Phase I Clinical Trials for Development of Neurotherapeutics

IDIQ

Description

Provide a full service, turn-key Phase I Clinical Trials Facility in support of the development of novel neurotherapeutic agents. This full service facility will be required to perform a full range of services from protocol development through submission of clinical study reports to be used by the NINDS, sponsored Investigators or Contributors in support of Investigative New Drug (IND) applications. The primary emphasis of this Phase I Clinical Trials Facility will be to perform Single Ascending Dose (SAD) and possibly Multiple Ascending Dose (MAD) Phase I clinical trials utilizing NINDS-supplied novel agents developed by NINDS, sponsored Investigators or Contributors with an emphasis on first in human testing to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters.

Overview

Ceiling

$19,500,000

Primary Sponsoring Agency

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Who Can Use

One Agency

Primary NAICS

541712 - Research And Development In The Physical, Engineering, And Life Sciences (Except Biotechnology)

Primary PSC

AN12 - Health R&D Services; Health Care Services; Applied Research

Primary Set Aside

None

Extent Competed

Full And Open Competition

Related Opportunity

Phase I Clinical Trials for Development of Neurotherapeutics (NIH-NINDS-15-01)

Phase I Clinical Trials for Development of Neurotherapeutics awarded by National Institute on Drug Abuse (NIDA) in July 2016 accepts orders through June 2026. The IDIQ has a reported ceiling of $19,500,000, and as of today, $13,016,901 has been obligated through the vehicle with a total reported backlog of $3,946,955. The IDIQ was awarded full & open and has a primary NAICS code of 541712.

Award Hierarchy

Vehicle

Phase I Clinical Trials for Development of Neurotherapeutics

Indefinite Delivery Vehicles

Prime Contracts

Subcontracts

Status

Period of Performance

7/1/16

Start Date

6/30/26

Ordering Period End Date

98.0% Complete

Task Order Obligations and Backlog

$13.0M

Total Obligated

$13.0M

Current Award

$17.0M

Potential Award

77% Funded

$0.0

Funded Backlog

$3.9M

Total Backlog

Vehicle Award Share

Contractors with greatest percentage of obligations for Phase I Clinical Trials for Development of Neurotherapeutics

Vehicle Award Share

Federal Award Analysis