RFQ_75F40126Q00371_final.docx

75F40126Q00371 - QELS Dynamic Light Scattering Detector This is a combined synopsis/solicitation for commercial product prepared in accordance with the format in Federal Acquisition Regulation (FAR), Revolution FAR Overhaul (RFO) Part 12.2, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-1, 3/13/2026.

This announcement constitutes the only solicitation and a separate solicitation will not be issued. The solicitation number is 75F40126Q00371. This solicitation is issued as a Request for Quotes (RFQ).

The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 - Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 employees. This requirement is solicited for full and open competition. This requirement is being solicited as an open market. Prospective offerors are responsible for downloading the solicitation and amendments from SAM.gov. The Government reserves the right to award a contract without discussion if the Contracting Officer determines that the initial offer provides the best value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) is requesting a quote for a Quasi-Elastic Light Scattering (QELS) Dynamic Light Scattering detector compatible with the existing FFF system, featuring advanced real-time particle size characterization capabilities.

Interested Quoters shall submit any questions concerning the RFQ at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Pamela.Lee@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: September 14, 2026, at 3:00 PM ET may not be considered.

The deadline for receipt of offers for this requirement is: September 16, 2026, at 3:00 PM ET. Quote submissions must be submitted by email only to Pamela Lee at: Pamela.Lee@fda.hhs.gov. Subject line of the email should be titled: “Quote Submission: 75F40126Q00371 _ Quasi-Elastic Light Scattering (QELS) Dynamic Light Scattering Detector”.

Part 1.0: Quotation Submission Instructions

1.1 Quoters shall submit a firm-fixed price quote, including details of all prices supporting the required deliverables.

1.2 The quoter shall complete the pricing chart below. Pricing shall include all applicable fees including FOB destination shipping and handling. Any charges presented after contract will not be considered.

1.3 Quotes shall clearly reference the RFQ, date of offer, company proposing and point of contact.

1.4 Quote shall be valid for at least 60 days after close of RFQ.

1.5 Quoters shall include in the quote:

· a point of contact (name, telephone number, and email address),

· proposed firm-fixed-prices,

· business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

· Unique Entity ID (UEI) number,

· certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Quoters shall ensure the RFQ number is visible in the header of the email transmission of their quote.

1.6 Award Criteria:

Quotations that do not respond to all requirements in the solicitation may be considered non-responsive without further evaluation nor consideration. The Government reserves the right to award without discussions. The Government contemplates award of a Firm-Fixed-Price Purchase Order resulting from this solicitation to the responsible Quoter whose quote conforming to the solicitation will be most advantageous to the Government and whose quote is the Lowest Priced Technically Acceptable (LPTA).

1.7 52.252.-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

Provisions Number Title

(End of provision)

1.8.1 Authorized Deviations in Provisions (Nov 2020)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of any ______________ [insert regulation name](48 CFR Chapter______) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of provision)

Part 2: Schedule of Products (all shipping and handling shall be included in the price)

Item #

Total:

` Part 3 Quasi-Elastic Light Scattering Unit for FFF

3.1 Background

The Department of Health and Human Services (HHS) supports its mission of protecting and enhancing public health by leveraging advanced analytical characterization technologies for pharmaceutical product evaluation. This requirement supports ongoing initiatives in the comprehensive assessment of complex biologics, biosimilars, nanomaterial containing drugs, and advanced therapeutic medicinal products. Field-Flow Fractionation (FFF) coupled with multi-angle light scattering (MALS) is a critical analytical technique essential for separating and characterizing heterogeneous samples based on size but lacks the capability to simultaneously measure hydrodynamic radius in real-time during elution. Advanced dynamic light scattering detection is essential for obtaining orthogonal size measurements that complement separation-based analysis, enabling comprehensive characterization of particle size distributions, aggregation states, and conformational properties of therapeutic proteins and nanoscale drug delivery systems. This detector provides the specialized capabilities needed for real-time hydrodynamic radius determination, polydispersity assessment, and validation of size distributions obtained through FFF separation. It is necessary for OPQ to support high-fidelity analytical characterization that enhances the understanding of how formulation variables and manufacturing processes impact Critical Quality Attributes (CQAs), such as protein aggregation, particle size distribution, and structural integrity of complex drug products. The detector will enable more accurate regulatory reviews and scientific research by allowing staff to independently verify the sophisticated analytical data and comparability assessments submitted by industry sponsors for biosimilar applications, nanomaterial containing drug products, and other complex therapeutics. Furthermore, the integration of QELS DLS with existing MALS detection allows for the correlation of molecular weight with hydrodynamic size, facilitating comprehensive structural characterization and supporting the development of robust analytical methods for life-cycle management of approved products. While size characterization efforts have been previously supported through offline DLS measurements requiring separate sample preparation and analysis, this acquisition aims to formalize the implementation of a comprehensive online detection capability—utilizing real-time hydrodynamic radius measurements—to align FDA's internal analytical capabilities with the current "state-of-the-art" in pharmaceutical characterization and Regulatory Science.

3.2 Objective

The objective is to establish a new contract for a Quasi-Elastic Light Scattering (QELS) Dynamic Light Scattering detector compatible with the existing FFF system, featuring advanced real-time particle size characterization capabilities.

3.3 Requirements

OPQR has a requirement to obtain an advanced dynamic light scattering detector to enhance characterization capabilities for emerging pharmaceutical products and complex biologics. For a quoter's detector to be deemed acceptable, the following salient characteristics shall be met:

· QELS Dynamic Light Scattering Detector: Real-time hydrodynamic radius measurement capability that operates inline with Field-Flow Fractionation separation to provide simultaneous size characterization as samples elute from the FFF system.

· Compatibility with Existing FFF System: Must be fully compatible with and integrate seamlessly into the existing FFF system, including hardware connections, software integration with chromatography software, and synchronized data acquisition with existing MALS detectors.

· High-Sensitivity Detection: Capable of measuring hydrodynamic radii across a wide dynamic range from approximately 10 nm to 1000 nm to accommodate diverse sample types including proteins, protein aggregates, liposomes, and lipid nanoparticles.

· Orthogonal Size Validation: Provides diffusion-based size measurements that complement separation-based FFF analysis, enabling validation of particle size distributions and detection of sub-populations or aggregates that may not be fully resolved by separation alone.

· Data Correlation and Analysis: Integrated software functionality that enables direct correlation between molecular weight data from MALS detection and hydrodynamic size from DLS detection to provide comprehensive analysis of absolute molar mass, root-mean-square radius, and hydrodynamic radius.

· Data Output: Generates validated, audit-trail-compliant data files suitable for regulatory submissions and scientific publications, with full integration into existing software platform for unified data processing and reporting.

· Maintenance and Support: Technical support, software updates, preventive maintenance, and alignment with FDA's quality assurance requirements for analytical instrumentation.

3.4 Deliverables

Detector hardware with all necessary cables, connectors, and mounting hardware for integration with existing FFF system. Software licensing and installation files compatible with current chromatography software version. User manuals, technical specifications, and standard operating procedure templates provided in digital format via download or physical media (CD/DVD). CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor. Deliverables are delivered to the following address:

U.S Food and Drug Administration Center for Drug Evaluation and Research / Office of Pharmaceutical Quality / Office of Pharmaceutical Quality Research Attn: TBD 645 S Newstead Avenue St. Louis, M0 63110

3Schedule: Delivery shall be no later than 120 days after contract award.

Vendor is responsible for coordination with FDA staff for installation and integration with existing FFF system. FDA staff will provide access to laboratory space and existing instrumentation for installation activities.

3.6 Maintenance and Technical Support: At minimum the contractor must:

· Provide support via email, phone, and/or web conference for troubleshooting and technical assistance.

· Provide on-site installation, integration testing, and performance qualification of the detector with existing FFF-MALS system.

· Provide on-site training for FDA staff on detector operation, data analysis, method development, and routine maintenance procedures.

3.7 Inspection and Acceptance Criteria

Partial acceptance is made upon delivery of all the parts. Full acceptance is made after completion of Installation and Operational Qualification (IQ/OQ) by the contractor that the system meets all the specifications and requirements.

3.8 Terms of Use

Fixed Term License: FDA shall the ability to purchase a new subscription after the original subscription expires to continue the use of the software and to gain access to technical support and product upgrades.

3.9 Period of Performance

The period of performance is 12 months from the installation date of the system. The delivery of the entire system with accessories as outlined in the SOW should be completed within 120 days of award. Instrument installation and qualification should be completed within 120 days of award. Instrument familiarization and training should be completed on the day of installation.

3.10 Options

None

3.11 Order Type

The order type is firm-fixed-price.

3.12 Points of Contacts

The COR assigned to this contract is the person at the delivery location who will receive the goods, schedule, and ensure proper installation, is responsible for maintaining the contract record, timely receiving of receipts, and for communicating with the Contracting Officer to ensure the vendor is meeting the requirements of the contract. The COR for this contract is Changning Guo.

Part 4: Contract Clauses

4.1 52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Clauses Number Title

(End of clause)

4.1.1 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

4.2 Department of Health and Human Services Acquisition Regulation (HHSAR) Clauses:

4.2.1 Contractor Compliance with Defending Women and Protecting Children Requirements – Certification (MARCH 2025) (DEVIATION)

(a) Certification. By submission of this offer and during performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor certifies that: [Offeror shall check each item.] ___ (1) It is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Contractor will remain compliant for the duration of the contract.

___ (2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

___ (3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

___ (4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

____ (5) Submitting a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of provision)

4.2.2 352.209-2 Contractor Compliance with Defending Women and Protecting Children Requirements (March 2025) (DEVIATION)

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

(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)

4.2.3 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(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)

4.2.4 Contract Administration

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

The contact information for the Contracting Officer is: Name: Madeline Bryant, Contracting Officer Phone: 240-402-7611 Email: Madeline.Bryant@fda.hhs.gov

The contact information for the Contract Specialist is:

Name: Pamela Lee, Contract Support Specialist Phone: 240-402-3847 Email: Pamela.Lee@fda.hhs.gov

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

The following COR will represent the Government for the purpose of this contract: Name: (To be completed at time of award) Email:

Phone:

4.2.5 Inspection/Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

4.2.6 Payment Terms

Net 30 days after government acceptance of a proper invoice which shall only be submitted after services have been performed. In accordance with the “Advance Payment Statute” at 31 U.S.C § 3324: Advance payments will not be made.

4.2.7 Invoice Submission

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/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.

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 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.

4.2.8 Notice Regarding the Use of Macros in Submitted Documents 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.