International Clinical Studies Support Center

Introduction 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 Microbiology and Infectious Diseases (DMID), has a requirement to enhance the capacity of foreign clinical sites to design, conduct and manage clinical research projects. Description As part of NIAID's mission to advance the global health agenda, DMID supports a spectrum of international clinical research involving sites in resource-limited countries and focusing on those infectious diseases which disproportionately affect the populations residing in those countries. As of 2009, DMID-supported research in international settings included nearly 650 projects, more than of half of which involve human subjects. The work is distributed in 74 countries, 55 of which are resource-limited, through grants and contracts to foreign institutions, grants to U.S. institutions conducting international clinical research, and through multiple research groups. An important aspect of the DMID international infectious disease research agenda involves enhancing the capacity of foreign sites to design, conduct and manage clinical and non-clinical research projects, including compliance with regulatory requirements and established guidelines and standards for the conduct of human subjects research. In order to enhance clinical research capabilities at international clinical sites, DMID awarded a contract in FY2005, under the title "International Clinical Sciences Support," to provide training and assistance to such clinical sites with respect to various aspects of clinical research. The contract awarded under this solicitation will continue this effort. It is anticipated that a level of effort type contract will be awarded. The Government's requirement for the work set forth in the Statement of Work (SOW) of this solicitation is estimated at 9360 labor hours per contract year based upon the assumption of 4.5 FTE's with a FTE being defined as 2080 hours. This requirement will consist of one (1) base period of one (1) year and six (6) one (1) year option periods. The labor hours are inclusive of vacation, sick, and holiday time. In addition to the Base requirements sited above, during each contract year the Government may exercise options up to 5 (five) times a year for additional level of effort by up to (0.3) FTE's (624 labor hours) in Principal Investigator/Project Manager, Professional, Technical support to respond to emerging needs related to the proposed research. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about November 1, 2011 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.