Sexually Transmitted Infections Clinical Trials Group (STI CTG)

SYNOPSIS 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 has a requirement to foster, develop and administer a research program that will contribute to human reproductive health and specifically lead to the prevention and control of Sexually Transmitted Infections (STI's). Description: Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents other than HIV. This includes basic and applied research to develop and evaluate therapeutics, vaccines and diagnostics that is funded through a variety of research grants and contracts. As part of this effort, the DMID Sexually Transmitted Diseases (STD) program supports research to develop more effective prevention and treatment approaches to control sexually transmitted infections (STIs). These diseases continue to be a world-wide problem, particularly in women, adolescents, infants and underserved populations, including minorities and low income populations. STIs are caused by several bacterial and viral agents and can manifest in individuals as diseases with both short- and long-term health consequences. Co-infection with more than one pathogen is common, as well as co-infection with HIV. The mission of the DMID STD program is to foster, develop and administer a research program that will contribute to human reproductive health and specifically lead to the prevention and control of STIs. The broad public health goals of this research program focus on the prevention of: (i) STIs and associated syndromes; (ii) infertility; (iii) adverse outcomes of pregnancy, including preterm birth and low birth weight; (iv) reproductive tract neoplasia; and (v) other chronic STI sequelae. The purpose of this solicitation is to recompete the Sexually Transmitted Infections Clinical Trials Group (STI CTG) research program to continue to provide DMID with the infrastructure necessary for the design and conduct of clinical trials and clinical studies focused on the screening, diagnosis, treatment, prevention and control of STIs. The NIAID awarded the Sexually Transmitted Diseases Clinical Trials Unit (STD CTU) contract in 1997 to the University of North Carolina (Contract N01AI75329), and the Sexually Transmitted Infections Clinical Trials Group (STI CTG) contracts in 2003 to the University of Alabama at Birmingham (Contract N01AI40073) and the University of California, San Francisco (Contract N0AI40074), with the goal of providing clinical trial capability for the evaluation of diagnostics, therapeutics, vaccines and microbicides for the control and prevention of STIs. NIAID anticipates awarding an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract to fulfill the technical requirements of this solicitation. Sample Task Orders will be provided in the RFP to evaluate offeror responses and capabilities. Task Orders for specific tasks within each of the following Task Areas will be issued after award of the Basic Contract. TASK AREA 1 A. Administrative and overall clinical operations support B. Concept proposal development C. Protocol development D. Identification of Clinical Populations TASK AREA 2 A. Clinical trial/study implementation and conduct in single or multiple sites. B. Clinical trial/study specific meetings and teleconferences support C. Clinical trial/study close-out and final study reporting D. Coordination and Collaboration with DMID Staff, contractors and other government entities. Contract(s) awarded as a result of this RFP will have an ordering period of seven years. The anticipated start date is on/or about June 7, 2013. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about May 25, 2012, 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.