OC-2026-132531

Dual Dissolution Bath with Autosampler System RFQ No.: 75F40126Q00091

Section 1 – General Information A. Summary of Requirement

This is a Request for Quotation (RFQ) for commercial products and commercial services prepared in accordance with Federal Acquisition Regulation (FAR) 12. THIS ANNOUNCEMENT

CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE

ISSUED.

The Request for Quotation (RFQ) number is 75F40126Q00091.

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

a. The NAICS for this requirement is: 334516 Analytical Laboratory Instrument Manufacturing

b. The SB size standard for the NAICS code is: $41.5mil. The full table of size standards can be found at: https://www.sba.gov/document/support-table-size-standards

Description of Requirement: The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) requires the purchase of a Dual Dissolution Bath System with Autosampler and Controller Software to replace existing obsolete dissolution bath system used for routine sample analysis.

Please refer to the attached Statement of Work (SOW) for the complete technical requirements.

The anticipated Period of Performance (POP) for this requirement shall consist of a one (1) year base period.

Delivery Schedule: Delivery, installation, and training shall occur within 6-8 weeks after contract award.

B. Points of Contact

Contracting Officer:

Iris Johnson Iris.Johnson1@fda.hhs.gov

Contract Specialist:

Erika Crawford Erika.Crawford@fda.hhs.gov

Contracting Officer's Representative:

TBD

https://www.sba.gov/document/support-table-size-standards mailto:Iris.Johnson1@fda.hhs.gov mailto:Erika.Crawford@fda.hhs.gov

Section 2 - Contract Clauses Clauses Incorporated by Reference

52.252-2 Clauses Incorporated by Reference (Feb 1998)

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

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

(End of clause)

Applicable Clauses

Clause Number Clause Title 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial

Services (Nov 2023) (Deviation Nov 2025) 52.212-5 Contract Terms and Conditions

Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (OCT 2025) (Deviation Nov 2025)

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Jan 2025) (DEVIATION Nov 2025)

52.219-6 Notice of Total Small Business Set-Aside (Nov 2020) (DEVIATION Nov 2025)

52.219-14 Limitations on Subcontracting (Oct 2022) (Nov 2025) 52.219-28 Post award Small Business Program Representation (Jan 2025)

(DEVIATION Nov 2025) 52.222-3 Convict Labor (Jun 2003) 52.222-19 Child Labor—Cooperation with Authorities and Remedies (Jan 2025)

(DEVIATION Nov 2025) 52.222-36 Equal Opportunity for Workers with Disabilities (Jun 2020) (Nov 2025) 52.222-50 Combating Trafficking in Persons (Oct 2025) (Nov 2025) 52.225-1 Buy American—Supplies (Oct 2022) (DEVIATION Nov 2025) 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) 52.240-91 Security Prohibitions and Exclusions (Deviation Nov 2025) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations (DEC 2015) HHSAR 352.232-71 Electronic Submission of Payment Requests https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

Clauses by Full Text

Addendum to FAR 52.212-4

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

(JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

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

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

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

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

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

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

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Section 3 – Attachments

Attachment Number

Title

1 Statement of Work (SOW) 2 Pricing Sheet

Section 4 – Solicitation Provisions

Provisions Incorporated by Reference

Provision Number Provision Title 52.212-1 Instructions to Offerors-Commercial Products and Commercial

Services (Sep 2023) (DEVIATION Nov 2025) 52.212-2 Evaluation-Commercial Products and Commercial Services (Nov

2021) (DEVIATION Nov 2025) 52.225-2 Buy American Certificate (Oct 2022)

Provisions by Full Text

52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

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

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

(End of provision)

Addendum to FAR 52.212-1

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

m. QUESTION DEADLINE: Submit all procurement-related questions in writing via email to the Contracting Officer and Contract Specialist listed in Section 1. Questions must be received by May 5, 2026, by noon EST, to be considered.

n. QUOTATION DEADLINE: Quotations are due by the date and time listed in SAM.gov.

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

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

1. Domestic End Product Requirement: In accordance with FAR 52.225-1, Buy American—Supplies, the Government requires the delivery of a domestic end product. A domestic end product means an end product manufactured in the United States with the cost of its components mined, produced, or manufactured https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses in the United States exceeding the percentage specified in FAR Part 25.

2. Offerors shall clearly identify the manufacturer and country of manufacture for the proposed equipment in their quotation. Failure to provide this information may result in the quotation being determined unacceptable.

New Equipment Requirement:

The Government will only accept quotations proposing new, unused equipment.

Refurbished, remanufactured, previously used, or demonstration units will not be accepted unless explicitly authorized in writing by the Contracting Officer.

Offerors shall clearly identify the manufacturer, model number, and condition of the equipment proposed in their quotation.

Failure to provide new equipment as specified may result in the quotation being technically unacceptable.

q. Submit two separate volumes:

1. Volume I – Technical: Must exclude pricing. Include specifications, work schedule, warranty, delivery timeline. Page limit: 10.

2. Volume II – Price: Include completed pricing schedule and cost breakdown.

r. Quotes shall clearly reference the RFQ number and include:

1. Date of quotation

2. Company Name

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

4. Contractor’s GSA schedule contract number

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

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

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

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

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

1. Technical

2. Price

Technical and price, when combined, are approximately equal in importance.

All non-price factors when combined are approximately equal to price.

(b) Options – Not applicable

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

Addendum to FAR 52.212-2

Fator 1: Technical Approach

The Government will evaluate the technical quotation to determine the offeror’s ability to meet the requirements of the Statement of Work (SOW).

The technical quotation shall demonstrate:

• Compliance with the minimum technical specifications for the Dual Dissolution Bath System with Autosampler and Controller Software, including all components, accessories, and system capabilities identified in the SOW.

• The offeror’s ability to provide delivery, installation, system setup, and qualification documentation, including any required operational qualification or performance verification documentation.

• The proposed delivery and installation schedule, demonstrating the ability to meet the required delivery timeframe specified in the SOW.

• Confirmation of the minimum three-year manufacturer warranty, including parts, labor, and technical support.

• The ability to provide onsite training for FDA personnel as required by the SOW.

The Government will evaluate the technical quotation for completeness, technical acceptability, and compliance with the requirements of the SOW.

Failure to clearly demonstrate compliance with the SOW requirements may result in the quotation being determined technically unacceptable.

Factor 2: Price

Price will be evaluated to determine whether the quotation includes a complete and itemized price breakdown and whether the proposed price is fair and reasonable for the supplies and services required under the RFQ.

The total evaluated price will be the sum of all items included in the pricing schedule.

The Government intends to make award without discussions; therefore, quoters are encouraged to submit their best technical quotation and price in response to this RFQ.

(End of provision)

52.225-2 Buy American Certificate (Oct 2022)

(a) (1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(b) Foreign End Products:

Line Item No. Country of origin Exceeds 55% domestic content (yes/no)

(b)[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No. ___

[List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision)

RFQ No.: 75F40126Q00091 Attachment 1

Statement of Work

1. Background

The FDA San Juan Medical Products Laboratory (SJNLMP) requires the replacement of its obsolete dissolution bath systems used for routine sample analysis. The replacement system must maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards for analytical equipment under existing accreditation.

The laboratory analyzes medical product samples using established protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program (DOD SLEP), and the Federal Contract Compliance (FCC) program. To maintain modern analytical capabilities, SJNLMP requires a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components, as the previous system has been discontinued by the manufacturer.

2. Objectives

• Acquire a fully functional modern dissolution system controlled by software with enhanced analytical capabilities.

• Replace the current obsolete system (over 15 years old).

• Enable analysis of extended-release formulations, automated profile sampling, and traceable reporting.

3. Scope

The Contractor shall provide all resources necessary to deliver, install, configure, and validate a dual bathless dissolution system with autosampler and controller software, including installation, training, and documentation.

4. System Requirements

4.1 Quality Standards

The dissolution system shall comply with the following standards:

• ISO/IEC 17025:2017 (https://www.iso.org/standard/39883.html)

• ISO 9001:2008 (https://www.iso.org/standard/46486.html)

• 21 CFR Part 11 Compliance

(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)

• USP, cGMP/cGLP (https://login.usp.org/cas/login)

4.2 Equipment Requirements

The system shall include following components:

Dual Bathless 115V Dissolution Instruments

• Six spindle drives https://www.iso.org/standard/39883.html https://www.iso.org/standard/46486.html https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm https://login.usp.org/cas/login

RFQ No.: 75F40126Q00091 Attachment 1

• Color touch screen display

• Quick-change paddles and baskets

• Automatic height adjustment

• Twelve wireless RTD shaft assemblies (serialized with certification)

• Two RTD power packs for six positions

• Twelve paddle blades (serialized with certification)

• 1L amber glass vessels (serialized with certificates)

• Twelve vessel covers

115V Autosampler

• Precision syringe pumps for accurate sampling

• Optimized pathway <5 mL internal volume

• Capable of sampling from two baths, independently or simultaneously

• Six sampling positions

• Media replacement and recycling capability

• Storage for 100 methods

• Multi-user security and audit trail

• Time-point sampling starting at 5 minutes

Autosampler Filter System

• Two filter systems (one per bath) for 25 mm syringe filters

• Two 8-position test tube racks

• Two 8-position HPLC vial racks

• Two RS-232 connection cables

• Twelve sample probes and 12 elbow fittings

• Filter disks (2 packs, 100 each, 45 µm)

• Glass test tubes (2 packs, 16 mm × 100 mm)

Controller Software and Workstation

• PC station with Windows 11 monitor

• One software license

• Controls dissolution baths and autosampler

• Program, monitor, and report results

• 21 CFR Part 11 compliant

• USB and RS-232 communication hub and cables

Instrument Software

• Current instrument controller software license

• Latest instrument firmware

Equipment Identification Requirement

Offerors shall clearly identify the manufacturer, model number, and country of manufacture for the proposed dissolution system and all major components in their quotation. Sufficient documentation, such as specification sheets or manufacturer product literature, shall be provided to demonstrate compliance with the requirements identified in this Statement of Work.

RFQ No.: 75F40126Q00091 Attachment 1

Compatibility with Existing Laboratory Methods

The proposed dissolution system shall support existing laboratory analytical methods and workflows currently used by SJNLMP. The system shall not require redevelopment or revalidation of established USP or FDA analytical methods currently in use by the laboratory.

5. Delivery, Installation, and Service

• Provide Onsite installation including labor, delivery, travel, and setup.

• Delivery shall occur within 90 days of award.

• Provide inside delivery and setup, including removal of packaging and debris.

• Delivery shall include all supplies required for installation and start-up.

• Provide Operational Qualification/Performance Verification (OQ/PV) kits.

• Factory-certified personnel shall install hardware and software.

• Demonstrate that the system meets or exceeds all performance specifications.

• Conduct Hardware IQ/OQ and Software IQ/OQ, including verification of 21 CFR Part 11 compliance.

• Provide electronic IQ/OQ documentation.

6. Warranty

• Provide a minimum three-year limited warranty beginning upon formal Government acceptance covering parts and labor.

• Provide unlimited telephone and email technical support.

• Provide on-site service response within 72 hours, if required.

• Warranty shall include all non-consumable replacement parts, labor, travel, software updates, and installation support.

• Provide 1 (one) preventative maintenance visit at 11-12 months after installation.

7. Training

• Provide onsite familiarization training for three (3) to five (5) users.

• Training shall cover basic system operation and routine maintenance procedures.

• Provide manuals and required consumables necessary to conduct training.

8. Trade and Service Specifications

• Equipment shall be new and not used; refurbished, remanufactured, previously used, or demonstration units will be accepted.

• Warranty shall cover the base instrument, parts, labor, and OEM-certified replacement components.

• Maintenance shall be performed by OEM-trained engineers; salvaged or non-certified parts shall not be used.

o OEM Certification Requirement: Offerors shall certify in their quotation that installation, maintenance, and warranty services will be performed by OEM-trained or OEM-certified engineers authorized to service the proposed equipment. Upon request, the Contractor shall provide documentation verifying authorization from the original equipment manufacturer.

• Provide technical support through call center staffed by senior engineers or equivalent qualified personnel.

RFQ No.: 75F40126Q00091 Attachment 1

• Include installation and validation services (IQ/OQ) with proof of certification.

• Perform inside delivery, unpacking, and equipment inventory with a lab representative.

9. Deliverables and Schedule

Deliverable Quantity Due Date Dual Bathless Dissolution System with Autosampler and

Software 1 Within 6–8 weeks after award

Installation and Operational Qualification Documentation 1 Within 6–8 weeks after award

Familiarization Training 3–5 users

Within 6–8 weeks after award

Instrument and Software User Manuals 1 Within 6–8 weeks after award

10. Place of Performance

FDA San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223

• Vendors shall coordinate delivery 48 hours in advance.

• Deliveries shall occur inside the facility between 8:00 AM – 4:00 PM, Monday–Friday

(excluding federal holidays).

• Provide a minimum two-week advance notice for installation and training scheduling.

• Contractor personnel shall have photo ID for building access.

11. Hours of Operation

• Contractor services shall be performed between 8:00 AM – 4:00 PM, Monday–Friday, excluding Federal holidays or Government-directed facility closures.