Attachment VII - Solicitation Doument.docx

Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation Brand Name or Equal

Section 1 — General Information & Summary of Requirement This is a Request for Quotation (RFQ) for commercial products prepared in accordance with FAR Part 12 and FAR Part 13 procedures utilizing the FAR Revolutionary FAR Overhaul clauses and provisions available at Acquisition.gov.

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR), requires the purchase, delivery, installation, validation support, training, and warranty of a Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation. The requirement supports FDA research in advanced pharmaceutical manufacturing and inhalation drug delivery systems.

Brand Name or Equal The Government has identified the following brand-name product:

Parmasol Semiautomatic Aerosol Propellant Filler System Offerors may submit quotations for the brand-name product or an equal product. To be considered for award, any equal product must meet all salient physical, functional, and performance characteristics identified in Attachment I – Statement of Work (SOW). The Government will determine equality solely based on information furnished in the quotation.

Section 2 — Delivery, Installation, and Period of Performance Delivery Requirements The Contractor shall furnish, deliver, install, test, train personnel, and provide warranty support for the required equipment. Delivery and installation shall be completed within 90 calendar days after award.

The Contractor shall provide:

· Packaging

· Shipping

· Delivery

· Installation

· Factory Acceptance Test (FAT) Documentation

· Validation Documentation

· Validation Execution Support

· Operator Training

· One-Year Warranty Coverage Including Onsite Repairs Place of Performance / Delivery Location U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Testing and Research 10903 New Hampshire Avenue Laboratory WO64, Room 1083 Silver Spring, MD 20993 Delivery shall occur during normal Government business hours.

Inspection and Acceptance The Government shall have thirty (30) working days following installation to inspect and verify operational functionality of the equipment.

Term of Contract The term of the resultant contract shall be from date of award through one year after award.

Section 3 — Contract Line Items (CLINs) Offerors shall provide pricing for all CLINs.

Section 4 — Points of Contact Contracting Officer Michele Jackson Michele.Jackson@fda.hhs.gov 301-796-6686 Technical Points of Contact To be determined after award

Section 5 — Contract Clauses

5.1 Clauses Incorporated by Reference

The following clauses are incorporated by reference and have the same force and effect as if given in full text. Full text may be accessed at https://acquisition.gov, https://acquisition.gov/far-overhaul, and https://acquisition.gov/hhsar.

5.2 Clauses Incorporated by Full Text

52.252-2 Clauses Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. The full text of clauses may be accessed electronically at:

· https://acquisition.gov

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

· https://acquisition.gov/hhsar (End of Clause)

52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of services within the limits and rates specified in the contract. The option may be exercised more than once but shall not exceed six months.

(End of Clause)

FDA Electronic Invoicing and Payment Requirements – Invoice Processing Platform (IPP) (JAN 2022)

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

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

c. The Agency will enroll 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 a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3–5 business days of contract award for new contracts or date of modification for existing contracts. 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. 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 the first, contains a temporary password. You must log in with the temporary password within 30 days. If your company is already registered to use IPP, you will not be required to re-register. 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-hour 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 and contract cumulative amounts. At a minimum, the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

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

· Indirect Costs (i.e., Fringe Benefits, Overhead, G&A, Other Indirects) – show rate, base, and total amount

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

· Travel – include for each trip the name of the traveler, date, destination, transportation costs (including ground transportation separately), and per diem costs

· Subcontractors (if applicable) – include, for each subcontractor, the same data as required for the prime Contractor

· Other Direct Costs – include a listing of all other direct charges to the contract (e.g., office supplies, telephone, duplication, postage)

· 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: (1) a list of all invoices submitted to date under the subject award, including invoice number, amount, and date submitted, as well as corresponding payment amount and date received; (2) total amount of all payments received to date under the subject contract or order; and (3) 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 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 the U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, 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. When emailing, please include the contract number, invoice number and date, your name, phone number, and a detailed description of the issue.

(End of Clause)

5.3 Provisions Incorporated by Reference

The following provisions are incorporated by reference and have the same force and effect as if given in full text.

5.4 Provisions Incorporated by Full Text

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) This solicitation incorporates one or more provisions by reference with the same force and effect as if they were given in full text. The full text of provisions may be accessed electronically at:

· https://acquisition.gov

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

· https://acquisition.gov/hhsar (End of Provision)

Section 6 — Basis for Award The Government intends to issue a purchase order to the responsible quoter whose quotation:

· Is determined Technically Acceptable;

· Demonstrates Acceptable Past Performance; and

· Offers the Lowest Total Evaluated Price.

Award will be made using the Lowest Price Technically Acceptable (LPTA) source selection process. The Government will first evaluate quotations for technical acceptability. Quotations determined Technically Unacceptable will not be further considered for award. Among quotations determined Technically Acceptable, the Government will evaluate past performance. Quotations receiving an Unacceptable past performance rating will not be eligible for award. Award will be made to the responsible quoter submitting the Lowest Total Evaluated Price among those quotations determined Technically Acceptable with Acceptable (or Neutral) Past Performance.

6.1 Evaluation Factors

The following evaluation factors will be evaluated:

· Factor 1 – Technical Acceptability (Pass/Fail)

· Factor 2 – Past Performance (Acceptable/Neutral/Unacceptable)

· Factor 3 – Price

6.2 Technical Acceptability (Pass/Fail)

Technical Acceptability is defined as demonstrating compliance with all material requirements identified in the Statement of Work. For Brand Name or Equal submissions, the quoter shall demonstrate that the proposed equipment meets or exceeds all salient physical, functional, operational, and performance characteristics identified in Attachment I.

The Government will evaluate:

· Pressure filler requirements

· Crimper requirements

· Crimp height gauge requirements

· Propellant pump requirements

· Validation documentation and support

· Installation services

· Training services

· Warranty coverage

· Delivery schedule

· Compliance with all required salient characteristics A quotation that fails to demonstrate compliance with any material requirement may be determined Technically Unacceptable.

6.3 Past Performance

Quoters shall provide at least two references for contracts, purchase orders, or projects of similar scope and complexity completed within the previous five years. The Government will evaluate past performance using information provided by the quoter and any other information reasonably available to the Government.

Ratings:

· Acceptable

· Neutral

· Unacceptable A Neutral rating will not be evaluated favorably or unfavorably.

6.4 Responsibility Determination

Prior to award, the Government will determine whether the apparent successful quoter is responsible in accordance with applicable Federal acquisition requirements, including verification of active registration in the System for Award Management (SAM).

6.5 Price Evaluation

The Government will evaluate pricing for completeness and reasonableness. Total Evaluated Price shall include:

· CLIN 0001 through CLIN 0007

Quoters provide pricing for all CLINs. Failure to provide pricing for all required CLINs may render a quotation ineligible for award.

6.6 Order of Evaluation

The Government intends to evaluate quotations in the following order:

1. Technical Acceptability

2. Past Performance

3. Price The Government may evaluate quotations in the order most advantageous to the Government consistent with applicable acquisition procedures.

Section C — Instructions to Offerors 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (NOV 2025) Applies in its entirety except as modified below.

Addendum to FAR 52.212-1

(b) Period for Acceptance of Offers Offerors shall hold pricing firm for 120 calendar days after quotation closing.

(f) Question Deadline Submit all questions in writing to: Michele.Jackson@fda.hhs.gov Questions are due no later than: June 15, 2026, at 9:00 AM Eastern Time Questions received after this date may not receive a response.

(g) Quotation Deadline Submit quotations electronically to: Michele.Jackson@fda.hhs.gov No later than: June 22, 2026, at 11:00 AM Eastern Time Subject Line: [Company Name] – 75F40126Q00231/CDER-2026-133243 Quote

(h) Brand Name or Equal Requirements Offerors proposing an equal product shall provide:

· Manufacturer Name

· Product Name

· Model Number

· Technical Specifications

· Product Literature

· Product Brochures

· Drawings and Datasheets The Government will evaluate equality solely from information submitted with the quotation. Failure to provide sufficient information may result in the quotation being determined technically unacceptable.

(i) Quote Content Requirements The quotation shall include:

· RFQ Number

· Date of Quote

· Company Name

· Point of Contact

· UEI

· SAM Registration

· Product Literature

· Compliance Matrix addressing all SOW requirements

· Delivery Schedule

· Warranty Information

· Country of Origin

· Trade Agreements Act Compliance Certification

· Past Performance References

· Confirmation of 120-day quote validity

Attachments