NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the 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 Allergy, Immunology and Transplantation (DAIT) has a requirement for providing comprehensive clinical site monitoring services to fulfill its responsibilities as the funder and/or sponsor of clinical research studies conducted by ensuring compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and E6 International Conference on Harmonization Good Clinical Practices (ICH/GCP).

The purpose of this contract is to provide DAIT with clinical site monitoring services for the Collaborative Network for Clinical Research on Immune Tolerance Network (ITN), DAIT-supported, investigator-initiated clinical research studies conducted under grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis.

It is anticipated that one cost reimbursement, level of effort will be awarded for a 1 year period of performance beginning on or about November 2011. The Government may exercise an option for an additional year of performance up to nine times during the life of the contract. The total period of performance resulting from the base period plus all potential exercising of this option is ten years. The services required will be the same scope provided during the base year. The anticipated contract award will also contain an option for an increased level of effort in increments of 10% over the base period which can be exercised up to 10 times per contract year.

It is estimated that the provision of FTEs will be approximately as follows: 10.7 FTEs for the Base Period.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about November 18, 2010, and may be accessed through 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.