SOLICITATION NOTICE
A -- Services for the Pre-Clinical Development of Therapeutic Agents
- Notice Date
- 7/25/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DMID-06-09
- Response Due
- 8/16/2005
- Archive Date
- 8/31/2005
- Description
- 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. Point of Contact Erin Goldstein, Contracting Officer, Phone 301-496-6423, Fax 301-402-0972, Email eg108r@nih.gov; Lawrence Butler, Acting Branch Chief, Clinical Research Contract Branch, NIAID, NIH, DHHS Phone 301-496-7119, Fax 301-402-0972, Email lbutler@niaid,nih.gov
- Record
- SN00853736-W 20050727/050725211730 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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