FDARFQ1194566.doc

FDA–RFQ-1194566

Upgrades to the 500 and 700 MHz NMR Spectrometers

PART 1 – DESCRIPTION

The Food and Drug Administration (FDA), requires brand new equipment to replace the aging electronics console, to provide improved sensitivity through a new cryoprobe and a new backup room temperature probe, and to achieve additional efficiency via two new temperature controlled automatic sample changers, one for the 500 MHz NMR system and one for the 700 MHz NMR system. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-96 November 6, 2017. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing, Small Size Standard 1,000 Employees. The associated Federal Supply Code (FSC) / Product Service Code (PSC) procurement is 6640.

This requirement is for a Brand Name OR Equal Upgrades to the 500 and 700 MHz NMR spectrometers as outlined in the Pricing Table 2.2.

PART 2 – SUPPLIES OR SERVICES AND PRICES

Purchase Order Type: Firm-Fixed Price

2.2 Pricing Table

Bruker/Console/Avance III HD 500

Bruker/CryoProbe/cryoprobe+compressors/TCICP 500

Bruker/SampleCase/Autosampler+air chiller (one for the 500 and one for the 700)

Bruker/Probe/RT probe/500 TXI xyz-gradient

No cost

No Cost

Total Firm Fixed Price

Option Years

Total Firm Fixed Price

The total cost for the requirement is $____________.

Company Name: ________________________ DUNS Number: ________________________ *The firm-fixed-prices are inclusive of all costs, such as shipping, parts, installation, labor, travel, and any other warranty and service maintenance costs. Payment is only authorized for the respective firm-fixed-prices upon successful completion of the respective CLINs, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR), and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

PART 3 – DESCRIPTION/SPECIFICATIONS

3.1 Background

In the United States, the FDA/CBER regulates licensing of polysaccharide and polysaccharide-conjugate vaccines for clinical use against Haemophilus influenza b, Vibrio cholera and streptococcal and meningococcal diseases. NMR (nuclear magnetic resonance) spectroscopy is part of the routine characterization of intermediates in the manufacturing process of these vaccines, however, conjugate vaccines are not yet characterized by NMR spectroscopy. CBER is committed to improving FDA's NMR capabilities in characterizing polysaccharide conjugate vaccines. Using NMR as a microscope to study polysaccharides and their protein conjugates at the molecular and atomic levels, we probe the individual atoms and their locations in relationship to each other. This information helps to determine the identities and shapes of these molecules and gives valuable insights into how polysaccharides interact with antibodies and proteins. Ultimately, this will provide the foundation to define vaccine components in detail using NMR spectroscopy.

The instruments are used to delineate structure-function relationships in biomolecules, such as glycans, proteins and nucleic acids. Structures are determined using state-of-the-art NMR experiments including, but not limited to, triple resonance 1H-15N-13C three- and four-dimensional NMR. The instruments are also used to detect minor components such as impurities, contaminants and must be able to detect as little as one part per billion of such impurities. This RFQ is for brand new equipment to replace the aging electronics console, to provide improved sensitivity through a new cryoprobe and a new backup room temperature probe, and to achieve additional efficiency via two new temperature controlled automatic sample changers, one for the 500 MHz NMR system and one for the 700 MHz NMR system. This upgrade to our 500 MHz NMR spectrometer with a new console, cryoprobe, room temperature probe and temperature-controlled sample changer, as well as the addition of the same temperature-controlled sample changer to our 700 MHz NMR spectrometer, will optimize and improve the characterization of oligosaccharides, polysaccharides and polysaccharide conjugate vaccines.

3.2 Statement of Work/Salient Characteristics

500 MHz System: This statement of work covers the purchase of an upgraded console, cryoprobe, room temperature probe and temperature-controlled sample changer for CBER's existing 500 MHz NMR spectrometer. The current request includes a total warranty period of three years for the new cryoprobe, one year and 3 option years for full service maintenance of the 500 MHz NMR console and room temperature probe.

700 MHz System: This SOW also covers the acquisition of a temperature-controlled sample changer for CBER's existing 700 MHz NMR spectrometer, and includes a three-year warranty period for the 700's existing TCI x/y/z gradient cryoprobe.

Performance Specifications

Below we use the following abbreviations for simplicity:

· 1H – hydrogen;

· 2H – deuterium (an isotope of hydrogen);

· 13C – carbon-13 (an isotope of carbon);

· 15N – nitrogen-15 (an isotope of nitrogen);

· 19F – fluorine-19 (an isotope of fluorine);

· 31P – phosphorus-31 (an isotope of phosphorus);

· X nucleus – a nucleus other than 1H;

· VT – variable temperature;

· ns – nanoseconds;

· MHz – Megahertz; and

· GHz – Gigahertz.

We require a console upgrade and the purchase of a cryoprobe, a room temperature probe, and a temperature controlled sample changer for the 500 MHz NMR, together with a temperature controlled sample changer for the 700 MHz NMR spectrometers, equipped so that the following specifications are met:

Mandatory Technical Specifications for 11.75 Tesla High Resolution NMR Console

The Laboratory of Bacterial Polysaccharides, Division of Bacterial Parasitic and Allergenic Products, OVRR/CBER/FDA requires the purchase of a console, cryoprobe, probe, temperature-controlled sample changer and shim system upgrade for the 500 MHz NMR Bruker Spectrometer. The list of new components and requirements, which are compatible with the magnet and room temperature probes already owned by our lab, are as follows:

A. 500 MHz NMR Console and preamplifier:

1. Digital lock control, including digital frequency generation, digital quadrature receiver, computer-controlled lock regulation system and ultra-stable, low current noise shim control boards. The lock channel must be compatible with gradient shimming.

2. Orthogonal shim system with 36 low current and low heat dissipation gradient shims. 2x20 shims is an acceptable configuration.

3. Sample transport upper shim stack for sample insertion and ejection. Enables high flow rates for VT gas, downsample detection and includes integral sensors for communication with the system.

4. Two-Bay, 19” rack mounted cabinet with radio frequency shielding and full front access to all sub-assemblies and cabling. The setup can incorporate at least a router for automatic samples changers, cryoprobe platform and magnet control and monitoring.

5. Timing controller capable of 12.5 ns timing resolution to ensure precise control over pulsing and signal detection.

6. Acquisition characteristics: At least five and up to eight transceiver units. Each unit shall be capable of full broad-banded transmit and full broad banded receive at up to 1200 MHz; 80 MHz system clock with synchronicity of all channels within 12.5 ns; Timing and gradient control unit (gradient control within 12.5 ns for all (X, Y, Z) gradients; pulse program trigger for up to four trigger inputs at 12.5 ns resolution; and NMR synchronized and real-time control output of external devices (up to 11 independent controls within 12.5 ns resolution).

7. Each transceiver board shall be a highly integrated NMR RF transceiver for transmitting and receiving signals. Each board shall have:

· A built-in pulse program engine to include a sequencer with waveform memory capable of providing an RF signal bandwidth of 5 to 1200 MHz with a timing resolution of 12.5 ns;

· Capability for simultaneous RF amplitude, phase and frequency settability within 12.5 ns;

· High speed ADC (analog to digital conversion) 240 MSPS at a minimum of 16 bits, Digital down conversion;

· High speed DAC (digital to analog conversion) 960 MSPS Digital upconversion;

· High Intermediate frequency (1852 MHz);

· A sequencer memory board with 1 GB memory for pulse shaping and composite pulses;

· The ability to acquire with a spectrum window of 7.5 MHz; and

· An effective dynamic range > 17 Bit (5 MHz) / > 19 Bit (1 MHz) / > 23 Bit (6 KHz)

8. Each preamplifier unit shall be digital with integrated high performance digital filters and digital quadrature detection, as stated in 8.

9. Two ultra-stable high-resolution shim current boards, each providing 20 shim currents and having 20 Bit digital resolution and a ± 1A shim current range and compatible with the current 36-orthogonal shim system.

10. Three gradient amplifier boards for x, y, and z pulsed field gradients. The gradients must be capable of simultaneous x, y and z pulsing for acquisition and gradient shimming (line shape optimization). Gradients power must reach at least 10 A with built-in pre-emphasis.

11. One highly linear, low noise 1H GaAs based preamplifier to permit 1H and 19F observation and decoupling. The 1H preamplifier shall have a noise figure of ca. 1 dB and the ability to handle a maximum of 4 kW RF power.

12. One linear, low noise, X, broad band GaAs based preamplifier to permit detection, observation and decoupling from 57Fe (Iron-57) to 19F. This preamplifier shall have a noise figure of ca. 1.4 dB, a built-in 1H stop filter and the ability to handle a maximum of 500 W RF power.

13. One linear, low noise 13C broad band GaAs based preamplifier to permit detection, observation and decoupling from 13C to 79Br (Bromine-79). This preamplifier shall have a noise figure of ca. 1.4 dB, a built-in 1H stop filter and the ability to handle a maximum of 500 W RF power.

14. One linear, low noise, highly selective 15N GaAs based preamplifier to permit detection, observation and decoupling of 15N. This preamplifier shall have a noise figure of ca. 1.4 dB, a built-in 1H stop filter and the ability to handle a maximum of 500 W RF power.

15. One 2H integrated lock transceiver with a 5W amplifier field to lock on deuterated solvents. This shall provide fast and accurate gradient shimming and reliable locking.

16. One linear, low noise 2H broad band GaAs based preamplifier to permit detection, observation and decoupling of 2H. This preamplifier shall have a noise figure of ca. 1.4 dB, a built-in 1H stop filter and the ability to handle a maximum of 500 W RF power.

17. 2H stop filter.

18. VT controller, including a digital temperature sensor, a safety sensor to prevent overheating, VT gas flow monitoring up to 3000 L/hr, antifreeze protection for cryoprobes, up to four independent channels and accurate sample temperature regulation. VT controller shall be capable of providing sensor resolution of better than 5 milliKelvin.

19. Enhanced digital quadrature detection capability with integrated high-performance Analog to digital converters. The system shall provide very high dynamic range (> 21 bit at 10 kHz) spectral width, high digital resolution and large bandwidth digital filtering.

20. A transmitter system capable of pulsing X nuclei (500 Watt amplifier), 1H (100 Watt amplifier) and 2H (250 Watt amplifier), including:

· 1H, 19F transmitter for observation and detection of homo/heteronuclear decoupling, 100 Watt pulse power with 25 Watt continuous wave, with all operations under computer control.

· X-frequency (6-365 MHz) broadband transmitter system for X-frequency observe and decoupling; for both CW and high-power pulse operations; 500 Watt pulse power with 30 Watt linear CW, with all operations under computer control.

· 2H transmitter for decoupling and gradient shimming, 150 Watt pulse power, with all operations under computer control.

21. Linear three channel RF amplifier for observing and decoupling with:

· Minimum 100 W RF power (180 – 600 MHz);

· Minimum 500 W RF power (15 – 600 MHz); and

· Minimum 150 W RF power (30 – 92 MHz);

· Must be capable of pulsing two frequencies simultaneously.

· Amplifiers shall be pulse-program controlled and have fast rise/fall times.

· The 2H lock channel must be capable of fast switching between 2H decoupling and lock operations.

· The Broad Band channel shall provide two identical RF outputs connecting to different preamplifiers without manual re-wiring or re-cabling.

· RF amplifiers shall be under computer control with forward and reflected RF power monitoring.

· Hardware components shall be integrated.

22. One linear CH Broad Band RF amplifier for observing and decoupling with:

· A minimum of 500W RF power (15-600 MHz, max 50W during continuous wave irradiation);

· Amplifier shall be pulse-program controlled and have fast rise/fall times and have very low droop.

· The CH channel shall provide two identical RF outputs connecting to different preamplifiers without manual re-wiring or re-cabling.

· RF amplifiers shall be under computer control with forward and reflected RF power monitoring.

· Hardware components shall be integrated.

23. Preamplifier unit, including preamplifiers for: 1H/19F, 2H (for lock and 2H observe), 13C, 15N, and X-BB. Control unit with touch screen graphical display and built-in tune/match display. The preamplifier shall have a noise figure of 1.4 (see below).

24. 13C and 79Br low noise preamplifier made of Gallium-Arsenide (or equivalent), be capable of 500 Watts maximum radio frequency power, capability for accurate tuning and matching.

25. 15N low noise preamplifier made of Gallium-Arsenide (or equivalent), be capable of 500 Watts maximum radio frequency power, capability for accurate tuning and matching.

26. Temperature control unit, with digital control module for full computer control. Temperature accuracy must be within ± 0.2 °C (with ± 1.0 °C room temperature stability), but ± 0.01°C within the temperature range of -20 to +35 °C. The system shall allow a maximum temperature of 200 °C.

B. Computer system:

1. Industry standard host Linux workstation (CENTOS 7), 64 bit with 3GHz CPU, 16GB RAM, 24 inch flat panel monitor, 2 TB hard drive, DVD/CD (+/- RW) drive, Ethernet adapter, keyboard, mouse.

2. Up to date installed software package for acquisition and processing of 1D, 2D, 3D, 4D and 5D NMR data, including an NMR Guide and software shall include:

· 1D and 2D deconvolution software;

· simulations of all pulse programs using a full Liouvillian treatment of two-dimensional pulse programs;

· spectral simulation of one-dimensional spectra;

· multiplet analysis;

· analysis of nuclear relaxation data;

· analysis of molecular dynamics data; and

· processing of non-uniformly sampled data.

C. Probes

1. One 5mm cryogenically cooled inverse probe for enhanced 1H and 13C sensitivity. The cryogenically cooled shall be capable of pulsing 1H, 13C and 15N and having specifications listed under "Specifications" below. The probe shall be able to lock on 2H and be equipped with X/Y/Z gradients and have a temperature range of -40 to +80 °C.

2. An external (air cooled) unit is required to cool the helium gas required for the cryogenically cooled probe. This unit also has a compressor as a component. This compressor is intended to be placed outdoors and shall be configured so that it can be placed outdoors: Extra-long (20 m) flex lines must be provided.

3. A cryoplatform compatible with an outdoor air-cooled compressor must be provided.

4. 3 years total maintenance service contract shall be provided for the cryoprobe.

5. One 5 mm room temperature X/Y/Z gradient 1H, 13C, 15N inverse probe. Specifications are listed under "Specifications" below.

D. Sample changers

1. Two temperature-controlled sample changers, one to be installed on the 500 MHz system and one on the 700 MHz system. Each shall hold 24 samples, include 24 sample shuttles, include push-button operation for manual sample insertion and ejection directly at the instrument, compatible with all sample diameters from 1-10 mm, compatible with standard and Shigemi tubes, compatible with TopSpin™ and IconNMR™ software.

2. Five (5) Shaped Tube Shuttles for use with Shaped Sample Tube Shuttle.

E. Specifications

Upon installation, the following specifications must be guaranteed and demonstrated on site for all newly purchased probes:

1. The non-spinning line-shape specifications on a 5mm sample tube for this instrument must be 6 Hz at 0.5% and 12 Hz at 0.1% or better, as measured for the chloroform resonance of the peak height of said resonance. The resolution of the same sample shall be 0.35 Hz at 50% of the peak height.

2. 90° pulse widths must be < 8 microseconds for 1H, < 11 microseconds for 13C, < 35 microseconds for 15N, and < 65 microseconds for 2H measured in an aqueous non-saline sample, and the same for a sucrose sample containing 150 mM NaCl, except for 15N.

3. The 1H radio frequency homogeneity of the 1H/13C/15N cryogenically cooled probe probe-head must be such that an 810° 1H pulse (2 x 360° + 90°) retains at least 70% of the anomeric proton signal relative to a single 90° pulse, using a 0.5 mL aqueous solution containing 2mM sucrose in D2O. The 13C radio frequency homogeneity must be such that after a 90° (1H) – 1/(2J) – 720o (13C) pulse sequence the methyl signal for a sample of 13C enriched acetate is attenuated by less than 30% relative to the 1H signal acquired with a 90o(1H) – 1/(2J) – 0° (13C) pulse sequence. The 15N radio frequency homogeneity must be such that after a 90° (1H) – 1/(2J) – 720° (15N) pulse sequence the methyl signal for a sample of 15N enriched urea is attenuated by less than 30% relative to the 1H signal acquired with a 90° (1H) – 1/2J – 0° (13C) pulse sequence.

4. The 1H sensitivity of the cryogenically cooled probe shall be at least 4500:1 for ethylbenzene, 750:1 for sucrose in H2O (2mM sample) and 320:1 in a 2mM sucrose sample containing 150 mM sodium chloride.

5. The 13C sensitivity of the cryogenically cooled probe shall be at least 680:1 for ASTM.

6. The 1H sensitivity of the room temperature probe shall be at least 1200:1 for ethylbenzene, 300:1 for sucrose in H2O (2mM sample) and 200:1 in a 2mM sucrose sample containing 150 mM sodium chloride.

7. The console shall be able to pulse and observe 2H nuclei without physically re-cabling the console.

8. The system must be capable of performing spin-lock experiments on the 5mm cryogenically cooled probe-head for up to 200 ms for 1H ((B1 = 12 kHz), up to 50 ms for the 13C channels ((B1=12 kHz for 13C), and up to 200 microseconds for the 15N channel (B1=3 kHz for 15N) with droop < 2% and total duty cycles (time of radio frequency on divided by total time) of up to 5%, for a one hour period.

9. The console electronics must permit application of user defined shaped pulses to operate independently on each of the available channels. The shaped pulses must allow a minimum of 16,000 user definable elements within a single pulse shape. The dynamic range of each channel for shaped pulses must be > 70dB total range with 0.1 dB resolution at half range.

10. The system must be equipped with a pulse program controlled, pulsed field gradient power supply capable of generating a field gradient along the X, Y and Z axes with a strength > 50 for 5 mm probe-heads. The recovery of the magnetic field homogeneity shall be such that a signal acquired 200 microseconds after a rectangular 1 ms, 25 Gauss/cm simultaneous X/Y/Z pulsed field gradient shall be such that a 1D spectrum (10 kHz spectral width, 1.64s acquisition time, 1 Hz line broadening, no water suppression) differs less than 3% from that acquired with no preceding gradient pulse. This shall be measured on the anomeric proton resonance of a 2 mM sucrose in D2O with 1 scan and no dummy scans. The data shall be processed using 1 Hz exponential line broadening and identical phasing.

11. The system shall have the capability to conduct variable temperature experiments over the range of -40 to 80 °C in normal operation, without the requirement of external cooling substances such as dry ice or liquid nitrogen. The system shall be capable of operating in the variable temperature mode using dried air (with a dew point < -80°C and pressure of 80 psi) and meet all the above listed performance specifications. The sample temperature shall be adjustable in 0.1°C increments.

12. The system must be able to conduct the following tests successfully after the installation in the buyer’s laboratory. (All tests shall be conducted at 25 °C, while operating in temperature controlled mode):

a. The largest intensity observed in any of ten consecutive 1H-13C spin-echo difference spectra for the anomeric proton at 5.4 PPM in a sample containing 50 mg sucrose in 0.5 ml H2O, using the following pulse sequence:

1H 90x – 3 msec - 180x 3 msec Acquire

13C

90 x

90 +x shall be smaller than 50% of the largest 13C satellite of the same anomeric proton. Parameters: 25°C, SW=5 kHz, exponential line broadening 1Hz, 13C transmitter at 100 ppm, non-spinning, full power 13C pulses, 4 dummy scans, acquire 2 scans, acquisition time 1.5 sec., (8192 complex points, no zero fill) repetition rate 10 seconds (including acquisition time).

13. For a cryogenically cooled probe, a significant increase in signal-to-noise ratio is expected compared to a room temperature probe. The signal-to-noise ratio increase seen in the one-dimensional spectra shall be demonstrated to be realized in two-dimensional spectra. The following experiments shall be run to show that the increase in signal-to-noise ratio seen in a 1D 1H NMR spectrum for a 2 mM sucrose sample is also realized in 1H – 15N and 1H – 13C 2D spectra of a sample containing minimal salt:

a) Two-dimensional 1H – 15N NMR HSQC (1-hour) spectra of GB1, a 15N-labeled protein sample we have in the lab;

b) Two dimensional 1H – 13C NMR HSQC (7 or 14 hour) spectra that also show the same signal-to-noise ratio increase on the same GB1 sample for the new cryoprobe;

14. Two dimensional 1H – 13C HCCH-TOCSY (~3 hr) experiment showing no arcing, increased noise or carbon artifacts on a label sample which we will provide.

3.2.1 Delivery, Installation, Training, and Support:

The vendor is responsible for delivery (FAR 52.247-34 FOB Destination).

The vendor shall cover all costs associated with the following:

1. System crating, shipping, and delivery.

2. Complete console installation by qualified personnel.

3. Full system software and peripheral installation (if applicable).

4. On-site hardware and software training. The vendor should be able to perform instrument installation and provide basic training within three working days of delivery.

5. IQ/OQ and PQ shall be performed and documented by the vendor during installation of the instrument.

PART 4 –PERFORMANCE AND DELIVERABLES

4.1 Place of Performance and Work Hours

Delivery shall be during regular work hours which are 9:00AM to 5:00PM Monday through Friday excluding US federal holidays. Service visits shall be coordinated with (TBD), see below.

Delivery Location and Point of Contact:

Contact: TBD Phone: TBD E-mail: TBD

US FOOD AND DRUG ADMINISTRATION

10903 NEW HAMPSHIRE AVE

WO BLDG 52-72 RM G434

SILVER SPRING MD 20993

4.2 Period of Performance

The period of performance in any resultant award will be based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. The equipment shall be delivered within 9 months of contract award. Installation includes necessary set up and connection to operate the system and training of FDA scientists on the equipment, standard manufacturer’s warranty. All results of the tests demonstrated and documented in the Contractors technical proposal shall be performed on-site by the Contractor following installation. The Contractor shall demonstrate that these results are equivalent to the results demonstrated in the Contractor's proposal.

Following initial warranty/service/technical support coverage, the FDA shall have a unilateral right to exercise optional periods to extend the warranty/service agreement to include preventative maintenance. The optional warranty extension and preventative maintenance agreement shall start following standard manufacturer’s warranty. Period of Performance shall be for 1 (base) year plus 3 option years following installation.

Optional Periods

PART 5 –CONTRACT ADMINISTRATION

5.1 Representative’s

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

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and services to be provided.

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Matthew Bucher U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

5630 Fishers Lane

Rockville, MD 20857

The contact information for the Contract Specialist is the following:

Christine Russman U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

5630 Fishers Lane

Rockville, MD 20857

Christine.Russman@fda.hhs.gov;

The contact information for the Contractor is the following:

(TBD)

5.2 FDA Three-Way Match Invoicing Procedures

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Office of Financial Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742

Email: FDAVendorPaymentsTeam@fda.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. 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) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(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;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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 (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. 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.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the email address or phone number provided above in Section A.

PART 6 – CONTRACT CLAUSES

6.1 HHSAR Clauses Incorporated by Reference

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: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses.

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (DEC 2015)

6.2 FAR Clauses Incorporated by Reference

52.204-16 Commercial and Government Entity Code Reporting 52.204-18 Commercial and Government Entity Code Maintenance 52.212-1 Instructions to Offerors—Commercial Items 52.212-4 Contract Terms and Conditions—Commercial Items 52.232-39 Unenforceability of Unauthorized Obligations 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

6.3 FAR Clauses Full Text

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (Nov 2017)

(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

(4) 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.]

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

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

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

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

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

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

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

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

__ (13) [Reserved]

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

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

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

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

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (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).

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

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

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

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

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

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

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

__ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (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).

__ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (38)(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.

__ (39)(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.

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (41)(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_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

_X_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (47)(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.

__ (48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 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).

__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017)(15 U.S.C. 637(d)(12)).

__ (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

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

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

[Contracting Officer check as appropriate.]

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

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

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

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

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

__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

__ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 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.

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

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

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

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

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(x) 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.

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

(xii)

__(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).

(xiii) 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).

(xiv) 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).

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

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xviii)(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xix) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xx) 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.

(xxi) 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)

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause.”

Alternate II (Nov 2017). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial…