Notice Number: NOT-AI-09-009
Key Dates
Release Date: November 4, 2008
Receipt Date: April 7, 2009
RFP will be available electronically on/about December 8, 2008, and may be accessed through FedBizOpps http://www.fedbizopps.gov/.
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
Description
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS, as the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, has a requirement to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. The NIAID, Division of AIDS, is seeking a contractor to provide comprehensive clinical site and study monitoring services for the NIAID/DAIDS extramural clinical trial research portfolio. The scope of activities to be performed includes:
It is anticipated that one cost reimbursement, completion type contract will be awarded for a seven-year period of performance beginning on or about December 4, 2009. In addition to the above functions and services to be provided for the Base Period, up to four Options for expanded services under the contract may be exercised at the discretion of the Government. These Options include staffing, management, oversight and additional facilities and equipment required for:
Option 1 – Clinical Site and Study Monitoring for a Phase IIb/III Vaccine Clinical Trial
Option 2 – Clinical Site and Study Monitoring for a Phase IIb/III Microbicide Trial
Option 3 – Clinical Site and Study Monitoring for Phase IIa Vaccine Clinical Trials
Option 4 – Clinical Site and Study Monitoring for Phase IIa Microbicide Clinical Trials
Estimated Staffing requirementsTHE NAICS Code is 541712 with a size standard of 500 employees. All responsible sources may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
Inquiries
For questions or further information, contact:
Michael Finn, Contract Specialist
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3105
Phone: 301-496-0612
Fax: 301-480-4675
finnm@niaid.nih.gov
Eileen Webster-Cissel, Contracting Officer
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3151
Phone: 301-496-0612
Fax: 301-480-4675
webstere@niaid.nih.gov
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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