combined_synopsis-Solicitation-_cigarette_smoke_machine_1163703.pdf

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

proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Simplified Procedures for Certain Commercial Items. The solicitation number is 1163703. 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) 2005-88 dated May16, 2016.

The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. This RFQ is issued as full and open competition.

Schedule of items (price inclusive of all shipping, handling, duty etc. to Destination)

Line item

Description Estimated Quantity

Unit Price Total Price

Base Year: Lease of Cigarette Smoking Machine System to include installation and on-site training as specified herein.

1 $__________ $___________

Base Year: Preventative maintenance agreement as specified herein.

1 $__________ $___________

Option Item (FAR 52.217-7):

Purchase of Human Puff Profiler Module

1 $__________ $___________

Option Year 1 Item (FAR 52.217-9): Lease of Cigarette Smoking Machine System as specified herein.

1 $__________ $___________

Option Year 1 Item (FAR 52.217-9): Preventative maintenance agreement as specified herein.

1 $__________ $___________

Optional Item (FAR 52.217- 7): Performance during Option Year 1. One day on-site emergency service repair visit including all labor and travel.

1 $__________ $___________

7 Option Year 2 Item (FAR 52.217-9): Lease of Cigarette 1 $__________ $___________

Line item

Description Estimated Quantity

Unit Price Total Price

Smoking Machine System as specified herein.

Option Year 2 (FAR 52.217- 9): Preventative maintenance agreement as specified herein.

1 $__________ $___________

Optional Item (FAR 52.217- 7): Performance during Option Year 2. One day on-site emergency service repair visit including all labor and travel.

1 $__________ $___________

Option Year 3 (FAR 52.217- 9): Lease of Cigarette Smoking Machine System as specified herein.

1 $__________ $___________

Option Year 3 (FAR 52.217- 9): Preventative maintenance agreement as specified herein.

1 $__________ $___________

Optional Item (FAR 52.217- 7): Performance during Option Year 3. One day on-site emergency service repair visit including all labor and travel.

1 $__________ $___________

Grand Total Items 1 through 12

52.207-5 Option to Purchase Equipment. For purchase price information only.

Description Quantity Total Price Option to Purchase Cigarette Smoking Machine and components at Option Year 1 performance period. FAR (52.207-5 Option to Purchase Equipment)

1 $___________

Option to Purchase Cigarette Smoking Machine and components at Option Year 2 performance period. FAR (52.207-5 Option to Purchase Equipment)

1 $___________

Option to Purchase Cigarette Smoking Machine and components at Option Year 3 performance period. FAR (52.207-5 Option to Purchase Equipment)

1 $___________

Option to Purchase Cigarette Smoking 1 $___________

52.207-5 Option to Purchase Equipment. For purchase price information only.

Description Quantity Total Price Machine and components at the end of Option Year 3 performance period. FAR (52.207-5 Option to Purchase Equipment)

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), has a collaborative research project with the Center for Tobacco Products (CTP) which requires a cigarette smoking machine. The collaborative research product is to conduct toxicity evaluation of whole smoke generated from a variety of tobacco products using several machine smoking regimens (e.g., ISO regimen and Canadian Intense regimen) in airway in vitro tissue models (project No. E07549.01). Such collaborative work will generate scientific evidence that supports the regulatory mission of CTP using the toxicology expertise and facilities at NCTR. Generating whole smoke aerosols from conventional burning cigarettes for exposing cells in vitro or animals in vivo requires using a specialized smoking robot. The smoking machine will be the core equipment in this joint study and the performance of the smoking machine is crucial for the success of this project.

Study design for in vitro smoke exposure at the air-liquid-interface to better mimic the human exposure and puffing pattern, NCTR proposes to expose airway air-liquid-interface cultures to diluted whole smoke in an intermittent manner. Up to five cigarettes for each dose will be smoked one at a time. Concentrated smoke from one cigarette will be delivered to a dilution system interfaced with Vitrocell® Exposure Modules and diluted with clean air, and then will be drawn to the air-liquid interface of the cultures by a vacuum pump. In this way, cells will be exposed to various dilutions of whole cigarette smoke produced once every 60 s (for the ISO smoking protocol) or 30 s (for CI machine smoking regimen), with up to 5 cigarette-equivalents of smoke being used to expose cultures for each run. Preliminary dose-range finding studies will expose the cultures to 9%, 20%, and 34% of whole cigarette smoke using the smoking protocols mentioned above every day for 5 days. Changes in cytotoxicity, tissue integrity, cilia beating frequency, mucin secretion, and cytokine secretion will be measured after 1, 3, and 5 exposures.

The test doses and treatment durations will be further adjusted based on the responses measured with these endpoints. Should changes in the frequency of smoke delivered to the cells be deemed necessary, the smoking machine will be programmed to smoke more than 1 cigarette at the same dose at a time, resulting in higher rates of smoke delivery.

Performance requirements

General specifications:

The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. All electrical components shall be US standard plugs and voltages (115 V or 208 V, 60 Hz).

- The engineering of the smoking machine shall be in compliance with ISO3308:2012 Routine analytical cigarette-smoking machine; ISO3308-specified parts shall be provided by the manufacturer;

- The Contractor shall include information demonstrating the compatibility of the smoking machine with the commercially available Vitrocell® Exposure Modules for 6-, 12-, and 24-well tissue culture inserts which are currently being used for NCTR’s in vitro aerosol exposures, which will be connected to the smoking machine solicited in this document;

- The smoking machine shall be operated in a rotary fashion;

- The smoking machine shall automatically load, light, and extract cigarettes;

- The smoking machine shall have at least 2 syringe drives with pinch valves;

- The valves of the syringe drive shall not be in direct contact with mainstream smoke for easy cleaning and switching between tobacco products;

- The leakage rate of the smoking robot shall be in compliance with the ISO3008 and no more than 5 millimeters/minute;

- The smoking machine shall be capable of adjusting the air flow rate in accordance with the ISO3308;

- The smoking machine shall operate without consuming a large quantity of oil-free compressed air. Machine shall use compressed air commercially available in cylinder/tanks;

- Regarding the source of compressed air for the tobacco smoke generating machines, the requirements for the compressed air source shall be specified by the contractor in order to properly determine the compressed air requirements in each room;

- If the tobacco smoke generating machine requires fume extraction for operation, the requirements for the exhaust shall be specified by the Contractor in order to properly determine the requirements in the smoking lab;

- The smoking machine shall NOT include any piston dilution for the whole smoke;

dilution of the whole smoke will be achieved using a separate dilution system that is part of the Exposure Module currently in use at NCTR;

- The smoking machine shall be equipped with a cigarette feeder having the capacity of holding more than 200 cigarettes for the smoking machine to load into the carousal for extended exposure runs;

- The smoking machine shall have no less than 10 cigarette positions on the cigarette carousal;

- The smoking machine shall have the capability of smoking 1 cigarette at a time or up to 10 cigarettes in series;

- The smoking machine shall be equipped with a butt length sensor and be able to be operated under both puff count mode or butt length mode;

- The smoking machine shall be able to smoke cigarettes using either bell-shaped, square-shaped puffs, or human puff profile;

- The smoking machine shall be able to smoke cigarettes using partial puffs at the accuracy of 0.1 puff (10% of a whole puff);

- Each smoking machine shall be designed with the capability of delivering intact whole mainstream cigarettes smoke (i.e., gas phase and particulate phase) as it is generated;

- The smoking machine shall have at least 10 individual exhaust lines for delivering whole smoke to the exposure system;

- The dead space within the smoking machine shall be as small as possible, e.g., less than 10 mL;

- The smoking machine shall be able to deliver whole smoke to the piston pump with minimum total particulate matter (TPM) loss;

- The smoking machine shall be capable of operating under the ISO, Canadian Intense (CI), and Massachusetts regimens or under a user-defined machine smoking regimen without additional upgrades;

- The smoking machine shall be capable of delivering whole smoke at higher frequencies than ISO and CI by smoking different cigarettes consecutively;

- Option Item CLIN 3: The smoking machine shall be able to be connected to an external human puff profiler and capable of smoking the recorded human puff profiles;

- The Contractor shall provide cigarette holders for all commercially available cigarette sizes (i.e., length and diameter). The smoking machine also shall have the capability of smoking other smoked tobacco products, such as e-cigarettes and small cigars, etc.;

- The smoking machine shall have a position for holding in-line Cambridge filter holders for TPM collection;

- The smoking machine shall be operated using software that is capable of recording the operational data (number of cigarettes smoked, puff counts, start/end time of an experiment);

- The smoking machine shall be capable of storing an unlimited number of standard or user-defined smoking recipes;

- Operational information stored on the computer shall be able to be exported in the Excel format;

- Any computer components, whether it be hardware or software or an actual computer that is required to perform the functions of the smoking machine, shall be included with the machine and listed as line items on the quote;

- The Contractor shall supply, with the quote, information regarding installation requirements, including unit footprint, electrical, air supply, and smoke extraction requirements;

- The Contractor shall provide Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) data on the smoking machine delivered, including measurements of TPM and CO as the testing parameters;

- The Contractor shall supply information on chemical and solvent compatibility for the parts of the smoking machine that may come in contact with the test articles. Specifically, the Contractor will provide documentation on preferred cleaning procedures for the equipment following the use of the test articles and provide information regarding the compatibility of the components to detergents and solvents that may be used in the cleaning process;

- This purchase will be dependent on the availability of funds.

Installation, Training and Additional System Requirements.

The contractor shall provide inside delivery, installation and operator familiarization training for each system. The contractor shall provide two (2) days of on-site training (in addition to installation of the system) for up to six personnel to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The contractor shall provide all installation materials. The US Government is responsible for room preparations for the installation of the equipment.

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

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

Preventative Maintenance Agreement shall, at a minimum, include the following

- Minimum of one (1) planned preventative maintenance visits per contract period.

- Unlimited phone and email support during the contractor’s normal operating hours.

- Preventative maintenance shall include all labor and travel. Parts required not included with PM shall be purchased via a modification to the contract if needed. Contractor shall provide current catalog price of parts provided and any applicable discounts.

- Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

- Access by 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.

- System software and firmware updates required for reliability improvements and correction of any defects.

- Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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.

- Optional Item CLINs 6, 9 and 12: One day on-site emergency service repair visit including all labor and travel.

FOB Point Destination. Items shall include shipping, handling and inside-delivery to/at the destination identified below. To be delivered within 180 calendar days after receipt of order.

FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. Payment shall be made after government acceptance.

Period of Performance

FOB Destination. All items shall include shipping, handling, in-side delivery, installation and training to the destination identified herein. Delivery/installation/training date is within 180 calendar days after receipt of order. The option items period of performance is dependent on actual award and delivery/installation date. If/when Option Year 1 is exercised; the periods of performance for all options will be firmed via bilateral modification.

Warranty and preventative maintenance visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Solicitation provisions

Contract Type: Commercial Item-Firm Fixed Price.

FAR Provision 52.252-1 Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that shall be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (OCT 2015) applies to this solicitation. The following addenda have been added to this provision:

Addendum Paragraph (b):

Offerors are afforded the opportunity to inspect the existing systems and laboratory that the smoke machine is to be installed prior to the date set for receipt of quotes by contacting the Contract Specialist/Contracting Officer identified herein to schedule an appointment. Failure to inspect the system/location will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Technical Capability: will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered instruments, components, and services meet or exceed the technical requirements identified above. Offerors shall specifically address the performance specifications and support same with submitted technical specifications, descriptive material, literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered solution at meeting or exceeding the stated needs of the FDA. Provide preventative maintenance information.

Provide detailed price quote for each item/component proposed to meet the minimum performance requirements outlined above which will be used for competitive price evaluation. Include the firm’s DUNS number with quote. The preventative maintenance periods will not be funded at time of award. 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 government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

Service Contract Act Exemption This solicitation is being issued under the premise that the Contractor will certify that the post-warranty maintenance/repair services are exempt from the Service Contract Act then Clause 52.222-51 will flow per usual from this solicitation to the resulting order. Offeror shall complete the certifications as applicable in the provision at FAR provision 52.212-3(k) or FAR 52.222-48 (see below) for the application of the Service Contract Act (SCA). The offeror must certify that the maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per conditions set forth in FAR 22.1003-4(c). If this positive certification is not provided the FAR Clauses at 52.222-41, 52.222-42 and 52.222-43 shall be incorporated and the applicable SCA wage determination at the delivery location shall become part in any resultant contract. Wage Determination No.: 2005-2035, Rev 18, dated 12/29/2015 which can be found at:

http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=18.

FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certifications (MAY 2014).

(a) The offeror shall check the following certification:

CERTIFICATION

http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=18

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 Labor Standards statute—

(1) Will not apply to this offeror, then the Service Contract Labor Standards 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 Labor Standards 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 Labor Standards 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 Labor Standards 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.

https://acquisition.gov/far/current/html/Subpart%2022_10.html#wp1105165 https://acquisition.gov/far/current/html/52_222.html#wp1155380 https://acquisition.gov/far/current/html/52_222.html#wp1155380

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2016.

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

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

- Technical Capability

- Past Performance

- Price

Technical capability and past performance, when combined, are more important than price.

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

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

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement (items 1 through 12). The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

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

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2016), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov.

One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.

Contract clauses-

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

http://www.acquisition.gov/

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (MAY 2015), applies to this acquisition. The following addenda apply:

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 52.207-5 Option to Purchase Equipment (FEB 1995) FAR Clause Option for Increased Quantity—Separately Priced Line Item (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within:

At time of award through the base year period of performance for Item 3 Any time during option year 1 period of performance for Item 6 Any time during option year 2 period of performance for Item 9 Any time during option year 3 period of performance for Item 12.

Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree

FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) “… within 1 day of contract expiration; …. at least 15 days before the contract expires...”

(c) “…shall not exceed four years exclusive of the period set forth for delivery, acceptance, installation and training.”

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

(DEC 2013)

HHSAR Clause 352.203-70 Anti-lobbying DEC 2015 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations DEC 2015

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

Contract Administration

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

HFT-320

Jefferson, AR 72079 Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov

b. Contractor’s Point of Contact mailto:nick.sartain@fda.hhs.gov

(To be completed by the contractor) Name:

Phone:

Email:

c. Technical Point of Contact- Technical Representative TR The following TR will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The TR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

Payments

Payment terms Net 30 days after government acceptance of the system (inclusive of delivery, installation and training). Annual maintenance services will not be paid more frequently than monthly in arrears or after annual on-site preventative maintenance visit. There will be no advance payments under this contract.

Invoice Submission

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

I. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

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

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

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

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

(ix) Taxpayer identification number (TIN);

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

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

(xii) Company’s DUNS number; and

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

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

Nick Sartain 3900 NCTR Road Building 50, Room 422 Jefferson, AR 72079

An electronic invoice can be emailed to the following address:

Nick.sartain@fda.hhs.gov

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

To be completed at time of award by Government.

mailto:Nick.sartain@fda.hhs.gov

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

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

Schedule of Items Updates –Technology Refresh- As described in this section the Contractor may provide technology updates to current versions and shall support the FDA in periodic technology refresh and insertion activities. These activities will result in an updated schedule of items list in the basic contract that reflects current technology, version upgrades and FDA needs.

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAR 2016)

(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 (Nov 2015)

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

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

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

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

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

[Contracting Officer check as appropriate.]

X (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 (Oct 2015) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (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. (Oct 2015) (31 U.S.C. 6101 note).

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

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.

X (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

X (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 2015) (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 2015) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(Nov 2011) (15 U.S.C. 657 f).

X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15

U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

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X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2016) (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 (Oct 2015)(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 (FEB 2016) (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).

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 (OCT 2015). (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 (Oct 2015) of 52.223-13.

__ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s

13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

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

__ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (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.

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__ (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 (FEB 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (44) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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

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

5150).

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

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

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

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

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

__ (51) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013)…