MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biological Evaluation and Research (CBER) requirement for mouse muscle physiology system.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required products/services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors 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 1000 employees.

Statement of Work (SOW) for a mouse muscle physiology system

A. Introduction

A mouse muscle physiology system is needed to support a new laboratory research program that will study gene therapy in mice that have genetic muscular diseases. The muscle physiology system will allow measurement and control of muscle strength and length in live mice, in muscles in situ, and in excised muscles.

B. Scope

Purchase of a mouse muscle physiology system (Scientific Instrument)

Part II: Work Requirements

A. Technical Requirements

• The system shall enable measurement of mouse muscle strength and length in situ, in vivo and in vitro.
• Include temperature-controlled plate for limb muscle measurement and bath for in vitro muscle measurement.
• Include electrical stimulator and 2-channel muscle lever.
• Include computer and software for muscle physiology data acquisition and analysis.

B. Deliverables

Contractor shall deliver and install the mouse muscle physiology system.

Part III: Supporting Information

A. Security
Contractor shall pass through FDA White Oak security.

B. Place of Performance
Deliver to:
To be provided at time of award
FDA/CBER
Bldg. 52 Rm 3148
10903 New Hampshire Ave
Silver Spring, MD 20993

C. Period of Performance
Delivery and installation shall occur 30-100 days from date of award.

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

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:

• Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. 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.
• Three (3) years of past performance product/service information, where the respondent has provided same or substantially similar products/service solutions on the same or near-same brand name equipment. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 ID number and size status) if not the respondent.
• If applicable, identification of the firms GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.
• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.
• If a large business, identify the subcontracting opportunities that would 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; and
• Though this is not a request for quote, informational pricing is encouraged for both the purchase of the monitoring, gas and delivery.

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 14, 2024 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2024-123728.

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.

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).

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