RFQ_1166447.docx

FDA-15-SOL-1166447

MDI DDU PSD Testing Equipment

PART 1 – Description

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 a TOTAL SMALL BUSINESS SET-ASIDE 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 05-87 dated April 6, 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

The Food & Drug Administration, Northeast Regional Laboratory conducts related regulatory and research projects and is in need of MDI Delivered Dose Uniformity (DDU) testing equipment, Dry Powder Inhalers (DPIs) Delivered Dose Uniformity (DDU) testing equipment and the dose uniformity sampling apparatuses: cascade impactors: Anderson Cascade Impactor (ACI) and Next Generation Impactor (NGI). The particle or droplet size distribution in the spray discharged by metered-dose inhalers and the particle size distribution in the cloud discharged by dry powder inhalers are crucial in assessing the performance of inhaler products and the major performance measures for nasal and inhalation aerosols, sprays, and powders relate to dose delivery to the patient, including delivered-dose uniformity and relevant measures of particle size (optical or aerodynamic) depending on the dosage form.

For the determination of the Delivered Dose Uniformity (DDU) and Particle Size Distribution (PSD) of inhalable drug products, particularly Metered-Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs), special sampling and testing equipment such as: MDI Delivered Dose Uniformity (DDU) testing equipment, Dry Powder Inhalers (DPIs) Delivered Dose Uniformity (DDU) testing equipment is necessary. The dose uniformity sampling apparatuses, cascade impactors; Anderson Cascade Impactor (ACI) and Next Generation Impactor (NGI) for the Particle Size Distribution (PSD) in Dry Powder Inhalers are also specified by the USP (chapters <601> and <1601>). The Andersen Type Cascade Impactor is designed to measure the fine particle dose or fraction of the inhaler output having an aerodynamic diameter less than the size defined in the individual monograph. This relates to the drug dose or fraction that penetrates the lung during inhalation. The purpose of a Cascade Impactor is to separate aerosol particles and droplets into distinct categories on the basis of particle aerodynamic size. The Next Generation Impactor (NGI) is a high-performance, precision, particle-classifying cascade impactor for testing metered-dose, dry-powder, and similar inhaler devices in the Pharmaceutical industry. The NGI is a high-performance, precision, particle classifying cascade impactor designed for testing MDIs, DPIs, nebulizers and aerosol and nasal sprays. The instrument shall include a one year manufactured warranty for parts and labor and three option periods for an extended warranty/maintenance agreement. The option year warranties will began after the one year manufacture warranty has expired.

Pricing Table:

Line Item

*Includes shipping and 12 month warranty

*Includes shipping and 12 month warranty

*Includes shipping and 12 month warranty

Part 3 -Technical Requirements

The MDI DDU PSD Testing Equipment shall “meet or exceed” the following salient characteristics/specifications:

MAZ3000 Mastersizer 3000 laser diffraction system or Equal:

· A laser diffraction system for particle size distribution measurements.

· Shall have the ability to measure over a size range of 0.01 -3500 microns, or a larger range, using a single lens range.

· Includes a complete wet sample dispersion unit and a complete dry powder dispersion system, for small or medium volume samples.

· Includes an in-line imaging accessory for use alongside laser diffraction

· The accessory and its software display image frames showing particles over a 1.4 # 1400 micron range (sample dependent).

· Volume weighted Circular Equivalent Diameter and Particle Elongation distributions can be evaluated over a 9 -1000 micron range.

· Ability to report in real time during a laser diffraction measurement, enabling the state of dispersion of the sample to be assessed.

· Includes DustControl DC1800 Cyclone Vacuum Cleaner for use with the dry disperser system (110V).

· Includes application software for measurement control and data analysis.

· Includes a computer for instrument operation and data analysis, with the following minimum specifications:

· 64-Bit Standard PC Package – US

· Common 64-Bit PC Base Unit

· Common PC Monitor ( 22 inches or more)

· US keyboard

· Kit of Mains Cables-US

MDI DDU Delivered Dose Uniformity Testing Equipment, Particle Size Distribution (PSD) for Dry Powder Inhalers or Equal

MDI DDU Testing Equipment:

· Includes MDI DUSA Kit Tecapro w PTC Silicone Rubber Seals (3 each)

· Includes Pack of 500 Glass Fiber Filters (25mm) (3 each)

MDI DDU Testing Options & Spares:

· Must Include MDI DUSA Set of 3 PTC Silicone Rubber Seals

· Must Include Gasket Pkg10 DUSA-MDI PTC Silicone

· Must Include Stainless Steel Filter Support Disc

DPI DDU Testing Equipment:

· Includes DPI DUSA Kit - Tecapro w PT Cured Silicone Rubber Seals (3 each)

· Includes a Box of 100 Glass Fiber Filters (47mm) (3 each)

DPI DDU Testing Options & Spares:

· Must include DPI DUSA Set of 3 PTC Silicone Rubber Seals

· Must include a Stainless Steel Filter Support Disc

· Must include a Base Plate with Switching Valve

· Must include a Waste Shot Collector WSC2 lncl 1 Cartridge

· Must include a Spare Filter Cartridge for WSC2

· Must include a Waste Shot Tally Counter

PSD Testing Equipment - Andersen Cascade Impactor (ACI) Stainless Steel (SS):

· Includes 28.3 L/min. Andersen Impactor (316 SS) (2 each)

· Includes Universal Induction Port (Standard) (316 Stainless Steel) (2 each)

· Includes Box of 100 Glass Fiber Filters (81 mm) (3 each)

ACI Options:

· Must include Stage -1 for 60 L/min (316 Stainless Steel) (2 each)

· Must include Conversion Kit for 90 L/min Operation (316 Stainless Steel) (2 each)

· Must include 60 L/min Preseparator (316 Stainless Steel) (2 each)

· Must include 90 L/min Preseparator (316 Stainless Steel) (2 each)

DPI PSD Testing Equipment- Next Generation Impactor (NGI):

· Includes a Next Generation Impactor (NGI)

· Includes a USP Induction Port

· Includes a Preseparator for NGI Certified

· Includes a Cup Set/8 (2Lrg/6Std) for NGI

· Includes a Leak Tester

Pumps, Flow Meters, and Flow Controllers:

· Must include Low Capacity Pump Model LCP5 110V 60Hz

· Must include High Capacity Pump Model HCP5 110V 60Hz

· Must include Flow Meter Model DFM 2000 110V (3 each)

· Must include Critical Flow Controller TPK2000 100/120V Selectable to 220

Adapters, Tubing & Misc.:

· Must include Adapt MPiece Custom-Molded (3 each);

· Must include a Tool for Making Custom Adapter;

· Must include Adapt Flow Meter 4043/DFM2000 to IP/DUSA (3 each)

· Must include Tubing PVC 10mm ID (20 feet)

Test Data Analysis Software:

· Includes test data analysis software, Copley Inhalers test data analysis software (CITDAS) V 3.10 or equivalent.

Installation/Qualification/Training:

· Includes IQ/OQ Documentation for Inhaler Testing Systems

· Includes On-Site Execution of IQ/OQ Protocol on up to 2 MDI DDU and/or PSD testing stations

· Provides on-site training with customer-owned equipment on the theory and practice of MDI testing to be conducted at the customer site in the US.

Malvern STP5311 or Equal:

· System has the ability of measuring the droplet size distributions in Nasal Spray systems such as: Metered Dosage Inhalers (MDI), Dry Powder Inhalers (DPI) and Nebulisers.

· The laser diffraction system should be capable of measuring a wide droplet size from 0.1 – 900 um with one single lens.

· The Laser diffraction system shall readily accept popular actuators like Proveris and Innova.

· Includes a Spraytec NSS Nasal Spray Support.

· Provides software feedback of the distance between the Spraytec measurement zone and the nasal pump spray nozzle (0 - 10cm range, 1mm precision), along with the angle of actuation (Vertical # 45 degree range in 5 degree increments). Within the Spraytec software users can specify that measurements only be made at a specific distance and angle as part of a Standard Operating Procedure (SOP)

· Includes a Short bench Spraytec Laboratory system with a 950mm optical bench and a 300mm lens

· Providing the ability to measure over a size range of 0.01 -3500 microns, or a larger range, using a single lens range.

· Includes a complete wet sample dispersion unit and a complete dry powder dispersion system, for small or medium volume samples.

· Includes a 300mm Fourier lens system, covering a size range from 0.1 to 900 microns (Dv50: 0.5 to 600 microns).

· Optical configuration provides a maximum working distance of 150mm at 0.5microns, increasing to greater than 1000mm above 5 microns.

· 950mm optical bench, providing a spray measurement zone width of 300mm and a laser height above the optical bench of 363mm.

· Includes a Spraytec Extraction System (100V variant)

· Includes spray collector assembly, tubing, HEPA filter unit and a switching box to synchronize operation

· Includes a Spraytec Inhalation cell for the measurement of Metered Dose Inhalers,

· Dry Powder Inhalers and Nebulisers.

· Enables measurements to be made in an enclosed flow cell at a controlled flow rate

· Cell shall be able to be mounted vertically and horizontally

· Includes an Electronic switching box to synchronise mains-operated external devices

· Includes a COPLEY SCIENTIFIC VACUUM PUMP HCP5 (110V) and DOSE COLLECTION DEVICE

· Includes a SoloTM for Spraytec nasal spray actuator system, for control of the velocity of actuation of a standard nasal pump spray. Consisting of:

· Solo for Spraytec actuator unit

· Two Proveris #universal device holders# for vertically actuated nasal spray pumps;

· Universal power supply with auto-sensing AC input

· US, UK, and EU (Schuko style) power cords

· Interface cables (I/O, trigger, and trigger pendant)

· DAQ board (half-slot length PCI plug-in board)

· Load cell calibration kit

· Solo for Spraytec System User manual

· Installation DVD containing the Proveris Solo for Spraytec actuator software and required third-party driver software.

· Includes a Diffraction Product Line - Bronze Service Level

· Includes a computer for instrument operation and data analysis, with the following minimum specifications:

· DELL Mini Tower PC (wide case variant) or equivalent with Country specific Keyboard and Operating System,

· Windows 7 Professional (32 bit),

· Intel Core i7-3770 Processor (3.40GHz, 8MB, HD4000 Graphics),

· 4GB RAM, 1TB HDD,

· 16x DVD+/-RW Drive,

· IEEE 1394 adapter card,

· Serial port Adapter card,

· full height PCI slot,

· Mouse and

· one 22" or greater LED wide-screen monitor.

· Includes a DPI feature on the Spraytec system; Spraytec COPLEY SCIENTIFIC TPK2000 (110V) + CABLE.

General Specifications:

The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The life cycle of the instrument is intended to be greater than ten years at full performance. Northeast Regional Laboratory must be able to expect service and technical support from the vendor during its lifecycle. Software updates to be furnished at no additional cost during the warranty period. Technical support is to be furnished at no additional cost during the warranty period.

Training:

The contractor shall provide 5 hours of on-site operator training/familiarization for the installed instrument for 2 employees at the delivery location listed in Part 6 of this request for quote. The training shall include basic use and operation of the installed equipment. Training shall be conducted at the time of installation.

Technical /Support Services:

The contractor shall provide a manufacture warranty for all parts, labor, and service for a 12 month (one year) period after complete delivery at no additional cost to the government. This warranty shall also include one scheduled visit to carry out an Operational Qualification (OQ) on the system along with comprehensive Preventive Maintenance checks. The contractor shall provide full service support for the installed equipment, Including but not limited to labor, parts, travel on-site support, telephone support, software updates and enhancements. The contractor shall provide continuous online and telephone support for the instrument. The support services shall include, but not limited to, trouble shooting, equipment maintenance and repair, and provide responses to operator questions. The contractor shall provide a three (3) day response time for all on-site service and repairs. All service reports shall be provided to the government point of contact within 5 business days of completion of the repair or service.

Optional Extended Warranty/Maintenance:

The vendor shall provide optional extended warranty/maintenance agreement for four additional years, at discretion of the government. The specific requirement for this optional service is:

1) Service contract coverage shall include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

2) Service shall be provided by service engineers who are trained and certified by the original manufacturer. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

3) The Project Officer shall have access to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

4) The contractor shall be able to guarantee that a service engineer will be scheduled to work with priority over non service contracted work.

5) The contractor shall provide all travel, labor and parts at no additional charge. There shall be at least one (1) scheduled maintenance visit per year of the order. The vendor shall also include coverage for software and firmware updates.

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 Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment, installation and services to be provided. For the purpose of this PART, (COR – to be determined upon contract award) 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. This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available.

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. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. The instrument shall be delivered on a truck with a lift gate as there is no loading dock available. Deliveries required by the contractor shall be made F.O.B. destination within 60 days from receipt of the award of order to the addresses/addressees listed below:

Delivery Locations:

The equipment shall be delivered at the location listed below:

U.S. Food & Drug Administration Northeast Regional Laboratory 158-15 Liberty Ave.

Jamaica, NY 11433 *POC 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 10) between the hours of 8:00 a.m. and 4:00 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.

The vendor shall demonstrate and document upon installation that the item meets all performance specifications. The vendor shall provide initial qualification operational qualification and performance qualification for all provided components. The instrument shall not be accepted until those performance specifications have been met.

Period of Performance

The equipment shall be delivered 60 days from contract award unless the government approves a different delivery schedule. The manufacture warranty shall not begin until the equipment is delivered to the government’s location.

Option Year 1: 12 months (if exercised) Option Year 2: 12 months (if exercised) Option Year 3: 12 months (if exercised)

Part 7 – Contract Administration Data

Contracting Officers Representative (COR)

The following COR will represent the Government for the purpose of this contract:

(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.

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.

The contact information for the Contracting Officer:

Tiffany Williamson 5630 Fishers Lane Rockville, MD 20853 Tiffany.williamson@fda.hhs.gov 240.402.7558

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/VFHHSARA.HTM.

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) 52.249-2 - Termination for Convenience of the Government (Fixed-Price) (Apr 2012)

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:

[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 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.

___ (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 (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)).

___ (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).

___ (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).

___ (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.)

___ (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 (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) __X__ (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).

(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)

FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days.

(End of clause)

PART 9 - 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 (Apr 2014) 52.212-2 - Evaluation -- Commercial Items (Oct 2014) 52.217-5 – Evaluation of Options (Jul 1990)

Part 10 – 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.

Part 11– Instructions to the Offerors

The provision 52.212-1 incorporated above is tailored as follows. Quotes are due May 27, 2016 at 12:00 p.m. (Eastern Time). Quotes shall be valid until the end of the fiscal year. 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 2:00 p.m. (Eastern Time) on Tuesday, May 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.