RFP Announcement: Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases - NIH-NIAID-DMID-08-06

Notice Number: NOT-AI-07-024

Key Dates
Release Date: February 13, 2007
Receipt Date: July 2, 2007

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), ( http://www.niaid.nih.gov )

Description

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than HIV. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

The Division also supports substantial preclinical research efforts to develop new therapeutics. It is anticipated that these efforts will produce many promising investigational products that will require initial testing in humans in Phase I clinical trials. In order to ensure the capacity to evaluate the growing pipeline of investigational products as they become available, it is critical for DMID to establish the dedicated resources necessary to undertake Phase 1 clinical trials for a broad range of infectious diseases.

The NIAID therefore has a requirement to fulfill the need to provide and manage a Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases. This phase I unit will operate under Good Clinical Practices (GCP) and will provide and support electronic data capture system.

NIAID anticipates that a minimum of four protocols will be implemented in each year of the contract. Each protocol will include pharmacokinetic (pK) and pharmacodynamic (pD) and safety evaluation of investigational therapies. It is estimated that 150 healthy individuals (18 – 45 of age) will be recruited each year, and at least 45% of those will be from minority groups. The clinical protocols and all additional clinical documents needed, such as, Case Report Forms (CRFs), and Manuals of Procedures (MOPs), will be developed by the Contractor. The Contractor will also provide independent clinical site monitoring abilities, electronic data capturing ability and data management capacity.

It is anticipated that one cost reimbursement, completion type contract will be awarded for a seven-year period of performance beginning on or about March 4, 2008. The total annual estimated effort anticipated is 17.5 FTE.

Any responsible offeror may submit a proposal which will be considered by the Government.   This RFP will be available electronically on or about March 1, 2007, and may be accessed on FedBizOpps http://www.fedbizopps.gov/ .  This notice does not commit the Government to award a contract.   No collect calls will be accepted.   No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.

Inquiry

Inquiries regarding this notice may be directed to:  
David T. Lisle
Contracting Officer
Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive , Room 3214, MSC 7612
Bethesda , MD 20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone 301-451-2617
Fax 301-402-0972
Email: Dlisle@niaid.nih.gov


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