DDRP Amp. Testing Synopsis-Solicitation 7AUG2024.docx

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the information in FAR 12.6, using Simplified Acquisition Procedures under the test program for commercial items found at FAR 13, as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; a written solicitation will not be issued. PAPER COPIES IF THIS SOLICITATION WILL NOT BE AVAILABLE. This combined synopsis/solicitation SHALL be posted on Sam.gov (https://sam.gov/).

The RFQ number is N0018924Q0515. This solicitation documents and incorporates provisions and clauses in effect through FAC 2023-06 (effective 05 October 2023) and DFARS Publication Notice 20231025 (effective 25 October 2023). It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at this address:

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

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 products which the government intends to solicit and negotiate a Firm-Fixed-Price IDIQ contract basis – under which delivery orders will be issued.

NOTE TO QUOTERS

Questions:

Questions must be received in writing via email to Austin Waller at Austin.p.waller.civ@us.navy.mil later than 1730 EST on 16 AUGUST 2024.

SUBMISSION OF QUOTES

The Navy is soliciting interested sources in accordance with FAR 13.106-1(a) 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 procedures of FAR 15.3 do not apply to the source selection. The contracting officer will make the source selection using the following two-step process.

Step One

To be submitted no later than 21 August 2024 at 1730 EST via email to Austin.p.waller.civ@us.navy.mil, interested sources shall provide sufficient technical documentation (including but not limited to: product literature, specifications) demonstrating their ability to meet the Statement of Work and containing the information required below:

FDA, ISO Certification or Quality Assurance Documentation, Statement of Work (SOW) Compliance Attestation, and OEM requirements.

-Documentation of FDA approval/authorization for use of the d-amphetamine/d-methamphetamine Immunoassay Reagent.

-Documentation of current certification compliance with applicable ISO Standards OR documentation of compliance with Statement Of Work.

-Interested source is AND has provided evidence of being 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.

If the interested source’s Step One submission does not include ALL of the items above, the Step One submission will not be considered and the interested source will be excluded from further evaluation.

Reagent Preparation and Calibration Information. Package inserts shall contain complete, accurate, and verifiable information including:

-Explanation and principles of the testing procedure.

-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.

-Instructions for reagent handling, mixing, and storage.

-Reagent stability and storage requirement for both un-opened and opened reagent kits.

-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.

-Calibration and Instrument parameters for use on the Beckman Coulter AU5800 Series Analyzer. The calibrators and controls shall be DoD-prepared and -certified solutions containing d-amphetamine/d-methamphetamine.

-Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the target analyte, d-amphetamine/d-methamphetamine.

-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.

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 ½ “ 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 ½" 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, and as broken out below, will not be evaluated. The Government may exercise discretion in determining which specific pages are considered to be in excess of the page limitations.

The contracting officer will evaluate each submission and determine which sources are viable competitors for award. Sources that fail to meet the requirements above will be deemed nonviable. The contracting officer may communicate with an interested source 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 sources determined nonviable that they are eliminated from further consideration and invite interested sources determined viable to submit a quote in response to Step Two.

Step Two

Upon the completion of Step One, the Contracting Officer will request the information detailed in FAR 52.212-1 and its addendum, and FAR 52.212-2 of the Request for Quotations from quoters (i.e., all sources determined to be viable competitors under Step One). Refer to FAR 52.212-1 and its addendum for entirety of instructions and FAR 52.212-2 and its addendum for evaluation criteria.

The non-price evaluation factors in Step Two are: Performance Test, Past Performance, and Socio-Economic Plan. Performance Test is more important than Past Performance. Performance Test and Past Performance are each significantly more important than Socio-Economic Plan. The non-price quote is considered more important than price quote.

In addition to the information submitted by quoters, the contracting officer may consider other information reasonably related to the evaluation factors, to include the personal knowledge of the quoter’s commercial and Government customers, and past performance databases. The contracting officer is not obligated to evaluate all information submitted from each quoter. For example, the contracting officer may curtail evaluation of a quote if at any point the contracting officer determines the quoter is unlikely to provide best value.

Any quotations received from sources that were determined not viable during Step One and not invited to submit a quotation based on the review conducted during Step One will not be evaluated and will be immediately disqualified for consideration in this requirement. Sources determined to be viable will be requested to submit a non-price and price quote via email to Austin.p.waller.civ@us.navy.mil. Sources determined to be viable will also be required to ship a SUFFICIENT number of reagent kits to perform at least 5,000 tests, plus enough reagents for instrument start 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 DoD forensic toxicology drug testing laboratories (FTDTL) in the Continental United States (CONUS). The location for shipment of reagent kits will be provided by the contracting agency upon notification of viability as a result of Step One. The non-price quote, price quote, and reagent kits shall be received no later than 6 September 2024 at 1730 PM Eastern Time.

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE

The minimum quantity for this IDIQ shall not be less than 50 kits and the maximum shall not exceed 5,550 kits over the course of the five year ordering period. Minimum delivery order value for the given Delivery/Task Order issued under this IDIQ shall not be less than $1,000.00.

DELIVERY INFORMATION

31-OCT-2029

GOVERNMENT REPRESENTATIVE

1681 NELSON STREET

FORT DETRICK MD 21701-9203

FOB: Destination N62645

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

ESSENTIAL CHARACTERISTICS

D-AMPHETAMINE/ D-METHAMPHETAMINE IMMUNOASSAY REAGENT KITS

The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented d-amphetamine/d-methamphetamine Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting d-amphetamine/d-methamphetamine in human urine samples. Quotes shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance (PoP) of five (5) years.

Only Original Equipment Manufacturer (OEM) of reagents, 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, will be considered. All storage, shelf-life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions, as specified in the SOW.

The OEM’s reagent product shall not be repackaged by the Offeror unless authorized, as specified in the SOW.

The vendor shall comply with the FDA and Quality Management Documentation, as specified in the SOW.

The vendor shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW.

STATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF D-AMPHETAMINE AND D-METHAMPHETAMINE IN URINE

The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented d-amphetamine and d-methamphetamine Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting d-amphetamine and d-methamphetamine in human urine samples. Quotes shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance (PoP) of five (5) years.

Only Original Equipment Manufacturer (OEM) of reagents, 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, will be considered. All storage, shelf-life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions, as specified in the SOW.

The OEM’s reagent product shall not be repackaged by the Offeror unless authorized, as specified in the SOW.

The vendor shall comply with the FDA and Quality Management Documentation, as specified in the SOW.

The vendor shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW.

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of both d-amphetamine (DAMP) and d-methamphetamine (DMETH) in urine when present individually, or in combination, at a concentration equal to or greater than 500 ng/mL. The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers (hereafter referred to as “analyzer”) purchased from Siemens Healthcare Diagnostics in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division, without modification of the equipment. The immunoassay procedure is limited to a two reagent assay procedure. A vendor’s reagent quote which requires a separate pretreatment of each testing specimen prior to testing on the analyzer will not be considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor’s reagent on the analyzer. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DoDI 1010.16 Rev. (June 15, 2020). Immunoassay kits will be evaluated based on their ability to accurately detect DAMP and DMETH based on the testing and performance characteristics in conjuncture with all evaluation factors.

1.2. Sensitivity and Specificity. The analyzer will be calibrated at 500 ng/mL using DOD FTDTL prepared and certified solutions of the vendor’s recommended calibrator (either DAMP or DMETH). The controls will utilize the same compound as the calibrator. The cross-reactivity of the reagent to the non-target analyte must be 80 percent or greater. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to the drugs/metabolites on the current DOD drug testing panel, listed below (excluding the compound(s) of interest). The reagent shall demonstrate calibration stability, as evaluated by frequency of control failures, and shall require calibration no more than one time during an 8 hour period. The following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

(ng/mL)

Codeine

Hydrocodone

Hydromorphone

2-oxo-3-hydroxy-LSD

1.3. Compliance with Food & Drug Administration (FDA) Requirements.

1.3.1 Immunoassay kits are considered medical devices and shall have clearance from the FDA to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes in the manufacture of the devices. Any mandatory recalls of the kits provided under the resulting contract and any other problems that require notification to the FDA shall be resolved as required by the FDA regulations current at the time. The contractor shall notify the Contracting Officer of any recall or FDA notification within two working days of the event.

1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modification shall be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered. The contractor's quote shall include documentation that demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification.

1.4. Packaging. The reagents provided shall be in volumes and packaging that are convenient and applicable to the sample throughput at the FTDTLs and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. The contractor shall not be required to provide calibrators/controls. The reagents shall be provided with an instruction sheet that complies with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as accuracy, precision, sensitivity, specificity, cross-reactivity, and safety precautions. The instruction sheet(s) shall include procedures and instrument parameters optimized for FTDTL operations as represented in these specifications and cutoffs as utilized by the DOD. The Government shall not develop procedures or optimize the performance of a kit for the contractor. Offeror shall not repackage or relabel an OEM product unless authorized.

1.5. Shelf Life. The minimum shelf life of any unopened component of the assay shall be at least 180 days from the date of delivery to the FTDTL. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days.

1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval. The package insert and information for the analyzer settings must contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device’s FDA approval. This ensures that the FTDTLs can use the immunoassay kits properly and derive the full benefit of the FDA approval.

2. TESTING and QUALITY CONTROL PROTOCOL.

2.1. The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 500 ng/mL, shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings as follows: drug free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch.

3. PERFORMANCE CHARACTERISTICS.

3.1. The reagent shall be capable of identifying specimens as positive for DAMP and DMETH when present individually or in combination in human urine at concentrations equal to or greater than 500 ng/mL as determined by the current immunoassay and gas chromatography-mass spectrometry (GC-MS) or liquid chromatography- tandem mass spectrometry (LC-MS/MS) procedures utilized in the FTDTLs (and AFMES).

3.2. The reagent shall be capable of identifying specimens as negative for DAMP and DMETH when present individually or in combination in human urine at concentrations below 500 ng/mL as determined by the current immunoassay and GC-MS or LC-MS/MS procedures utilized in the FTDTLs (and AFMES).

3.3. The reagent performance, as evaluated through the performance of controls, shall be stable over the course of the day and shall not require re-calibration within an eight hour period.

3.4. The reagent shall display precision and accuracy both within and between batches for concentrations ranging between 50-200% of the calibrator concentration.

3.5. The reagent shall produce non-overlapping ranges for samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator/cutoff concentration.

3.6. The reagent shall have at least 80 percent cross reactivity to DAMP and DMETH.

3.7. The reagent shall have minimal cross reactivity with analytes other than DAMP and DMETH.

4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES CERTIFICATION, CURRENT ISO 13485 SERIES OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS:

4.1. Chemicals and Reagents

4.1.1. Quality and Authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, GC-MS, Nuclear Magnetic Resonance, and spectrophotometric measurements.

4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).

4.2. Manufacturer’s Equipment

4.2.1. Preventative maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment.

4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature Checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.

4.2.4. Glassware and other reusable supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody

4.3.1. Authenticity. The prepared antibody shall be verified to be authentic and its purity established.

4.3.2. Stability. The antibody shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (a minimum of 180 days from date of delivery to the FTDTL/AFMES).

4.3.3. Specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of DAMP and DMETH in urine. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing may include biochemical materials produced normally in the human body.

4.4. Immunoassays

4.4.1. Technical Performance. Performance of each lot of reagent shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecules and that all other parameters as specified in the contract are met. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.4.2. Manufacturer’s production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control procedure shall be described thoroughly.

4.4.3. Records. The production and quality control records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of the completion of all production parameters and shall be available for inspection during the term of the contract.

4.4.4. Corrective action. When a specified quality control parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur. All records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. The FDA shall be notified according to its regulations.

4.4.5. Lot numbers. Lot numbers shall be used to identify reagents to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit.

5. PACKAGING AND MARKING.

5.1. Thermal Protection for Biologic Reagents. The contractor shall ship biologic reagent items used in the reagent kits in insulated thermal containers to ensure protection of the reagents against thermal (heat and cold) damage which would affect reagent performance contained in the Statement of Work of this contract.

5.2. Marking of Shipments (Commercially-Packaged Items). Marking shall be in accordance with ASTM D 3951 15, "Standard Practice for Commercial Packaging."

5.2.1. Additional markings include: Contract Number & Government Delivery Order Number.

5.3. Deteriorative Material Marking. The contractor shall include as part of the marking, the following information: (a) Expiration date; (b) Required storage conditions for each kit component; and (c) Type I or Type II shelf life date as specified in MIL-STD-129 for each unit of material, issue, package, intermediate container and exterior shipping container.

CONTRACT ADMINISTRATION

1. CONTRACT ADMINISTRATION

The agency and individual responsible for administering this contract will be provided with the award distribution.

2. INVOICING INSTRUCTIONS

See 252.232-7006 Wide Area Workflow Payment Instructions.

3. DESIGNATION OF ORDERING ACTIVITIES

In addition to NMRLC, the following Requiring Activities and their designated Ordering Office are hereby authorized to place delivery orders:

Navy Drug Screening Laboratory 2500 Rodgers Street, Bldg 5501 Great Lakes, IL 60088-2952

SAME AS REQUIRING ACTIVITY

Navy Drug Screening Laboratory Building H-2033 Adams Avenue Naval Air Station Jacksonville, FL 32212-5000

SAME AS REQUIRING ACTIVITY

Headquarters Air Force Drug Testing Laboratory Wilford Hall Medical Center Building 3750, Ladd Street Lackland Air Force Base, TX 78236

SAME AS REQUIRING ACTIVITY

Army Forensic Toxicology Drug Testing Laboratory 2490 Wilson Street Fort Meade, MD 20755-5235

SAME AS REQUIRING ACTIVITY

Army Forensic Toxicology Drug Testing Laboratory ATTN: MCHK-FT 1 Jarrett White Road, Building 40 Tripler AMC, HI 96859-5000 Pacific Contracting Center

ATTN: MCAA-PC

Tripler AMC, HI 96859

Armed Forces Medical Examiner System (AFMES) 115 Purple Heart Drive Dover Air Force Base, DE 19902

SAME AS REQUIRING ACTIVITY

All delivery orders must be signed by a warranted Contracting Officer or Purchasing Officer. Any deviations from the terms of this base contract must be submitted and approved in writing via an executed modification signed by a warranted Contracting Officer from the base contract issuing agency.

4. ORDERING /DELIVERY ORDERS

The contract hereby authorizes requiring/ordering activities to place delivery orders via SF 1449, DD Form 1155, or other locally approved form signed/executed in writing by the Contracting/Purchasing Officer using the government purchase card or Wide Area Workflow for payment methods. Deliveries shall NOT be shipped to 693 Neiman Street, Fort Detrick, MD 21702.

5. MAXIMUM QUANTITIES

Available quantities shall not exceed those specified in Contract Line Item Number (CLIN) 0001.

6. CONTENT OF DELIVERY ORDERS

Delivery orders shall contain the following "minimum" information:

1. Date of order.

2. Contract Number and Order Number.

3. Item Number and Description, Quantity, and Unit Price.

4. Unit of Issue.

5. Delivery Date and Place of Delivery.

6. Accounting and Appropriation data

7. Payment Office Address.

8. Invoicing Instructions with Point of Contact Information.

Ordering activities are required to provide a copy of each delivery order via email to the DDRP Laboratory Services Mailbox at:

usn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil. (SUBJECT: Contract Number & Delivery Order Number).

7. REPORTS

The contractor shall provide an electronic monthly report of sales within ten (10) calendar days after the close of each month’s sales.

Reports, in Microsoft Excel, shall be emailed to DDRP Laboratory Services Mailbox at:

usn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil. (SUBJECT: Contract Number).

Reports shall contain the following information:

a. Date of order.

b. Contract number and delivery order number.

c. Item number, description, quantity, and unit price.

d. Total Amount.

e. Delivery date and place of delivery.

f. Payment method.

8. COMMUNICATIONS

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction, or request of Government personnel unless it is issued in writing and signed by the Contracting Officer or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

AMP and Meth Reagent Kits

FFP

The vendor shall provide Emit II Plus Amphetamine and Methamphetamine reagent kits in support of the Drug Demand Reduction Program in accordance with the Statement of Work and resulting delivery orders.

FOB: Destination

PSC CD: 6550

NET AMT

CLAUSES INCORPORATED BY FULL TEXT

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020)

(a) Definition. As used in this clause--

Commercial and Government Entity (CAGE) code means--

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

(b) Contractors shall ensure that the CAGE code is maintained throughout the life of the contract for each location of contract, including subcontract, performance. For contractors registered in the System for Award Management (SAM), the DLA Commercial and Government Entity (CAGE) Branch shall only modify data received from SAM in the CAGE master file if the contractor initiates those changes via update of its SAM registration. Contractors undergoing a novation or change-of-name agreement shall notify the contracting officer in accordance with subpart 42.12. The contractor shall communicate any change to the CAGE code to the contracting officer within 30 days after the change, so that a modification can be issued to update the CAGE code on the contract.

(c) Contractors located in the United States or its outlying areas that are not registered in SAM shall submit written change requests to the DLA Commercial and Government Entity (CAGE) Branch. Requests for changes shall be provided at https://cage.dla.mil. Change requests to the CAGE master file are accepted from the entity identified by the code.

(d) Contractors located outside the United States and its outlying areas that are not registered in SAM shall contact the appropriate National Codification Bureau (points of contact available at http://www.nato.int/structur/AC/135/main/links/contacts.htm) or NSPA at https://eportal.nspa.nato.int/AC135Public/scage/CageList.aspx to request CAGE changes.

(e) Additional guidance for maintaining CAGE codes is available at https://cage.dla.mil.

(f) If the contract includes Federal Acquisition Regulation clause 52.204-2, Security Requirements, the contractor shall ensure that subcontractors maintain their CAGE code(s) throughout the life of the contract.

(End of Clause)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered 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" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [X] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [X] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

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

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2023)

(a) Definitions. As used in this clause--

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)--

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use-

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, "No TikTok on Government Devices" Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor's employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in--

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management, which can be accessed via https://www.sam.gov (see 52.204-7).

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition--

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar…