Solicitation-1145309.doc

FDA-15-SOL-1145309

PART 1 – GENERAL INFORMATION

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6 and 13.5 Test Program for Certain Commercial Items as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; quotes are being requested and a written solicitation will not be issued. This requirement is being solicited as full and open and the Government contemplates a Firm-Fixed Price Purchase Order will result from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-80 dated March 2, 2015.

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

Brand Name or Equal:

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

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Description of supplies or Services The Detroit Laboratory (DET-LAB), Office of Regulatory Affairs (ORA), U.S. Food and Drug Administration (FDA) require a dissolution instrument with UV/Vis spectrometer to run dissolution analysis on pharmaceutical medications for shelf life and drug survey samples. The Detroit District Laboratory will be receiving up to 60 samples per month, through 2015 as part of its defined work plan. These investigative samples will be collected primarily from Department of Defense (DOD) and Veterans Administration (VA) stockpiles of medications, as well as from random locations for drug survey testing, and DET-LAB will receive and process samples from FDA ORA District Offices across the nation. To accommodate the large sample volume on a monthly basis, we will require a larger capacity for testing these samples than we have currently. The dissolution system and UV/Vis spectrometer will be essential to the DET-LAB efforts to ensure the US DOD and VA medication supply meets acceptable dosing limits for the medication. The dissolution system will allow the Detroit Laboratory to respond to testing requirements in a timely and efficient manner.

The Bathless Dissolution System shall include a one year manufactured warranty and preventative maintenance service agreement for one (1) 12 month option period.

Pricing Table Pricing Table: Listed below is the pricing table for two Bathless Dissolution which includes one (1) year manufacture warranty for each instrument and 12 month (one year) option period for preventative maintenance for each instrument.

Extended Maintenance Package. Coverage shall be the same as the new product warranty and include 2 Preventative Maintenance visits scheduled every 6 months.

PART 3 – DESCRIPTION

Item 1: Quantity = 2

Symphony 7100 Bathless Dissolution System (Part ID 2022-7106) or Equal The dissolution instrument must meet or exceed the minimum requirements listed below:

· The instrument must include dissolution test parameters which are monitored and reported to confirm compliance with stated USP guidelines for temperature and RPM. This feature is user selectable to OFF, ALERT, and ABORT.

· The instrument must have high watt heaters that raise media temperatures from ambient to 37 degrees Celsius.

· The instrument must have security and password protection

· The instrument must store and sort up to 100 methods by name and create date.

· Serialize paddles and vessels

· Dissolution Vessels – Minimum of 6 vessels with programmable volume of 500 mL – 1000mL

· Vessel Heating Rate 2ºC per Minute

· RPM Control Range 25 – 350 RPM, Digitally Controlled

· Resolution 0.1 RPM

· Accuracy ± 0.2 RPM

· Motor High Torque, Permanent Magnet

· Vessel Temperature Control Independently Controlled Two-Zone Heater Jackets

· Bathless Display Resolution 0.01ºC

· Accuracy ±0.25ºC

· Calibration Built-in Calibration Probe

· Shaft Wobble Less than 0.010” (0.254 mm)

· Program Modes Manual (Individual Vessel Control)

· Automatic (Up to 100 Pre-Programmed Methods)

· Interface Ports RS-232 (2), RS-485 (1), Parallel Printer (1)

· Solid State Heating Elements

· Electrical Power 115V 50/60Hz 15A or 220V 50/60Hz 8A (operating voltage pre-set at factory) Sipper Sampler

· Must be capable of pulling samples from multiple baths and run samples through the UV/Vis Spectrometer

· Variable pump, delay, and return time

· Flow cell with 10-mm path length, 3-mm diameter, and 80-μl volume

· Constant-speed peristaltic pump with pump tubing

· Minimum sample volume of approximately 1 ml

· Typical sampling time of ~20 seconds (with <1% cross-contamination)

· Test Tube and HPLC Vial collection, for Extended Release testing.

· 8 Channel Syringe Pump

· Test Tube Rack

· HPLC Vial Rack

UV/Vis Spectrometer

· Compliance must be in line with all requirements of the United States Pharmacopeia (USP)

· Must include a pre-aligned deuterium and tungsten lamp light sources

· Must include built-in buttons to measure sample, standard, and blank for convenient measurements even when wearing gloves

· Must be thermally stable for a wide operating temperature range

· Communication through GPIB or LAN for dedicated or networked PC control

· Firmware upgrade from PC for easy participation in future developments

· Built-in GPIO interface for control of accessories

· Serial and firmware revision number held in firmware

· Own clock for time and date stamps of the spectra

· Extensive self-test procedures that check the electronics and key optical characteristics to ensure consistent performance between validations

· Built-in electronic logbooks which contain the results of self-tests, notes on instrument

· Maintenance, events and errors Optical performance

Must be in compliance with all requirements of the US Pharmacopeia and American Society for Testing and Materials (ASTM)

· Wavelength range 190–1100 nm

· Slit width 1 nm

· Stray light <1 %

· Wavelength accuracy <±0.5 nm 0.5-second scan (NIST 2034)

· Wavelength reproducibility <±0.02 nm ten consecutive scans (NIST 2034)

· Baseline flatness <0.001 A 0.5-second blank

Physical dimensions

The unit will be stored on a bench. Due to space limitation, the dimensions and weight must be:

· Approximate Height × width × depth 185 × 344 × 560 mm (7.3 × 13.5 × 22.0 inches)

· Approximate Weight about 16.5 kg (36.3 lb)

Environmental conditions

· Operating temperature 0–50 °C (32–122 °F)

· Non-operating temperature -40–70 °C (-4–158 °F)

· Humidity <95 %, at 25–40 °C (77–104 °F)

Instrument Software

The instrument shall be supplied with software to control the dissolution system, spectrometer, and sipper sampler delivery system. All parameters including but not limited to solvent flow rate, solvent composition, injection volume, bath position, bath temperature, switching valve(s) position and pump shall be controlled from the UV/Vis spectrometer data system and software. The software shall comply with 21 CFR, Part 11 laboratory standards. In addition to instrument control, the software shall provide data analysis including but not limited to peak detection, peak integration, quantification and data reporting. Software qualified upon installation.

Data System

The instrument shall include a data system. At a minimum the data system shall include: Dual Core computer, 2.66GHz processor or faster, minimum 4 GB RAM, minimum 320GB hard drive, DVD RW (CD RW capable), mouse and keyboard. The internal video card shall support a maximum resolution of 1920x1200 (DVI) and 2048 x 1536 (Analog). No less than 3 network connections. The computer shall be RoHS compliant. Include color laser jet style printer.

Data System Display The data system display shall be one flat panel LCD display at least 15” wide.

Training:

The contractor must provide 8 hours of on-site training for 10 employees at the delivery location listed below. The on-site training must include, but not limited to basic functions, operation of equipment, hardware and software integration, overview of the equipment, and the functionality of the equipment. On-site training shall be conducted at the time of installation or scheduled no later than one (1) week after installation and successful qualification of the instrument.

Installation:

The contractor shall provide a full installation of the equipment.

IQ/OQ Performance Verification:

The vendor shall provide Instrument Qualification/Operational Qualification (IQ/OQ) and Instrument Performance Verification (IPV) for the system offered, which includes a qualification report.

The qualification report shall include the standard operation procedures and the allowed manufacturer limits for a new instrument. A copy of the qualification report should be reviewed and approved by an FDA DET-LAB representative before the installation of the equipment.

Technical /Support Services:

The contractor must provide one year manufacture warranty for all parts, labor, travel, technical, on-line, and telephone support service for a 12 month (one year) period after complete delivery, installation, and training at no additional cost to the government. The contractor shall provide full service support for the installed equipment, including but not limited to labor, parts, travel on-site support, telephone support, retesting and re-qualification of the unit, software updates and enhancements. The contractor must 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.

Option Period - Preventative Maintenance:

The annual on-site preventative maintenance/service agreement shall include the support of qualification and calibration service, test guidelines to USP 711, software and hardware updates, technical, on-line/telephone support services, and replacement of parts, labor, and travel in support of the instrument at the location. The preventative maintenance service will be listed as option periods on the contract. The preventative maintenance (PM) service will be for one (1) 12 month option period after the 12 month (one year) manufacture warranty is expunged. The contractor shall provide a services report to the government point of contact after completion of the annual PM services.

PART 4 – PACKING, MARKING AND SHIPPING

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

PART 5 – INSPECTION AND ACCEPTANCE

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

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

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

PART 6 – DELIVERIES OR PERFORMANCE

Deliveries:

Deliveries required by the contractor shall be made F.O.B. destination within 30 days from receipt of the award of contract/order to the addresses/addressees listed below:

Delivery Location

Food and Drug Administration

300 River Place, Suite 6900

Detroit, MI 48207 *Complete address and Point of contract shall be listed at the time of award.

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see (PART 8) between the hours of 8:30 a.m. and 4:30 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to setup of the laboratory instrument and component parts.

PART 7 – CONTRACT ADMINISTRATION DATA

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

1. Contracting Officers Representative (COR):

To be determined upon contract award The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

2. Contracting Officer Tiffany Williamson 5630 Fishers Lane, Room 2131A Rockville, MD 20857

Tiffany.Williamson@fda.hhs.gov Tel: (240) 402-7558 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

b. Invoice Submission The contractor shall submit 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 should be directed to the FDA Payment Office at telephone number provided above.

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays

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

January

(New Year’s Day)

January

(Martin Luther King Day)

February (President’s Day)

May

(Memorial Day)

July

(Independence Day)

September (Labor Day) October (Columbus Day)

November (Veterans Day)

November (Thanksgiving)

December (Christmas Day)

PART 9 - CONTRACT CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/ 52.212-4 - Contract Terms and Conditions – Commercial Items (Dec 2014) FAR Clauses in Full Text

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Mar 2015)

(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 (Dec 2014)

(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 and 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 (Apr 2010) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (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).

__ (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.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Jan 2011) of 52.219-4.

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-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 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)).

__ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting 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. 657 f).

__ (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 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).

_X_ (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 (Feb 1999).

_X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (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).

__ (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 (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 Televisions (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 (June 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).

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

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 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).

__ (4) 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).

__ (5) 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).

__ (6) 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).

__ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

__ (10) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order 13658).

(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 (l) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

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

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

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

(viii) 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.

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

(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 and E.O 13627).

(xi) 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).

(xii) 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).

(xiii) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xiv) 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).

(xv) 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.

(xvi) 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.

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order 13658).

(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)

52.217-8 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 1 day.

(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 2 years.

(End of clause)

HHSAR Clauses HHSAR 352.202-1 Definitions (Jan 2006)

HHSAR 352.203-70 Anti-lobbying (Jan 2006) HHSAR 352.215-70 Late Proposals and Revisions (Jan 2006) HHSAR 352.228-7 Insurance--Liability to third persons (Dec 1991)

HHSAR 352.233-71 Litigation and claims (Jan 2006) HHSAR 352.242-71 Tobacco-free Facilities (January 2006) HHSAR 352.242-73 Withholding of contract payments (Jan 2006)

HHSAR 352.242-74 Final Decisions on Audit Findings (April 1984)

PART 10 - SOLICITATION PROVISIONS

52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

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

52-212-1 - Instructions to Offerors – Commercial Items (Apr 2014)

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

PART 11– INSTRUCTIONS TO THE OFFERORS

The provision 52.212-1 incorporated above is tailored as follows. Quotes are due 3/27/2015 at 12:00 p.m. (Eastern Time). Send via email in native (Word/Excel) and PDF format to the Contract Specialist, Tiffany Williamson (Tiffany.Williamson@fda.hhs.gov). Send any questions, via email, to the Contract Specialist no later than 12:00 p.m. (Eastern Time) on Wednesday, March 25, 2015.

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

Funds are not currently available for this requirement; however FDA anticipates receiving funding before the end of the fiscal year. All quotes shall be dated as “valid through 9/30/2015.

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.

PAGE