FDA-SOL-1176723.doc

FDA-SOL-1176723

Electronic Nicotine Delivery System Testing Equipment

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and 13, 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. The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2005-92, effective 18 November 2016.

This is a total small business set-aside, under NAICS code 334516 – Analytical Laboratory Instrument Manufacturing with a small business size standard of 1,000 employees. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation.

The Food and Drug Administration (FDA) intends to award a purchase order for an instrument capable of simulating use of electronic nicotine delivery systems (ENDS), (i.e. e-cigarettes, vapors, mods, e-hookahs, etc.). This solicitation is issued as Request for Quote (RFQ) FDA-SOL-1176723.

PART 1 – Description

Background

WEAC requires an instrument capable of simulating use of electronic nicotine delivery systems, (i.e. e-cigarettes, vapors, mods, e-hookahs, etc.). This equipment will be necessary to conduct research and develop test methods related to such products. The capability provided by this instrument will enable WEAC engineers to analyze the physical parameters and characteristics while the products are in operation, (i.e. power delivery, battery performance, draw resistance, heating element temperature, etc.). Without this instrument, such analysis will not be practical in a laboratory setting. This work is being conducted in accordance with an agreement between the Center for Tobacco Products and WEAC.

PART 2 – Supplies or Services and Prices/Costs The Food and Drug Administration (FDA) requires the purchase of an instrument capable of simulating use of electronic nicotine delivery systems (ENDS), (i.e. e-cigarettes, vapors, mods, e-hookahs, etc.).

Pricing Table:

Line Item

PART 3 - Technical Requirements

All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor.

**Offerors shall address each of the salient characteristics in order to be considered.**

Specifications/Salient Characteristics:

· Programmable puffing routines, (i.e. the airflow parameters must be programmable)

· Control of puff shape, volume, duration, interval and number of puffs taken allowing capture on a filter pad

· Must be able to test various types of ENDS devices

· Capable of testing a single ENDS, or multiple ENDS devices simultaneously.

· I.e. Test between 1 and 8 e-cigarettes

· Stand-alone device with built in computer and touch screen display/interface

· Windows 7 operating system

· LIMS system

· Data interface: USB2 / Ethernet / RS232

· Output interface to a printer

· The equipment must be able to tilt the ENDS downward from horizontal

· Ability to test ENDS at various angles

· E.g., test at 10⁰-20⁰ intervals between ±90° from the horizontal position.

· Automatic push button activation for switch activated ENDS devices

· Ability to test ENDS devices with push button activation.

· Software allowing the operator to setup libraries and test regimes

· Fully password protected with administrator defined user profiles

· Approximate size requirements:

· Depth: 25 in; Width: 36 in; Height: 20 in

· Exhaust outlet(s) to vent to local exhaust system

Additional requirements:

· On-site installation qualification, operational qualification and performance qualification (IQ/OQ/PQ) of these instruments.

· On-site training of seven (7) analysts.

· One (1) year warranty on parts and labor.

· Four (4) Option Years for continuing Technical Support/Service/Maintenance of the instruments

· Annual Maintenance Service is to include:

· Cleaning and replacement of internal seals, o-rings, valves, fittings, filters at smoking ports, as needed.

· Operational check 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 number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

PART 5 – Inspection and Acceptance The Contracting Officer’s Representative (COR) will perform inspection and acceptance of performance. For the purpose of this PART, (COR – to be provided upon contract award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the location identified in Part 6. Acceptance is communicated in writing unless otherwise indicated by the COR within 30 days of receipt.

PART 6 – Deliveries or Performance Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, and confirmation of performance specifications described in PART 3 of this RFQ and/or upon acceptance by the Contracting Officer or the COR, of these services.

Delivery Location*:

Winchester Engineering & Analytical Center (WEAC)

109 Holton Street

Winchester, MA 01890

*Point of Contact will 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 9) between the hours of 8:00 a.m. and 4:30 p.m. Eastern Time. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery and installation shall be coordinated through the POC. The Contractor shall provide (1) week’s scheduling notice prior to delivery and installation of equipment and component parts.

Period of Performance

Base Year: One year from award date

Option Year 1: One year after end of Base Year

Option Year 2: One year after end of Option Year 1

Option Year 3: One year after end of Option Year 2

Option Year 4: One year after end of Option Year 3

PART 7 – Contract Administration Data

Contracting Officers Representative (COR) The COR, to be determined upon contract award, will represent the Government for the purpose of this contract.

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.

Contracting Officer (CO)

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.

Contracting Officer:

Phillip Frame 5630 Fishers Lane

Rockville, MD 20853

Phillip.Frame@fda.hhs.gov 204.402.7578 Contract Specialist:

Marty Nemec

5630 Fishers Lane

Rockville, MD 20853

Marty.Nemec@fda.hhs.gov 240.402.7663

FDA Invoice Requirements

The contractor shall submit one (1) original copy of each invoice to the address specified below:

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

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

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 (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;

(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 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 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; and

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

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 shall be directed to the FDA Payment Office at telephone number provided above.

PART 8 - FAR and HHSAR CLAUSES 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulation (FAR) System, 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: http://farsite.hill.af.mil/.

52.212-4 Contract Terms and Conditions—Commercial Items (May 2015)

FAR Clauses in Full Text 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Nov 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.] ___ (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 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (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.

___ (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]

_X_ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Nov 2016) (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 (Nov 2016) 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 (Oct 2016) (E.O. 13126).

_ X _ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_ X _ (28) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

___ (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 (Feb 2016) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

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

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

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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.)

Per Court Injunction dated 24 Oct 2016 and OMB memo dated 25 Oct 2016 do not implement the following until further direction.

___ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

___ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

___ (37) (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.)

___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (40) (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.

___ (41) (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.

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

___ (43) (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_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (46) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (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.

___ (49) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_ X _ (50) 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).

___ (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 (Oct 1995) (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 (Jul 2013) (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) (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 (Nov 2016) (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 (Sep 2016) (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 (Feb 2016) (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).

Per Court Injunction dated 24 Oct 2016 and OMB memo dated 25 Oct 2016 do not implement the following until further direction.

(xvi) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

(xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

(xviii) 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).

(xix) 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.

(xx) 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 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 days 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 clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015) 352.239–74 Electronic Information and Technology Accessibility (DEC 2015)

PART 9 – 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)

September (Labor Day)

January (Martin Luther King Day)

October (Columbus Day)

February (President’s Day)

November (Veterans Day)

May (Memorial Day)

November (Thanksgiving)

July (Independence Day)

December (Christmas Day)

Part 10– Instructions to the Offerors 52.212-1 Instructions to Offerors – Commercial Items (Oct 2015) applies with the following addenda: Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2017.

52.212-2 Evaluation – Commercial Items (Oct 2014) The Government will award a firm-fixed price contract to the lowest price technically acceptable (LPTA) offeror who can “meet or exceed” the specifications listed in this Request for Quote (RFQ) and delivery requirements in Part 6. See additional information below in Part 10 c. “Technical Acceptability Criteria.” The contractor shall provide the price and all documentation to support the total price of the service.

52.212-3 Offeror Representations and Certifications—Commercial Items (Apr 2016) An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov . If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision.

a. Quote Preparation Instructions The quote shall include:

(1) Price(s);

(2) FOB point;

(3) Point of Contact (name and telephone number);

(4) Offeror statement verifying that they are SAM Registered under either of the appropriate NAICS codes

(5) Delivery date;

(6) Business size; and

(7) Payment terms.

(8) A product brochure or other reference pertaining to the specific equipment and characteristics referenced in Part 3

b. Price The Offeror shall submit a complete price table for a firm fixed price contract as indicated in Part 2. The Offeror must provide a detailed (itemized) price quote and the cost of the equipment must be separately priced from the preventative maintenance service or options. The itemized pricing must include description or part number of equipment, service, unit price (as applicable) and total price as outlined in Part 2.

c. Technical Acceptability Criteria The Government will evaluate the contractor’s quote for technical acceptability based on the following:

1) Offers shall provide specifications confirming the instrument meets the technical salient characteristics/specifications and requirement in accordance of this RFQ and Part 3 of this RFQ and

2) The offeror shall state their ability to “meet or exceed” the salient characteristics/ technical specifications and requirements in accordance of this RFQ. Also, the contractor shall provide an itemized price listing (detail listing) of parts, equipment, and other items that equals the cost of the equipment.

d. SAM: All interested offerors shall be registered in the System for Award Management (SAM), if the offeror is not registered in SAM, please visit https://www.sam.gov. You will need your Tax ID, DUNS Number and banking information.

Vendors who are not registered in SAM will not be eligible for award. The Government reserves the right not to negotiate and award without discussion.

QUESTIONS are to be submitted via email to Marty.Nemec@fda.hhs.gov no later than January 9, 2017 1:00 p.m. ET.

QUOTATIONS shall be submitted via email to Marty.Nemec@fda.hhs.gov by January 12, 2017 by 3:00 p.m. ET.