75F40124Q00359_SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Drug Evaluation and Research (CDER) in order to determine if there are existing small business sources capable of providing one cascade impactor.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/CDER is in need of one cascade impactor. Advanced pharmaceutical manufacturing is an innovative pharmaceutical manufacturing technology, which has the potential to enhance drug quality, improve the reliability and robustness of the manufacturing process and supply chain, and increase timely access to quality medicines for the American public. One of FDA’s research priorities is to explore advanced manufacturing techniques, including manufacturing of inhalation products.

Minimum Technical Requirements for a Cascade Impactor:

• Shall be equipped with a sample inlet stage with a cutoff of at least 2.5μm of particle retention.

• Shall be equipped with at least six (6) stages of piezoelectric biosensors that detect resonance frequency variation associated with mass change on the chip surface (aka, quartz crystal microbalance stages). These stages shall cover a range of cut-sizes of 45-2440nm.

• Shall be equipped with collection efficiency curves and calibrated cut points range of 960 - 45 nm at 10-L/min inlet flow rate.

• Shall have a nanogram resolution with true mass sensing of solid particles.

• Shall be equipped with automatic humidity and temperature controllers of the sample loaded that operate at a range of 0-100% RH and 15–30 °C.

• Shall be equipped with a vacuum pump.

• Shall measure mass fractions of aerosol samples at 1 Hz data collection over the range of 1 nanograms to 1 milligram.

• Shall operate at a sampling flow rate of 10 L/min.

• Shall be equipped with a touch-screen color display for operation.

• The Contractor shall provide Factory Acceptance Test, Installation Qualification (IQ), Operational Qualification (IQ/OQ) Documentation, and Validation Support Factory Acceptance testing (FAT), validation documentation and execution support.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

• Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

• The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

• The Contractor shall provide on-site hardware and software training.

• The Contractor shall install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• The Contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for one day. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

• System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates; unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Estimated Delivery Date: 120 days after award

Delivery Location:

Food and Drug Administration Center for Drug Evaluation and Research 10903 New Hampshire Ave Building 62; Loading Dock Silver Spring, MD 20993

Service 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 a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• The Government is not responsible for locating or securing any information, not identified in the response.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 1, 2024, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40124Q00359.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.