Notice Number: NOT-AI-05-052

Key Dates
Release Date: August 26, 2005
Proposal Receipt Date(s): December 16, 2005
Peer Review Date(s): February 13, 2006
Earliest Anticipated Start Date: July 13, 2006

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

The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), NIH, DHHS has a requirement for a resource to provide services for activities commonly associated with preclinical development of therapeutic agents, including those activities required for the submission of Investigational New Drug (IND) applications.

Specifically, the Contractor shall: 1) provide an infrastructure for the overall technical and administrative management; 2) provide the personnel, equipment, technical expertise, and infrastructure either at their own facilities or identify qualified subcontractors; 3) solicit for and evaluate subcontract proposals, and execute, manage and assess subcontractor performance; 4) retain all records, samples, histopathological slides, etc., as indicated by GLP and cGMP guidelines; 5) maintain awareness of evolving regulatory requirements for preclinical evaluations of therapeutic agents; 6) arrange for site visits and independent audits, as needed or as requested by the NIAID Project Officer; 7) develop and/or submit to NIAID, Standard Operating Procedures (SOPs) for any of the assays, processes, procedures, etc. performed by the Contractor or a subcontractor in the execution of this contract; 8) participate as necessary in discussion with the FDA during pre-IND, IND, pre-new drug application (NDA), and pre-biologic license application (BLA) meetings; and 9) provide an orderly transition to a successor contractor or to the United States Government at the end of the contract.

RFP-NIH-NIAID-DMID-06-09 will be available electronically on or about August 16, 2005 with a closing date tentatively set for December 16, 2005, and may be accessed through the NIAID Contract Management Program (CMP) Home Page at http://www.niaid.nih.gov/contract -- and will also be posted on FedBizOps at: http://www.fedbizopps.gov.

It is anticipated that one five year cost reimbursement, completion type contract will be awarded on or about September 15, 2006.

Any responsible Offeror may submit a proposal, which will be considered by the Government.

This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Inquiries

For questions or further information, contact:

Erin Goldstein
Contracting Officer
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
MSC 7612
Bethesda, MD 20892-7612
Phone 301-496-6423
Fax 301-402-0972
Email: eg108r@nih.gov

Lawrence Butler
Acting Branch Chief
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
MSC 7612
Bethesda, MD 20892-7612
Phone 301-496-7119
Fax 301-402-0972
Email: lbutler@niaid.nih.gov

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