A. Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System
Department of Health and Human Services, Food and Drug Administration | Published August 12, 2015 - Deadline August 19, 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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Test Program for Certain Commercial Items. The solicitation number is FDA-15-223-SOL-1152366 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) 2005-83 dated August 03, 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.
Part I: General Information (Introduction/Background/Scope)
The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), offices of Microbiology Surveillance and Research Animal Diagnostic and Investigative Laboratory (Micro RADIL), within the Office of Scientific Coordination, conduct basic and applied research to support regulatory decision-making recommendations. This microbiology research involves the isolation, identification, and characterization of microorganisms potentially harmful to animals and humans and includes monitoring and evaluation of the sanitation levels of animal rooms, caging, equipment, and cage washing facilities. The microbiological monitoring of the test animals helps maintain the integrity of the research program by guarding against both primary and opportunistic pathogens that may interfere with research results.
Formerly, Micro RADIL used a sterilization system with an ethylene-oxide base unit. Ethylene-oxide is a highly toxic gas that is flammable, carcinogenic, and can cause damage to multiple organs (kidneys, lungs, the reproductive system, liver, upper respiratory tract, skin, eyes, and central nervous system). To ensure operator and environmental safety, the new system shall operate with low temperatures and dry, Vaporized Hydrogen Peroxide (VHP) methods. Hydrogen peroxide is a non-flammable, colorless, odorless liquid and is listed as GRAS (Generally Regarded as Safe). Dry VHP is produced by vaporization of 35% liquid hydrogen peroxide and maintaining the vapor concentration below the dew point throughout the sterilization cycle. VHP rapidly degrades in the environment to water vapor and oxygen; non-toxic innocuous byproducts.
The contractor shall provide a Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System inclusive of inside delivery, installation, training, and up to four (4) option years of post-warranty preventive and corrective maintenance.
Part II: Technical Requirements
A. Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System
At a minimum the contractor shall provide:
• VHP Low Temperature Sterilization System/Bio Decontamination Unit
• System that controls the VHP vapor concentration below the dew point throughout the sterilization cycle; thus providing dry sterilization
• Operator protection mechanisms to limit operator exposure to the liquid hydrogen peroxide
• Dispensing or transferring of the hydrogen peroxide draws directly from the bottle to the sterilization system to ensure operator safety
• Small footprint, countertop or cart size, due to limited laboratory space
• Minimum of three sterilization cycles, Lumen, Non-Lumen, and Flexible
• Minimum 60L volume
• Plasma-free processing
• Exhaust free system
• Equipment operation manuals; electronic format acceptable
• Maximum 15 Amp/115V/60/60Hz
• Turn-key solution which shall include, but not be limited to: all hardware, software, components, connectors, interfaces, instruments, kits, etc. required to meet these specifications and the FDA's stated need and intended use for the system.
B. Inside delivery, Installation Training
At a minimum the contractor shall provide:
• Inside delivery, installation, and clean-up of installation system with on-site training for up to five (5) system operators, including but not limited to system operations, quality control, instrument programming, basic and routine preventative maintenance procedures, and troubleshooting techniques.
C. Service Agreement
At a minimum the contractor will be required to provide:
• Minimum 12-month warranty on the entire system inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training.
• Warranty work shall guarantee operation of the equipment to FDA stated intended use in accordance with OEM specifications.
II. Post-Warranty System Service Plan: Preventive Maintenance/Corrective Maintenance Service
• One (1) scheduled preventive maintenance visit per contract year inclusive of parts, travel, and labor expense
• Unlimited corrective/remedial maintenance visits within 3 business days of call for service inclusive of parts, travel, and labor expense
• Unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.)
• All maintenance and repair activities 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 Technical Point of Contact (TPOC) 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
Part III: Supporting Information
A. Place of Performance
System in-side delivery, installation, and training shall occur at:
U.S. Food and Drug Administration
National Center for Toxicological Research
3900 NCTR Road
Jefferson, AR 72079
B. Period of Performance
System in-side delivery, installation, and training shall occur within 60 calendar days (or less) from receipt of contract award.
Estimated Option Year POP:
Option Year 1 Service Agreement: November 30, 2016 through November 29, 2017
Option Year 2 Service Agreement: November 30, 2017 through November 29, 2018
Option Year 3 Service Agreement: November 30, 2018 through November 29, 2019
Option Year 4 Service Agreement: November 30, 2019 through November 29, 2020
Schedule of Items
See attached PDF file labeled FDA-15-223-SOL-1152366 with Scedule of Items
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 (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 or exceed all of the work requirements identified herein. Offerors shall furthermore supply brochures, literature, and specification sheets describing the equipment features, functions and benefits, along with any scientific publications relative to the use of the equipment.
The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, offerors must furnish as part of their proposal all descriptive material, technical literature, scientific papers, etc. necessary for the government to unequivocally determine whether the offer meets or exceeds the technical requirements.
The period of performance for the option periods in any resultant award will be estimated based on the date of award. The periods of performance for all options will be firmed via bilateral modification once the system acceptance date and corresponding warranty period are known.
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 well as Wage Determination WD 05-2035 (Rev.-16): http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=16.
FAR 52.222-48 Exemption from Application of the Service Contract Act 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.
The provision at FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation.
(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:
(i) Technical Capability of the Offered Equipment to meet the Government's requirement;
Technical capability is more important when compared to price.
(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.
(End of Provision)
The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items (March 2015), 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, Contract Terms and Conditions - Commercial Items (May 2015) 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 full text of a clause may be accessed electronically at this/these address(es):
FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014)
FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)
FAR Clause 52.217-9 Option to Extend the Term of the Contract (Mar 2000)
(a) ... within 1 day of contract expiration; .... at least 10 days before the contract expires...
(c) ...shall not exceed 4 years exclusive of the period set forth for delivery, acceptance, and warranty under item 1 of the contract.
FAR Clause 52.223-6 Drug-Free Workplace (May 2011)
FAR Clause 52.225-8 Duty-Free Entry (Oct 2010)
FAR Clause 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)
FAR Clause 52.242-13 Bankruptcy (July 1995)
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)
Inspection and Acceptance
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments 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.
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.
Payment terms are net 30 days after Government receipt and acceptance of the equipment inclusive of the installation and training. Post warranty service payments will be made no more than monthly in arrears.
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:
NCTR Office of Financial Services
3900 NCTR Road
Building 50, Suite 616
Jefferson, AR 72079
An electronic invoice can be emailed to the following address: firstname.lastname@example.org
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 email@example.com
Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above.
FAR 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive 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).
_X_ (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 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]
_X__ (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 2015).
_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (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).
_X_ (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 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).
_X__ (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.
__ (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:
[Contracting Officer check as appropriate.]
___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)
___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).
___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).
___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
_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)
All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-15-223-SOL-1152366. The offers are due in person, by postal mail or email to the point of contact listed below on or before August 19, 2015 by 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.