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Analytical Services Center for Medications Development Program Tender, USA - 97236820

HEALTH AND HUMAN SERVICES, DEPARTMENT OF has floated a tender for Analytical Services Center for Medications Development Program. The project location is USA and the tender is closing on 04 Mar 2024. The tender notice number is 75N95024R00032, while the TOT Ref Number is 97236820. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Procurement Summary

Country : USA

Summary : Analytical Services Center for Medications Development Program

Deadline : 04 Mar 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 97236820

Document Ref. No. : 75N95024R00032

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

A. Objectives:

The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals UNDER FULL AND OPEN COMPETITION procedures from qualified organizations certified under NAICS Code 541715; to identify and quantify drugs and their metabolites in biological fluids and tissues such as plasma/serum, urine, sweat, saliva, hair, brain and other tissues.

The National Institute on Drug Abuse (NIDA), Division of Therapeutics and Medical Consequences (DTMC) supports research and development of new medications for the treatment of substance use disorders (SUDs). The purpose of this contract is to provide the NIDA DTMC with a centralized bioanalytical facility services to support the preclinical PK/toxicokinetic studies, clinical pharmacology/PK studies and clinical trials for assessing the efficacy and safety of the study medications. The Contractor shall carry out qualitative and/or quantitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies using validated analytical methods. The analytes include, but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and surrogate outcome measures and/molecular biomarkers (small molecules, peptides, proteins, enzymes, etc). The Contractor shall also develop and validate new assay methods for medications/compounds for which established assays do not exist. The data generated by this contract will be utilized by the NIDA DTMC in the evaluation of new medications under development for the treatment of SUDs. The data will generally be integral to Investigational New Drug (IND) and New Drug Application (NDA) submissions for the Medications Development program and as such must abide by published/appropriate procedures and in a format suitable for this purpose.

B. General Requirements:

Independently, and not a...
Active Contract Opportunity Notice ID 75N95024R00032 Related Notice Department/Ind. Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier NATIONAL INSTITUTES OF HEALTH Office NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Presolicitation (Original)
All Dates/Times are: (UTC-05:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Feb 16, 2024 03:31 pm EST
Original Response Date: Mar 04, 2024 11:00 am EST
Inactive Policy: 15 days after response date
Original Inactive Date: Mar 19, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: AN11 - Health R&D Services; Health care services; Basic Research
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance: North Bethesda, MD USA