial maintenance visits, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Standard Time (CST).
• Shall include unlimited software and firmware updates.
• All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.
• All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.
• Service Records and Reports - The Contractor shall, commensurate 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 a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.
Delivery Address (FOB Destination):
Inside delivery, installation/integration, IQ/OQ testing, on-site operator training/familiarization familiarization, and post-warranty maintenance shall be conducted at:
US Food and Drug Administration
Division of Pharmaceutical Analysis
645 South Newstead, Room #2023
St Louis, MO 63110
POC: "Shall be provided at time of award."
Period of Performance:
Delivery, to include installation, IQ/OQ testing and on-site operator training/familiarization, required within sixty (60) calendar days of award with up to four (4) 1-year option periods for post-warranty maintenance.
Item No. Description Quantity Unit Unit Price
0001 Upgrade, UV/vis Spectrophotometer, 1 each $
including inside delivery,
Qualification (IQ/OQ) testing, on-site
in accordance with requirements above.
0002 Option Period 1, Annual Post-warranty 1 each $
Maintenance in accordance with the
0003 Option Period 2, Annual Post-warranty 1 each $
Maintenance in accordance with the
0004 Option Period 3, Annual Post-warranty 1 each $
Maintenance in accordance with the
0005 Option Period 4, Annual Post-warranty 1 each $
Maintenance in accordance with the
FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:
The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (Apr 2014) applies to this solicitation. Addenda to this provision are as follows:
Offerors are afforded the opportunity to inspect the equipment to be upgraded prior to solicitation response date by contacting the Contract Specialist, Crystal G. McCoskey, email@example.com, phone: 870-543-7267, to schedule an appointment no later than July 13, 2015, 9:00 AM CST. Failure to inspect the equipment to be upgraded will not relieve the successful Offeror from fully meeting the requirements of the resulting contract at the price offered.
Service Contract Act Exemption
This solicitation is being issued under the premise that the Contractor will certify that the post-warranty maintenance services are 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 well as Wage Determination No. 2005-2309 (Rev 15):
FAR 52.222-48 - Exemption From Application Of The Service Contract to Contracts For Maintenance, Calibration, Or Repair Of Certain Equipment - Certification (May 2014)
(a) The offeror shall check the following 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. (End of provision)
The government is not responsible for locating or securing any information, which is not identified in the quote. To ensure information is available, offerors must furnish as part of their proposal, all descriptive material necessary for the government to determine whether their item meets or exceeds the stated technical requirements and that those items will absolutely support FDA's stated need and provide compatibility with the existing systems. The quote shall provide information on any turn-key solutions, inclusive of all supplies, equipment, components, adapters, software, accessories, etc. necessary to achieve the intended application. Offers other than Vortex Pharma Group shall include evidence/demonstration that the product has and will work with the existing system without complications or interruptions in the research to be conducted using the equipment, and provide a solution to avoid negative impact on current warranty coverage of the base system. Any proprietary information shall be marked as such.
Offeror shall include a price breakout for all components within Item No. 0001's extended total, to include detailed description, catalog/part number, quantity, and unit price of each accessory or ancillary item to the system. Any items offered on GSA Contract shall be indicated on offer as such. The post-warranty maintenance periods will not be funded at point of equipment purchase. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly. The period of performance for the option periods in any resultant award will be estimated based on the date of award, estimated ultimate delivery of Item No. 0001, and applicable warranty period. If/when Option Period 1 is exercised, the periods of performance for all options will be firmed via modification.
The provision at FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation and is hereby incorporated by reference. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:
(i) technical acceptability;
Technical acceptability will be determined, by review of information submitted by the Offeror, that the item quoted meets the Government's minimum technical requirement and assures compatibility with the existing equipment with no negative impact on current system warranty. The Government intends to award an order to the lowest priced technically acceptable offer. Offers will be evaluated on their ability to meet the minimum technical requirements provided above. 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 Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition.
The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015), applies to this acquisition. Addenda to this clause are as follows:
Inspection and Acceptance
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) 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.
Payment terms net 30 days after government acceptance of the items/services.
Invoices shall be submitted, once the equipment is accepted and quarterly in arrears for post-warranty maintenance periods, to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.
I. An original and two (2) copies shall be submitted to:
Attn: Division of Payment Services
3900 NCTR Road, HFT-324
Building 50, 6th floor, suite 616
Jefferson, AR 72079
Phone: (870) 543-7446
An electronic invoice can be emailed to the following address:
II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only":
Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above.
Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. firstname.lastname@example.org.
The following clauses are incorporated by reference:
• FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000),
(a) "...by written notice to the Contractor within one (1) day of contract expiration; ...preliminary written notice of its intent to extend at least 30 days before the contract expires."
(b) "...shall not exceed four (4) years beyond the warranty expiration."
• 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013)
• 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)
• 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010)
• 352.231-71, Pricing of Adjustments (Jan 2001)
• 352.242-71, Tobacco-Free Facilities (Jan 2006)
FAR 52.212-5 - 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 (Apr 1999).
_X__ (28) 52.222-26, Equal Opportunity (Apr 2007) (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).
_X__ (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 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.
_X__ (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 (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) 52.222-17, 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).
_X__ (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 (Sep 2008) (31 U.S.C. 5112(p)(1)).
(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(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) 52.222-21, 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 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) (E.O. 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)
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Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 16, 2015 to email@example.com, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502.
For information regarding this solicitation or site visit request, please contact Crystal G. McCoskey by e-mail at firstname.lastname@example.org. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 09:00 AM CST on July 13, 2015. Please reference solicitation number 1150021 in subject line of all correspondence.