Phase I Clinical Trials for Development of Neurotherapeutics

Closed Pre-Solicitation Posted

Not the latest version. See the latest solicitation from .

Solicitation number
75N95024R00086
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute on Drug Abuse (NIDA), part of the Department of Health and Human Services National Institutes of Health, is seeking contractors to provide full-service, turn-key Phase I clinical trials operations and facilities to support the development of novel therapeutics, including small molecules and biologics, for neurological disorders. The forthcoming Request for Proposals (RFP) No. 75N95024R00086 will be issued via SAM.gov on or about July 30, 2024, and will be conducted using full and open competition. NIDA anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts with a ten-year ordering period to allow for the issuance of fixed-price or cost-reimbursement task orders. The scope of work includes providing a Phase I clinical research unit, conducting the trials, and providing a full range of supporting services in compliance with FDA and ICH GCP regulations, such as protocol development, regulatory submissions, data management, quality control, investigational agent management, and final reporting.

This opportunity is not set aside for any specific business category. There is no information provided about potential incumbents or current contractors. The Pre-solicitation Notice does not specify award values or budget ranges, but the services required suggest a potentially significant contract value. Offerors must be registered in SAM.gov, and no individual notification of amendments will be provided.

Notice text

3 versions

Update #3 · Latest ·

This pre-solicitation notice for Request for Proposals (RFP) NO. 75N95024R00086, entitled: "Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics" has been extended until August 19, 2024, at 3 pm ET. It is anticipated the RFP will be issued via www.SAM.gov on or around this date.

Update #2 ·

This pre-solicitation notice for Request for Proposals (RFP) NO. 75N95024R00086, entitled: "Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics" has been extended until August 16, 2024, at 3 pm ET. It is anticipated the RFP will be issued via www.SAM.gov on or around this date.

Update #1 ·

Please see the attachment.

Files

File Type Posted
Pre-sol_Notice_75N95024R00086_1.pdf PDF

Notice history

Notice Type Posted
Request for Proposals - Phase I Clinical Trials Latest solicitation Solicitation
This notice Original Pre-Solicitation

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