(3) Mechanical Qualification for Dissolution

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.
    
2. The solicitation number is FDA-RFQ-24Q1708340. This requirement is issued as Request for Quote (RFQ).
   
   The solicitation is issued as a Full and Open competition.
    
3. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024.
    
4. The associated North American Industry Classification System (NAICS) Code is 334516 with a small business size standard of 1000 employees.
    
5. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.  

1. 1. BACKGROUND

The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products in the Office of Regulatory Science, Office of Medical Products and Specialty Laboratory Operations, located at 158-15 Liberty Avenue, Jamaica, NY 11433 (Lead Laboratory for this request). The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The dissolution system is used to evaluate the rate and extent that a compound forms a solution, typically, for drug samples using specific protocols and methods established by USP monographs. Dissolution testing is performed with apparatus described in General Chapter <711> Dissolution.

1. OBJECTIVE

The purpose of this acquisition is to acquire (3) Mechanical Qualification of Dissolution

REQUIREMENTS

All the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government prior to purchase.

The Contractor shall provide three (3) Mechanical Qualification for Dissolution with the following requirements:

• Mechanical Calibration Device
• Shall include Installation.

The contractor shall provide a system compatible with Industry Dissolution Instrumentation Models:

• VanKel VK7000
• Hanson Research SR8Plus
• Distek    2100C
• Distek 6100
• Distek 7100
• Hanson Research Vision Elite 8
• SOTAX AT MD

The Contractors shall provide a system capable of calibrating Dissolution Apparatus:

• • Benchtop level
  • Basket depth
  • Paddle depth
  • Rotational speed
  • Shaft wobble
  • Shaft verticality
  • Basket wobble
  • Vessel / shaft centering
  • Vessel verticality
  • Vessel plate level
  • Bath Temperature
  • Vessel Temperature

TRADE AND SERVICE SPECS

• The Mechanical Qualification for Dissolution must be a newly manufactured unit, not used and refurbished or previously used for demonstration.  The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.
• The government requires a minimum one-year Original Equipment Manufacturer’s warranty on electronic components which shall include at a minimum: coverage on all non-consumable items and parts supplied and unlimited on-site service visits. All replacement parts, engineer labor and travel costs. The warranty begins on the date of formal government acceptance.
• The Contractor is responsible of doing the actual installation and dispose pallets, empty boxes and any associated garbage off site of FDA facilities the day of the delivery.
• The vendor shall provide to the user documentation of the qualification upon installation.
• The vendor shall demonstrate upon installation that the system meets or exceeds all salient characteristics which have been included in the vendor’s response and/or used are evaluation criteria for award, examples include, but are not limited to mass spectrometer sensitivity specification, mass spectrometer dynamic range, system reproducibility, etc.  The instrument shall not be accepted until those characteristics have been met. 
• All solutions and accessories for instrument maintenance, calibration and qualification must be provided by vendor at time of installation.
• Contractor shall provide on-site familiarization introductory on-site training for 15 users per site.
• Installation and familiarization shall be performed by a certified and trained engineer.  Contractor to provide any necessary manuals and/or consumables to be used during training. 

Repair Service (during warranty period)

• The Service Technician under the service agreement shall repair or replace any part or parts that prove to be defective at no additional charge to the Government.
• The Contractor shall plan for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon time frame.
• All parts replaced will be new replacement parts which meet the original manufacturer's specifications (no refurbished or third-party parts).
• The Service Technician under the service agreement shall agree to unlimited repair service of any part or problem at no additional charge to the Government.  This includes replace any part or parts that prove to be defective at no additional charge to the Government and includes upgrading any software etc. so that the system maintains its original functionality and intended purpose.
• Equipment repair and maintenance work is performed by an OEM-trained engineer.  This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts.  The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs.  All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.
• Parts, labor, and travel/per-diem costs for PM and repairs shall be included in the price of the service agreement.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.  In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications.  At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. 

1. INSPECTION/ACCEPTANCE CRITERIA

The Project Officer will perform inspection and acceptance of equipment, installation and services to be provided. The Project Officer (to be identified upon contract award) is the authorized representative of the Contracting Officer.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the Government to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within 1 business day of task being completed.  The Government will provide written notification of acceptance or rejection within 2 business days.  Inspection will include review of the deliverables to ensure adequacy.

The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

The Government will reject non-conforming products and services.  The Contractor shall correct any deficiencies within two 2-business days of when the Government issues the rejection notice.  If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within 1 day via email. 

1. CONTRACT TYPE

This is firm fixed price.

1. PERIOD OF PERFORMANCE

Deliverable                                                            Quantity                Due Date                   

Mechanical Qualification for Dissolution              3                       Within 60 days from award

Installation                                                                3                       Within two weeks 

Training                                                               15 users                 Within two weeks 

One-year manufacturer’s warranty                        3                       

The period of performance (POP) is 60 days from award.

1. PLACE OF DELIVERY AND PERFORMANCE

Delivery must be coordinated with the New York Medical Products Laboratory at least 48 hours in advance:

U.S. Food and Drug Administration

New York Laboratory Medical Products

158-15 Liberty Avenue

Jamaica, NY 11433

POC: POC to be identified at time of the award.

U.S. Food and Drug Administration

Detroit Laboratory Medical Products

300 River Place Dr., Suite 6th Floor

Detroit, MI 48207

POC: POC to be identified at time of award.

U.S. Food and Drug Administration

Irvine Laboratories

19701 Fairchild

Irvine, CA 92612-2506

POC: POC to be identified at time of award.

HOURS OF OPERATION

Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays. 

FEDERAL HOLIDAYS

The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/.

• New Year's Day
• Birthday of Martin Luther King, Jr.
• Washington’s Birthday
• Memorial Day
• Juneteenth National Independence Day
• Independence Day
• Labor Day
• Columbus Day
• Veterans Day
• Thanksgiving Day
• Christmas Day