Solicitation_-_1162066.doc

FDA-15-SOL-1162066

Cigar Smoking Machine with CO Analyzer

PART 1 – GENERAL INFORMATION

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6 Streamlined Procedures for Evaluation and Solicitation for Commercial Items as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; quotes are being requested and a written solicitation will not be issued. This requirement is being solicited as full and open and the Government contemplates a Firm-Fixed Price Purchase Order will result from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-86 dated February 1, 2016.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. Its associated Small Business Size Standard is 500 employees.

Brand Name or Equal:

This is a BRAND NAME OR EQUAL acquisition; in accordance with FAR 52.211-6, to be considered for award, offers of equal products must meet the salient physical, functional, or performance characteristics provided in the statement of requirements. In order to be considered an “equal” solution, any alternative solution proposed must be able to perform in strict accordance with the salient operational and technical features described below.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Description of supplies or Services The Southeast Regional Laboratory (SRL) needs to purchase a 10 port, cigar linear smoking machine with attachments for impingers and carbon monoxide detection for the purpose of developing and transferring methods in SRL to support regulatory work for the Center for tobacco Products. The unit is used to simulate human cigar smoking under a variety of conditions and to collect smoke residues for further regulatory chemical analysis. This instrument will increase SRL’s capabilities to analyze cigar smoke products.

Pricing Table Listed below is the pricing table for the Cigar Linear Smoking Machine or equal instruments (which includes one (1) year manufacture warranty for each instrument and four (1) 12 month (one year) option period for post warranty and preventative maintenance.

* Includes 12 month warranty

Post Warranty and Preventative Maintenance

Post Warranty and Preventative Maintenance

Post Warranty and Preventative Maintenance

Post Warranty and Preventative Maintenance

PART 3 – DESCRIPTION

The contractor shall provide:

Item 1: Quantity = 1

Cigar Linear Smoking Machine (Cerulean Part #: SM410-CV) or Equal

Salient Characteristics

1. The linear smoking machine must be capable of smoking cigar product with a diameter up to 22.5mm.

2. The linear smoking machine must be configurable to run on US 208-240 VAC electrical supply standards.

3. The linear smoking machine must be able to operate in a room with a maximum ceiling height of 89 inches.

4. The linear smoking machine must be supplied with all fitting and/or adapters to exhaust the smoke gases to a single (1) exhaust port

5. All shipped components of the linear smoking machine must be able to fit through a doorway that is 33.5 inches wide and 77 inches tall.

6. The linear smoking machine shall have the ability to smoke ten (10) cigars simultaneously with the ability to select different smoking regimes.

7. The linear smoking machine must be able to smoke the following standard regimes used in regulatory testing:

· ISO 3308 - Bell shaped profile, 35 mL puff volume, 2 second puff duration, 60 second puff frequency.

· Canadian Intense – Bell shaped profile, 55 mL puff volume, 2 second duration, 30 second puff frequency.

· Massachusetts Intense - Bell shaped profile, 45 mL puff volume, 2 second duration, 30 second puff frequency.

· CORESTA Method No. 64 “Routine Analytical Cigar-Smoking Machine Specifications, Definitions and Standard Conditions” OUTINE ANALYTICAL CIGAR- SMOKING MACHINE SPECIFICATIONS, DEFINITIONS AND STANDARD CONDITIONS”

8. The linear smoking machine must have a cigar termination function.

9. The linear smoking machine must have a cigar lighting bar that allows the lightning of all ten (10) cigars at the same time.

10. The linear smoking machine must be provided with all cigar holders and any other needed accessories to smoke cigar with diameter of at least between 6.5mm to 22.5mm. Must include holder for ventilated and unventilated cigar products.

11. The linear smoking machine must have a smoke shield closure system that can be closed once the smoking run has started.

12. The linear smoking machine must have the capability of collecting each port smoke individually in different size bags (at least 3, 5 and 10 liter gas bag).

13. The linear smoking machine shall be equipped or provided with equipment to detect leaks at each port.

14. The linear smoking machine must be supplied with an anemometer that can measure airflows within the range of 160 to 300 millimeters/second with an accuracy of at least 10 millimeters/second.

15. The linear smoking machine shall be supplied with an anemometer and all necessary probes, fittings and attachments so that airflow measurement can be made at each of the ten (10) cigar ports.

16. The linear smoking machine shall be equipped with dual glass or Teflon impingers for each of the 10 smoking ports, including any racks and/or attachments needed on the smoking machine unit.

17. Each impinger set shall come equipped with all fittings, tubing and protection devices so that it can be used as-is.

18. The linear smoking machine shall be equipped with ten (10) Cambridge Filter Pad (CFP) holders, 1 for each of the 10 smoking ports.

19. The linear smoking machine shall have ten (10) smoke collection bags, one for each port, so that online gas analysis can occur in the smoke bag.

20. The linear smoking machine must have an online, carbon monoxide (CO) detector so that CO levels can be measured for each of the ten smoking ports.

21. The linear smoking machine must be supplied with all bags, tubing and fittings needed for CO gas calibrations.

22. The linear smoking machine shall be controlled through a software interface that allows the user to select ISO3308, Canadian Intense and/or Massachusetts Intense smoke regimes as well as define customized smoke regimes for puff profiles, puff durations, puff volumes and puff numbers.

23. The smoking machine must be capable of performing cleaning puffs at the end of the smoking run.

24. The smoking machine must be capable of performing different puff profiles: ISO bell, triangle, square, etc.)

25. The linear smoking machine shall be controlled through a computer interface. If that interface is based on a Microsoft platform, then the underlying system must be at least Windows 7 or more recent operating system.

26. The linear smoking machine shall be supplied with all computers, monitors, user input devices like Keyboard and/or touchscreen monitor, and a network capable color laser printer.

Warranty:

1. Price should include a 12 month warranty agreement for all on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour on-site response time, factory- certified replacement parts, engineer labor and travel costs, software updates and notifications.

2. Direct and trained service employees of the successful offeror shall provide maintenance and repair service. A toll-free telephone number for placing service calls is required.

3. Technician response shall be within 72 hours of a service call and provided during normal business hours M-F, 8 am – 5 pm.

Installation:

1. Only trained service personnel shall provide full system installation.

2. The offeror shall provide Installation and Operational Qualification (IQ/OQ) for the linear smoking machine hardware and software. The IQ/OQ service shall occur on a date requested by the COR and the contractor shall receive 72 hour notice of the requested service.

3. The offeror shall provide a minimum of two (2) days of onsite training at the installation location, for five (5) analysts on the operation and maintenance of the linear smoking machine, including software. The onsite training shall occur on a date requested by the COR and the contractor shall receive 72 hour notice of the requested training.

General Requirements:

1. The equipment supplied shall be new equipment and must meet manufacturer’s performance standards for new equipment.

2. The new equipment shall not have been used previously, actively marketed as a new model and contains no used components or parts. Remanufactured, refurbished, or reconditioned equipment is not acceptable.

3. The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

Option Periods:

FDA requests four 12 month option periods for post warranty and preventative maintenance. Post warranty and preventative maintenance shall include all services of the initial manufacturer’s warranty.

PART 4 – PACKING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract/order number and contractor name.

PART 5 – INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and equipment’s installation.

· For the purpose of this PART, the COR (TBD) is the authorized representative of the Contracting Officer.

· Inspection and acceptance will be performed at the locations identified in PART 6. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

PART 6 – DELIVERIES OR PERFORMANCE

Deliveries required by the contractor shall be made F.O.B. destination within 90 days from receipt of the award of contract/order to the addresses/addressees listed below:

Food and Drug Administration

Southeast Regional Laboratory (SRL) 60 Eighth Street NE

Atlanta, GA 30309 POCs: “Shall be provided at time of award.”

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see (PART 8) between the hours of 9:00 a.m. and 3:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to setup of the laboratory instrument and component parts.

PART 7 – CONTRACT ADMINISTRATION DATA

a. The following personnel will represent the Government for the purpose of this contract:

1. Contracting Officers Representative (COR):

To be determined upon contract award 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.

2. Contracting Officer Tiffany Williamson 5630 Fishers Lane

Rockville, MD 20857

Tiffany.Williamson@fda.hhs.gov 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 RFQ; (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.

b. Invoice Submission The contractor shall submit all invoices to all addresses in the manner specified below:

1. One original copy to the approving official:

U.S. Food and Drug Administration

Office of Acquisitions and Grant Services

Attn: Tiffany Williamson 5630 Fishers Lane

Rockville, MD 20857

Tiffany.williamson@fda.hhs.gov

2. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “Courtesy Copy Only”.

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) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed, including:

· Period of performance for which costs are claimed;

· Itemized travel costs, including origin and destination;

· 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;

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

(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; and

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

(xiii) Contractor is not 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:

· List of all invoices submitted to date under the subject award, including the following:

· Invoice number, amount, and date submitted

· Corresponding payment amount and date received

· Total amount of all payments received to date under the subject contract or order

· And, for definitzed contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) 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.

Questions regarding invoice payments should be directed to the FDA Payment Office at:

Office of Financial Services

Food and Drug Administration

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January

(New Year’s Day)

January

(Martin Luther King Day)

February (President’s Day)

May

(Memorial Day)

July

(Independence Day)

September (Labor Day) October (Columbus Day)

November (Veterans Day)

November (Thanksgiving)

December (Christmas Day)

PART 9 - CONTRACT CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/ 52.212-4 - Contract Terms and Conditions – Commercial Items (May 2015) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR Clauses in Full Text 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Feb 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, 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) 52.204-10, 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).

___ (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 Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 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—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, 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).

_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).

___ (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (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).

___ (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).

_X__ (34) 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.)

___ (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 Television (Jun 2014) (E.O.s 13423 and 13514).

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

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

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

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

___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

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

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

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

___ (43) 52.225-5, Trade Agreements (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 (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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

___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

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

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

___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

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

___ (51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

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

___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

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

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

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

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

(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 (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $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.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

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

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

(viii) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

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

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

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

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

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

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

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

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within one (1) day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least the day before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

(End of clause)

HHSAR Clauses HHSAR 352.203-70 Anti-lobbying (Dec 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

PART 10 - SOLICITATION PROVISIONS

52.252-1 Solicitation 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 must 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):

www.acquisition.gov/far 52.211-6 – Brand Name or Equal (Aug 1999)

52-212-1 - Instructions to Offerors – Commercial Items (Oct 2015)

52.212-2 - Evaluation -- Commercial Items (Oct 2014)

PART 11– INSTRUCTIONS TO THE OFFERORS

The provision 52.212-1 incorporated above is tailored as follows. Quotes are due Monday February 29, 2016 at 12:00 p.m. (Eastern Time). Send via email in native (Word/Excel) and PDF format to the Contract Specialist, Tiffany Williamson (Tiffany.Williamson@fda.hhs.gov). Send any questions, via email, to the Contract Specialist no later than 3:00 p.m. (Eastern Time) on Wednesday February 24, 2016.

Vendors shall include a copy of their reps and certs with their quote.

PART 12 – GENERAL EVALUATION INFORMATION:

The provision 52.212-2 incorporated above is completed as follows. FDA will evaluate quotes received in response to this RFQ on using the low-price-technically-acceptable (LPTA) methodology. To be determined “Technically Acceptable” the offeror must meet or exceed all salient characteristics. The proposal must outline all characteristics of the statement of work. FDA will make the award to the offeror whose proposed equipment meets all salient characteristics and whose overall price is the lowest in price.

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