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) 2005-101. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. Business size standard of 500 employees. The solicitation is intended for full and open competition.

SUPPLIES OR SERVICES AND PRICES/COSTS

FDA has a requirement for a rheometer to determine the viscoelastic properties of abuse deterrent formulations of opioid drug products currently on the market and generic drug products soon to be on the market. Viscoelastic nature of polymer matrix in the formulation is a key component to limit the amount of opioid that can be extracted and injected by the abuser via syringe. A rheometer is required for this testing.

CLIN Description Price
0001 Rheometer $
Total Cost $

REQUIREMENTS

Product Specifications: Main Primary Feature/Functionality Requirements

1. The rheometer shall be a single-head or combined motor and transducer design, and shall incorporate a magnetic levitation thrust bearing, as compared to traditional air or mechanical bearings. A magnetic bearing is required to allow true accurate instrument torque measurements down to at least 0.5 nN.m in oscillation measurements and at least 5 nN.m in steady shear. Additional requirements for the air bearing are related to reducing air consumption and a more rugged design not susceptible to costly damage from moisture or particulates which can occur in air supplied to air bearings.

2. The rheometer shall have two radial bearings along the length of the rotating shaft for maximizing radial rigidity.

3. The torque motor shall be a low mass drag-cup induction design with a moment of inertia of no larger than 25 N.m.s². The moment of inertia reported shall include all moving parts of the motor without a geometry installed. The motor shall incorporate a non-contact induction temperature sensor to provide a direct measure of the temperature of the drag cup and insure absolute accurate torque control unaffected by temperature change in the drag cup. The motor shall employ digital current control to avoid range switching and supply seamless torque over the entire range.

4. The rheometer shall be capable of applying a maximum torque of at least 200 mN.m and capable of applying at least 200 mN.m of torque continuously in steady shear or creep mode for at least 15 minutes without the need of any external fluid circulating for motor cooling.
5.
The rheometer shall have an option for a first principle torque calibration with National Institute of Standards and Technology (NIST) traceability. Torque calibration with certified oil or other material is unacceptable because true first principle calibration cannot be accomplished with materials affected by two degrees of freedom (temperature and torque).

6. The instrument software shall report absolute uncorrected torque applied by the motor (not sample torque corrected for moment of inertia) in addition to the stress applied by the motor and the inertia corrected stress applied to the sample.

7. The rheometer shall include an optical encoder for displacement measurements with a dual encoder reader. The optical encoder dual reader is required for obtaining low angular displacement resolution and to eliminate displacement drift that occurs in encoders with single read heads.

8. The rheometer shall have an angular velocity up to 300 rad/s.

9. The rheometer shall have a frequency in oscillation mode up to 100 Hz.

10. The rheometer shall include the ability to control and measure normal forces using a force rebalance transducer over a force range of at least 0.005 to 50 N. The force rebalance transducer is required because normal force measurements are accomplished by driving the motor to zero deflection. This provides reduced axial compliance, which is a requirement of strain gauge and capacitive sensors, enhancing the true accuracy of normal force measurements, particularly the short time transient response.

11. During any test the normal force, compression or tension, on the sample can be kept within defined limits. In addition, during temperature sweeps or ramps the gap shall automatically adjust for thermal expansion or contraction of the measurement plates by actual movement of the geometry as long as the normal force control limits are not violated. Software gap correction for parallel plates shall be invoked if the limits have been reached.

12. The rheometer shall include a position sensor at the base of the rheometer head capable of making real-time corrections for the effects of thermal expansion/contraction of the rheometer shaft, in addition to active gap-temperature compensation capabilities to adjust for geometry expansion/contraction. The position sensor and gap temperature compensation shall work together yet independently and not place any restrictions on geometry or temperature system selection or their temperature ranges. Any gap compensation shall be accomplished by physically moving the rheometer head as opposed to passive adjustments to calculated gap. The latter allows sample to be squeezed out of plates on heating or shrinkages of sample away from plate testing surface on cooling. This feature is required to ensure the most accurate gap possible under any possible testing conditions of wide torque and/or temperature swings.

13. Shall have ability to test solid materials to generate Young Modulus (E', E", and tan delta) over a wide temperature range.

14. The rheometer shall have primary testing station and power supply and main electronics housed in a separate enclosure. This requirement ensures the data generated is unaffected by heat generated by electronics and vibrations from electronic cooling fans. It is necessary to have this architecture to truly have torque measurements down to at least 0.5 nN.m, as on-board vibrations shall generate torques in excess of this level. This architecture also gives greater flexibility with maximizing bench space as the electronics box can be placed on the floor or on a shelf on the wall.

15. The rheometer shall be constructed on a solid cast single-piece frame to reduce compliance as much as possible which needs to be corrected and can impact absolute instrument measurable ranges.

16. The rheometer shall include a parameter display and control panel on the test station for performing the following functions: raise and lowering head, gap zero, sample loading with trim gap pause, electronic trim lock, temperature system interchange, and experiment start/stop.

17. The rheometer shall include both automatic temperature system and geometry recognition to minimize operator time and eliminate potential mistakes with configurations and test set-up. All temperature systems and accessories shall be powered by the main instrument electronics and NOT by additional power and electronics boxes which take up valuable laboratory bench space.

18. The instrument software shall report both raw phase angle and corrected phase angle for oscillation measurements for validation of data quality. Viewing these signals enable full understanding of the effect of moment of inertia on measured data for acceptance.

19. The rheometer shall include a "drawrod" geometry connection because it minimizes any moment of inertia typical of bulky connectors with large radii. In addition, the rheometer shall have the ability to use a modified drawrod with an embedded Platinum resistance thermocouple and non-contact signal transfer capability, which can be used to control and measure the upper plate temperature for upper non-contact heating systems. Because the requested rheometer is a single head design, no contact shall be made with the system because it shall interfere with the torque/displacement signals. The ability to control and measure both top and bottom plate temperatures has the following advantages: faster temperature response, true temperature ramps because top and bottom plates heat at the same rate, and elimination of offset calibration tables for upper heater.

20. The rheometer shall allow for the gap to be closed in the following ways: user defined velocity; user defined exponential decay, and user defined normal force. The speed of gap closure shall be continuously variable.

21. The rheometer system shall display the oscillation waveforms real-time and store the waveform for each data point. The waveform shall be viewable to provide an indication of the amount of noise, slip, or inertial correction for each point.

22. The rheometer shall include full large amplitude oscillatory shear (LAOS) testing capability. This includes the ability to collect correlated and transient oscillatory data, and a software analysis package capable of analyzing transient data and generating non-linear parameters including: G'M, G'L, 'M 'L, S, T, and Q.

23. The rheometer shall be capable of operating in the following modes:
Oscillation Mode Tests
• Torque/Stress sweep (linear or log) at single frequency
• Frequency sweep (linear or log) at single torque
• Frequency sweep (linear or log) at single strain
• Strain/angular displacement sweep (linear or log) at single frequency
• Temperature sweep at single frequency/torque
• Superimposed stress oscillation and steady shear
• Superimposed strain oscillation and steady shear
• Multiple simultaneous frequencies superimposed on above modes

Flow Mode Tests
• Controlled stress or torque sweeps
• Controlled rate (s-1) or speed (rad/s) sweeps
• Stress stepped flow
• Equilibrium stress stepped flow (ensures material has time to respond to each level of stress)
• Temperature sweeps at constant stress or rate
• Squeeze flow and pull off

Creep Mode (transient) Tests
• Constant stress creep and recovery
• Automatic sensing of steady state during creep test
• Stress growth
• Stress relaxation (transient) test
• The rheometer shall be capable of running any of the available tests described above in one mixed procedure. In addition, while running the procedure, succeeding steps can be adapted or new steps added.

24. The rheometer shall correct for residual bearing friction.

25. The rheometer shall allow for motor and geometry inertia correction in both flow and oscillation mode, with the actual inertia measured by the instrument, not with just "book" values of inertia.

26. The rheometer shall automatically zero the gap.

TEST GEOMETRY REQUIREMENTS AND SPECIAL FIXTURES

1. The rheometer shall offer a large variety of testing geometries readily available to react quickly to varied testing requirements.

2. Custom geometries shall be available for purchase in the future.

3. Minimum requirements for standard geometries are listed below and shall be available for purchase in the future.
a. Cone and/or plate diameters: 8, 20, 25, 40, 60 mm.
b. Cone angles: 0.5, 1, 2, & 4° and 0.02, 0.04, & 0.1 rad
c. Standard construction materials: Hard Anodized Aluminum, Stainless Steel &Titanium
d. Standard Plate types: no solvent trap, solvent trap, heat break solvent trap, disposable
e. Surface finishes: Sandblasted, cross hatched
f. Concentric Cylinder Cups: Double Gap, Single gap, grooved
g. Concentric Cylinder rotors: Conical DIN, Recessed End, Double Gap, Vane, Helical, & propeller
h. Solids testing fixtures: Torsion rectangular, Torsion Immersion
i. Interfacial fixtures: Double Wall Ring, DuNouy Ring, and Bicone
j. Special fixtures: SER for extensional viscosity, Quartz plate

4. At a minimum, the geometries listed below are requested at time of purchase.
a. Stainless steel plates with diameters of 20 and 40 mm
b. Sandblasted plate with a diameter of 40 mm
c. 2° Cone with a diameter of 40 mm
d. Disposable aluminum plates with a diameter of 25 mm
e. Insulated solvent trap
f. Holders to accommodate interchangeable plates and cones

TEMPERATURE CONTROL SYSTEM AVAILABILITY

The rheometer shall include the following optional temperature control system. All temperature control systems shall include automatic recognition and compatible with position sensor. Non-contact temperature systems shall include ability to actively measure and control the upper geometry directly with a PRT sensor included in the connecting draw rod.

1. The rheometer shall offer a Peltier with a temperature range of at least -20 °C to 200 °C, heating rates up to at least 20 °C/min, and a temperature accuracy of at least 0.1 °C. The Peltier plate shall incorporate four Peltier heating elements to cover an 80 mm plate surface directly in contact with an 8 mm thick copper surface with an extremely rugged, hardened chrome surface. This design is required to provide rapid, precise, and uniform temperature control over the entire 80 mm diameter surface allowing testing with geometries 60 mm in diameter without sacrificing horizontal temperature accuracy. The Peltier plate shall be available in a stepped model with interchangeable plate material and surface finishes as well as stepped disposable model for curing samples. The Peltier plate shall be capable of controlling from at least -20 °C to 200°C using a single heat sink temperature of 1 °C. This is required because it allows uninterrupted testing over a very wide temperature range and eliminates the need for slow responding expensive computer-controlled circulators. The Peltier plate shall offer the following accessories:
a. Solvent Trap. Solvent trap shall be in contact with Peltier heating surface to and not require a separate heating system to efficiently prevent evaporation of solvents without condensation issues.
b. Purge Gas Cover: The purge gas cover allows introduction of a dry purge to prevent condensation from forming at sub ambient testing conditions or to introduce a stream of moist air to maintain some level of humidity around a specimen.
c. Immersion Cover: The immersion cover allows testing on Peltier plate with sample fully immersed in a liquid to assess the effect of the liquid on the mechanical properties of the specimen
d. Peltier Camera Accessory: An optional camera shall be available for capturing an image of the sample in the geometry with every data point. This option is helpful for data validation during unattended operation.
e. Insulating Thermal Cover and Insulating Solvent trap: A thermal insulation cover constructed of Anodized Aluminum surrounded by an insulating material shall be available for use with Peltier Plate. The Aluminum shall be in contact with surface heated by Peltier elements to pull heat around the sample to help eliminate vertical temperature gradients over moderate temperature ranges between -10°C and 80°C without the use of a separate upper heater. A solvent trap version shall be available for testing of samples with volatiles.

2. The rheometer shall offer a dual-stage Peltier plate with a temperature range of at least -45 °C to 200 °C, heating rates up to at least 20 °C/min, and a temperature accuracy of at least 0.1 °C. The Peltier plate shall be capable of controlling from at least -45 °C to 200° C using a single heat sink temperature of 1 °C. The dual stage Peltier plate shall be capable of cooling to a minimum of -45 °C in 10 minutes. This is required because it allows testing to very low temperatures without the need for liquid nitrogen or large expensive fluid circulators and special circulation fluids.

3. The rheometer shall offer an upper heated plate system that can be used in conjunction with all Peltier plate models for use with 8, 25, and 40 mm diameter cones and plates (including disposable) and capable of a maximum temperature 150 °C. The upper heated plate shall include non-contact temperature control that directly measures and controls the temperature of the upper plate and eliminate the need for temperature offset calibration tables. The geometries shall be of heat spreader design to insure heat transfer is not affected by change in gap. The heating system shall use an electric heating element and cooling via a cooling channel. This design allows for flexible cooling options including Peltier Circulator, Circulator, Peltier air cooling, and Vortex Cooling. When using upper heater with lower Peltier the system shall match the heating rate of the Peltier plate with the upper heater to ensure both plates are at the same temperature reported by the instrument. This is necessary because it eliminates guessing experiment thermal equilibration times for samples and allows for true temperature ramp control.

4. The rheometer shall offer to include a Peltier heated concentric cylinder geometry temperature system with a temperature range of at least -20 °C to 150 °C and a maximum heating rate up to 13 °C/min. The Peltier concentric cylinder system shall have the following rotors available: conical DIN standard, Recessed End, Double Gap Options, propeller, vanes, and helical. The system shall have available a Torsion Immersion system for measuring solid mechanical properties under the influence of liquids under controlled temperature environments.

5. The rheometer shall offer and electrically heated plate temperature system (EHP) for use with 8, 25, and 40 mm diameter cones and plates (including disposable plates) over a temperature range of at least -70°C to 400 °C and maximum heating rate of at least 20°C/min. The EHP shall include non-contact temperature control that directly measures and controls the temperature of the upper plate and eliminate the need for temperature offset calibration tables. The geometries shall be of heat spreader design to ensure heat transfer is not affected by change in gap. The EHP system shall match the heating rate of the lower and upper plates to insure both plates are at the same temperature reported by the instrument. This is necessary because it eliminates guessing experiment thermal equilibration times for samples and allows for true temperature ramp control. The upper portion of the EHP shall be compatible as an upper heater for use with any Peltier Plate model to a maximum temperature of 200°C. The EHP shall offer a transparent cover for sample viewing and offer a camera viewer option for capturing images of the sample during experiments for subsequent data validation.

6. The rheometer shall offer an additional temperature system with a range of at least -160 to 600C and maximum heating rate of at least 60C/min. This system shall be a combined radiant and convection heating system for efficient heat transfer to samples. It also shall be coupled with an optional mechanical air chiller system to reach sub-ambient temperatures down to at least -85°C. The system shall offer parallel plate, cone and plate, disposable plate (for curing), torsion fixtures (for solids), and SER for extensional viscosity. The temperature system shall offer an optional camera viewer with remote illumination and focusing to easily see inside the enclosed chamber. The camera shall be capable of capturing sample images over the entire temperature range. The images shall be stored with each data point taken during the experiment and viewable in the analysis software. This shall allow the user to access the integrity of the sample during the experiment and provide an additional means of validating data.

SOFTWARE REQUIREMENTS

The Instrument Operation and Analysis software shall conform to the industry standard Microsoft Windows operation system. The instrument operation and basic analysis software shall be native 32 bit Windows 7/XP/Vista applications. Software shall be capable of multitasking and operating multiple instruments from a single workstation. Software shall comply with the following:
a. The instrument software shall aid 21 CFR compliance with the inclusion of an audit trail for tacking purposes and user restriction functionality.
b. The personal computer (PC) shall communicate via internet protocol with the test instrument electronics.
c. The software shall offer ability to automatically update both instrument software and firmware through the Internet using an update routine. The software shall be able to automatically look for updates and inform user when available.
d. All raw data or instrument parameters shall be accessible at any time.
e. The software shall make use of Windows conventions and features such as long file names.
f. The software shall include image capture and streaming video capability that shall be interfaced with a web camera through computer USB connection.
g. Ability to run the instrument and perform other tasks simultaneously such as data analysis, Microsoft Word, or Microsoft Excel.
h. Software shall also feature true 'cut-and-paste' functionality with common Windows applications such as MS Word, MS Excel and Lotus. In addition, data export into MS Excel/ASCII and XML format shall be a standard feature of the software.
i. The data analysis package shall have the ability to run on any computer within the customer's organization without the use of a hardware key. This allows the user to make full use of the data analysis capability remote from computer that runs the instrument.
i. Data analysis options shall include the following curve modeling or analysis /transformation functions:
ii. Mathematical model: straight line, onset point, modulus crossover, first and second derivative, integration, Polynomial, exponential, sine/cosine, Fourier series,
iii. Flow: Newtonian, Casson, Bingham, Herschel-Buckley, Power Law, Sisko, Cross, Shalliamson, Ellis, Carreau, Best fit Polynomial.
iv. Creep: discrete retardation spectrum, Burger model.
v. Oscillation: Discrete and continuous relaxation spectrum, Spriggs, Oldroyd and Coz-Merz
vi. Stress relaxation: Discrete and continuous relaxation spectrum
vii. User defined model
viii. Software shall include transformations software transformations of G', G", G(t), J', J", J.
ix. Time-Temperature Superposition, with automatic horizontal and vertical shift. Automatically generates master curves. After fitting with WLF or Arrhenius, curves shall be generated for any temperature within the range tested. Shift parameters in the scalar database other than temperature can be chosen. Shifting direction (horizontal, diagonal) shall be set for the selected curves. Time/Temp Superposition capability shall be built into the software package and not a third party program.
x. The base software package shall also include statistical analysis (column and page based) including error bar generation and data (point) editing, FFT and spline smoothing, and data reduction and page merge functions.
xi. Fluid inertia corrections shall be included in the software, as well as Berger's/Rabinowitch's correction.
xii. Automatic determination of rheological parameters such as Zero Shear Viscosity, Plateau Modulus, Equilibrium Compliance, and Flow Activation Energy and savings in the scalar database
xiii. Advanced Mw and MWD calculations based on Double Reptation theory shall be available.

Advanced Analysis Modules: In addition to the standard rheological testing platform, the instrument shall be capable of accepting the following modules to provide enhanced materials characterization functions:
a. UV curing
b. Asphalt
c. SALS
d. Interfacial
e. Fourier Transformation Rheology Analysis Package:
i. Sample the raw stress and strain data using SineStrain or Transient data collection in oscillation test modes
ii. Conversion of temporal data to frequency data (DFT)
iii. Extraction of the odd harmonics and calculation of Fourier and Chebyshev polynomial coefficients
iv. Ability to recast the results as a function of the sweep parameter used
v. Calculation of non-linear parameters (G'M, G'L, 'M, 'L, S, T, Q)
vi. Reconstruct temporal data. This function recalculates from the odd harmonics total stress, viscous and elastic stress.

ADVANCED ACCESSORY AVAILABILITY

1. The rheometer shall offer a solvent traps or evaporation blocking systems for Peltier plate and Peltier concentric cylinder temperature systems. The evaporation blocking system consists of a cover and solvent trap geometries which together create a thermally stable vapor barrier to eliminate solvent loss during rheological experiments.

2. The rheometer shall offer a small angle light scattering (SALS) option for simultaneous rheological and structural characterization such as particle size, shape, orientation and spatial distribution. The SALS system shall have Peltier Plate temperature control. The SALS system shall install directly onto the rheometer base and not require any special assemblies for elevating the instrument on the bench. The system shall be factory aligned as to not require any lengthy set up procedures.

1. The rheometer shall offer a sealed vessel for studying the effect of pressure up to 2,000 psi on rheological properties or materials that volatilize under atmospheric pressure.

2. The rheometer shall offer both mercury lamp light and LED light accessories for rheological characterization of UV-curable materials. LED systems shall be available with primary peaks of 365 nm and 455 nm, and both systems shall offer disposable acrylic plates and temperature control to 150°C.

3. The rheometer shall offer a double wall ring interfacial, DWR, system for the most accurate interfacial measurements. This system is far advanced over traditional bicone and Du Nouy ring designs because it eliminates subphase contribution corrections, is quantitative compared to the qualitative results from Du Nouy ring, has enhanced sensitivity and improved geometry design for pinning the interface. The DWR shall include double wall cup with interface viewing window and sample injection port. System shall allow for testing of interfacial properties in all standard oscillatory and steady shear testing modes.

4. The rheometer shall offer an SER2 universal testing platform for performing extensional rheology measurements and a range of physical material property measurements such as tensile, peel, tear and friction on small solid samples.

5. The rheometer shall offer both Peltier Plate and Torsion Immersion systems. These options allow samples to be measured while fully immersed in a fluid on the Peltier Plate or for testing of solid rectangular bar-shaped samples while immersed in a temperature-controlled fluid in the Peltier Concentric Cylinder temperature system.

6. The rheometer shall offer a Dielectric analyzer module to provide a simultaneous measurement with any mechanical test mode and shall be used as a stand-alone dielectric analyzer.

7. The rheometer shall offer an Electro-Rheology accessory with all available rheological test modes.

8. The rheometer shall offer a Magneto-Rheology accessory with all available rheological test modes.

9. The rheometer shall offer a tribology accessory for measuring coefficient of friction between two solid surfaces using ring on plate, ball of three plates, three ball on plate, or ball on three balls geometries.

10. The rheometer shall offer an optical plate accessory for viewing of the sample from below during testing to visualize material structure during rheological experiments.

11. The rheometer shall offer a modular microscope accessory for viewing the sample in brightfield, polarization and fluorescence microscopy modes with piezo-ceramic objective positioning. The rheometer shall support counter-rotation during microscopy tests to generate a zero-velocity, stagnation plane.

12. The rheometer shall offer an immobilization cell accessory with Peltier temperature control that permits the characterization of drying, retention, and immobilization kinetics of paints, coatings and slurries.

13. The rheometer shall offer a building materials cell with a large diameter cup, slotted cage, and paddle rotor for testing materials with large particles in a concentric cylinder setup.

STANDARD MATERIALS

The standards listed below are required for instrument performance verification.
1. Low viscosity standard oil
2. High viscosity standard oil
3. Polydimethylsiloxane

SOFTWARE SECURITY COMPLIANCE

1. The Offeror(and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

2. The Offeror(and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that shall limit system software vulnerability exploits.

3. The Offeror(and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The Offerorshall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.

4. The Offeror(and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

SECTION 508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.
There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - shallconform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site shallcomply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the Offeroror consultant retained to produce the Web-suitable content or communications material.
Unless an agency exception to this requirement exists, the Offerorshallconform to applicable Section 508 standards and shallapply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Offerorshall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 provisions apply to the content identified in this SOW:
• Shall meet WCAG 2.0 A and AA
• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)
• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)
• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)
• E205 Electronic Content (Appendix A, Application and Scoping Requirements)
• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)
• Electronic content shall be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery shall be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative
• E206 Hardware (Appendix A, Application and Scoping Requirements)
• E207 Software (Appendix A, Application and Scoping Requirements)
• Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements)
• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

TRADE AND SERVICE CRITERIA

1. The vendor shall be accredited with an ISO certification.
2. The instrument shall come with a 1-year limited warranty including parts and labor.
3. Instrument qualification/operational qualification (IQ/OQ) shall be performed at time of installation.
4. On-site training shall include a lecture of theory, instrumentation, and applications and hands-on calibration, maintenance, sample analysis, and data interpretation.
5. The vendor shall provide documentation showing installation and calibration, on-site training, and IQ/OQ have been performed.

SHIPPING LOCATION

Food & Drug Administration
645 S. Newstead Ave
St. Louis, MO 63110

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer's Representative is: TBD

The contact information for the FDA Contracting Officer is: TBD

The contact information for the FDA Contract Specialist is the following: TBD

CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

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: www.acquisition.gov/far/index.html

52.202-1 Definitions (November 2013)
52.203-5 Covenant Against Contingent Fees (May 2014)
52.203-7 Anti-Kickback Procedures (May 2014)
52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018)
52.217-8 Option to Extend Services (Nov 1999) (The Contracting Officer may exercise the option by written notice to the Contractor within 30 (thirty) days of contract expiration).
52.217-9 Option to Extend the Term of the Contract (March 2000) (a The Government may extend the term of this contract by written notice to the Contractor within 30 days of expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires.) (c The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years and six (6) months).
52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OF EXECUTIVE ORDERS-COMMERCIAL ITEMS (Jan 2019)
(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:
(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).
(
(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 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)).
X (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C.
637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside
(Nov 2011) (15 U.S.C. 657f).
(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 (Apr 2015). X (28) 52.222-26, Equal Opportunity (Apr 2015) (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). X (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).
X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act
(Dec 2010) (E.O. 13496).
X (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and
E.O. 13627).
(ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).
X (34) 52.222-54, Employment Eligibility Verification (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).
X (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.

X (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
(45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.
5150).
(47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov
2007) (42 U.S.C. 5150).
(48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41
U.S.C. 4505), 10 U.S.C. 2307(f)).
(49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505,
10 U.S.C. 2307(f)).
X (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management
(Jul 2013) (31 U.S.C. 3332).
(51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
(52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
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:
(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 (Oct 2015) (38 U.S.C. 4212).
(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause
52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).
(xi) (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78
and E.O. 13627).

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

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

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).
(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year
2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42
U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

HHSAR Clauses Incorporated by Reference

This order incorporates the following U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) 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 the following website: http://www.hhs.gov/policies/hhsar/.

HHSAR Clause Description Date
352.203-70 Anti-lobbying (Dec 2015)
352.215-70 Late proposals and revisions (Dec 2015)
352.223-70 Safety and health (Dec2015)
352.224-70 Privacy Act (Dec 2015)
352.233-71 Litigation and claims (Dec 2015)

INSTRUCTIONS TO OFFERORS

COVER PAGE

Offeror shall include a cover page which shall include a point of contact (name, telephone number, and email address). Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.

The award will be evaluated and awarded as Lowest Price Technically Acceptable. Quoters must demonstrate they are capable of satisfying the maintenance requirements set forth in this solicitation.
Faxed quotes will not be accepted.

Offerors Response Date and Time

All quotes shall be submitted via email to [email protected] by or before 10:00 AM Eastern Time on July 17, 2019 with the subject titled "Requisition 1212673".

Quotes must be valid through September 30, 2019