Solicitation - N0018926RB011 27May2026.pdf

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N0018926RB011 - Drug Demand Reduction Program, Fentanyl/Norfentanyl Immunoassay Reagent Kits
Solicitation number
N0018926RB011
Issued by

About this file

This is a combined pre-solicitation notice and solicitation (Notice ID N0018926RB011) for FDA and quality management documented fentanyl/norfentanyl immunoassay reagent kits compatible with Beckman Coulter AU5800 series analyzers, issued by the U.S. Navy (Department of War) on May 27, 2026. The procurement is structured as a firm-fixed-price indefinite delivery/indefinite quantity (IDIQ) contract under FAR Part 12 simplified acquisition procedures, designated for women-owned small business (WOSB) set-aside. The estimated quantity is 30,000,000 kits over a five-year base ordering period from August 1, 2026 through July 31, 2031, with individual orders ranging from a minimum of 1,000 to a maximum of 6,000,000 kits per order, and government minimum/maximum orders of 5,000 to 30,000,000 kits. The NAICS code is 325413 (in-vitro diagnostic substance manufacturing) with a small business size standard of $1,250.

The solicitation employs a two-step source selection process. Step One requires interested sources to submit technical proposals by June 3, 2026 at 12:00 PM ET, with evaluation on a Pass/Fail basis covering FDA authorization/ISO certification, SOW compliance attestation with OEM requirements, and reagent preparation/calibration information. Only sources determined viable proceed to Step Two, due by June 26, 2026, consisting of written non-price and price proposals plus performance testing. Step Two non-price evaluation factors include performance test minimum requirements (Pass/Fail), performance test enhancing factors (linearity, sensitivity/predictive rates, specificity, ease of preparation), past performance, and small business participation plan. The government will conduct performance testing of reagent kits at Department of War forensic toxicology drug testing laboratories, requiring offerors to ship sufficient kits for at least 5,000 tests within five business days of viability notice. Small business subcontracting goals include 30% small business, 5% small disadvantaged business, 5% women-owned small business, 3% HUBZone, and 3% service-disabled veteran-owned small business. Questions must be submitted by May 29, 2026 to contracting officer Austin Waller at Austin.p.waller.civ@us.navy.mil. The contract incorporates standard FAR and DFARS clauses including buy American requirements, payment via wide area workflow, and electronic funds transfer.

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Text version

WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect calls)

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

Created On:

27 May 2026, 12:53 PM Greenwich Mean Time

Solicitation/Contract Form Continuation

Drug Demand Reduction Program - Fentanyl Reagent Kits

This is a COMBINED PRE-SOLICITATION NOTICE/SOLICITATION for commercial items prepared in accordance with the information herein, using Simplified Acquisition Procedures under FAR Part 12. This announcement constitutes the only solicitation. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This combined synopsis/solicitation SHALL be posted on the Governmentwide Point of Entry (https://sam.gov/).

The Notice ID number is N0018926RB011. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The applicable provisions and clauses may be accessed in full text at this address:

https://www.acquisition.gov/far-overhaul

The NAICS code is 325413 - In-Vitro Diagnostic Substance Manufacturing and the small business standard is $1,250.00. The proposed contract action is for the acquisition of products which the Government intends to solicit and negotiate on a Firm-Fixed-Price IDIQ contract basis, under which delivery orders will be issued.

NOTE TO OFFERORS

Questions:

Questions must be submitted in writing via email to Austin Waller at Austin.p.waller.civ@us.navy.mil, and must be received by Mr. Waller no later than 12:00pm Eastern Time (Philadelphia) on 29 May 2026.

GENERAL INFORMATION

The Navy is soliciting interested sources in accordance with FAR 12.201-1, Simplified procedures, using the procedures and evaluation factors described in this provision. It is emphasized that this is intended to streamline the source selection and be minimally burdensome for both the Navy and vendors interested in competing for this requirement.

The contracting officer will make the source selection using the following two-step process.

Step One

Under Step One, interested source shall submit Volume I, consisting of the interested source's Technical Approach, which includes three aspects detailed below. Step One is to be submitted no later than 12:00pm Eastern Time (Philadelphia) on 03 June 2026 via email to Austin Waller at austin.p.waller.civ@us.navy.mil

Submissions in response to Step One shall not exceed 40 pages, excluding a Cover Sheet and Table of Contents, in length. The page limitations are inclusive of any charts, diagrams, and/or other graphics. Each "page" is defined as one sheet, 8 1/2 " x 11", with at least one inch margins on all sides, using a font with a point size of 12 or greater (e.g., "Times New Roman" style with 12 point font) and "Normal" character spacing. Lines shall, at a minimum, be single-spaced. The only exceptions to the font size requirement include the following: (1) the text contained in graphics, charts, headers and footers may be point size of 8 or greater. Pages shall be consecutively numbered. Multiple pages, double pages, or two-sided pages, will count as an equivalent number of 8 1/2" x 11" pages. The cover sheet and table of contents (not to exceed one page each) will not count toward the page limit. Pages submitted in excess of the page limitations described above will not be evaluated. The Government may exercise discretion in determining which specific pages are considered to be in excess of the page limitations.

N0018926RB011

The contracting officer will evaluate each Step One submission and determine which interested sources are viable competitors for award. Each aspect of the interested source's Technical Approach, outlined below, will be evaluated individually on a Pass/Fail basis.

Volume I: Technical Approach. The three aspects of Technical Approach include:

- FDA Authorization and ISO Certification or Quality Assurance Documentation (Pass/Fail)

- Statement of Work (SOW) Compliance Attestation and OEM Requirements (Pass/Fail)

- Reagent Preparation and Calibration Information (Pass/Fail)

FDA Authorization and ISO Certification or Quality Assurance Documentation. For a Pass rating, the interested source's submission shall contain ALL of the following:

* Documentation of FDA approval/authorization for use of the Fentanyl Immunoassay Reagent.

* Documentation of current certification compliance with applicable ISO Standards OR documentation of compliance with SOW Sections 4.1 through 4.4.5.

SOW Compliance Attestation and OEM Requirements. For a Pass rating, the interested source's submission shall contain ALL of the following:

* SOW Compliance Attestation in accordance with the SOW Section 6.1.

* Evidence of being an Original Equipment Manufacturer (OEM) of reagents, OR an authorized dealer, authorized distributor, or authorized reseller for the proposed reagents such that OEM parameters, quality controls, and services are provided and maintained by the OEM.

Reagent Preparation and Calibration Information. For a Pass rating, the interested source's submission shall contain ALL of the following:

1) Explanation and principles of the testing procedure;

2) Description of each reagent's composition for use on the Beckman Coulter AU5800 Series Analyzer in the processing of specimens. The immunoassay procedure is limited to a two (2) reagent assay procedure;

3) Instructions for reagent handling, mixing, and storage;

4) Reagent stability and storage requirement for both un-opened and opened reagent kits;

5) Minimum shelf life for un-opened and opened reagent kits. In accordance with the SOW Section 1.5, the un-opened reagent kits shall have a 180-day minimum shelf life from the date of product delivery and opened reagent kits shall be stable for at least 14 days;

6) Calibration and Instrument parameters for use on the Beckman Coulter AU5800 Series Analyzer. The calibrators and controls shall be Department of War (DoW)-prepared and -certified solutions containing fentanyl;

7) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the target analyte fentanyl; and

8) Table of cross-reactivity and specificity of the assay to commonly encountered scheduled compounds, common over-the-counter medications, and other principal drugs of abuse.

An interested source must provide all of the required documentation to support each aspect of the Technical Approach in order to receive a Pass. An interested source must receive a Pass in each aspect of the Technical Approach in order to be determined to be viable for award. If an interested source does not provide the required documentation for each aspect of the Technical Approach, the interested source will receive a Fail rating and will be determined to be nonviable for award.

In addition to the information submitted by interested sources in Step One, the contracting officer may consider other information reasonably related to the Step Two evaluation factors, to include the personal knowledge of the interested source's commercial and Government customers, and past performance databases. The contracting officer is not obligated to evaluate all information submitted from each interested source. For example, the contracting officer may curtail evaluation of an interested source's Step One submission if at any point the contracting officer determines that the interested source is unlikely to be determined to be a viable competitor for award.

The contracting officer may communicate with an interested source at any time during the Step One process without regard to the FAR Subpart 15.2 and Subpart 15.3 rules concerning competitive range determinations and negotiations, if such communications will enhance the contracting officer's determination of whether the source is a viable competitor for award.

The contracting officer will notify those interested sources determined nonviable that they are eliminated from further consideration and invite interested sources determined viable to submit a proposal in response to Step Two.

Step Two

Upon the completion of the Step One process and notice of viability, the Contracting Officer will invite those sources determined to be viable to provide non-price and price proposals as part of Step Two of the evaluation process.

Offerors (i.e., interested sources invited to submit Step Two proposals) shall follow the method of proposal submission set forth in FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, and its Addendum. Offerors' proposals will be evaluated in accordance FAR 52.212-2, Evaluation-Commercial Products and Commercial Services.

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Allowed Per Order Minimum: 1,000 Each Maximum: 6,000,000 Each

Government Minimum/Maximum to Order Minimum: 5,000 Each Maximum: 30,000,000 Each

Item Supplies/Service Estimated Quantity

Unit Unit Price Amount

FDA and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems

Pricing Arrangement: Firm Fixed Price

30,000,000 Each

Continuation of Description

Requirements FDA and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting fentanyl /norfentanyl in human urine samples.

Continuation of Packaging and Marking

Continuation of Inspection and Acceptance

Continuation of Deliveries or Performance

Overall Contract Delivery Period

Period of Performance From 01 Aug 2026 to 31 Jul 2031

The ordering period above may include unexercised options

Contractor Destination

Line Item Delivery Schedule Estimated Quantity

Address and POC Special Handling/Notes

Period of Performance From 01 Aug 2026 To 31 Jul 2031

30,000,000 Each FoB Details Contractor Destination

Continuation of Accounting and Appropriation Data

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.219-16 Liquidated Damages-Subcontracting Plan. (Deviation 2026-O0038) Feb 2026 52.219-8 Utilization of Small Business Concerns. (Deviation 2026-O0038) Feb 2026 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. Jan 2017 52.204-13 System for Award Management-Maintenance. (Deviation 2026-O0038) Feb 2026 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving. May 2024 52.232-33 Payment by Electronic Funds Transfer-System for Award Management. Oct 2018 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. Mar 2023 52.233-3 Protest after Award. (Deviation 2026-O0038) Feb 2026 52.233-4 Applicable Law for Breach of Contract Claim. (Deviation 2026-O0038) Feb 2026

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.203-7000 Requirements Relating to Compensation of Former DoD Officials. Sep 2011 252.203-7002 Requirement to Inform Employees of Whistleblower Rights. Dec 2022

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services.

Jan 2023

252.223-7008 Prohibition of Hexavalent Chromium. Jan 2023 252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime. Jan 2023 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports. Dec 2018 252.232-7010 Levies on Contract Payments. Dec 2006 252.247-7023 Transportation of Supplies by Sea. Oct 2024

FAR Clauses Incorporated by Full Text

52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. (Deviation 2026-O0038)

(Feb 2026)

NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS (FEB 2026) (DEVIATION 2026- O0038)

Evaluation preference.(a)

Offers will be evaluated by adding a factor of 10 percent to the price of all offers, except-(1)

(i) Offers from HUBZone small business concerns that have not waived the evaluation preference; and

(ii) Otherwise successful offers from small business concerns.

(b) . A HUBZone small business concern may choose to waive the evaluation preference. If the concern waives Waiver of evaluation preference the preference, the factor will be added to its offer for evaluation purposes.

Offeror chooses to waive the evaluation preference.

(c) A HUBZone joint venture agrees that, in the performance of the contract, at least 40 percent of the aggregate work performed by Joint venture.

the joint venture shall be completed by the HUBZone small business parties to the joint venture. Work performed by the HUBZone small business parties to the joint venture must be more than administrative functions.

(End of provision)

DFARS Clauses Incorporated by Full Text

252.232-7006 Wide Area WorkFlow Payment Instructions. (Jan 2023)

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) As used in this clause- Definitions.

"Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit, activity, or organization.

"Document type" means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

"Local processing office (LPO)" is the office responsible for payment certification when payment certification is done external to the entitlement system.

"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as Electronic invoicing.

authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) To access WAWF, the Contractor shall- WAWF access.

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice WAWF training.

Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at https://wawf.eb.mil/

(e) Document submissions may be via web entry, Electronic Data Interchange, or File Transfer WAWF methods of document submission.

Protocol.

(f) The Contractor shall use the following information when submitting payment requests and receiving reports WAWF payment instructions.

in WAWF for this contract or task or delivery order:

(1) The Contractor shall submit payment requests using the following document type(s): Document type.

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items-

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either "Invoice 2in1" or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial financing, submit a commercial financing request.

(2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF "combo" document type to create some combinations of invoice and receiving report in one step.]

(3) The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in Document routing.

WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC ____

Issue By DoDAAC ____

Admin DoDAAC ____

Inspect By DoDAAC ____

Ship To Code ____

Ship From Code ____

Mark For Code ____

Service Approver (DoDAAC) ____

Service Acceptor (DoDAAC) ____

Accept at Other DoDAAC ____

LPO DoDAAC ____

DCAA Auditor DoDAAC ____

Other DoDAAC(s) ____

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert "See Schedule" or "Not applicable.")

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in Payment request.

accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F. Receiving report.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

(Contracting Officer: Insert applicable information or "Not applicable.")

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Addendum to 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services

Contract Terms and Conditions Required To Implement Statutes or Executive Orders — Commercial Products and Commercial Services

Addendum to Contract Clauses

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.219-9 Small Business Subcontracting Plan. (Deviation 2026-O0038) (Alternate II) Feb 2026 Alternate II Feb 2026 52.247-34 F.o.b. Destination. Jan 1991

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (Deviation 2026- O0038)

Feb 2026

52.240-91 Security Prohibitions and Exclusions. (Deviation 2026-O0038) Feb 2026

52.244-6 Subcontracts for Commercial Products and Commercial Services. (Deviation 2026- O0038)

Apr 2026

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.225-7001 Buy American and Balance of Payments Program. Feb 2024 252.225-7012 Preference for Certain Domestic Commodities. Apr 2022

FAR Clauses Incorporated by Full Text

52.216-18 Ordering. (Aug 2020)

Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from through .01 August 2026 31 July 2031

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when-

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either-

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

52.216-19 Order Limitations. (Oct 1995)

Order Limitations (Oct 1995)

(a) . When the Government requires supplies or services covered by this contract in an amount of less than [insert dollar Minimum order $1,000.00 figure or quantity], the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) . The Contractor is not obligated to honor-Maximum order

(1) Any order for a single item in excess of ;the maximum basic value of the contract

(2) Any order for a combination of items in excess of ; orthe maximum basic value of the contract

(3) A series of orders from the same ordering office within days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) 30 of this section.

(c) If this is a requirements contract ( includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the i.e., Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the Contractor's 30 intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 Indefinite Quantity. (Deviation 2026-O0038) (Feb 2026)

Indefinite Quantity (Feb 2026) (Deviation 2026-O0038)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after .31 July 2032

(End of clause)

List of Contract Documents, Exhibits, or Attachments

Attachments:

Number Attachment Name Attachment Description Reference Identifier

Date

SOW - DDRP

Fentanyl Testing Kit FINAL

Statement of Work 26 May

Solicitation Provisions

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.203-7005 Representation Relating to Compensation of Former DoD Officials. Sep 2022 252.204-7024 Notice on the Use of the Supplier Performance Risk System. Mar 2023 252.225-7055 Representation Regarding Business Operations with the Maduro Regime. May 2022

DFARS Clauses Incorporated by Full Text

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services-Representation.

(May 2021)

PROHIBITION ON THE ACQUISITION OF COVERED DEFENSE TELECOMMUNICATIONS EQUIPMENT OR SERVICES-

REPRESENTATION (MAY 2021)

The Offeror is not required to complete the representation in this provision if the Offeror has represented in the provision at 252.204-7016, Covered Defense Telecommunications Equipment or Services-Representation, that it "does not provide covered defense telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument."

(a) . "Covered defense telecommunications equipment or services," "covered mission," "critical technology," and "substantial or Definitions essential component," as used in this provision, have the meanings given in the 252.204-7018 clause, Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services, of this solicitation.

(b) . Section 1656 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91) prohibits agencies from Prohibition procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service to carry out covered missions that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system.

(c) . The Offeror shall review the list of excluded parties in the System for Award Management (SAM) at for Procedures https://www.sam.gov entities that are excluded when providing any equipment, system, or service to carry out covered missions that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless a waiver is granted.

(d) . If in its annual representations and certifications in SAM the Offeror has represented in paragraph (c) of the provision at Representation 252.204-7016, Covered Defense Telecommunications Equipment or Services-Representation, that it "does" provide covered defense telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument, then the Offeror shall complete the following additional representation:

The Offeror represents that it will will not provide covered defense telecommunications equipment or services as a part of its offered products or services to DoD in the performance of any award resulting from this solicitation.

(e) . If the Offeror has represented in paragraph (d) of this provision that it "will provide covered defense telecommunications Disclosures equipment or services," the Offeror shall provide the following information as part of the offer:

(1) A description of all covered defense telecommunications equipment and services offered (include brand or manufacturer; product, such as model number, original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable).

(2) An explanation of the proposed use of covered defense telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition referenced in paragraph (b) of this provision.

(3) For services, the entity providing the covered defense telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known).

(4) For equipment, the entity that produced or provided the covered defense telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services

ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

This provision applies to only those contractors invited to submit Step Two submissions. Any proposal received from sources that were determined nonviable during Step One and not invited to submit a proposal based on the review conducted during Step One will not be evaluated and will be immediately disqualified for consideration this requirement. for award for

SUBMISSION OF PROPOSALS (FFP BEST-VALUE TRADEOFF)

GENERAL

The offeror's proposal shall be in the form prescribed by, and shall contain a response to each of the areas identified in this solicitation section. The following instructions are provided in addition to instructions to offerors contained elsewhere in this solicitation.

Initial proposals and any modifications thereto are to be submitted to the Contracting Officer on or before the closing date and time cited elsewhere in the solicitation. Faxes, e-mails, and/or responses through NECO/SAM.gov or any method or format than listed below are not acceptable. All proposals shall be submitted to the Contract Specialist (identified elsewhere in this solicitation) via email. No proposals shall be submitted by mail or by any other means except in the form explicitly stated herein. Offerors shall make all efforts to confirm receipt of proposals PRIOR to the date and time specified for receipt of proposals. Proposals not received by the solicitation point of contact by the date and time specified for receipt of proposals will be considered late, and will not be considered for award.

Offerors shall submit their proposals in two separate volumes as follows:

Volume II Non-Price Proposal - Microsoft Word or Adobe PDF Format only

Volume III Price Proposal - Microsoft Excel Format only (supporting documentation can be provided in Microsoft Excel, Microsoft Word, or PDF format)

Proposals shall comply with the detailed instructions for the format and content of the proposals contained herein; proposals that do not comply may be considered unacceptable and may render the proposal ineligible for award. All electronic files and versions of proposals shall be submitted in Adobe Acrobat and Microsoft Office Suite (Excel) formats and be in an unlocked and searchable format. The offeror shall be responsible for ensuring that its submissions are virus free. Each proposal submission email shall not exceed 10 Megabytes (MBs). If the proposal package exceeds 10 MBs, the offeror shall submit multiple emails so that each email is under 10 MBs. If the offeror submits multiple email submissions, they should label them accordingly (i.e., RFP N0018926RB011, Volume II - Non-Price Proposal - Email 1 of 3, etc.).

In addition to the Price Proposal, offerors shall include the following in Volume III:

Solicitation cover sheet with appropriate blocks completed by the offeror.

Acknowledgement of solicitation amendments, if any, pursuant to FAR 52.212-1(a)(6).

Representations and Certifications completed by the offeror in accordance with instructions contained elsewhere in this solicitation. If the offeror has completed all of the representations and certifications required by this solicitation in SAM (www.sam.gov) in accordance with FAR 52.204-7, then the offeror need not submit the hardcopy of those Representations and Certifications.

The offeror's (this Plan not required from mall business concerns). The target Small Business Subcontracting Plan pursuant to FAR 52.219-9 Alt II is s subcontract small business goals are as follows: by socio-economic category

Socio-Economic Category Percentage of Total Planned Subcontracting Dollars

Small Business (SB) 30%

Small disadvantaged business (SDB) 5%

Women-owned small business (WOSB) 5%

Service-disabled veteran-owned small business (SDVOSB) 5%

Historically underutilized business zone small business (HUBZone) 3%

The completion and submission of the above items will constitute an offer (proposal) and will be considered the offeror's unconditional assent to the terms and conditions of this solicitation and any attachments and/or exhibits hereto. Offerors shall respond to all requirements of the solicitation document. Offerors are cautioned not to alter the solicitation. Any affirmative exception to the material terms and conditions of the solicitation will render the offer ineligible for award. Alternate proposals are not authorized.

In the event any person who is not a bona fide employee of the offeror participated in the creation, formulation, or writing of any portion of the proposal, a certificate to this effect shall be included in the proposal which shall be signed by an officer of the offeror.

Such certificate shall identify the name of the person who is not a bona fide employee, that person's employment capacity, the name of the person's firm, the relationship of that firm to the offeror, and the portion of the proposal in which the person participated.

II. REQUIREMENTS FOR PROPOSAL CONTENT

(1) Do not include CLASSIFIED data in your proposal.

(2) Introduction and Purpose - This section specifies the format that offerors should use in proposals submitted in response to this solicitation. The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the proposals for evaluation purposes.

(3) Each volume should contain the following items in addition to the other information required by this solicitation:

Cover: The cover should indicate the following:

Title of the proposal

Volume Number (I or II)

Solicitation number

Name and address of offeror

Contractor point of contact (POC) with POC's email address and phone number.

DUNS and CAGE of offeror.

Identification of original signature copies

Table of Contents: The table of contents should provide sufficient details to allow the important elements to be easily located. The use of tabs and dividers is encouraged.

(4) Requirements for Style: Each offeror shall submit a proposal that clearly and concisely sets forth the contractor's response to the requirements of the solicitation. Unnecessary elaboration or other presentations beyond that sufficient to present a complete and effective proposal are not desired. Elaborate artwork, expensive paper or bindings, and expensive visual or other presentation aids are neither necessary nor desired. The proposal shall contain all the pertinent information in sufficient detail in the one area of the proposal where it contributes most critically to the discussion. When necessary, the offeror shall refer to the initial discussion and identify its location within its proposal.

(5) Page Limitations

Volume II, "Non-Price Proposal," is limited to a maximum of pages in length inclusive of any charts, diagrams, and/or 10 other graphics. Each "page" is defined as one sheet, 8 1/2 " x 11", with at least one inch margins on all sides, using a font with a point size of 12 or greater (e.g., "Times New Roman" style with 12 point font). Lines shall, at a minimum, be single-spaced.

Pages shall be consecutively numbered. Multiple pages, double pages, two-sided pages, or foldouts will count as an equivalent number of 8 1/2" x 11" pages. The cover sheet, table of contents (not to exceed one pages per volume), tabs, and dividers will not count toward the page limit. All charts, tables, graphics and information on the "past performance information form" in the non-price proposal are excepted from the font size requirement shown above. Text within charts, tables, graphics, and the "past performance information form" may be completed with point size of 10 or greater. Pages submitted in excess of the page limitations described above will not be evaluated. The Navy may exercise discretion in determining which specific pages are considered to be in excess of the page limitations.

Volume II, "Price Proposal," is not page limited. However, the price proposal is to be strictly limited to price information (including the completed solicitation documentation) and the contents of Volume III stated above.

III. PROPOSAL CONTENT

Step Two will consist of Volume II: Non-Price Proposal, and Volume III: Price Proposal. Note that Step Two consists of written proposals as well as performance tests of the offerors' reagent kits. Upon notice of viability and invitation to Step Two, offerors will be directed to provide reagent kits for Performance Test and instructions will be provided with notice of viability. The written portion of Step Two proposals (Volumes II and III) via email to Austin Waller at austin.p.waller.civ@us.navy.mil. The Step shall be submitted Two proposal (Volumes II and III) shall be received no later than 26 June 2026 at 12:00pm Eastern Time (Philadelphia).

(1) Volume I - Non-Price I Proposal

Each page of the proposal should include the following legend:

Source Selection Information - See FAR 2.101 and 3.104

Volume I of the proposal shall include all information required for the evaluation of the offeror's non-price proposal. It shall exclude any reference to the price aspects of the proposal.

The non-price evaluation factors in Volume II: Non-Price Proposal are as follows:

- Performance Test - Minimum Requirements

- Performance Test - Enhancing Factors

- Past Performance

- Small Business Participation Plan

(a) Performance Test - Minimum Requirements

(b) Performance Test - Enhancing Factors

The offeror shall ship a number of reagent kits to perform at least 5,000 tests, plus enough reagents for instrument start SUFFICIENT up, calibration, quality control checks, and shut down. These reagents shall be shipped, via express delivery at no cost to the Government, to one of the DoW forensic toxicology drug testing laboratories (FTDTLs) in the Continental United States (CONUS).

The location for shipment of reagent kits will be provided by the contracting agency with notice of viability. The reagent kits for the Performance Test shall be received by the testing laboratories no later than five (5) business days from notice of viability.

(c) Past Performance

The offeror shall demonstrate relevant past performance or affirmatively state that it possesses no relevant past performance. Relevant past performance is experience within the five years prior to the solicitation closing date that is the same as or similar to the scope and magnitude of the work described by this solicitation. To demonstrate its past performance, the offeror shall identify up to three of its most relevant contracts or efforts within the five years prior to the solicitation closing date, and provide any other information the offeror considers relevant to the requirements of the solicitation.

The offeror shall provide a detailed explanation demonstrating the relevance of the contracts or efforts to the requirements of the solicitation. The offeror shall also provide for each reference submitted: the number of ordered reagents; the number of rejected or returned reagents (with reasons for rejection or return); the total number of kits replaced; the offeror's compliance with established delivery schedules; and the offeror's ability to provide timely replacement reagents due to recall or return.

The offeror may identify contracts or efforts for its proposed subcontractors among the three past performance references provided in its proposal. If subcontractor past performance is provided as part of the three most relevant contracts or efforts, the subcontractor past performance will be given weight proportional to the scope and magnitude of the aspects of the work under the solicitation for which the subcontractor is proposed. Therefore, the offeror's proposal shall detail clearly the aspects of the work in the solicitation that the subcontractor is proposed to perform. It is the offeror's responsibility to adequately explain the relevance of a reference provided for a subcontractor's past performance to the effort that the subcontractor is proposed to perform under the solicitation.

The Past Performance evaluation will result in a past performance confidence assessment.

The offeror should complete a "Past Performance Information Form" - which is included as a separate attachment to the solicitation - for each reference submitted. The forms will count toward the non-price proposal page limit described above. For additional information regarding a particular reference beyond that which will fit on the form, the offeror may continue onto another sheet of paper. Such continuation sheet(s) for submitted references will count toward the non-price proposal page limit. Only a single set of up to three (3) references shall be submitted.

(d) Small Business Participation Plan

The offeror shall address the extent of participation of small businesses, small disadvantaged businesses, women-owned small businesses, service-disabled veteran-owned small businesses, and HUBZone small businesses in performance of any resultant contract. The solicitation, however, does not require participation by such entities. The offeror shall provide targets, expressed as percentages of total total planned subcontracting dollars and contract value, for small businesses, small disadvantaged businesses, women-owned small businesses, service-disabled veteran-owned small businesses, and HUBZone small businesses in any of the North American Industry Classification System (NAICS) Major Groups as determined by the Department of Commerce. The targets may provide for participation by a prime contractor, joint venture partner, teaming arrangement member, or subcontractor.

If the offeror fails to provide targets for the contract and/or any of the five (5) socio-economic categories, the offeror's proposal will be evaluated at zero percent for the contract and/or any socio-economic category for which a target is not provided. However, an offeror that provides no small business participation plan in response to this factor may be considered ineligible for award.

All offerors, including small business concerns, must submit a small business participation plan and may designate themselves as the primary or sole contractor on the effort.

Note: The Small Business Participation Plan factor and the separate requirement for submission of a Small Business Subcontracting Plan are included in the solicitation in an effort to promote small business participation under the solicitation and the resultant contract.

The Small Business Participation Plan factor is a non-price evaluation factor and is separate and distinct from the requirement for an offeror to submit a Small Business Subcontracting Plan. The requirements for a Small Business Subcontracting Plan are set forth in this solicitation under FAR clause 52.219-9 Alt II (Dev).

Government small business participation objectives are set forth in FAR clause 52.219-9 Alt II (Dev) in conjunction with the Small Business Subcontracting Plan. The solicitation does not establish separate small business participation objectives for the Small Business Participation Plan evaluation factor. As set forth in FAR 52.219-9 Alt II (Dev), the offeror, if other than a small business, is required to submit a Small Business Subcontracting Plan that includes the offeror's proposed small business subcontracting goals. The successful offeror's approved Small Business Subcontracting Plan will be incorporated into the contract. While Contracting Officer approval of the offeror's Small Business Subcontracting Plan may be required prior to any contract award, the Small Business Subcontracting Plan is not a component of the comparative evaluation of proposals; rather, it will be treated under the solicitation as a matter of contractor responsibility.

(2) Volume III - Price Proposal

Each page of the proposal should include the following legend:

Source Selection Information - See FAR 2.101 and 3.104

The Price Proposal in Volume III shall include the solicitation pricing pages completed by the offeror in accordance with the instructions in this section and in the CLIN descriptions on the solicitation pricing pages. The offeror shall include prices for each of the CLINs on the solicitation pricing pages and shall provide a total firm fixed price consisting of the total of all CLINS for the anticipated five-year base ordering period.

That total proposed price shall represent the offeror's firm-fixed price for performance of all of the solicitation's requirements.

A price realism analysis will not be conducted.

For the purpose of preparing a price proposal, the offeror shall assume that the following dates for each ordering period:

Base Ordering Period: 1 August 2026 through 31 July 2031

IMPORTANT NOTES:

(1) A firm-fixed-price (FFP) is no subjec to an adjustmen o th basi o th contractor' cost experience in performing t t y t n e s f e s the contract. The Government shall not be responsible for compensating the contractor for any costs tied to solicitation requirements but not factored into the proposed prices, either by the contractor's intention or by mistake.

(2) All price and price supporting information shall be contained in the price proposal. No price or pricing information shall be included in any other volume. Offerors are responsible for submitting sufficient information to enable the Government to fully evaluate their price proposal.

(3) Any and all subcontracts identified in the non-price proposal shall be identified and priced in the price proposal.

Subcontracts (regardless of dollar value) shall be adequately documented. Subcontractor price breakdowns may be submitted in separate emails.

NOTE: The prime contractor shall provide a list of all its subcontractors, the type of contract it will hold with each subcontractor (i.e.

CPFF, FFP, LH, T&M, etc.), the value of each subcontract and the cognizant Security Office (name, address, and identification code) for each subcontractor.

Evaluation - Commercial Products and Commercial Services

Addendum to Evaluation - Commercial Product and Commercial Services

FAR 52.212-2, EVALUATION-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

This provision applies to only those contractors invited to submit Step Two submissions. Any proposal received from sources that were determined nonviable during Step One and not invited to submit a proposal based on the review conducted during Step One will not be evaluated and will be immediately disqualified for consideration for award for this requirement.

(1) Evaluation factors. The Government will award a single firm, fixed price (FFP) Indefinite Delivery, Indefinite Quantity (IDIQ) type contract resulting from this solicitation to the responsible offeror whose proposal represents the best value after evaluation in accordance with the factors in the solicitation.

The Government will conduct a tradeoff between non-price factors and price. The tradeoff process allows the Government to accept other than the lowest-priced proposal or other than the highest technically-rated proposal to achieve a best-value contract award. Best Value means the expected outcome of an acquisition that, in the Government's estimation, provides the greatest overall benefit in response to the requirement. Inasmuch as the best value offer will be determined through tradeoff analysis, the Government is not bound to award to the lowest evaluated price. Conversely, if the Government determines that a higher-rated proposal offers value-added features but at an unreasonable/unjustifiable incremental amount, it is not bound to award to a higher technically-rated proposal.

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