RFQ75F40125Q00350.docx

Section 1 – General Information A. Summary of Requirement

This is a Request for Quotation (RFQ) for commercial products and services prepared in accordance with the procedures outlined in Federal Acquisition Regulation (FAR) 8.405-3. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED.

The Request for Quotation (RFQ) number is 75F40125Q00350.

This requirement is being solicited as a total small business set-aside.

a. The NAICS for this requirement is: 541380

b. The Small Business Administration (SB) size standard for NAICS code 541380 (Testing Laboratories) is $47 million in average annual receipts. The full table of size standards can be found at: https://www.sba.gov/document/support-table-size-standards Description of Requirement: The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has a need for services to assist in the validation of molecular assays to detect determine the viability of the ASFV in animal feed/food to support study 414.30. The level of the methods validated should provide regulatory scrutiny so the methods can be used immediately for regulatory emergencies.

Base Period: 10/15/2025 - 10/14/2026

Delivery Location:

FDA/CVM

8401 Muirkirk RD Laurel, MD 20708.

FOB Destination to include inside delivery

B. Points of Contact Contracting Officer:

Ian Weiss Ian.Weiss@fda.hhs.gov

Contract Specialist:

Ryan Alexander Ryan.Alexander@fda.hhs.gov

Technical Contact:

Haile Yancy Haile.Yancy@fda.hhs.gov

Contracting Officer's Representative:

TBD

Section 2 - Contract Clauses Clauses Incorporated by Reference

All applicable terms and conditions from the Contractor’s MAS under SIN 334516 flows down to the associated and awarded order.

Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (JAN 2025)

Clauses by Full Text

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):

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days.

(End of clause)

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.

1. 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;

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

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

4. 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;

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

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

7. 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:

(1) 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

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

(3) 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 Delivery 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.

Section 3 – Attachments

Section 4 – Solicitation Provisions Provisions Incorporated by Reference

Provisions by Full Text 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):

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

(End of provision)

Addendum to FAR 52.212-1

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(m) QUESTION DEADLINE: Questions related to this procurement shall be submitted directly by email to the Contracting Officer and Contract Specialist points of contacted listed in Section 1. All questions must be submitted in writing. Questions not received by the question submission deadline of: August 25, 2025, at 12:00 PM Eastern Time (ET) may not be considered.

(n) QUOTATION DEADLINE: The deadline for receipt of quotations for this requirement September 5, 2025, at 12:00 PM Eastern Time (ET).

(o) The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables. Quotes shall be for all the deliverables requested.

(p) The Contractor shall include and complete the attached pricing schedule/pricing chart. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

(q) Submit two separate volumes: Volume I (Technical) and Volume II (Price). Each volume must be submitted as separate volumes. Volume I must exclude pricing. Volume I shall include personnel qualifications, evidence of trained staff, equipment specifications, work schedule, warranty, and delivery timeline, and is limited to 10 pages.

(r) Quotes shall clearly reference the RFQ number and include:

1. Date of quotation

2. Company Name

3. Company Point of Contact name, email address and phone number

4. System for Award Management Unique Entity ID (UEI)

5. Quotation validity of at least 90 days after RFQ due date and time

(s) The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

52.212-2, Evaluation-Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical

2. Price

All non-price factors when combined are more important than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Addendum to FAR 52.212-2

Factor 1, Technical, will be evaluated to ensure the technical solution meets or exceeds the stated technical requirements and the offeror understands the work.

Factor 2, Price, will be evaluated to ensure it contains an itemized breakdown of price and that it is complete, fair, and reasonable given the items or scope of work. The total evaluated price will be the sum of the base period, any option periods, any optional quantities, and any pro-rated amount for the option under FAR 52.217-8.

The Government anticipates selecting the best-suited quoter from initial responses, without engaging in exchanges with quoters. Quoters are strongly encouraged to submit their best technical solutions and price in response to this RFQ.

Once the Government determines the quoter that is the best-suited (i.e., the apparent successful quoter), the Government reserves the right to communicate with only that quoter to address any remaining issues, if necessary, and finalize a Purchase Order with that quoter. These issues may include technical and price. If the parties cannot successfully address any remaining issues, as determined pertinent at the sole discretion of the Government, the Government reserves the right to communicate with the next best-suited quoter based on the original analysis and address any remaining issues. Once the Government has begun communications with the next best-suited quoter, no further communications with the previous quoter will be entertained until after the Purchase Order has been awarded. This process shall continue until an agreement is successfully reached and a Purchase Order is awarded.

(End of provision)

ALP: CVM-2025-129648

RFQ # 75F40125Q00350

Description: validation of molecular assays to detect determine the viability of the ASFV in animal feed/food to support study

Statement of work

Background Due to the current emerging threat and unavailability of a vaccine or treatment for ASFV, the validation efforts will focus on a rapid and reliable detection of the ASFV in animal food. This proposal presents a test protocol to validate molecular methods to first detect then determine viability, the first step in the infectivity phase of ASFV. The method development consisted of optimizing nucleic acid extraction, virus detection determining ASFV viability using modern state-of-the-art molecular methods (Biosensor, Viability qPCR, BioTag ,and Loop-mediated isothermal amplification (LAMPtracers)). The methods passed in-house testing for the assessment of the sensitivity (identifying true positives), selectivity (identifying true negatives), and ruggedness of the assays. Additional trials of the assays were also conducted as well as by an external laboratory for peer verification using synthetic nucleic acids (sDNA) and EhV-86. The goal of this study is to validate an ASFV-like modeling systems that can be conducted in a BSL-2 laboratory and second validate the molecular assays, using the ASFV in a BSL-3 facility, that can detect and infectivity of the ASFV in animal food and food ingredients. The purchase of the BSL-3 laboratory rental time, controls and consumables are needed for validation study. The development of alternative modeling systems and validation of these molecular assays to detect ASFV is a critical component in the establishment of a US Animal Food Biosecurity Safety System.

Objectives The government needs the services to assist in the validation of molecular assays to detect determine the viability of the ASFV in animal feed/food to support study 414.30. The level of the methods validated should provide regulatory scrutiny so the methods can be used immediately for regulatory emergencies.

Scope

The government expects the contractor to provide the services of generating the validation data to support the methods acceptance for regulatory use to support study 414.30. The data generated is expected to confirm the utility of the modeling system as well as the molecular methods for regulatory use. The expectations of the services are to assist the implementation of strict biosecurity measures, surveillance, and control measures to prevent and control ASF outbreaks and mitigate its public health and economic impact.

Minimum Technical Requirements

The government is requiring the minimum technical requirements for the validation of three African swine fever virus (ASFV) assays, to be conducted in a BSL-3 laboratory setting.

Minimum Technical Requirements for Validation of ASFV Assays in am BSL-3 Laboratory

1. The Ability to Validate the Analytical Sensitivity and Limit of Detection (LOD) of the government’s provided assays

- Standard Curve Development: Create a standard curve using known concentrations of ASFV DNA to determine the assay's LOD.

- Repeatability and Reproducibility: Conduct multiple assays to evaluate repeatability (within-run) and reproducibility (between-run) across different days and operators.

2. Sample Type and Preparation

- Acceptable Animal Feed/Food Matrices: Define acceptable sample types (e.g., blood, tissue, animal feed) and establish protocols for handling and processing.

- Virus Viability Assessment: Include methods to assess the viability of ASFV in different matrices and determine the stability of the virus under various conditions.

3. Quality Control Measures

- Internal Controls: Incorporate positive, negative, and inhibition controls in each assay run.

- Reagent Quality Assurance: Use high-quality reagents from reputable suppliers, ensuring compatibility with BSL-3 standards.

- Equipment Calibration: Regularly calibrate and maintain PCR equipment to ensure optimal performance and reliability.

4. Data Analysis and Interpretation

- Threshold Definitions: Establish clear criteria for interpreting assay results based on standard curves and controls.

- Statistical Evaluation: Implement statistical methods for data analysis to validate assay performance metrics.

5. Safety and Regulatory Compliance

- BSL-3 Laboratory Protocols: Adhere to BSL-3 safety protocols throughout the assay validation process, including appropriate personal protective equipment (PPE) and biosafety practices.

- Standard Operating Procedures (SOPs): Develop and maintain SOPs for all procedures related to assay validation, ensuring compliance with regulatory guidelines.

6. Training and Personnel Competency

- Personnel Training: Ensure all personnel are trained in BSL-3 laboratory practices, PCR techniques, virology, and molecular biology.

- Competency Assessments: Conduct regular competency assessments through proficiency testing and continuous education.

7. Documentation and Record Keeping

- Comprehensive Documentation: Maintain thorough records of all validation activities, including experimental designs, results, and analyses.

- Audit Trail: Ensure traceability for all materials, processes, and personnel involved in the assay validation.

8. Post-Validation Review

- Review and Approval: Establish a process for reviewing and approving assay validation results by qualified personnel.

- Continuous Monitoring: Implement a system for ongoing monitoring and evaluation of assay performance in routine use.

Tasks

Task Areas Include specific titles of all tasks for required performance.

Milestones Projected Completion Date

Task 4.2 Submit method validation protocol.

Task 4.5 Conducting the ASFV Validation experiments.

Task 4.6 Validation data and final report submitted to the government.

Total

4.1 Task 1 – Study protocol meeting

The contractor shall meet with the government to outline the criteria of the validation studies to be conducted in a biosafety level 3 (BSL-3) facility. The meeting shall be conducted within 30 days of the approval of the contract. The meeting may be online or in person for all participants (government/contractors, or any other participants deemed necessary that will have a role in the protocol development).

4.2 Task 2 - Submit method validation protocol.

The method validation protocol shall be summitted to the government for approval. The validation shall include testing guidelines the agreed testing utilizing the Guidelines for the Validation of Microbiological Methods for the FDA Foods Program SOP and follow a similar approach conducted for two current validated molecular methods for detecting animal material in FDA regulated products (animal food and crude heparin). Specifically, addressing the molecular method to be evaluated (BioGx, LAMP, and biosensor), experimental controls (live ASFV, Emiliania huxleyi virus 86 (EhV-86), ASFV inoculated levels, and ASFV viability parameters.

4.3 Task 3 - Study supplies and consumables ordered

The commencing of ordering the supplies and consumables shall begin within four (4) weeks after the validation protocol is approved by all parties (government/contractors).

1. Efficiency: Gathering all necessary materials beforehand will help streamline the workflow, minimizing interruptions and delays that can occur if there is a need to stop to search for or purchase additional supplies.

2. Time Management: Planning and preparing supplies in advance allows the allocation of time more effectively, ensuring that the study can completed within the contract deadlines.

3. Quality Control: Having all supplies ready enables the ability to check the quality and suitability for the project, reducing the risk of using inadequate or inappropriate materials.

4. Cost Management: By purchasing supplies in advance, it may be possible to take advantage of better pricing or sales, preventing last-minute purchases that may be more expensive.

5. Problem-Solving: By having all the supplies, any potential issues or shortages can be identified and addressed before the start of the validation experiments, leading to a smoother project execution.

Because of the complexity of the ASFV validation experiments, preparation will be the key to a successful project execution, and having all supplies ready is a fundamental part of that preparation.

Task 4 - Validation controls (ASFV, Eh-V, biotags) created

The commencing of designing and ordering the ASFV experimental controls shall begin within four (4) weeks after the validation protocol is approved by all parties (government/contractors).

Controls are vital in the ASFV validation experiments for several reasons:

1. Establishing Baselines: Controls provide a standard for comparison. They help researchers determine what happens under normal conditions, allowing them to assess the effects of the experimental variable.

2. Eliminating Variables: By using controls, researchers can isolate the effect of the independent variable on the dependent variable. This helps ensure that any changes observed are due to the treatment being tested rather than other factors.

3. Enhancing Validity: Controls improve the internal validity of an experiment by reducing confounding variables. This means that the results are more likely to reflect a true cause-and-effect relationship.

4. Reproducibility: Experiments with well-defined controls can be replicated by other researchers. This is crucial for verifying results and building upon previous findings in scientific research.

5. Understanding Variability: Controls help account for natural variability in experimental results. This understanding allows researchers to make more accurate conclusions about the effects of the tested variable.

6. Identifying Errors: Controls can help identify experimental errors or biases. If the control group produces unexpected results, it may indicate flaws in the experimental design or methodology.

7. Supporting Claims: Controls provide evidence to support or refute hypotheses. They strengthen the credibility of the findings by showing that the observed effects are not due to random chance.

In summary, controls are essential for ensuring that experiments are valid, reliable, and capable of producing meaningful results. They play a critical role in the scientific method by helping to isolate variables and confirm hypotheses.

Task 5 - Conducting the ASFV Validation experiments.

The contractor shall conduct the ASFV validation experiments contained in the parties agreed upon protocol. The validation studies may include the following:

Task 6 - Validation data and final report submitted to the government.

A detailed scientific final report that shall be provided to the government by 10/17/2026 and shall consist of several key sections, each serving a specific purpose in presenting the ASFV validation experimental findings clearly and systematically.

The outline of the essential components of a scientific report shall include:

1. Title: A concise and descriptive title that reflects the focus of the research.

2. Abstract: A summary (usually 150-250 words) of the purpose, methods, results, and conclusions of the study. It provides readers with a quick overview of the research.

3. Introduction:

- Background information on the topic.

- A literature review summarizing relevant research.

- The research question or hypothesis.

- The purpose and significance of the study.

4. Materials and Methods:

- Detailed description of the materials, equipment, and procedures used.

- Information on experimental design, sample size, and controls.

- Any statistical analyses performed.

5. Results:

- Presentation of the findings, often using tables, graphs, and figures for clarity.

- A clear and objective reporting of the data without interpretation.

6. Discussion:

- Interpretation of the results, explaining their significance and implications.

- Comparison with existing literature and theories.

- Discussion of limitations and potential sources of error.

- Suggestions for future research.

7. Conclusion: A summary of the main findings and their relevance to the research question, highlighting the key takeaways.

8. References: A list of all sources cited in the report, formatted according to a specific citation style (e.g., APA, MLA, Chicago).

9. Appendices: Additional material that supports the report but is not essential to its main text, such as raw data, supplementary figures, or detailed calculations.

Each section shall be written clearly and concisely, following appropriate scientific conventions. The structure may vary slightly depending on the writing style of the contractor.

Delivery

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

The government (Haile Yancy POC) will provide the LAMP assay for testing.

Security

Not Applicable. The work will be performed offsite at the contractor’s facility. Contractor will not be required to be badged nor will the contractor have access to Government systems. Information security does not apply to this requirement.

Travel

Not Applicable Special Material Requirements

Not Applicable Other Unique Requirements

Not Applicable Place of Performance

The government requires the experimental controls; sample feed preparation and testing will be performed at the contractor’s BSL-2 and 3 facilities.

Period of Performance

The study design, sample preparation, validation testing, and data analysis services are needed from October 15th 2025 - October 14th, 2026 with no option years to follow.

Attachment 2, Pricing Schedule