combined_synopsis-Solicitation-e-cigarette_smoke_machine_1217394.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 1217394. 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) 2019-05 August 13, 2019.

The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees. This RFQ is issued as full and open competition.

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires an e-cigarette smoking machine to evaluate the toxicity and inflammation produced by electronic nicotine delivery systems (ENDS) using human in vitro airway models.

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), has a new collaborative research project with the Center for Tobacco Products (CTP) that is identical to an existing project (project No. E07549.01) with the only difference that the new project involves the use of ENDS as the smoke source to conduct toxicity evaluation of e-vapors generated from a variety of ENDS using both non-intensive and intensive smoking regimens in airway in vitro tissue models. NCTR requires the purchase of an additional Vitrocell VC-10 S-type smoking robot with an 24/48 exposure module for 6.5mm cell culture inserts or technologically similar instrument with supporting hardware/software to use in a new collaborative project with CTP. Such collaborative work will generate scientific evidence that support the regulatory mission of CTP using the toxicology expertise and facilities at NCTR.

Generating whole smoke aerosols or e-vapors from tobacco products for exposing cells at the air-liquid interface in vitro or animals in vivo requires using a specialized smoking robot. The smoking machine and the exposure modules will, therefore, be the core equipment in this joint study and the performance of the smoke exposure system (i.e., the smoking robot and exposure system) is crucial for the success of this project.

To better mimic the human puffing pattern, NCTR proposes to expose airway air-liquid-interface (ALI) cultures to e-vapors diluted to different concentrations in an intermittent manner. E-vapors will be generated from a variety of ENDS products. E-vapors will be delivered to a dilution system interfaced with the Vitrocell® Exposure Modules and diluted with clean air, and then drawn to the air-liquid interface of the cultures by a vacuum pump. Temperature of the e-vapor path from the smoking robot to the exposure module will be maintained at 37oC to prevent condensation of the test substances before reaching the cells. In this way, cells will be exposed to various dilutions of e-vapors produced using non-intensive or intensive E-cigarette smoking regimens; the parameters for the smoking regimens remain to be determined. The smoking robot should have the capacity to either increase the puff duration to greater than 3 seconds or puff frequency to greater than 2 puffs/minute. Cultures will be exposed to a range of e-vapor concentrations every day for at least 5 consecutive days. Changes in cytotoxicity, tissue integrity, cilia beating frequency, mucin secretion, cytokine secretion, and morphology will be measured at several timepoints. The test doses and treatment durations will be optimized based on the responses measured with these endpoints. Smoking machine shall generate e-vapors from ENDS and an exposure system for exposing cells at the air-liquid interface in vitro. The solicitation is for Brand Name or Equal solution. Proposed equal needs to meet all the salient characteristics listed below.

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).

Minimum specifications-

- The smoking machine shall be able to activate a variety ENDS products either by puffing or pressing down a button actuator;

- The engineering of the smoking machine shall be in compliance with ISO3308:2012 Routine analytical cigarette-smoking machine and CRM81; ISO3308 and CRM81-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 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 entry and exit valves of the syringe drive shall not be in direct contact with e-vapors or mainstream smoke for easy cleaning and switching between tobacco products;

- The e-vapor pathway within the smoking machine shall be heated to 37oC;

- The leakage rate of the smoking robot shall be in compliance with the ISO33008 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. Dilution of the cigarette smoke aerosols of e-vapors shall be conducted using 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 an aerosol dilution system in the syringe for the whole smoke and e-cigarette aerosol; such dilution shall take place at the level of the exposure system;

- 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/ENDS 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;

- For the conventional combustion cigarettes, 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 tobacco products ( i.e. both conventional combustion cigarettes and ENDS) using either bell-shaped, square-shaped puffs, or user defined puffing regimens;

- 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) or e-vapors as they are generated;

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

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

- For conventional combustion cigarettes, 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), Massachusetts and CRM81 regimens or under a user-defined machine smoking regimen without additional upgrades;

- For conventional combustion cigarettes, the smoking machine shall be capable of delivering whole smoke at higher frequencies than ISO and CI by smoking a specified number of cigarettes consecutively;

- The smoking machine shall have the option of being connected to an external human puff profiler and capable of smoking user defined human puff profiles;

- The manufacturer shall provide holders for smoking a variety of ENDS products currently on the market with different activating mechanisms and dimensions;

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

- The smoking machine shall be able to connect to impingers for e-vapor collections;

- 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 operational software shall be able to be upgraded to be in compliance with good laboratory practice (GLP);

- The smoking machine shall be capable of storing a minimum of 30 standard or user-defined smoking protocols;

- 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;

Required minimal specifications for the 24/48 exposure module:

- The module must have at least 48 places for 24-well sized cell culture inserts that are routinely used in the lab;

- The base module must have an electronic heating system for maintaining temperature at 37oC;

- The module must have an aerosol exposure top with 48 individual inlets to allow 8 doses with 6 replicates;

- The module shall have the capability to set the trumpet height at different levels;

- The module must come with the required vacuum calibration valves, all required tubing, and distribution line/tubing/materials;

- The module shall hold 0.5-2.0 mL of media in each position;

- The module must be made of medical grade stainless steel;

- The module, which is in contact with media, cells, bacteria, etc., must be autoclavable at

121oC for 20 min;

- The module shall allow dose regulation via dilution, exposure time, and/or flow rate;

- The module must have condensation-free operation, 1 shell housing, 1 heating system, 1 sensor for heating monitoring, and software for read-out of sensor data to a computer;

- The module shall have trumpet-shaped inlets made of stainless steel for controlled flow and good distribution/deposition;

- Exposure of cultures must take place at the air-liquid interface for realistic assessment of exposure particles;

- The aerosols must be diluted with clean air dynamically for dose-response measurements in a freely defined dilution range of 0.1-12 L air/min;

- The flow of the dilution clean air shall be set and recorded by software;

- The dilution system must be made of medical grade stainless steel with a non-stick surface treatment;

- Exposure top and base module should fit in a rack system with locking device;

- The exposure system must have a humidification station that provides a pressure regulator with safety valve, liquid separator, a heated probe, instrument panel for monitoring relative humidity and temperature, rotameters for adjusting the humidity level, and all connectors must be provided; the humidification system shall provide a minimum of 80 % RH at 37°C supplied to the dilution systems;

- All electronic components must have US plugs 115 V 60 Hz;

- The exposure module shall have a clean air distribution system, humidification station, calibration valves, and mass flow meter to check for vacuum flow;

- The exposure system must be housed inside a climatic chamber equipped with a heating system for maintaining a temperature at 37°C consistent with the culture of the cells (must not require an incubator to maintain the temperatures);

- The exposure system shall be airtight with a Borgwaldt leak tester drop rate maximum of 15 mm/min;

- The manufacturer shall provide documentation or guidance 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;

- The manufacturer shall provide a list of the maintenance and cleaning requirements for the end users;

- Vendor shall provide installation materials, minimum of 5 days of on-site training and product installation;

- The manufacturer shall provide Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) data on the exposure module delivered;

Installation, Training and Additional System Requirements.

The contractor shall provide on-site delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of two (2) days 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.

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 all that otherwise is 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.

- Pricing shall be inclusive of all labor and travel;

- 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 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.

- 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.

Schedule of Items (shipping, handling, delivery, installation and training included)

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price

Extended Price e-cigarette smoking machine as specified herein

1 Each $________ $_________

Option Item (FAR 52.217-9)

Option Year 1: Post-warranty service/maintenance agreement on e-cigarette smoking machine

12 Months $_______ $_________

Grand Total Items 1 through 2

FOB Point Destination. All items shall include shipping, handling, delivery, installation and training to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079.

Period of Performance

Delivery, installation and on-site training shall occur within 180 calendar days from date of award. Warranty shall commence upon acceptance of the system. Post-warranty Preventative and corrective/remedial maintenance repair service on the system, if exercised, shall commence, upon expiration of the warranty period and continue for one year, which may be extended in annual increments. If/when Option Year 1 is exercised; the periods of performance for all options will be firmed via bilateral modification.

Delivery 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

Contract clauses-

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

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018) (Deviation 2017-02), applies to this acquisition. Paragraph “r” is changed as follows:

“(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.”

The following addenda apply:

FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

(MAY 2011)

FAR Clause 52.204-13 System for Award Management and Maintenance (Oct 2018) FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016) FAR Clause 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) 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 one year exclusive of the period set forth for delivery, acceptance, training and warranty.”

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 HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility DEC 2015

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC 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. Technical Point of Contact (TPOC) The following TPOC will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The TPOC 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.

Contractor Performance Evaluation (s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at the CO’s discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.gov/. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 calendar days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by FDA. Any disagreement between the CO and the Contractor will be referred to a contracting official one level above the CO, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period (6 years for construction) in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/webtrain.htm. There is no fee for registration or use of the CPARS system.

Payments

Payment terms Net 30 days after government acceptance. Payments shall be made no more frequently than monthly and will be in arrears. No advance payments will be made.

FDA THREE-WAY-MATCH INVOICE SUBMISSION

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC). The TPOC will be determined at the time of award.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. 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) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(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;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

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

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

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

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742);

or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (August 2019) (Deviation 2017-02)

(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and

Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and

Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(4) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(5) 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:

[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 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

X (4) 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014) (41 U.S.C. 4712) relating to whistleblower protections)

X (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (6) [Reserved]

___ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111- 117, section 743 of Div. C).

___ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (9) 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).

___ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

___ (11) [Reserved]

___ (12) (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 (13) (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.

___ (14) [Reserved]

___ (15) (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).

___ (16) (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 (17) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

___ (18) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Nov 2016) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9.

___ (19) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (20) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

___ (21) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

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

___ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657f).

X (23) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (24) 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)).

___ (25) 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 (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

X (28) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (29) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

___ (ii) Alternate I (Feb 1999) of 52.222-26.

X (30) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

X (31) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

X (32) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

X (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (34) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019)

(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).

___ (35) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 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.)

___ (36) (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.)

___ (37) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (38) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (39) (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.

___ (40) (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.

___ (41) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (42) (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 (43) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (44) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (45) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (46) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (ii) Alternate I (Jan 2017) of 52.224-3.

___ (47) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (48) (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 (49) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (50) 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).

___ (51) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (52) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (54) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (55) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.

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

X (56) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (57) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (58) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (59) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (60) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C.

637(d)(13)).

___ (61) (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.

___ (iii) Alternate II (Feb 2006) 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 (Aug 2018) (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) (Aug 2018) (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 2015) (E.O.

13658).

___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O.

13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jan 2019) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and

Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(v) 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.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2019) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(xi) 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.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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).

(xiv) 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.)

(xv) 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)

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xviii) 52.222-62, Paid sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 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.

(xxii) 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)

Solicitation provisions

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

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

Contract Type: Commercial Item-Firm Fixed Price.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (OCT 2018) 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 supplies/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. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Any proprietary information shall be marked as such.

Price: Provide detailed price quote for each item/component/service proposed to meet the Schedule of Items. Include the firm’s DUNS number with quote. The preventative maintenance periods will not be funded at time of award.