VACCINE AND TREATMENT EVALUATION UNITS (VTEU)

Presolicitation Notice Information 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 for a clinical trial network to conduct clinical studies and clinical trials, including evaluation of new and improved vaccine, diagnostics and therapeutic candidates for a wide variety of infectious diseases. Description Research supported and conducted 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 infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) (www.niaid.nih.gov/dmid/clinresearch) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of the NIAID. The Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the 1960's, have designed and conducted a broad range of clinical studies and clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. These have included IDE, IND and non-IND trials, many Phase I first in man clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken a variety of other studies, including: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. In addition to conducting clinical trials, the VTEUs are responsible for identifying new concepts for clinical trials. These concepts have included new methods to utilize currently available vaccine, diagnostics, and treatments; clinical trials of promising investigational products; and clinical studies conducted to better characterize responses to vaccines. The VTEUs work with DMID protocol teams and other collaborators to develop concepts, proposed by the VTEUs or other sources, into clinical protocols. The VTEUs also provide expert consultation to DMID in areas of infectious disease clinical research. Finally, the VTEUs have an important role in responding to emerging public health needs at the direction of the NIAID. This Request for Proposals (RFP) provides for the recompetition of the VTEU clinical research program. The current contracts (HHSN272200800002C, HHSN272200800003C , HHSN272200800004C, HHSN272200800005C, HHSN272200800006C, HHSN272200800007C, HHSN272200800008C, and HHSN272200800057C ) are due to expire on or about October 31, 2014. Approximately 40 clinical trials and clinical studies have been conducted during the past three years under these contracts. Several of these clinical trials/studies were performed in a compressed time frame to address emergent public health research needs, for example the 2009 H1N1 influenza pandemic. The contracts to be awarded under this RFP will support the conduct of clinical studies and clinical trials related to infectious diseases in a variety of domestic and international populations. Examples of studies that will be conducted include Phase 0 through Phase IV clinical trials, clinical trials for devices and diagnostics, clinical studies, sample collection, sample analysis, surveillance, and epidemiology studies. In addition and in order to carry out clinical studies and trials spanning as wide a variety of infectious diseases as possible, the VTEUs will be required to have the ability to conduct studies in international populations. To this end, offerors must document in their proposals access to at least 200 subjects per year from an international population in a resource poor setting (low and middle income countries as defined by the World Bank (see: http://data.worldbank.org/about/country-classifications/country-and-lending-groups) that includes healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location. The NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts to fulfill the technical requirements of this solicitation. The anticipated award date will be on or about September 13, 2013. Task Orders for specific tasks within each of the following Task Areas will be issued after award of the Parent Contract; Task Area A - Administrative and Overall Clinical Operations Support, Including Identification and Review of Concept Proposals Task Area B - Protocol Development Task Area C - Protocol Implementation, Conduct, Analysis, Completion, and Oversight Task Area D - Research Laboratory Analysis All projects carried out under this contract must be conducted in a manner consistent with all applicable Federal regulations and the DMID, NIAID, NIH and DHHS policies and guidelines for the conduct and oversight of research involving human subjects. Offerors are expected to have the expertise, personnel, and facilities to meet requirements of this project, and be able to demonstrate their capability to perform this requirement, with particular attention to the following areas: - 1. The ability to design, develop, conduct, and analyze clinical research studies and trials, carrying out protocol development, implementation and management activities in compliance with NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf). Include a discussion regarding ability to receive, package, distribute and track study products, as well as collect and process clinical specimens. - 2. The ability to access the number and type of populations, both general and specialized, required to serve as study participants, and ability to recruit and retain such study participants. In addition to an ability to access a variety of populations in the United States, sources must demonstrate the ability to conduct studies in international populations and demonstrate access to at least 200 subjects per year from an international population in a resource poor setting, as described in the Description section above. - 3. The availability, adequacy and suitability of the clinical research facilities, equipment and other resources of the Offeror and all proposed subcontractors for the conduct of clinical trials, clinical studies and other evaluations and analyses in accordance with Federal regulatory requirements and guidelines, including GCP, NIH, NIAID and DMID policies and procedures and the scope and requirements of the RFP. - 4. The ability to provide adequate scientific and technical personnel who have expertise with Good Clinical Practices, food and drug law (21 CFR312), and other regulatory requirements governing the conduct of research involving human subjects, including a Principal Investigator with an active physician's licensure in the United States. - 5. The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities. - 6. Ability to identify domestic and international clinical sites and manage by subcontracting, if necessary. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about May14, 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.