combined_synopsis-Solicitation-_exposure_modules_1142612.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 Test Program for Certain Commercial Items. The solicitation number is 1142612. 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) 2005-80 dated March 2, 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.

Schedule of items

Schedule of items is for evaluation purposes. The final schedule of items will depend on Contractor’s full catalog of items for their proposed system. See solicitation instructions in FAR provision 52.212-1 below. A detailed schedule of items will be completed at time of award.

Line item

Description Estimated Quantity

Unit Price Total Price

1 Base Year: Exposure module system as specified herein. 1 $__________ $___________

Installation of exposure system, installation materials, and on-site training.

1 $__________ $___________

Option Item (FAR 52.217-9).

Option Year 1: Exposure module system as specified herein.

1 $__________ $___________

Installation of exposure system, installation materials, and on-site training.

1 $__________ $___________

Line item

Description Estimated Quantity

Unit Price Total Price

Option Item (FAR 52.217-9).

Option Year 1: Post-Warranty preventative maintenance agreement on exposure system and components.

1 $__________ $___________

Option Year 2: Post-Warranty preventative maintenance agreement on exposure

Line item

Description Estimated Quantity

Unit Price Total Price system and components.

Option Year 3: Post-Warranty preventative maintenance agreement on exposure system and components.

1 $__________ $___________

Option Year 4: Post-Warranty preventative maintenance agreement on exposure system and components.

Grand Total Items 1 through 8 $_____________

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) anticipate requirements for multiple exposure modules or systems that are specially designed for dose-controlled and spatially uniform deposition of liquid aerosol nanoparticles on cells cultured at the air-liquid interface (ALI Cultures) in 12-well culture sized inserts. The Division of Genetic and Molecular Toxicology (DGMT) has several collaborative on-going research projects involving nanoparticles. The exposure modules will be used for exposing the 3D tissue culture cell models (ALI cultures) to nanoparticle aerosols that are nebulized. The research aim is to develop 3D tissue culture models to mimic human like exposures to nanoparticles. The exposures of the 3D tissue cultures to nebulized aerosol nanoparticles require the use of a highly specialized exposure module.

The ALI culture models will be cultured in 12-well inserts and then get consistent exposure using the exposure modules specified herein.

The project involves exposing human cell ALI cultures used in the cytotoxicity assays to nebulized aerosol nanoparticles. This equipment will be used to conduct the studies outlined above to provide needed data to determine the risks associated with exposure to specific levels of nanoparticles, thus filling in data-gaps that exist in risk assessment models. In addition, the equipment will allow the FDA to be able to quantify the toxicity of nanoparticles, and will provide the FDA with data regarding the relative toxic and biomarkers of harm for FDA regulated nanoparticles. Annual quantities are estimates only, more or less quantities may be ordered as needed. A Firm Fixed-Price Indefinite Delivery, Requirements contract is anticipated from this solicitation.

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 (115V, 60 Hz).

Stainless steel exposure modules for the ALI cell culture inserts shall have at least 12 places to hold 12-well plate culture inserts that are commercially available. Module shall be compatible with the existing inserts that the Government is currently using (Corning PET Membrane Transwell Clear inserts catalog 3470, 3460 and 3450 and Greiner Bio-One ThinCert Cell Culture Inserts catalog 657-641, 665-641 and 662-641;

• Stainless steel exposure modules (i.e. cultivation base for ALI exposures) shall have at least 12 places to hold 12-well plate culture inserts that are commercially available.

Module shall be compatible with the existing inserts that the Government is currently using (Corning PET Membrane Transwell Clear inserts catalog 3470, 3460 and 3450 and Greiner Bio-One ThinCert Cell Culture Inserts catalog 657-641, 665-641 and 662-641;

• Nebulizing Aerosol exposure capability;

• Module (i.e. cultivation base for ALI exposures) shall be made of medical grade stainless steel;

• Aerosol generator head with a range of 4.0-6.0 micron

• Aerosol generator control unit

• Housing for the exposure system

• Exposure of cultures shall take place at the air/liquid interface for realistic assessment of nanoparticle exposures;

• The nebulized nanoparticle aerosols shall be delivered to each compartment for ALI cultures in a dose-controlled and spatially uniform aerosol deposition

• System shall have an integrated base plate with electronic heating to maintain the ideal temperature consistent with the culture of the cells or bacteria;

• Aerosol nanoparticle exposure shall be applied in a short time, less than 4 minutes;

• Module which is in contact with media, cells, bacteria, etc., shall be capable of withstanding standard autoclavable procedures (i.e. at 121 °C for 20 min);

• Module shall allow the culture medium supply to be static, intermittent or continuous;

• Exposure system shall be expandable to connect an inline photometer for dose control online in real time for each single compartment.

Stainless Steel Dilution System:

• Aerosol nanoparticle distribution system for 12-well SS exposure modules delivering the aerosol to the 12 inserts in the module at specific programmable concentrations

• Shall have 12 dose outlets for 9 places for exposures & 3 places for controls

• Shall measure dose online in real time using a quartz crystal microbalance which can be set instead of a culture insert. Minimum resolution 10/ng/cm2 per second

• Microbalance shall have separate controller computer workstation with monitor with all required connectors and software. Module shall hold 12-well plate culture inserts and have optional adapters for 24-well sized inserts.

Rack / Cart System:

• Stainless Steel cart on casters that shall hold all items in solicitation and shall be capable of supporting the weight of all of the items. Cart shall be capable of being rolled from room to room.

Installation, Training and Additional System Requirements.

The contractor shall provide in-side delivery, installation and operator familiarization training for each system. The contractor shall provide two (2) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements.

Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that 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.

Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following

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

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

- Preventative maintenance shall include all labor, travel, and parts (except consumables);

- 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.

FOB Point Destination. Items shall include shipping, handling and inside-delivery to/at the destination identified below. To be delivered within 160 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

Line Items 1-4 period of performance is dependent on actual award date. The period of performance could potential by as follows.

Base Year: 9/30/15 (award of contract) through 9/29/16.

Option Year 1: 9/30/16 through 9/29/17.

Line Items 5-8: Note: Warranty and Post-Warranty Preventative Maintenance Service (line items 5-8) period start/end dates are dependent on delivery, installation and acceptance of the instrument. The post-warranty PM service is four (4) 1-year option periods. The period of performance for the option periods in any resultant award will be estimated based on the date of delivery order award, required delivery of the system (inclusive of inside delivery, installation, site cleanup and training), and the offered warranty period. If/when Option Period 1 is exercised;

the periods of performance for all options will be firmed via bilateral modification.

Option Year 1: Post-Warranty preventative maintenance agreement 9/30/17 through 9/29/18.

Option Year 2: Post-Warranty preventative maintenance agreement 9/30/18 through 9/29/19.

Option Year 3: Post-Warranty preventative maintenance agreement 9/30/19 through 9/29/20.

Option Year 4: Post-Warranty preventative maintenance agreement 9/30/20 through 9/29/21.

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

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (APR 2014) applies to this solicitation. The following addenda have been added to this provision:

Addendum Paragraph (b):

Technical acceptability: will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered 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. Provide preventative maintenance information.

Provide detailed price quote for each item proposed to meet the minimum performance requirements outlined above which will be used for competitive price evaluation. The Contractor shall also provide their full catalog of optional components/items that may be used to enhance the functionality of the instrument which the Government may order during the base or option year period of performance. Include the firm’s DUNS number with quote.

The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2015.

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

The Government will award a contract resulting from this solicitation to the lowest priced, technically acceptable offeror. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined. The Government reserves the right to 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. 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).

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

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

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (MAR 2015), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov.

FAR Provision 52.209-5 Certification Regarding Responsibility Matters (APR 2010) FAR Provision 52.209-7 Information Regarding Responsibility Matters (JUL 2013)

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 16, dated 12/22/2014 which can be found at: 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 Certifications (MAY 2014).

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that—

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

http://www.acquisition.gov/ http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=16

(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.

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:

https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf.

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 https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (DEC 2014), 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 FAR 52.216-18, Ordering (OCT 1995)

(a) “…may be issued from date of award through the end of the contract period of performance to include options periods if exercised.”

FAR 52.216-19, Order Limitations (Oct 1995)

(a) “…$3,000…” (b)(1) “…$600,000;”

(b)(2) “…$600,000: or” (b)(3) “…30 calendar days…”

(d) “…five (5) calendar days…”

FAR 52.216-21, Requirements (OCT 1995)

(f) “…after the date of final payment under this contract.”

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 two years for line items 1-4 and four years exclusive of the period set forth for delivery, acceptance, training and warranty for line items 5-8.”

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

(DEC 2013)

FAR Clause 52.232-18 Availability of Funds (Apr 1984)

HHSAR Clause 352.202-1 Definitions JAN 2006 HHSAR Clause 352.203-70 Anti-lobbying JAN 2006 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations JAN 2010 HHSAR Clause 352.223-70 Safety and Health JAN 2006 HHSAR Clause 352.231-71 Pricing of Adjustments JAN 2001 HHSAR Clause 352.242-71 Tobacco-free facilities. JAN 2006

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the 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.

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

(To be completed by the contractor) Name:

Phone:

Email:

c. Technical Point of Contact-Contracting Officer’s Representative The following COR will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The COR 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.

Placing and Processing of Orders

A. Authorized Ordering Activities: The following activity(ies) or individual(s) is/are designated as Ordering Officers under this contract:

1. Any Contracting Officer of the U.S. Food and Drug Administration-Office of

Acquisitions and Grants Services (OAGS); subject to the limitations contained in their respective contracting officer warrants (SF 1402, Certificate of Appointment).

2. Others as authorized in writing by the Contracting Officer.

mailto:nick.sartain@fda.hhs.gov

B. Content of Order: Each delivery order placed under this contract shall include the following minimum information:

1. The contract number, delivery order number, and data of order.

2. Description of the supplies/service to be provided.

3. Applicable accounting and appropriation data, and special invoicing instructions where applicable.

Additional Information can include:

1. Item number and description, quantity and unit price.

2. Delivery or performance date.

3. Place of delivery or performance (including consignee). Packaging, packing, and shipping instructions, if any.

4. Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

C. Pricing of Orders: The Contractor warrants that the prices charged under this contract shall not exceed the costs charged by the Contractor to its most favored customers for like items or services under comparable conditions.

D. The FDA Ordering Official placing the delivery order shall issue an OF347or other designed form to the Contractor.

Payments

Payment terms Net 30 days after government acceptance of the system (inclusive of delivery, installation and training). Post-warranty annual maintenance services will not be paid more frequently than monthly in arrears. 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 Contracting Officer Representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

To be completed at time of award by Government.

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

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

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 2015) mailto:Nick.sartain@fda.hhs.gov mailto:nctrinvoices@fda.hhs.gov

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

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

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

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

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

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

[Contracting Officer check as appropriate.]

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 (Apr 2010) (41 U.S.C.

3509)).

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

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

X (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.

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.

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__ (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)).

X (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)).

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

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

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

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

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

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

__ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned

Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB)

Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

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

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014)

(E.O. 13126).

X (27) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

X (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

X (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).

X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)

(29 U.S.C. 793).

X (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(Dec 2010) (E.O. 13496).

X (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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X (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order

12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA– Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-13.

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

13423 and 13514).

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

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

__ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

__ (41) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (42)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act

(May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109- 169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

X (43) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (44) 52.225-13, Restrictions on Certain Foreign Purchases (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).

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

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

(29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

X (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014)

(42 U.S.C. 1792).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

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