SOW_4 Mass Spectrometers.docx

STATEMENT OF WORK

Four (4) Mass Spectrometers Background The regulatory laboratories of the Food and Drug Administration (FDA) Office of the Chief Scientist (OCS), conduct a range of chemical analyses on pharmaceutical products and dietary supplements to determine if they meet regulatory requirements. As such we require a wide range of unique types of mass spectrometers to complete our regulatory work. These instruments are needed for current projects involving β-lactam, nitrosamine, complex health fraud, and CRADA mass spectral data. Additionally, these systems will enhance capabilities for the detection and quantitation of drugs of abuse, such as synthetic opioids, the results of which would support criminal and regulatory investigations involving foods, drugs, dietary supplements, medical products.

Purpose/Objective The purchase of one (1) high resolution quadrupole-ion trap mass spectrometer with an ultra-high performance liquid chromatography (UHPLC) system for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA is required to ensure the laboratory has sufficient instrumentation for the timely analysis of dietary supplements which are analyzed to detect the presence of undeclared active pharmaceutical ingredients to include GLP-1 receptor agonist ingredients.

The purchase of one (1) UHPLC with Ultra High-Field Triple Quadrupole Mass Spectrometer for the San Juan Medical Products Laboratory (SJLMP) can perform targeted analysis with a high degree of sensitivity and specificity. Additionally, San Juan needs the ability to perform robust quantitative analyses with low detection limits in complex pharmaceutical analyses. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by the FDA Laboratories, internal FDA programs, and the FCC program.

The purchase of two (2) hybrid quadrupole/linear ion trap mass spectrometers with two (2) ultra-high performance liquid chromatographs (LC-MS/MS) for the National Forensic Chemistry Center (NFCC). The systems must offer data-dependent acquisition (DDA), data-independent acquisition (DIA), and MSn acquisition through use of the hybrid quadrupole/linear ion trap and will enhance capabilities for both targeted and non-targeted identification and quantitation of small molecules, particularly approved and counterfeit drugs, opioids, designer drug isomers and analogs, synthetic cannabinoids, misbranded/adulterated dietary supplements, and designer steroids in support of investigations involving foods, drugs, dietary supplements, medical products, tobacco products and vape products.

Scope OCS requires one (1) high resolution quadrupole-ion trap mass spectrometer with an ultra-high-performance liquid chromatography (UHPLC), one (1) UHPLC with Ultra High-Field Triple Quadrupole Mass Spectrometer system and two (2) hybrid quadrupole/linear ion trap mass spectrometers with two (2) ultra-high performance liquid chromatographs (LC-MS/MS) and accessories as well as Nitrogen Generator(s) Power Conditioner(s), and Uninterruptible Power Supply (UPS) as well as delivery, installation, and training to FDA personnel that meets or exceeds the requirements below:

Requirements

1. High resolution quadrupole-ion trap mass spectrometer with an ultra-high performance liquid chromatography (UHPLC)

A. The contractor shall provide an Orbitrap Exploris 480 mass spectrometer or equivalent. The quadrupole-ion trap mass spectrophotometer shall meet or exceed the following requirements:

· The mass spectrometer must be a high-resolution, high-field bench top system that can occupy a bench space of 36 x 36 x 36 inches (h x d x w) and can connect to existing utilities to include nitrogen gas and an exhaust outlet.

· The mass spectrometer must be a quadrupole-ion trap configuration.

· The mass spectrometer must have an electrodynamic ion funnel for ion transmission from atmosphere.

· The mass spectrometer must have a minimum resolution of 7500 (FWHM) at m/z 200 for all scan modes and both polarities and a maximum resolution of at least 480,000 (FWHM) at m/z 200 for all scan modes and both polarities.

· The mass spectrometer must operate in the m/z range of at least 40-8,000.

· The mass spectrometer shall utilize accelerated Higher-Energy Collisional Dissociation (HCD) cell for generating fragment spectra.

· The mass spectrometer must be equivalent to a LC-MS/MS system utilizing a Quadrupole Mass Filter consisting of segmented mass filter, providing variable and step-less precursor isolation width selection from 0.4 Da up to 2000 Da.

· The mass spectrometer must only require nitrogen as an external gas.

· The mass spectrometer must have the following minimum sensitivity:

· MS/MS: 50 fg Reserpine on column yields S/N 100:1

· SIM: 50 fg Reserpine on column yields S/N 150:1

· The mass spectrometer must have the following scan speed, at a minimum:

· Highest scan rate of at least 35 Hz at resolution setting at 7,500.

· Scan speed for MS/MS is up to 22 MS/MS scans per second at resolution (R=15,000 at m/z 200) in targeted or data dependent mode

· The mass spectrometer must have the following mass accuracy, at a minimum:

· < 3 ppm RMS – with external calibration over 24 h and without any kind of mass recalibration

· < 1 ppm RMS – with internal calibration (used-defined lock mass)

· < 1 ppm RMS – with internal calibration for up to 5 consecutive days

· The mass spectrometer must be equipped with a two position RoHS valve or equivalent, to allow for solvents coming from the UHPLC to be diverted to waste.

· Software Package:

· Software for instrument control data acquisition, data processing, and analysis shall be included.

· The software shall have seamless control of both the mass spectrometer and liquid chromatography system.

· Software for instrument control and for data acquisition to include analysis software such as TraceFinder, Xcalibur or equivalent.

· Software such as BioPharma or equivalent, for data acquisition and analysis for protein characterization (ex. intact mass analysis, peptide mapping, oligonucleotide analysis) and to support the mass range of up to 8000 m/z.

B. The contractor shall provide a Vanquish Flex Binary Ultra High-Performance Liquid Chromatography (UHPLC) System or equivalent. The UHPLC system shall meet or exceed the following requirements:

· The UHPLC System must be compatible with the mass spectrometer system described above in Section A.

· The UHPLC shall be equipped with a binary pump with a minimum flow range of 0.001 to 5 mL/minute with a flow precision < 0.05% RSD or better.

· The UHPLC shall be equipped with an autosampler to allow for split loop injection with an injection volume range of 0.010-100µl, 25µl sample loop and an accuracy of at least ±0.5%.

· The UHPLC shall be equipped with a sample compartment temperature range from 5°C to 120°C, minimally and a sample capacity of at least four racks of at least 54 vials each.

· The UHPLC shall be equipped with a column compartment thermostat capable of regulating the temperature minimally in the range of 5°C up to 120°C and the column compartment capacity allows for 2 column slots.

· The UHPLC shall be equipped with a pre-heater and post-column cooler for the column compartment.

· The UHPLC shall include necessary accessories to connect to a mass spectrometer and complete installation to include a column, syringe and syringe filters.

· The UHPLC shall be equipped with a diode array detector with at least 10 UV channels and a UV-Vis lamp.

· The UHPLC shall have a titanium flow cell with a 7mm light path length and 2.5µl volume compatible with the diode array detector described above.

2. Ultra-High-Field Triple Quadropole Detector with an Ultra High Performance Liquid Chromatography (UHPLC) with DAD

A. The UHF-QQQ shall comply with the following quality requirements:

· ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html

· ISO 9001:2008 https://www.iso.org/standard/46486.html

· 21 CFR Part 11 Compliance Features Available https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

· USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin

B. The UHF-QQQ system shall include the following salient requirements:

a. Ultra-High Field Triple Quadropole

· Highly sensitive full-scan MS

· Selected-ion monitoring (SIM)

· SRM with up to 30,000 SRMs definable and up to 600 SRMs/sec and timed SRMs

· High-resolution (0.2 Da FWHM) selected-reaction monitoring (H-SRM)

· Product ion scan

· Precursor ion scan

· Neutral-loss scan

· Reverse energy ramp MS/MS spectra (RER) MS/MS spectra for compound identification

· Polarity switching capabilities

· Quantitation-enhanced data-dependent (QED) MS/MS

· Mixed Mode Scan Function

· Electrodynamic ion funnel RF lens

· Ion beam guide and neutral blocker

· 5.25 mm field radius

· Resolutions up to 0.2 Da FWHM

· Greater than six orders of dynamic range provide high confidence

· quantitation

b. Integrated Syringe Pump and Divert Valve

· Fully automated data system control of the divert valve and syringe pump with plug-and-play support.

· Automated control of the divert valve enables switching of the solvent front, gradient end point, or any portion of the HPLC run to waste.

C. The contractor shall provide a Ultra High Performance Liquid Chromatography (UHPLC) System. The UHPLC System must be compatible with the mass spectrometer system described above in Section B and shall meet or exceed the following requirements:

a. Ultra-High Performance Liquid Chromatograph that contains:

· Binary Pump

· Min. Flow Rate 0.001 mL/min

· Max flow 8 mL/min

· Pressure Range 2 to 103 MPa (20 to 1034 bar, 290 to

· 15,000 psi)

· Autosampler

· Column Compartment

· Column Capacity 2 x max, 300 mm w/pre-heater or guard column, Max. ID: 10 mm; 2 x max, 250 mm w/pre-heater and guard column, Max. ID: 10 mm

· Temperature Range 5 °C (max. 18 K below ambient) 120 °C

b. Diode Array Detector that contains:

· Data Collection Rate Up to 250 Hz

· Detection Mode UV-vis Detection (Up to 10 Channels)

· Detector Type Single-Beam

· Type Diode Array Detector

· Drift < 1 mAU/hour at 254 nm

· Lamp Deuterium lamp, tungsten lamp

· Linearity < 5% at 2.2 AU (typically < 5% at 2.7 AU)

· Max. Cell Operating Pressure Standard biocompatible: 5 MPa (50 bar, 720 psi)

· Other flow cells: 12 MPa (120 bar, 1740 psi)

· Noise <± 6 μAU at 254 nm (standard flow cell, bandwidth: 4 nm, slit width: wide, time constant: 2 sec)

· No. of Channels 10 + 3D field

· PC Connection USB 2.0; 3-port HUB to connect further

· Photodiode Array 1024 element

· Spectral Bandwidth Pixel resolution: 0.6 nm (average)

· Temperature Range 5 to 35°C; 20 to 80% RH (non-condensing)

· Validation Functions Internal validation with holmium oxide filter

· Wavelength Accuracy ± 1 nm

· Wavelength Range 190-800 nm

· Wavelength Repeatability ± 0.1 nm

· Flow Cell, 2.5uL

c. Vacuum System

· Four-stage differentially pumped vacuum manifold

· Advanced triple-inlet turbomolecular pump integrated with the

· vacuum manifold

· Environmentally friendly dry pump system

d. The system shall include the current Instrument Controller Software

· Instrument License

· Current Instrument Firmware

· Software Package One License for each Licensed software

· Capable of controlling and programming methods, sequences for the UHPLC and UHF-QQQ

· Data processing

· Capable of analyzing (spectral library) and reporting results (example: TraceFinder™ software or equivalent, method development software)

· Database of compound names, SRM transitions, and collision energies

· 21 CFR Part 11 compliant

3. Hybrid quadrupole/linear ion trap mass spectrometer systems with ultra-high performance liquid chromatographs (LC-MS/MS).

A. Mass Spectrometer (MS):

· The ionization source shall be an atmospheric pressure ionization (API) source that includes the following features:

· x, y, and z probe positioning

· Heated electrospray ionization (HESI) probe

· Interchangeable atmospheric pressure chemical ionization (APCI) functionality

· Integrated calibrant source for automated mass calibration

· A minimum of two linear ion trap mass analyzers capable of the following:

· Scan range m/z 50-1500 or greater (i.e., scan range may go lower than m/z 50 or higher than m/z 1500, but must cover this range at a minimum)

· Performing both higher-energy collisional dissociation (HCD) and resonant collision induced dissociation (rCID), or tandem-in-time MSn, with helium trapping/collision gas

· MSn precursor isolation, rCID and HCD fragmentation, and full-scan product ion spectra acquisition

· Maximum MS3 rate > 25 Hz

· Capable of data-dependent MSn, where n > 3

· The instrument shall be capable of multiplexing multiple precursor ions

· The instrument shall be capable of polarity switching

· The instrument shall be capable of performing both targeted and non-targeted analyses

· The instrument shall be capable of performing trace quantitation

· The instrument shall include a syringe pump for tuning and a 6-port valve (or equivalent) for LC-MS experiments

· Software Package:

· Software for instrument control and calibration, data acquisition, and data processing/analysis (qualitative and quantitative) shall be included.

· The software shall have seamless control of both the mass spectrometer and liquid chromatography system.

B. Liquid Chromatograph (LC):

· The liquid chromatography system must be compatible with the mass spectrometer described in Section A

· The LC shall be equipped with a binary pump with high pressure mixing and solvent degasser

· The LC shall have a flow rate range of 0.001-5 mL/min and be adjustable in 1 µL/min increments

· The LC shall be equipped with a pressure range of 50-600 bar (i.e., pressure may go lower than 50 bar or higher than 600 bar, but must cover this range at a minimum)

· The LC shall have a flow rate accuracy of ± 0.1% and a flow rate precision of ≤ 0.05% RSD

· The LC shall be operable at a pH range of 2-12

· The LC autosampler thermostat shall be controlled with a temperature range of at least 4-40 °C

· The LC column compartment thermostat shall be controlled with a temperature range of 20-80 °C (i.e., the temperature range may go lower than 20 °C or higher than 80 °C but must cover this range at a minimum)

4. A compatible computer running Windows 10 or 11 OS and monitor to be used as an instrument controller shall be included to run software and all instrument components of the mass spectrometer and liquid chromatography system

· Minimum 3.1 GHz Quad core processor with 32 GB RAM to ensure the controller can effectively run the software and hardware being purchased within this contract

· Video card and monitor capable of 1920 ×1080 resolution

· Minimum 2 TB hard drive (or two 1 TB hard drives)

· USB and Ethernet communication ports and Cables for all connections

· Minimum two ethernet connections (one for Lab Network)

5. An uninterruptible power supply compatible with the instrument described in this document, a compatible power distribution unit (PDU) module and any necessary power cords for the specified equipment.

6. Nitrogen generator with the following salient specifications:

• Nitrogen up to 35 L/min, up to 116 psi @ up to 99.5% purity

• Analytical grade nitrogen gas up to 99.5% purity.

• Full color user interface

• Electrical Requirements: 120VAC; 60Hz; 12A

Trade and Service Specifications

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

2. Offered systems shall be a turn-key solution, i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, printers, software, and accessories that are otherwise required to meet these specifications, the FDA’s stated need, and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications that have been included in the vendor’s response and/or used as evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met.

3. The entire system must be warranted for parts and labor for a minimum of 12 calendar months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include, at a minimum: coverage on all non-consumable items and parts supplied, including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

4. Instrument operators shall have access, for the duration of the 12-month warranty period, to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

5. Operator level training for 5 users at the delivery onsite location shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine regulatory analyses on the instrument. The training shall include manuals and any consumables to be used during training.

6. The Contractor shall provide installation by a trained and certified field service engineer who shall perform the necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer’s operational standards following installation. Calibration solutions and consumables used for the installation shall be included.

7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols.

8. FOB Point destination to include inside delivery and clean-up of area after installation. Installation shall be completed at each site identified in the “Delivery Location and Place of Performance” section of the SOW and shall be inclusive of all fees associates with labor, travel, and lodging.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Delivery Schedule

1. Onsite installation of the entire system shall be included and inclusive of labor, delivery, and travel costs.

2. System installation shall occur no later than 90-days from the date of award.

3. Inside delivery including unpacking the equipment and inventory of parts with a lab representative, setup and installation, cleanup (remove pallets, boxes and packing) of the area at the place of performance is required.

4. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

5. Standard kits for operational qualification and performance verification (OQ/PV) shall be included.

6. Installation of hardware and software shall be conducted by factory certified service personnel.

7. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used as evaluation criteria for award. The following shall be demonstrated at the time of installation:

· The contractor shall demonstrate that all modules start up properly, are correctly installed and connected.

8. Shall include Hardware IQ/OQ with Performance Verification.

9. Shall include Software IQ/OQ and testing of basic functional specifications and Chapter 21 CFR part 11.

10. The vendor shall provide IQ/OQ electronic documentation of Software and Hardware.

11. The vendor shall include a minimum of one preventative maintenance visit for to ensure the instruments are functioning at peak performance.

Warranty

1. The entire system shall be warranted for parts and labor for a minimum of 1-year limited warranty from date of formal government acceptance

2. The warranty shall include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period shall be no more than 72 hours, if needed.

3. Warranty coverage shall include all non-consumable items and parts supplied ensuring proper functioning.

4. As needed, factory-certified replacement parts, engineer labor and travel costs, software updates, notifications, and installation shall be included in the warranty plan to ensure maximum system operational readiness.

5. The warranty plan shall include a minimum of one subsequent preventative maintenance visit to ensure the instruments are functioning at peak performance.

Training

Operator level familiarization training for five (5) operator users of each Mass Spectrometer systems at the place of installation and acceptance shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine regulatory analyses on the instrument. The training shall include manuals and any consumables to be used during training.

Deliverable Timelines

Delivery Location and Place of Performance

Food and Drug Administration Irvine Medical Products Laboratory 19701 Fairchild Rd.

Irvine, CA 92612 1 High resolution quadrupole ion trap mass spectrometer with an ultra-high performance liquid chromatography (UHPLC) system and accessories 1 Computer 1 Uninterrupted Power Supply 1 Nitrogen Generator

Food and Drug Administration San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223 1 Ultra-High-Field Triple Quadropole Detector with an Ultra High Performance Liquid Chromatography (UHPLC) with DAD 1 Computer 1 Uninterrupted Power Supply 1 Nitrogen Generator

Food and Drug Administration National Forensic Chemistry Center 6751 Steger Dr.

Cincinnati, OH 45237 2 LC-MS/MS Systems 2 Computers

Government Points of Contact (POC)

Contracting Officer (CO)

Sephora Calderon Phone: 301-796-0965 Email: sephora.calderon@fda.hhs.gov

Contracting Officer Representative (COR)

Neal Alcalay Phone: 347-652-5155 Email: neal.alcalay@fda.hhs.gov

Contractor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Eastern Time, Central Time, or Pacific Time). The contractor shall provide at least a 2 week notice for installation, set-up, and training date(s). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility. Contractor staff must have photo ID to enter building. Unless otherwise specified, all reports or copies of service reports shall be delivered to the COR identified in each Order at time of service. These reports shall detail services, locations of performance and dates performed.

Period of Performance

The period of performance begins the date of award and delivery shall be completed no later than 90 days award. The equipment will include a 12-calendar month warranty period beginning the date of formal government acceptance

Hours of Operation

The contractor is responsible for conducting business, between the hours of 8:00 AM – 4:00 PM Monday through Friday except Federal Holidays or when the Government facility is closed due to local or nation emergencies, administrative closings, increment weather, or similar Government directed facility closings.

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

July (Independence Day)

HHS Section 508 and Accessibility Standards Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, B, C & D, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

For each proposed product, platform, or service, a fully completed Accessibility Conformance Report (ACR) using the Voluntary Product Accessibility Template (VPAT) (https://www.itic.org/policy/accessibility/vpat) must be submitted. Evaluation will be on an Acceptable/Unacceptable basis.

Prior to acceptance of deliverables, the offeror must demonstrate conformance to the HHS Section 508 requirements via HHS Section 508 checklist(s). The government reserves the right to perform testing on required ICT items to validate the offeror’s Section 508 conformance claims. If the government determines that Section 508 conformance does not meet the HHS Section 508 requirements, the government shall, at its option, require the offeror to remediate the item, at no additional cost to the government, to align with the HHS Section 508 conformance requirements prior to acceptance.

References:

· Section 508 Standards: https://www.access-board.gov/ict/

· HHS Policy on Section 508 Compliance and Accessibility of Information and Communications Technology (ICT): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/department-of-health-and-human-services-hhs-policy-on-section-508-and-accessibility-of-technology.html

Government Points of Contact (POC)

Contracting Officer (CO) Sephora Calderon Phone: 301-796-0965 Email: sephora.calderon@fda.hhs.gov

Contracting Officer Representative (COR) Neal Alcalay Phone: 347-652-5155 Email: neal.alcalay@fda.hhs.gov

FAR 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2025) (RFO DEVIATION), applies to this acquisition with the addenda for INVOICING provided under HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and invoicing instructions section.

Addendum to FAR 52.212-4(g) - Invoice, Contract Terms and Conditions – Commercial Items (NOV 2023)

Invoicing Instructions

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Feb 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

d. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

e. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24

f. hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

g. If your company is already registered to use IPP, you will not be required to re-register.

i. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7003, a written request must be submitted to the CO to explain the circumstances that require the authorization of alternate payment procedures.

1. 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:

i. invoice number, amount, & date submitted

ii. 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.

2. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

3. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

4. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

5. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

6. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

FAR CLAUSES Incorporated by Reference (IBR)

Services (DEVIATION RFO)

NOV 2025

FAR CLAUSES INCORPORATED by FULL TEXT

52.219-28 POSTAWARD SMALL BUSINESS PROGRAM REREPRESENTATION (DEVIATION RFO) (NOV 2025)

(a) Definitions. As used in this clause— Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

(b) If the Contractor represented that it was a small business concern, a small disadvantaged business concern, or a joint venture that was any of the small business concerns identified in 19.000(a)(3) prior to award of this contract, the Contractor shall rerepresent its size and socioeconomic status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon occurrence of any of the following:

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3) For long-term contracts-

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

(c) The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of this rerepresentation that corresponds to the North American Industry Classification System (NAICS) code(s) assigned to this contract. The small business size standard corresponding to this NAICS code(s) can be found at https://www.sba.gov/document/support--table-size-standards.

(d) The small business size standard for a Contractor providing an end item that it does not manufacture, process, or produce itself, for a contract other than a construction or service contract, is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(1) Was set aside for small business and has a value above the simplified acquisition threshold;

(2) Used the HUBZone price evaluation preference regardless of dollar value, unless the Contractor waived the price evaluation preference; or Was an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation(s) required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting officer in writing within the timeframes specified in paragraph (b) of this clause, that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs

(e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

(1) The Contractor represents that it □ is, □ is not a small business concern under NAICS Code 334516 assigned to contract number 75F40126F19007.

(2) [Complete only if the Contractor represented itself as a small business concern in paragraph (g)(1) of this clause.] The Contractor represents that it □ is, □ is not, a small disadvantaged business concern as defined in 13 CFR 124.1001.

(3) Women-owned small business (WOSB) joint venture eligible under the WOSB Program. The Contractor represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: .]

(4) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The Contractor represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: .]

(5) Service-disabled veteran-owned small business (SDVOSB) joint venture eligible under the SDVOSB Program. The Contractor represents that it □ is, □ is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402.

[ The Contractor shall enter the name and unique entity identifier of each party to the joint venture:

(6) HUBZone joint venture eligible under the HUBZone Program.[ Complete only if the offeror is a HUBZone small business concern. ] The offeror represents, as part of its offer, that It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: . ] Each HUBZone small business concern participating in the HUBZone joint venture must be certified as a HUBZone concern. [ Contractor to sign and date and insert authorized signer's name and title. ] (End of clause)

52.246-20 WARRANTY OF SERVICES (MAY 2001)

(a) Definition.

"Acceptance," as used in this clause, means the act of an authorized representative of the Government by which the Government assumes for itself, or as an agent of another, ownership of existing and identified supplies, or approves specific services, as partial or complete performance of the contract.

(b) Notwithstanding inspection and acceptance by the Government or any provision concerning the conclusiveness thereof, the Contractor warrants that all services performed under this contract will, at the time of acceptance, be free from defects in workmanship and conform to the requirements of this contract. The Contracting Officer shall give written notice of any defect or nonconformance to the Contractor 45 days after the discovery of the defect. This notice shall state either (1) that the Contractor shall correct or reperform any defective or nonconforming services, or (2) that the Government does not require correction or reperformance.

(c) If the Contractor is required to correct or reperform, it shall be at no cost to the Government, and any services corrected or reperformed by the Contractor shall be subject to this clause to the same extent as work initially performed. If the Contractor fails or refuses to correct or reperform, the Contracting Officer may, by contract or otherwise, correct or replace with similar services and charge to the Contractor the cost occasioned to the Government thereby, or make an equitable adjustment in the contract price.

(d) If the Government does not require correction or reperformance, the Contracting Officer shall make an equitable adjustment in the contract price.

(End of clause)

HHSAR CLAUSES

HHSAR 352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION

As prescribed in 332.7002:

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b), and the applicable payment clause included in this contract.

(b) Submission instructions: Refer to contract Section 11(I). Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer’s authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer’s written authorization with each payment request.

(End of clause)

HHSAR 352.239-79 Information and Communication Technology Accessibility (DEVIATION) (FEB 2024)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

FDA CONDITION Regarding Macros

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

(End of Condition)