Sources Source Notice.pdf

Sources Source Notice (SSN)

REQUIRING ACTIVITY:

April 23, 2024

Food and Drug Administration, (FDA)

CONTRACTING

ACTIVITY:

Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Programs (DAP), Facilities Support Branch (FSB)

1. DESCRIPTION OF

SERVICES:

Procurement of: CDRH-2024-122027 Leakage Testing in Microfluidic Devices

System under Solicitation: FDA-SSN-CDRH-2024-122027.

2. ESTIMATED COST

(INCLUDING

OPTIONS):

$28,986.00 104,522.69 for a Period of Performance: 07/05/2024 THRU 07/04/2025

The U. S. Food & Drug Administration has a requirement for the procurement of: CDRH-2024- 122027 Leakage Testing in Microfluidic Devices System under Solicitation: FDA-SSN-CDRH- 2024-122027.

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

Offerors must have an active registration in www.SAM.gov, with completed representations and certifications.

Introduction This Sources Sought Notice (SSN) is a market research tool to determine the availability and technical capability of small businesses (including the following subsets: Small Disadvantaged Businesses, HUBZone Firms, Certified 8(a), Service-Disabled Veteran-Owned Small Businesses and Woman Owned Small Business) to provide the required products and/or services.

Disclaimer This SSN is for informational purposes only. This is not a request for proposals. It does not constitute a solicitation and shall not be construed as a commitment by the Government. Responses in any form are not offers and the Government is under no obligation to issue a solicitation or award a contract as a result of this announcement. No funds are available to pay for the preparation of responses to this announcement. Any information submitted by respondents to this technical description is strictly voluntary.

Program Background The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Office of Science and Engineering Laboratories (OSEL) supports CDRH’s mission of protecting and promoting public health. OSEL undertakes the highest quality science to provide their customers with the best methods, tools and expertise to:

i. Ensure readiness for emerging and innovative medical technologies.

ii. Develop appropriate evaluation strategies and testing standards.

iii. Create accessible and understandable public health information and,

iv. Deliver timely and accurate decisions for products across their life cycle.

Purpose FDA needs a leakage testing system that will be used for accurate detection of leaks in microfluidic devices under different operating conditions (i.e., flow rates and pressures) to understand the performance of existing testing platforms for assessing emerging device technologies.

Required Capabilities This system will benefit FDA regulatory science research and significantly reduce the test method development time by removing the need for FDA to design, develop, build, test, and validate a custom solution.

Furthermore, the leakage testing system acquisition will help FDA to develop a test protocol for characterizing and quantifying small leaks occurring in microfluidic devices that may otherwise go undetected. The microfluidic group plans to disseminate leakage related test methods to industry via OSEL’s Regulatory Science Tools catalog, so that they can be used by microfluidic device developers for assessing the mechanical integrity of their finished devices. This is aligned with CDRH Advanced Health Equity Strategic priority to advance the development of knowledge and safe and effective technologies to meet the needs of all patients and consumers. This will support consistent, least-burdensome assessment of microfluidic devices during pre-market review while ensuring valid scientific evidence supports the performance of devices used in the care of diverse patient populations.

Additional Information The Office of Science and Engineering Laboratories (OSEL) Division of Applied Mechanics (DAM/OSEL/CDRH/FDA) is developing non-clinical test methods for evaluating leakage of microfluidic devices to accelerate patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science. Procurement of a leakage testing system is a key component in building a protocol for testing novel microfluidic devices, as CDRH has seen a steady increase of these type of devices in the past several years, and leakage is a commonly reported adverse event.

Eligibility The applicable NAICS Code for this requirement is 334516-Analytical Laboratory Instrument Manufacturing.

Submission Details Interested small businesses are requested to submit a capabilities statement. Interested businesses should submit a brief capabilities statement package that shall address, at a minimum, the following items:

1.) What type of work has their company performed in the past in support of the same or similar requirements? This should include the contract number, organization supported, indication of whether as a prime or subcontractor, contract value, Government point of contact, and a brief description of how the referenced contract relates to the items/services described in this SSN.

2.) What specific technical skills does their company possess which ensure capability to provide the requested items/services?

3) Note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Vendors shall thus provide an explanation of their company's ability to perform at least 50% of the tasks/terms/services requested.

4.) Respondents to this notice shall also indicate whether they qualify as a Small, Small Disadvantaged, Women-Owned, HUBZone, or Service-Disabled Veteran-Owned Small Business Concern.

In order for the Government to make a determination for a small business set-aside, two or more qualified and capable small businesses must submit responses that demonstrate their qualifications and ability to provide the requested items/services.

To assist the Government in making the subject determination regarding the level of participation by small business in any subsequent procurement that may result from this Sources Sought, Vendors are also encouraged to provide information regarding plans to use joint venturing (JV) or partnering to meet each of the requirements’ areas contained herein. This includes responses from qualified and capable Small Businesses, Small Disadvantaged Businesses, Service Disabled- Veteran Owned Small Businesses, Women-owned Small Businesses, HUBZone Small Businesses, and 8(a) companies.

Vendors shall provide information on how they will envision their company's areas of expertise and those of any proposed JV/partner, combined to meet the specific requirements contained in this announcement.

Responses to this SSN shall be electronically submitted to Emmanuel.mbah@fda.hhs.gov. The deadline for response to this request is 04/30/2024 (12: 00pm) Eastern Standard Time.

Proprietary information and trade secrets, if any, SHALL be clearly marked on all materials. All information received that is marked Proprietary will be handled accordingly. Be advised that all submissions become Government property and will not be returned.

No phone calls will be accepted. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise because of a response to these SSN, nor is the Government obligated to issue a solicitation/award from this

SSN.

Emmanuel T. Mbah.

Contracting Officer/Contract Specialist mailto:Emmanuel.mbah@fda.hhs.gov