FDA_75F40126SSN133239.pdf

This is a Sources Sought Notice (SSN) - a market survey designed to collect 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. There is no RFQ, or other iteration of a solicitation associated with this Notice, and no telephone calls will be accepted requesting an RFQ package or solicitation. To protect the procurement integrity of any future acquisition that may arise from this announcement, information regarding a government technical point of contact will not be given and no appointments for presentations will be made.

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV) requires an in vitro Subcutaneous Injection Site Simulator (SCISSOR) system to address critical regulatory research needs for the evaluation of complex long-acting injectable drug products. The development of generic versions of these products, such as in-situ forming gels and implants, presents significant regulatory challenges. Establishing bioequivalence (BE) through conventional in vivo pharmacokinetic (PK) studies is often complicated by high data variability, ethical considerations (as with drugs of abuse), and difficulties in patient recruitment. There is a pressing need to develop robust and reliable in vitro methodologies that can serve as an alternative BE pathway. A physiologically relevant in vitro subcutaneous injection site simulator provides a controlled environment that mimics the subcutaneous tissue, enabling the development and validation of IVRT methods for in situ forming products. This capability is critical for FDA laboratories to fully characterize these complex drug products and develop science-based bioequivalence recommendations. The new system will significantly advance DPQRV's analytical capability and research readiness to generate critical evidence to support both new drug applications (NDAs) and abbreviated new drug applications (ANDAs), and will enable the development of product-specific guidance documents with robust in vitro bioequivalence approaches.

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 1,00 employees, and you believe that your firm would be able to provide the FDA with the equipment and/or services described below, please submit an email containing capability statement(s) to timothy.walbert@fda.hhs.gov.

Other than small business concerns are also encouraged to submit capability statements. An interested supplier shall include information about the company and demonstrate that it can meet all the following minimum performance requirements.

The minimum technical requirements that a Subcutaneous Injection Site Simulator (SCISSOR) instrument system shall meet are as follows:

General System shall be a complete subcutaneous injection site simulator consisting of multiple independent chambers with integrated optical detection systems, automated sampling capabilities, and comprehensive software control for hardware operation and data management.

Main Instrument Configuration *Shall have minimum of six (6) independent chambers for simultaneous testing of multiple samples;

*Each chamber must have independent temperature and flow control capabilities;

mailto:timothy.walbert@fda.hhs.gov

*Integrated camera or imaging system for each chamber enabling real-time visual monitoring of gel formation, structure evolution, and dissolution processes;

*Compatible with standard laboratory power (115-240 VAC, 50/60 Hz);

*Physiologically relevant temperature regulation capability to simulate subcutaneous tissue environment, with control range including 32-37°C;

*Capable of introducing test samples via manual or automated injection methods;

*Simultaneous visual and spectroscopic monitoring capabilities for all chambers;

*System should be expandable or configurable to accommodate different experimental needs;

* Shall have a reasonable laboratory footprint suitable for standard laboratory benchtop installation.

Automated Injection System System should include or be compatible with an automated injection capability with the following specifications:

*Automated sample injection capability for reproducible and consistent sample introduction across all chambers;

*Full integration with the chamber system;

*Accurate and reproducible injection volumes with documented precision;

*Programmable injection parameters including volume, rate, and depth of injection;

*Capability to deliver consistent injections to minimize inter-sample variability;

*Compatible consumables (e.g., pipette tips, syringes) should be readily available.

Optical Detection and Monitoring System The system should include or be compatible with optical detection capabilities with the following specifications:

*Capable of simultaneous spectroscopic monitoring of all chambers;

*Fiber optic probe system or equivalent optical detection method suitable for in-line monitoring;

*Appropriate optical path length for drug quantification;

*UV-visible spectroscopy capability for drug quantification across relevant wavelength ranges;

*Real-time signal acquisition and transmission to spectrophotometer or data acquisition system;

*Sufficient sensitivity for detection of drug release at physiologically relevant concentrations;

*Stable baseline and reproducible measurements over extended time periods (hours to days).

Automated Fraction Collection System The system should include or be compatible with an automated fraction collection capability with the following specifications:

*Minimum capacity of 30 collection vials per chamber (180 total vials for 6-chamber system);

*Fully automated sampling from all chambers without manual intervention;

*Programmable sampling volumes ranging from minimal 0.1 mL to 1 mL or greater;

*Integrated automated cleaning/wash station for sampling components to prevent cross-contamination between samples;

*Automated buffer or media replenishment system to maintain consistent flow stream composition throughout extended experiments;

*Compatible with standard laboratory power (115-240 VAC, 50/60 Hz);

*Full integration with system control software for coordinated operation;

*Compatible with standard HPLC vials or other common laboratory vial formats for subsequent analysis;

*Programmable time-based or event-based sampling protocols with flexible scheduling options;

*Demonstrated reliability for unattended operation over extended periods (24+ hours).

Calibration and Standardization The system should include or be compatible with calibration and standardization tools with the following specifications:

*Standardization and calibration capabilities for optical detection systems;

*Tools and procedures to ensure consistent measurements across all chambers and over time;

*Clear calibration procedures and documentation for quality assurance;

*Straightforward standardization procedures suitable for routine operation.

Consumables and Accessories The vendor should provide initial consumables and accessories including:

*Appropriate consumables for automated injection system;

*Demonstration kit or validation materials suitable for initial system qualification and training;

*Reference cartridges, matrices, or materials for method development and validation;

*All consumables should be designed specifically for the proposed system;

*Ongoing availability of consumables should be guaranteed with reasonable lead times.

Software Control and Data Management The system software shall meet the following specifications:

*Complete control of all system hardware components including temperature regulation, injection parameters, and fraction collection scheduling *Simultaneous control and monitoring of all chambers with independent parameter settings *Real-time status display and monitoring of all chambers simultaneously with clear visual interface *Ability to create, save, modify, and execute experimental methods with all relevant parameters *Capable of running automated sequences across multiple chambers with programmable start times and conditions;

*Integration capability with external spectrophotometer systems for real-time data acquisition;

*Control and data capture from all integrated cameras or imaging systems;

*Automated System Integration: Full control and coordination of automated injection and fraction collection systems;

*Export capabilities for data analysis in standard formats (e.g., CSV, Excel, text files);

*Intuitive graphical user interface for method setup, execution, and monitoring;

*Comprehensive data logging and experimental documentation with time-stamped records;

*User access controls and audit trail capabilities suitable for regulated laboratory environment.

Warranty Shall include a minimum one-year full manufacturer’s warranty from date of FDA acceptance of the system.

Installation Contractor shall conduct complete installation of the system to include the following:

*Unpacking, inspection, and positioning of all equipment;

*Complete hardware setup and configuration;

*Integration with existing FDA spectrophotometer system (Rainbow R2 or equivalent);

*Software installation, configuration, and network integration as needed;

*Performance verification testing to confirm proper system operation according to specifications;

*Documentation of installation qualification (IQ) or equivalent installation documentation;

*Identification and resolution of any installation issues;

Training Contractor will provide comprehensive on-site training for FDA personnel including:

*Basic hardware operation and routine maintenance procedures;

*Software operation for method development, execution, and data management;

*Automated injection system operation and troubleshooting;

*Fraction collector operation, programming, and maintenance;

*Optical detection system setup, calibration, and standardization;

*Integration procedures with existing spectrophotometer system;

*Routine maintenance procedures and schedules;

*Basic troubleshooting guidance and problem resolution;

*Training materials, user manuals, and documentation;

*Minimum training duration: One (1) full day on-site, with additional remote support as needed.

Service and Support *Access to vendor technical support via phone and email during regular business hours (minimum Monday-Friday, 9 AM - 5 PM Eastern Time);

*Reasonable response time for technical issues and service requests (maximum 2 business days for initial response);

* Access to software updates, patches, and bug fixes during warranty period at no additional cost;

*Comprehensive user manuals, technical documentation, and standard operating procedures;

*Confirmed availability of replacement parts and consumables for ongoing operation with reasonable lead times;

*Remote diagnostic and troubleshooting capabilities where applicable.

Documentation and Compliance Contractor shall provide upon FDA acceptance of the system:

*Detailed technical specifications for all system components;

*Comprehensive user manuals and operating procedures;

*Detailed maintenance schedules and procedures;

*All relevant compliance certificates, safety certifications, or regulatory documentation;

*Material Safety Data Sheets (MSDS) or SDS for all consumables and materials provided.

Delivery Point

U.S. FDA CDER DPQRV

Attn: TBD Bldg. 64, 1st Floor Loading Dock 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Responses to this Sources Sought Notice shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar equipment and/or services. Though the target audience is small business vendors or small businesses capable of supplying a U.S.

product/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, Unique Entity ID (SAM) 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 (within the last 3 years) information for the sale of same or substantially similar product/service 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 SAM Unique Entity Identifier (UEI) and size status) if not the respondent;

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

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

• If applicable, the offeror’s capability to initiate service within 5 business days of original notification, to include estimated historical on-site response time for the brand name and model of instrument in this requirement;

• 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 applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available under;

• If a large business, provide whether 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 required.

Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes. The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements submitted ONLY by email on or before 2:00 pm (Central Time in Jefferson AR) on June 1, 2026 to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN133239 in the Subject line of the e-mail.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or 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 mailto:timothy.walbert@fda.hhs.gov 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.

Responses with weblinks will not be opened or viewed. Responses must demonstrate capability, not merely affirm the respondent’s capability (i.e. the response must go beyond the statement that, “XYZ company can provide the instrument, technical support etc.”).

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 or combined synopsis/ solicitation may be published on SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information 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. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.