Fed_Biz_Opps_RFP.pdf

FDA-SOL-1166215 Electronic Cigarette Smoking Machine

PART 1 – Description

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subparts 12.6 and 13.5 and as supplemented with additional information included in this notice.

This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; a quote is being requested and a written solicitation will not be issued. The government contemplates a Firm-Fixed Price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88 dated May 16, 2016.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing; the small business size standard is 500 employees.

PART 2 – Supplies or Services and Prices/Costs

The U.S. Food and Drug Administration (FDA) Southeast Regional Laboratory (SRL)has a requirement for an electronic cigarette (E-cigarette) smoking machine that can automatically smoke up to five

(5) electronic cigarettes simultaneously and collect the vapors on filter pads and impinger systems for offline chemical analysis. The electronic smoking machine shall have electrostatic trapping capabilities (electronic precipitator) to collect smoke residue for metals analysis of the electronic cigarette vapor. A 12-month manufacturer’s warranty shall be included. Inside delivery, Installation and Training shall be provided.

Pricing Table:

Line Item

Description QTY. Price

1 Part # 12000152 LX5.1E Electronic Cigarette Smoking Machine with Impingers, No BTU or Hood

1 $

2 Qualification Service IQ OQ 1 $

3 Part # 70830100 HV1 Electrostatic Trapper 1 $

4 Onsite Training and Installation 1 $

5 Part # 12011100 Cambridge Filter Holder 1 S

6 Shipping and Handling 1 $

7 Option Period One 12-Month Extended Warranty 1 $

8 Option Period Two 12-Month Extended Warranty 1 $

Total

PART 3 -Technical Requirements/Salient Characteristics

The Electronic Cigarette Smoking Machine System shall “meet or exceed” the following salient characteristics/specifications. Offerors shall include a technical brochure or otherwise reference the specific equipment, capabilities and characteristics referenced below. All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated prior to award.

The electronic cigarette (E-Cig) smoking machine shall meet the following criteria:

• The E-Cig smoking machine shall run on 110-120 VAC electrical supply.

• The E-Cig smoking machine shall have no compressed air requirement.

• The E-Cig smoking machine shall be able to hold between 1 and 5 electronic cigarettes simultaneously during operation.

• The E-Cig smoking machine shall have electrostatic trapping capabilities (electronic precipitator).

• The E-Cig smoking machine shall be able to provide a mechanism to depress or actuate a button on an electronic cigarette so that the electronic cigarette will operate unattended.

• The E-Cig smoking machine shall be supplied with a removable, filter pad assembly (Cambridge filter pad holders) at each electronic cigarette position to collect particulate matter generated during the E-cig smoking process.

• The E-Cig smoking machine shall accommodate dual glass or Teflon impingers at each electronic cigarette position so that vapors can be collected in the impingers for offline chemical analysis.

• The E-Cig smoking machine shall come supplied with two (2) sets of dual glass or Teflon impingers for each electronic cigarette position.

• The E-Cig smoking machine shall come supplied with at least two (2) sets of labyrinth seals per cigarette position to accommodate a range of E-cig sizes of at least 4.50-9.0 millimeters.

• The E-Cig smoking machine shall be controlled through a software interface that allows the user to select different puff profiles, puff durations, puff volumes and puff numbers and have Square, ISO, Triangle and optional Human Smoking capabilities.

• The E-Cig smoking machine shall be supplied with all user input devices necessary for operation.

• A separate contract line item number (CLIN) shall be included for Installation and Operational

Qualification (IQ/OQ) for the E-Cig smoking machine hardware and software.

• Pricing shall be quoted in US dollars.

• A separate CLIN shall be included for all shipping and handling fees at the installation location.

• A separate CLIN shall be included for at least one (1) day onsite training at the installation location, for five analysts (5) on the operation and maintenance of the E-cig smoking machine, including software.

• The system shall include a one year full manufacturer’s warranty 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, graphical user interface, and any additional components necessary for proper operation 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.

Installation, Warranty, Training and Maintenance

Installation

Installation, IQ and OQ are required. IQ and OQ shall be performed at time of installation and confirm that the equipment performs to manufacturer’s specifications.

1) Installation Qualification (IQ) is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. It is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument.

2) IQ/OQ and PQ shall be performed and documented by the vendor during installation of the instrument. If a Vendor does not perform these services, then the Vendor should provide a contracted IQ/OQ and PQ.

3) Operational qualification (OQ) is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment. Testing activities in the OQ phase is to verify that the instrument operates as intended by the manufacturer.

4) Performance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use. After IQ and OQ have been performed, the instrument’s continued suitability for its intended use is demonstrated through performance qualification. The PQ phase includes the following parameter.

5) Performance Checks—set up a test or series of tests to verify the acceptable performance of the system for its intended use. PQ tests are based on the instrument’s typical on-site applications and may consist of analyzing known components or standards. The tests should be based on good science and reflect the general intended use of the instrument.

The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

Warranty

The contractor shall provide a full manufacturer’s warranty for coverage on all non-consumable items and parts for warranty repairs, factory-certified replacement parts for a 12 month (one year) period following delivery at no additional cost to the government.

Training

The Contractor shall provide instrument installation and provide on-site basic training within three working days of delivery and installation.

Optional Extended Maintenance Services

The annual on-site maintenance/service agreement shall include but not be limited to calibration, cleaning of the equipment, support services, replacement of parts, and labor in support of the equipment at the location. The maintenance service will be listed as option periods on the contract. The maintenance service period shall consist of two (2) 12-month options to begin after the 12 month (one year) manufacturer’s warranty has expired, one year after date of delivery, at discretion of the government.

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. All equipment shall be new, not used or refurbished.

PART 5 – Inspection and Acceptance

The contractor shall perform installation of all equipment including verification of performance as part of this order. The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment, installation and services to be provided. For the purpose of this Part the COR – to be determined 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 in writing by the Contracting Officer or COR within 30 days of receipt.

The vendor shall demonstrate and document upon installation that the item meets all performance specifications. The instrument shall not be accepted until performance specifications have been confirmed.

PART 6 – Deliveries or Performance

Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, training, and performance of services described in PART 3 of this or and upon acceptance by the Contracting Officer, or the COR, of these products/services. Deliveries required by the contractor shall be made F.O.B. destination within 90 days from receipt of the award of order to the addresses/addressees listed below:

Delivery Location:

The equipment shall be delivered and installed to the location listed below.

Food and Drug Administration Southeast Regional Laboratory (SRL) 60 8th Street, NE Atlanta, GA 30309 ATTN: Yiming Ye

Phone: 404-575-1515 Yiming.ye@fda.hhs.gov

Delivery must occur during regular business hours (Monday-Friday) between 9:00 AM and 3:00 PM, excluding Federal holidays (See Part 9) and weather-related closures in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to delivery and installation.

Period of Performance The equipment shall be delivered within 90 days from contract award unless the government approves a different delivery schedule. The manufacture warranty shall begin at the date of award.

Installation shall occur at time of delivery.

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:

Gary Klaff 5630 Fishers Lane Rockville, MD 20853 Gary.Klaff@fda.hhs.gov 204.402.7555

Contract Specialist:

mailto:Yiming.ye@fda.hhs.gov

Anthony Webb 5630 Fishers Lane Rockville, MD 20853 Anthony.webb@fda.hhs.gov 240.402.7549

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.

mailto:fdavendorpaymentsteam@fda.gov

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/.

52.212-1 Instructions to Offerors – Commercial Items applies with the following addenda: Period for

Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2016.

52.212-2 Evaluation – Commercial Items (Oct 2014) 52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014) 52.212-4 Contract Terms and Conditions—Commercial Items (MAY 2015)

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.

FAR Clauses in Full Text

52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Commercial Items (MAR 2016)

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

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

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

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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:

http://farsite.hill.af.mil/

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (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 (Jul 2013) (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 (Aug 2013) (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 2011) (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.

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

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)).

(ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (Oct 2014) of 52.219-9.

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

_X_ (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 Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___(24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

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

____(26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

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

_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

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

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

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

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

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

13627).

___ (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 (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

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

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

___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13.

___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered 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 (Jun 2014) (E.O.s 13423 and 13514).

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

_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

_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 (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (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:

___ (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 2014) (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 (Apr 2010) (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 $650,000 ($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 (Jul 2014) (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 (Jul 2014) (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).

___ (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 (Aug 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (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 3 years.

(End of clause) HHSAR Clauses HHSAR clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm

352.203-70 Anti-Lobbying (Dec 2015) 352.208-70 Printing and Duplication (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (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) http://farsite.hill.af.mil/vfhhsara.htm

Part 10– Instructions to the Offerors

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 NACIS 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

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.

Instructions to Offerors 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 the “Technical Acceptability Criteria” section. The contractor shall provide the price and all documentation to support the total cost of the equipment, training and warranty/maintenance.

The 4 (four) 12-month preventative maintenance service periods will be priced separately to indicate options. The Government is not obligated to exercise the options. The manufacturing warranty shall be separate from the 12-month option period for preventative maintenance and service. The manufacturer warranty shall start at the time of award. The preventative maintenance and service option period shall not begin until the manufactured warranty is expired.

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.

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 Anthony.webb@fda.hhs.gov no later than May 31, 2016 12:00 noon ET. They will be addressed via an update to the solicitation by COB on June 1, 2016.

QUOTATIONS shall be submitted via email to anthony.webb@fda.hhs.gov by June 3, 2016 by 3:00 pm

ET.