CDER-2026-133241 Buchi Ultrasonic Package for Mini Spray Dryer S-300.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Ultrasonic Package for Buchi Mini Spray Dryer S-300

The U.S. Food and Drug Administration (FDA) is conducting market research in support of a requirement for an Ultrasonic Package for Buchi Mini Spray Dryer S-300. The FDA is seeking to identify capable small business sources to determine the availability and capability of small businesses equipped to provide the required products/services. Businesses that are ‘Other than small’ business concerns are also encouraged to submit capability statements. The following information is requested to assist the FDA in conducting Market Research to identify potential sources for this effort.

The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1,000 employees.

Statement of Work Ultrasonic Package (or equal) for Buchi Mini Spray Dryer S-300

1. Background

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) requires an Ultrasonic Package for Buchi Mini Spray Dryer S-300. 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 spray dried powder for intranasal drug delivery.

CDER requires an Ultrasonic Package for an existing FDA owned Buchi Mini Spray Dryer S-300 that can be installed on Buchi mini spray dryer S-300 and B-290. The ultrasonic nozzle should be capable of producing spray dried powders with ideal particle size for intranasal drug delivery (to produce particles up to sixty (60) microns).

2. Scope The scope of this contract is to procure an Ultrasonic Package for Buchi Mini Spray Dryer S-300 and the associated one-year Warranty.

3. Requirements

a. Salient Characteristics The proposed device shall meet the following requirements:

1. Shall be seamlessly integrated into the Buchi mini spray dryer S-300 for daily operation.

2. Shall be adjustable for ultrasonic power to obtain the desired particle size.

3. Shall be able to virtually eliminate clogging by ultrasonic vibrations.

4. Shall have the ability to produce larger sized microparticles compared to two fluid atomizing nozzles.

b. Tasks

The Contractor shall:

1. Deliver and install the selected unit no more than forty-five (45) calendar days after award.

2. Include all costs in their proposed pricing including system packaging, shipping, delivery, installation, maintenance, and maintenance/service.

3. Demonstrate the full operation of the selected unit after installation

4. Provide Factory Acceptance Test, validation documentation, and training support for six (6) scientists.

4. Warranty

The proposed device shall include one (1) year original equipment manufacturer (OEM) warranty. Warranty coverage shall commence on the date of acceptance.

5. Delivery Services shall be provided at the following location:

U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Testing and Research 10903 New Hampshire Ave., (Laboratory WO 64 Rm 1083) Silver Spring, MD 20993

POC: To be provided at time of award

6. Contract Type The required products/supplies will be provided on a Firm Fixed Price basis.

7. Period of Performance Dates are approximate to be finalized upon award.

Base Period: 9/1/2026 – 8/31/2027

8. Government Furnished Equipment/Government Furnished Information (GFI)

No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

9. Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

10. Contract Administration

a. Contract Specialist David Kramer, Contract Specialist Phone: 703-447-2694 Email: david.kramer@fda.hhs.gov

b. Contracting Officer’s Representative (COR) – The following COR will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The COR is responsible for:

1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

2) Interpreting the statement of work and any other technical performance requirements;

3) Performing technical evaluation as required;

4) Performing technical inspections and acceptances required by this contract; and

5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government mailto:david.kramer@fda.hhs.gov under this contract. Only the Contracting Officer has authority to:

1) Direct or negotiate any changes in the statement of work;

2) Modify or extend the period of performance;

3) Change the delivery schedule;

4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

5) Otherwise change any terms and conditions of this contract.

11. Inspection and Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are deemed acceptable in no more than thirty (30) calendar days, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

12. Payments

Payment terms Net-30 calendar days after government acceptance. No advance payments will be made.

END OF STATEMENT OF WORK

SOURCES SOUGHT RESPONSE INSTRUCTIONS

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond.

At a minimum, responses shall include the following:

1. Part 1: Company Overview

a. Business name;

b. SAM Unique Entity ID number;

c. Business address;

d. Business website;

e. Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB); and

f. Point of contact name and mailing address (if different from business address), phone number and email address.

2. Part 2: Product Information

a. Please indicate whether your applicable product and services will meet all of the requirements stated in the Statement of Work. Please identify any requirements that your product and service do not meet and recommend an alternative.

b. Please provide sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the requirements articulated in the Statement of Work.

c. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the contractor to meet the requirement.

3. Part 3: Other Information

a. GSA Schedule contract(s): If applicable, identify the respondent’s GSA Schedule contract(s) by Schedule number and SIN(s) that are applicable to this potential requirement. Include a detailed list of items included and not included on the GSA contract to meet this requirement.

b. Best in Class (BIC) contracts: If applicable, identify the respondent’s Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

c. Section 508: Demonstrate the capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

d. Subcontracting Opportunities: If a large business, identify the subcontracting opportunities that would exist for small business concerns.

e. Warranty and Terms: Include your standard commercial warranty and payment terms; and

f. Informational Pricing: Though this is not a request for quote, but informational pricing is encouraged.

Response Date and Time

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before July 20, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov. Reference CDER-2026-133241.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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.

http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility mailto:david.kramer@fda.hhs.gov

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).

Sources Sought Response Instructions