Toxicity testing on a new PET ligand (Sources Sought)

THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY. 

It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract.  Requests for a solicitation will not receive a response.  Responses to this sources sought must be in writing.  The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Small Businesses interested and capable of providing the services described below.

NIH-CC-OPC-25-002889

The information gained from this market research will help the National Institutes (NIH) Clinical Center (CC) plan for its acquisition strategy. 

Potential Large and Small Businesses shall include business information outlined in the section below as a part of their response.

Complete responses to this notice shall be in the following format:

1. SAM UEI Number
2. Company Name
3. Company Address, City, State and Zip Code
4. Company Point of Contact, Email Address and Telephone Number
5. Current GSA Schedule appropriate to this Sources Sought
6. Socioeconomic Status: (i.e., HUBZone, 8a, Small Business, Women Owned Small Business, Veteran-Owned Small-Business, etc.) as validated in Central Contractor Registration (CCR).  All offerors must register in CCR located in https://www.sam.gov.
7. Provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described in the Statement of Work.

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The National Institutes of Health, Clinical Center has a requirement for a single dose, single species Toxicity Study in Rats with 14-day Recovery for a proposed PET ligand (Fluoine-18-Fluorocellobiose).  The results of this study will be provided to the FDA as per the Center for Drug Evaluation and Research (CDER) requirements. This is a necessary step for the Investigational New Drug (IND) application. Offerors are referred to the attached Statement of Work (SOW) for all technical requirements and standards of service.  The period of performance is for a one year twelve (12 month) base period.  All services will be requested from the NIH, Clinical Center in Bethesda, Maryland.

Schedule/Period of Performance:

The project will be performed at the contractor’s facility. The estimated period of performance for the project is a maximum of 12 months following receipt of the completed Authorization Form signed by an authorized representative of the NIH Clinical Center, receipt of any study materials to be provided by NIH Clinical Center, and initial payment.

Contractors shall not reach out to the customer for any questions or clarifications. 

All communications must go through contracting.

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Important information:  The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request.  This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.  No sub-contracting opportunity is anticipated.

NAICS:  The North American Classification System (NAICS) code for this acquisition is 541380, business standard size of 1000 employees. 

PSC:  Q301

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered and have an active registration in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA).  

All interested Offerors should submit information by e-mail to Grace.Wong-Darko@nih.gov

All information submissions shall be received no later than 1:00 pm Eastern Standard Time Jan 31, 2025.