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40 2 of

Solicitation Number: 75F40126Q00294 Fabrication and Flow Field Quantification of Transparent Micronozzle Flow Models

This is a combined synopsis/solicitation for commercial products and commercial services 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; quotations are being requested, and a separate written solicitation will not be issued.

This solicitation is issued as a Request for Quotation (RFQ) under solicitation number 75F40126Q00294.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01, effective March 13, 2026.

The Government intends to conduct this acquisition using the procedures of FAR Part 12, Acquisition of Commercial Products and Commercial Services, in conjunction with FAR Part 13, Simplified Acquisition Procedures.

SET-ASIDE AND NAICS CODE

This acquisition is 100% small business set-aside.

The North American Industry Classification System (NAICS) code applicable to this acquisition is 541715, with a corresponding size standard of 1,000.

Section C – Description/Specifications/Statement of Work

Statement of Work

Title: Fabrication and Flow Field Quantification of Transparent Micronozzle Flow Models

1. Background and Purpose This Statement of Work (SOW) establishes requirements for the fabrication of optically transparent flow models and the performance of particle velocimetry and pressure measurements to characterize fluid dynamics in micronozzle model geometries. The work will support FDA's evaluation of blood flow characteristics through medical devices by utilizing surrogate flow models consisting of 22-Gauge and 25-Gauge micronozzle tips and extensions.

2. Scope of Work The contractor shall provide three primary deliverables:

1. Flow Models: Fabrication of optically transparent physical models replicating micronozzle fluid motion geometry.

2. Flow Systems: Development and operation of systems to generate steady and transient flow conditions.

3. Particle Motion Measurements: High-resolution 2D and 3D particle velocimetry analysis to determine velocity fields and flow characteristics.

Flow models are manufactured physical representations that replicate the fluid motion geometry of interest (e.g., blood flow through a medical device) and are typically fabricated using an optically transparent plastic material. The purpose of the flow models is to experimentally determine the velocity fields in them by using imaging techniques to quantitatively follow the trajectories of particles suspended in a liquid medium (with a refractive index similar to the flow model) that is pumped through the model. The flow system provides the capability to push fluid through the flow model, often using tubing connected to a rotary, pulsatile, or syringe pump to create steady or time-varying flow.

The flow system also provides the capability to maintain the temperature of the fluid at a near-constant value and has ports located upstream and downstream of the flow model so that fluid pressure can be measured. By using high-speed cameras to capture and computationally process multiple images of the traveling particles being pushed through the flow models, ‘particle motion measurements’ can be made to determine the fluid velocity fields in different regions of the models.

3. Technical Requirements

3.1 Flow Model Fabrication

The contractor shall fabricate a minimum of three (3) scaled (4x-10x size) or actual size (1x) optically transparent flow models based on FDA-provided dimensions:

• Model 1 : 22-Gauge micronozzle flow model (410 μm outlet) for particle velocimetry and cavitation assessment

• Model 2 : 22-Gauge micronozzle flow model (410 μm outlet) for pressure measurements at 10-14 locations along the flow axis

• Model 3 : 25-Gauge micronozzle flow model (250 μm outlet) for particle velocimetry and cavitation assessment

a. All flow models must meet FDA-provided internal dimensions (diameters, corner radii) within 1% of nominal values at specified locations.

b. At locations where dimensions are not measured, the contractor shall verify absence of aberrant crevices, seams, or protrusions affecting the flow field.

c. Inner-wall surface roughness (via polishing) must meet specification of Ra < 0.6 μm, verified by:

- Opening examination models prepared identically to final flow models

- Measuring surface roughness using contact or optical surface profilometers directly on models or indirectly via metrology rubber replicating the internal surface

d. The contractor shall report Quality Control methodology used to assess the geometry of the flow models, including:

- Methods and calibrated equipment used to verify fabricated model dimensions

- Measurement tolerances and repeatability of geometrical measurements

e. Flow models must be optically transparent when filled with the test fluid medium having similar refractive index. Verification shall include:

- Measurement and reporting of refractive indices of both models and test fluid medium

- Demonstration using orthogonal grid placement behind model with distortion measurement per methodology described in Aycock, K, et al., "Particle image velocimetry measurements in an anatomical vascular model fabricated using inkjet 3D printing," Exp Fluids (2017) 58:154

f. Flow models shall be able to withstand high-resolution quantitative 2D and 3D particle velocimetry techniques under steady and transient flow conditions without flow path alterations (e.g., deformation) due to high flow rates and pressures.

3.2 Flow System Specifications

The contractor shall provide flow systems meeting the following specifications:

a. Steady Flow Capability: Flow rates of 54-220 ml/min under high pressure conditions up to 3,300 mmHg (in 1x sized models using fluid with nominal blood viscosity of 3.6 cP)

b. Transient Flow Capability: Replication of rapid acceleration from zero flow to maximum flow rate in approximately 100 msec (for 1x sized models using fluid with nominal blood viscosity of 3.6 cP)

c. Temperature Control: Capability to maintain set fluid temperature throughout measurement timeframe

d. Pressure Measurement: Access ports to measure fluid pressure upstream and downstream of all flow models. In 22-Gauge micronozzle flow model (410 μm outlet) with pressure taps at 10-14 locations along the flow axis, capability to measure pressure at each of the tap locations.

e. Flow Rate Measurement: Method to accurately measure fluid volumetric flow rate under steady and transient flow conditions

3.3 Particle Motion Measurement System Specifications

a. The contractor shall perform particle motion measurements and analysis with calibrated particle velocimetry systems capable of providing 2D and 3D velocity fields on micronozzle flow models with internal dimensions as small as 1 mm for enlarged models (or 0.25 mm for actual sized models).

b. Measurements shall be performed with existing hardware having successful and relevant history of use, as demonstrated by the contractor in previous successful particle velocimetry studies.

c. The system shall measure flow field parameters including:

- Velocity

- Shear stress

- Recirculation

- Turbulent intensity

- Reynolds Normal Stress (RNS)

- Reynolds Shear Stress (RSS) when appropriate

Under laminar, transitional, and turbulent flow conditions.

d. The system shall measure flow field parameters under all steady and transient flow conditions.

e. Time-Resolved (High-Speed) imaging techniques shall be used to measure velocity and acceleration fields and turbulence quantities of transient flow phenomena during flow initiation.

f. Fluid Preparation Protocol:

- Particle-filled fluid shall be degassed for 0.5-1 hour using vacuum pump prior to testing

- Fluid shall be recirculated through loop for sufficient period prior to imaging data acquisition

- Loop shall be visually inspected to ensure microbubble removal and temperature equilibrium

4. Performance Requirements

4.1 Testing Protocol: 22-Gauge Flow Models

The contractor shall perform particle velocimetry and pressure analysis on 22-gauge flow models under the following minimum test conditions:

a. Flow Rates: Five (5) steady flow rates: 165, 175, 195, 210, 220 ml/min

b. Fluid Viscosities: Three (3) fluid kinematic viscosities at each flow rate: 3.5, 4.2, 4.9 cSt

- Corresponding to blood viscosities of 3.6, 4.4, 5.1 cP (measured at room temperature and at a shear rate of at least 700 s⁻¹)

- Fluid densities of 1.03, 1.04, and 1.05 g/mL, respectively

c. Measurement Locations: Ten (10) cross-sections for velocity profiles and shear stress measurements at each test condition, in agreement with FDA

d. Flow field Measurements: For each test condition at each location, measure:

- Velocity

- Shear stress

- Recirculation

- Turbulent intensity

- Reynolds Normal Stress (RNS)

- Reynolds Shear Stress (RSS) when appropriate

e. Cavitation Assessment: Determine whether cavitation occurs downstream of nozzle outlet based on:

- High-speed visual observation

- Pressure measurements

- Flow conditions under which cavitation occurs

- Gas content of fluid (measured and reported)

f. Centerline Velocity: Determine centerline velocity throughout models at each flow and viscosity condition

g. Transient Flow Analysis: Determine impact of impulse (transient) flow initiation on velocity profiles and shear stress measurements under each test condition (5 flow rates × 3 viscosities × 10 cross-sections)

h. Test Parameter Reporting: For each test, report:

- Flow rate

- Inlet and outlet pressures to model

- Fluid temperature

- Any fluctuations in test parameters

i. Pressure Tap Measurements: Pressure measurements in pressure tap model at 10-14 locations along flow axis

4.2 Testing Protocol: 25-Gauge Flow Model

The contractor shall perform particle velocimetry analysis on 25-gauge flow model under the following minimum test conditions:

a. Flow Rates: Five (5) steady flow rates: 54, 65, 70, 75, 80 ml/min

b. Fluid Viscosities: Two (2) fluid kinematic viscosities at each flow rate: 3.5 and 4.2 cSt

- Corresponding to blood viscosities of 3.6 and 4.4 cP (measured at room temperature and shear rate of at least 700 s⁻¹)

- Fluid densities of 1.03 and 1.04 g/mL

c. Measurement Locations: Ten (10) cross-sections for velocity profiles and shear stress measurements at each test condition, in agreement with FDA

d. Flow field Measurements: For each test condition at each location, measure:

- Velocity

- Shear stress

- Recirculation

- Turbulent intensity

- Reynolds Normal Stress (RNS)

- Reynolds Shear Stress (RSS) when appropriate

e. Cavitation Assessment: Determine whether cavitation occurs downstream of nozzle outlet based on:

- High-speed visual observation

- Pressure measurements

- Flow conditions under which cavitation occurs

- Gas content of fluid (measured and reported)

f. Centerline Velocity: Determine centerline velocity throughout models at each flow and viscosity condition

g. Transient Flow Analysis: Determine impact of impulse (transient) flow initiation on velocity profiles and shear stress measurements under each test condition (5 flow rates × 2 viscosities × 10 cross-sections)

h. Test Parameter Reporting: For each test, report:

- Flow rate

- Inlet and outlet pressures to model

- Fluid temperature

- Any fluctuations in test parameters

5. Reporting Requirements

5.1 Analysis and Documentation for Each Flow Model

The contractor shall provide the following analysis, quantification, and reporting:

a. Methods Description: Clear description of methods and analysis for:

- Fabrication and cleaning of flow models prior to each test

- Preparation and utilization of filtered fluid medium

- Particle velocimetry measurement processes

b. Quality Control Report: Describing methods and equipment utilized to measure geometry of fabricated flow models, including:

- Assessment of surface roughness

- Comparison of measured dimensions to nominal target dimensions at each specified location

- Verification that no aberrant crevices, seams, or protrusions affect flow field at all measured and unmeasured locations

c. Uncertainty Analysis: Quantification of experimental uncertainty and error analysis for particle velocimetry and pressure measurements

d. Data Quality Metrics: Report metrics evaluating quality of particle velocimetry measurement data, such as "vector quality" or "good vector percentage," in each flow model region of interest during testing

e. Data Deliverables: The contractor shall provide the following data for all flow models, test fluids, and flow conditions:

i. Raw Data: All raw data generated throughout contracting work, stored and available upon request

ii. Image Data: Full sets of pre-processed and post-processed images captured in common, non-proprietary, easy-to-read format, kept in repository and available to FDA personnel upon request

iii. Averaged Data: Averaged data files for each flow and pressure parameter at different model locations

iv. Processed Data: Velocity, shear stress, and pressure data in common, non-proprietary, easy-to-read format (e.g., *.txt, *.csv, *.xls, *.xlsx)

v. Visualizations: Post-processed 2D and 3D data presented in vector plots, contour plots, and graphs

5.2 Comprehensive Technical Report

The contractor shall provide a comprehensive report including:

a. Flow Loop System Description:

- Configuration and individual components (fluid pump, pistons/solenoids, thermal control system and thermistor, flow dampener, flow straightener, reservoirs, tubing and connectors, flow and pressure sensors, mounting stands, inlet length to model) used to create reproducible steady and transient flow conditions

b. Equipment Description: Equipment used to make flow, pressure, and fluid property measurements, including:

- Cameras, lasers, optics and filters for particle velocimetry imaging system

- Flow analysis software (including version number)

- Flow and pressure probes

- Thermistors, viscometer, balance, densitometer, refractometer, etc.

c. Calibration Specifications: For each piece of equipment used during testing:

- Calibration specifications

- Record of last calibration

- For flow sensors: in-house calibration using specific fluid medium prior to conducting each test condition

d. Fluid Medium Description: For each test, including:

- Composition

- Dynamic viscosity (measured at 22°C and shear rate of at least 700 s⁻¹)

- Kinematic viscosity

- Specific gravity

- Refractive index

- Temperature

- Filtering procedure prior to and after introduction into flow loop

e. Tracer Particle Description: For each test, including:

- Composition

- Size

- Seeding density

- Supplier name, product number, and lot number

- Justification for particle size selection and seeding density

- Number of pixels covered by single particle image to prevent peak locking

f. Particle Velocimetry Parameters: Including:

- Number of image pairs utilized at each location

- Laser pulse rate

- Camera recording rate

- Image pair time separation

- Interrogation window size and percent overlap

- Target number of particles in interrogation window

- Pixel resolution of particle images

- Light sheet thickness

- Spatial resolution of measurements

- Particle image size to prevent peak locking effect

- Particle tracking methodology (if applicable)

- Sampling rules utilized during data acquisition (e.g., time separation between two image pairs (ΔT) chosen so peak displacement is 0.25 times interrogation window size, or the one-quarter particle displacement rule)

- Convergence study to determine number of images required for velocity measurements and stress estimations to become independent of image count (likely 500- 2,500 image pairs depending on flow conditions and model region)

g. Post-Processing Software Description: Any post-processing software used to reduce data into readable formats such as vector plots, contour plots, and graphs

6. General Requirements

a. The contractor shall be able to fabricate high-quality, seamless, smooth inner-wall transparent flow and pressure tap models with flow dimensions as small as 1 mm for enlarged models (or 0.25 mm for actual sized models).

b. The contractor shall be able to analyze and quantify 2D and 3D flow and pressure fields under steady and transient flow conditions, including in laminar, transitional, and turbulent flow regions.

c. All reports and data shall be detailed and presented in clear English.

d. The contractor shall be a US-based service with ability to:

- Communicate clearly and promptly with FDA with updates at two-week intervals

- Communicate with Medical Device Innovation Consortium (MDIC) Hemolysis

Modeling Working Group on monthly basis (at FDA's discretion)

7. Deliverables

a. Report: As listed in the statement of work, a comprehensive report providing detailed information on the equipment and methods utilized, the experimental parameters studied, the measurements made (along with the experimental uncertainty and error analysis), and the results. The comprehensive report should be suitable for use as the basis for a peer-reviewed scientific publication. Summary minutes from meetings between the contractor, the FDA, and MDIC should be included in the report. The report should be provided in electronic format to an FDA-authorized collaboration sharing tool (e.g., FDA Cloud File Sharing or FDA Guest Collaboration Experience).

b. Data repository: The following data will be stored electronically on an FDA-provided IronKey encrypted hard-drive storage device sent to the contractor and returned to the FDA: (1) All raw data generated throughout the contracting work.

(2) Full sets of pre-processed and post-processed images captured in a common, non-proprietary, and easy to read format. (3) The comprehensive project report.

c. Physical flow models: If requested by the FDA, sample or actual fabricated flow models will be sent to the FDA.

8. Source Selection Criteria In addition to the contractor's ability to meet this Statement of Work, selection will be based on the following criteria:

1. Proven Track Record - Flow Model Fabrication: Contractor shall demonstrate proven track record of fabricating and performing quality control measurements of geometry on high-quality transparent flow models with flow dimensions less than 1.6 mm.

2. Proven Track Record - Particle Velocimetry: Contractor shall demonstrate proven track record of performing particle velocimetry and pressure measurements on flow models with flow dimensions less than

1.6 mm.

Travel

NA

Special Material Requirements

NA

Other Unique Requirements

NA

Place of Performance Contractor’s Facility

Inspection and Acceptance Criteria The Project Officer shall perform inspection and acceptance of materials:

Conformance to Specifications: Product must meet all specifications outlined in the contract, including physical, chemical, and microbiological parameters where applicable.

Documentation and Labeling Completeness: All required documentation and labeling (CoA, SDS, regulatory certificates) must be complete, accurate, and provided with the shipment.

Grounds for rejection include failure to meet cell viability and quality metrics, missing documentation, damaged packaging, improper storage conditions during shipment, or contamination.

Section D - Packaging and Marking

PACKAGING OF DATA

Data repository: The following data will be stored electronically on an FDA-provided IronKey encrypted hard-drive storage device sent to the contractor and returned to the FDA: (1) All raw data generated throughout the contracting work.

(2) Full sets of pre-processed and post-processed images captured in a common, non-proprietary, and easy to read format. (3) Comprehensive project report.

MARKING OF REPORTS

All reports delivered by the Contractor to the Government under this contract shall prominently show on the cover of the report:

(1) Name and business address of the Contractor

(2) Contract Number

A comprehensive report providing detailed information on the equipment and methods utilized, the experimental parameters studied, the measurements made (along with the experimental uncertainty and error analysis), and the results. The comprehensive report should be suitable for use as the basis for a peer-reviewed scientific publication. Summary minutes from meetings between the contractor, the FDA, and MDIC should be included in the report. The report should be provided in electronic format to an FDA-authorized collaboration sharing tool (e.g., FDA Cloud File Sharing or FDA Guest Collaboration Experience).

Section E – Inspection and Acceptance Term

INSPECTION AND ACCEPTANCE TERMS

Inspection and Acceptance of reports and deliverables will occur by the COR as listed in Section G – Contract Administration Data, or a designated representative of the Government.

Supplies/services will be inspected/accepted at:

US Food & Drug Administration Attention: Sailahari Ponnaluri 10903 New Hampshire Ave White Oak Building 62, Room 4215

Silver Spring, MD 20993

Section F - Deliveries or Performance

DELIVERABLES

All deliverables shall be delivered F.O.B. Destination, under transmittal letter, to the POC at the following address:

US Food & Drug Administration Attention: Sailahari Ponnaluri 10903 New Hampshire Ave.

White Oak Building 62, Rm. 4215 Silver Spring, MD 20993

The SOW specifies delivery dates. Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period 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.

DELIVERY DATES

Critical Deadline: All data shall be delivered to FDA by August 31, 2027.

Section G - Contract Administration Data

ADMINISTERING GOVERNMENT PERSONNEL

The administering Government Personnel are listed as follows:

Contracting Officer (CO) Name: Ian Weiss E-mail: Ian.Weiss@fda.hhs.gov Phone: 301-796-5782

Contract Specialist:

Name: Sheila Brown E-mail: Sheila.Brown1@fda.hhs.gov

Contracting Officer’s Representative (COR) Name: Derrick Johnson E-mail: derrick.j.johnson@fda.hhs.gov Phone: 301-796-5348

Note: Only the Contracting Officer has authority to direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of their contracts.

Section G – HHSAR AND FDA CLAUSES BY FULL TEXT

HHS INVOICE SUBMISSION

Invoicing instructions are prescribed under HHSAR 352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION) and FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022).

a. HHSAR 352.232-71 Electronic Submission of Payment Requests (APR 2026)

(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. 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) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. 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)

b. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 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/Contractors/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 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. (1) 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.

(2) 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.

(3) 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 hours of receipt of the first email, contains a temporary password. You must log in with the temporary http://www.ipp.gov/ http://www.ipp.gov/vendors/index.htm password within 30 days.

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

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

g. 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.

h. 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.

i. 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.

j. 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.

k. 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.

(END OF CLAUSE)

Section H – Special Contract Requirements

Section H – HHSAR CLAUSES BY FULL TEXT

HHSAR 352.204-71 Information and Information Systems Security (FEB 2024) (Deviation)

(a) Definitions. As used in this clause— Breach means the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where—

(1) A person other than an authorized user accesses or potentially accesses personally identifiable information, or

(2) An authorized user accesses personally identifiable information for an other than authorized purpose.

Business associate (see 45 CFR 160.103), except as provided in paragraph (2) of this definition, business associate means, with respect to a covered entity, a person who -

(1) On behalf of such covered entity or of an organized health care arrangement (as defined in this clause) in which the covered entity participates, but other than in the capacity of a member of the workforce of such covered entity or arrangement, creates, receives, maintains, or transmits protected health information for a function or activity regulated by this contract or agreement, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, patient safety activities listed at 42 CFR 3.20, billing, benefit management, practice management, and repricing; or

(2) Provides, other than in the capacity of a member of the workforce of such covered entity, legal, actuarial, accounting, consulting, data aggregation (as defined in 45 CFR section 164.501), management, administrative, accreditation, or financial services to or for such covered entity, or to or for an organized health care arrangement in which the covered entity participates, where the provision of the service involves the disclosure of protected health information from such covered entity or arrangement, or from another business associate of such covered entity or arrangement, to the person.

(3) A covered entity may be a business associate of another covered entity.

(4) Business associate includes the following:

(i) A Health Information Organization, E-prescribing Gateway, or other person that provides data transmission services with respect to protected health information to a covered entity and that requires access on a routine basis to such protected health information.

(ii) A person that offers a personal health record to one or more individuals on behalf of a covered entity.

(iii) A subcontractor that creates, receives, maintains, or transmits protected health information on behalf of the business associate.

(5) Business associate does not include:

(i) A health care provider, with respect to disclosures by a covered entity to the health care provider concerning the treatment of the individual.

(ii) A plan sponsor, with respect to disclosures by a group health plan (or by a health insurance issuer or HMO with respect to a group health plan) to the plan sponsor, to the extent that the requirements of 45 CFR 164.504(f) apply and are met.

(iii) A government agency, with respect to determining eligibility for, or enrollment in, a government health plan that provides public benefits and is administered by another government agency, or collecting protected health information for such purposes, to the extent such activities are authorized by law.

(iv) A covered entity participating in an organized health care arrangement that performs a function or activity as described by paragraph (1)(i) of this definition for or on behalf of such organized health care arrangement, or that provides a service as described in paragraph (1)(ii) of this definition to or for such organized health care arrangement by virtue of such activities or services.

Business associate agreement means the agreement, or other arrangement, as dictated by the HIPAA Privacy Rule (45 CFR 160), between an HHS covered entity and a business associate, which must be entered into in addition to the underlying contract for services and before any disclosure (see 45 CFR 160.103) of PHI can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of an HHS entity.

Controlled unclassified information (CUI) means information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.

Healthcare component means a component or combination of components of a hybrid entity designated by the hybrid entity in accordance with 45 CFR 164.105(a)(2)(iii)(D) (see 45 CFR 164.103). The Secretary of HHS has designated HHS as a covered entity (further designated as a “hybrid entity”), and has also designated four HHS divisions as healthcare components under HIPAA, including —

(1) The Centers for Medicare and Medicaid Services (CMS), insofar as it operates the fee-for-service Medicare program;

(2) The Program Support Center (PSC), Division of Commissioned Personnel, insofar as it operates a health plan for Commissioned Corps officers;

(3) The World Trade Center (WTC) Health Program; and,

(4) The Indian Health Service (IHS), insofar as it operates a health plan and a program providing healthcare that uses electronic transactions.

HHS Information Technology General Rules of Behavior means a set of HHS rules that describes the responsibilities and expected behavior of users of HHS information or information systems.

HHS sensitive information means all HHS data, on any storage media or in any form or format, which requires confidentiality, integrity, and availability protection due to the risk of harm that could result to interests of HHS, other agencies or entities, or individuals from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes—

(1) Information where the improper use or disclosure could adversely affect the ability of HHS to accomplish its mission, i.e., HHS proprietary information;

(2) Records about individuals requiring protection under laws and regulations such as the E- Government Act, Privacy Act and the HIPAA Privacy Rule, or based on a data use agreement or a promise or assurance of confidentiality; and

(3) Information that would be exempt from disclosure if requested under the Freedom of Information Act. Examples of HHS sensitive information include— (i) Individually-identifiable medical, benefits, and personnel information;

(ii) Financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, security-sensitive, procurement-sensitive, investigatory, and law enforcement information;

(iii) Controlled unclassified information;

(iv) Information that would be confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and (v) Other information which, if released, could result in a violation of law or agreement, could cause harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

HIPAA Rules means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and part 164.

Incident means an occurrence that (A) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information systems; or (B) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable policies.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

Information system security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

Information technology (see FAR 2.101) also means Information and Communication Technology (ICT).

Information technology-related contracts means those contracts that include services (including support services), and related resources for information technology.

Organized health care arrangement (see 45 CFR 160.103) means:

(1) A clinically integrated care setting in which individuals typically receive health care from more than one health care provider;

(2) An organized system of health care in which more than one covered entity participates and in which the participating covered entities: (i) Hold themselves out to the public as participating in a joint arrangement; and

(ii) Participate in joint activities that include at least one of the following: (A) Utilization review, in which health care decisions by participating covered entities are reviewed by other participating covered entities or by a third party on their behalf;

(B) Quality assessment and improvement activities, in which treatment provided by participating covered entities is assessed by other participating covered entities or by a third party on their behalf; or

(C) Payment activities, if the financial risk for delivering health care is shared, in part or in whole, by participating covered entities through the joint arrangement and if protected health information created or received by a covered entity is reviewed by other participating covered entities or by a third party on their behalf for the purpose of administering the sharing of financial risk.

(3) A group health plan and a health insurance issuer or HMO with respect to such group health plan, but only with respect to protected health information created or received by such health insurance issuer or HMO that relates to individuals who are or who have been participants or beneficiaries in such group health plan;

(4) A group health plan and one or more other group health plans each of which are maintained by the same plan sponsor; or

(5) The group health plans described in paragraph (4) of this definition and health insurance issuers or HMOs with respect to such group health plans, but only with respect to protected health information created or received by such health insurance issuers or HMOs that relates to individuals who are or have been participants or beneficiaries in any of such group health plans.

Privacy officer means the HHS official(s) with responsibility for implementing and oversight of privacy related policies and practices that impact a given HHS acquisition.

(b) General. Contractors, subcontractors, their employees, third-parties, and business associates with access to HHS information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, shall adhere to the HHS Cybersecurity Program and the directives and handbooks, complete HHS security training prior to accessing HHS information (including HHS sensitive information and information systems security and privacy) and on an annual basis thereafter, as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, HHS Personnel Security and Suitability Program, which establishes HHS procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards, and guidance for protecting HHS information, information systems (see 302.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing HHS information or information systems.

(c) Access to HHS information and HHS information systems.

(1) Contractors are limited in their request for logical or physical access to HHS information or HHS information systems for their employees, subcontractors, third parties and business associates to the extent necessary to perform the services or provide the goods as specified in the contracts, agreements, task, delivery, or purchase orders.

(2) All Contractors, subcontractors, third parties, and business associates working with HHS information are subject to the same investigative requirements as those of HHS appointees or employees who have access to the same types of information. The level and process of background security investigations for Contractors to access HHS information and HHS information systems shall be in accordance with HHS Personnel Security and Suitability Program.

(3) Contractors, subcontractors, third parties, and business associates who require access to national security programs must have a valid security clearance.

(4) The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be – (i) Marked appropriately;

(ii) Disclosed to authorized personnel on a need-to-know basis;

(iii) Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

(iv) Returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

(5) HIPAA business associate agreements. Under the HIPAA Privacy and Security Rules (see 45 CFR 164), pursuant to 45 CFR 164.502(e)(1), a covered entity may disclose protected health information to a business associate and may allow a business associate to create, receive, maintain, or transmit protected health information on its behalf, if the covered entity obtains satisfactory assurance that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor of a covered entity’s business associate. Additionally, a business associate may disclose protected health information to a business associate that is a subcontractor and may allow the subcontractor to create, receive, maintain, or transmit protected health information on its behalf, if the business associate obtains satisfactory assurances, in accordance with 45 CFR 164.504(e)(1)(i), that the subcontractor will appropriately safeguard the information. The satisfactory assurances required by 45 CFR 45 CFR 164.504(e)(1) of this section shall be documented through a written contract or other written agreement or arrangement with the business associate that meets the applicable requirements of 45 CFR 164.504(e). The contracts shall also include breach reporting policies and procedures for suspected or confirmed breaches of protected health information. The contract shall impose a duty to cooperate with the healthcare component and/or HHS breach investigation and response and must require all subcontractors to comply with the same HIPAA Rules requirements as a condition of receiving government data.