RFQ 75F40126Q00378.pdf

Request for Quotation (RFQ) 75F40126Q00378

HOUSE DUST MITE ANTIBODY SETS TO STANDARDIZE ALLERGEN EXTRACTS

75F40126Q00378

Solicitation number 75F40126Q00378 is issued as a request for quotation (RFQ).

All responsible sources may submit a quotation, which will be considered by the agency.

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

• NAICS Code: 541715 – Research and Development in the Physical, Engineering, and Life Sciences.

• PSC Code: AC23 – Applied Research — Health Sciences

• Set-Aside: None, Full and Open Competition

• Type of Contract: Firm Fixed Price (FFP)

• Acquisition Method: FAR Part 12 (RFO) Acquisition of Commercial Products and Commercial Services

• Response Due Date/Time: September 8, 2026, 2:00pm. Eastern Time

Line Item Structure

Firm Fixed Price (FFP)

Line Item Item Name Quantity Unit Price Total Cost

1 Monoclonal antibodies (mAb) to standardize house dust mite (HDM) allergen extracts.

1 $ $

Total Cost

STATEMENT OF WORK

FOOD AND DRUG ADMINISTRATION (FDA)

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

HOUSE DUST MITE ANTIBODY SETS TO STANDARDIZE ALLERGEN EXTRACTS

BACKGROUND

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The Center for Biologics Evaluation and Research (CBER) ensures the safety, purity, potency, and effectiveness of biological products—such as vaccines, blood, and gene therapies—while protecting public health against emerging infectious diseases and bioterrorism. Allergen extracts are heterogenous mixtures of naturally derived proteins that are used to treat and aid in the diagnosis of IgE-mediated allergic disease.

CBER's authority to regulate allergen extracts is found in Part 680 of Title 21 of the Code of

Federal Regulations (21 CFR 680). Allergen extracts may be standardized or unstandardized.

Standardization is the process by which a reference extract is selected, and methods and procedures are developed to quantitatively compare a test extract with a reference extract to establish equivalence. CBER's authority to standardize allergen extracts is found in 21 CFR

680.3, which states that once CBER has identified a potency test for an allergen extract, the extract is standardized and released with that potency designation.

Among the hundreds of allergen extracts sold in the United States, 19 are currently standardized, including extracts from Hymenoptera venoms, cat hair and pelt, short ragweed and grass pollens, and house dust mites (HDM). HDM extracts were last standardized in 1991 using the method of

“overall allergenicity” in which potency values are “allergy units” (AU) that were derived from skin testing. The advantage of defining potencies by overall allergenicity is that it is agnostic to the relative contribution of individual allergens to the sum of biological potency (i.e., overall allergenicity), which allowed for standardization in an era in which few allergens were identified or characterized. The disadvantage is that qualitatively dissimilar extracts can have the same overall allergenicity (i.e., equal AU/mL values). Since 1991, HDM allergen proteins have been identified and characterized, thus presenting an alternative to using overall allergenicity as a measure of HDM extract potency.

On October 9, 2025, LIB sought and received concurrence from the Vaccines and Related

Biological Products Advisory Committee (VRBPAC) on LIB's proposal to modernize CBER's allergen standardization program. The approved proposal included an initiative to change the manufacturing of HDM extracts from using source material (SM) solely comprised of HDM bodies to SM comprised of both HDM bodies and fecal pellets. One justification for including fecal pellets is that two major allergens, Der p 1 and Der p 23 or Der f 1 and Der f 23, from

Dermatophagoides pteronyssinus and Dermatophagoides farinae, respectively) are enriched in the fecal pellets. Additionally, the fecal pellets may be more relevant to allergic asthma because their small size enables them to penetrate the lower airways.

The pending revision of HDM source materials presents an opportunity to revisit the manner in which HDM allergen extracts are standardized by defining potencies according to levels of allergens from Groups 1, 2, and 23—which are considered the most important HDM allergens.

Therefore, CBER seeks specific antibody pairs for each of these allergens that can be used in an enzyme linked immunoassay (ELISA) format to define potencies of HDM allergen extracts.

OBJECTIVE

The objective of this SOW is to obtain antibody pairs that can be used in an ELISA to quantitatively measure levels the HDM allergens shown in Table 1.

Table 1 Allergen Extract

Allergen Extract

Allergen Group D. pteronyssinus Extract D. farinae Extract

Group 1 Der p 1 Der f 1

Group 2 Der p 2 Der f 2

Group 23 Der p 23 Der f 23

Since allergens from the same group (e.g., Der p 1 and Der f 1 are two Group 1 allergens) are highly homologous, it is financially advantageous to have mAb that are Group specific but not species specific. However, at least one of the assays should be species specific to ensure proper species identification. For example, it is acceptable and financially advantageous to have one set of antibodies for Der p 1 and Der f 1, one set of antibodies for Der p 23 and Der f 23. However, in that case, there should be two separate sets of ELISA reagents for Group 2 allergens (Der p 2 and Der f 2) to ensure that the two HDM extracts are not inadvertently switched.

Quantities supplied should be sufficient for 450 96-well microtiter assay plates to measure each allergen Group—50% D. pteronyssinus, 50% D. farinae.

SCOPE

The following antibody pairs are necessary:

1. Specific antibody pair that measures the Group 1 allergen Der p 1 by ELISA.

2. Specific antibody pair that measures the Group 1 allergen Der f 1 by ELISA.

3. Specific antibody pair that measures the Group 2 allergen Der p 2 by ELISA.

4. Specific antibody pair that measures the Group 2 allergen Der f 2 by ELISA.

5. Specific antibody pair that measures the Group 23 allergen Der p 23 by ELISA.

6. Specific antibody pair that measures the Group 23 allergen Der f 23 by ELISA.

Note that two of the three antibody sets may be used to measure allergens of the same group from the two different HDM species. However, at least one allergen Group must have a set of species-specific antibodies. For example, it is acceptable (and perhaps financially advantageous) to have one set of antibodies for Der p 1 and Der f 1, one set of antibodies for Der p 23 and Der f

23. However, in that case, there should be two separate sets of ELISA reagents for Group 2 allergens (Der p 2 and Der f 2) to ensure that the two HDM extracts are not inadvertently switched.

The supplier should present data to demonstrate that the antibody sets are fit for purpose for an

ELISA, demonstrating sufficient sensitivity for each set, and species specificity for the sets intended to be species-specific.

TASKS

TASK ONE: ADMINISTRATIVE

Throughout this purchase order, the Contractor shall work with the FDA’s Contracting Officer

Representative (COR), various FDA staffers and the Contracting Officer (CO), to provide technical and/or administrative assistance, review, and support services for the FDA to ensure that the tasks are performed efficiently, accurately, on time, and in compliance with the requirements of this SOW.

The Contractor shall coordinate, as necessary, with the technical POC and the COR to ensure that the tasks are managed consistently in accordance with overall Order requirements.

TASK TWO: DELIVERY

Deliver antibody sets.

DELIVERABLES

Antibody pairs that can be used for measurements by ELISA of house dust mite proteins Der p 1, Der p 2, Der p 23, Der f 1, Der f 2, and Der f 23 in sufficient quantity to measure each protein from each species on 225 96-well microtiter plates (See Table: Summary of Deliverables).

FORMAT OF DELIVERABLES

Liquid, either at 4oC or frozen on ice.

DELIVERY ADDRESS

Delivery POC: Aaron Chen

Delivery Address: Building 52/72, Room 3346

10903 New Hampshire Avenue

Silver Spring, MD 20993

SUMMARY OF DELIVERABLES

Deliverables Quantity/Frequency Due Date Quantity

Antibody pair for measuring House Dust

Mite protein Der p 1

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

Antibody pair for measuring House Dust

Mite protein Der f 1

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

Antibody pair for measuring House Dust

Mite protein Der p 2

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

Antibody pair for measuring House Dust

Mite protein Der f 2

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

Antibody pair for measuring House Dust

Mite protein Der p 23

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

Antibody pair for measuring House Dust

Mite protein Der f 23

One / Once 60 days after award.

Sufficient for 225

96-well microtiter

ELISA plates

CONTRACT TYPE

The expected contract type is a Firm-Fixed-Price Contract.

PERIOD OF PERFORMANCE

The expected period of performance is twelve (12) months.

HOLIDAYS AND GOVERNMENT CLOSURES

The Contractor is not required to provide on-site services on the following days that are Federal

Holidays or on any other day designated as a Federal holiday, Government closure, or shut-down for the Washington, D.C. area:

• New Year's Day

• Martin Luther King Day

• President 's Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veteran 's Day

• Thanksgiving Day

• Christmas Day

GOVERNMENT CONTACTS

Contracting Officer

Name: Ian Weiss

Email Address: ian.weiss@fda.hhs.gov

Contract Specialist

Name: Natalie Brown

Email Address: natalie.brown@fda.hhs.gov

Contracting Officer’s Representative

Name: TBD

Email Address: TBD

Technical Point of Contact

Name: TBD

Email Address: TBD

SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Federal Acquisition Regulation (FAR)

52.212-1 Instructions to Offerors – Commercial Products and Commercial Services SEP 2023

52.212-2 Evaluation – Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality

Agreements or Statements–Representation JAN 2017

52.204-7 System for Award Management NOV 2024

52.240-90 Security Prohibitions and Exclusions Representations and Certifications DEC 2025

52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services

NOV 2023

52.203-17 Contractor Employee Whistleblower Rights NOV 2023

52.204-13 System for Award Management Maintenance OCT 2018

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations NOV 2015

52.222-3 Convict Labor JUN 2003

52.222-19 Child Labor–Cooperation with Authorities and Remedies DEC 2022

52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020

52.222-50 Combating Trafficking in Persons NOV 2021

52.222-90 Addressing DEI Discrimination by Federal Contractors APR 2026

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving MAY 2024

52.227-14 Rights in Data—General--Alternate IV DEC 2007

52.232-33 Payment by Electronic Funds Transfer–System for Award Management OCT 2018

52.233-3 Protest after Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.240-91 Security Prohibitions and Exclusions DEC 2025

52.240-93 Basic Safeguarding of Covered Contractor Information Systems DEC 2025

52.244-6 Subcontracts for Commercial Products and Commercial Services

Health and Human Services Acquisition Regulation (HHSAR)

352.235-70 Notice to Offerors, Protection of Human Subjects MAR 2026 (RFO DEVIATION)

352.239-78 Information and Communication Technology Accessibility Notice (Feb 2024)

(DEVIATION)

352.223-70 Safety and Health DEC 2015

352.224-70 Notification of System of Records Notice FEB 2024 (Deviation)

352.224-71 Confidential Information FEB 2024 (Deviation)

352.227-72 Publications and Publicity JUN 2026 (RFO DEVIATION)

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

(DEVIATION)

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

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) (see 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 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 Products and Commercial Services 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.

(1) At a minimum the following cost information must 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 must 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 must 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:

*Invoice number, amount, & date submitted

*Corresponding payment amount & date received

*Total amount of all payments received to date under the subject contract or order, 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 must 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 must not be paid, or must 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.

QUOTATION SUBMISSION INSTRUCTIONS

Quotations shall consist of two (2) separate volumes:

• Volume I - Technical Approach: Describe the offeror's technical approach, methodology, qualifications, and key personnel for each task in the SOW. Page limit: 50 pages

• Volume II - Price/Business: Quote formatted using the Line-Item Structure. Provide a basis of estimate, including representations and certifications

Please submit any questions/clarifications regarding this requirement as soon as possible to

Natalie Brown at Natalie.Brown@fda.hhs.gov.

Quotations shall be submitted electronically to Natalie Brown at Natalie.Brown@fda.hhs.gov for this solicitation no later than September 8, 2026, 2:00pm. Eastern Time.

The subject line shall read: RFQ 75F40126Q00378 House Dust Mite Antibody Sets to

Standardize Allergen Extracts

Award will be made to the responsible offeror whose quotation represents the best value to the

Government. Quotations will be evaluated using the following evaluation factors, in order of importance:

(1) Technical Capability and Approach

(2) Past Performance- HDM-relevant experience (e.g., allergen extract characterization, ELISA development, immunological reagent supply).

(3) Price/Cost-evaluated for reasonableness and realism.

Non-price evaluation factors, when combined, are significantly more important than price. The

Government reserves the right to award without discussions. Offerors are encouraged to submit their best quotation initially.