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 AIDS has a requirement for a comprehensive quality assessment program for virologic assays for HIV, and HIV-related viral co-pathogens. The program must ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials. The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking a contractor to provide a comprehensive quality assessment program for virologic assays for HIV, and HIV-related viral co-pathogens. The program must ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials by providing laboratories with validation and proficiency testing panels and real time assay run controls, and analyzing proficiency panel and assay run data from each laboratory. The contractor must also plan and execute single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies, implement standards of performance for existing and state-of-the-art new virologic assays, develop and test biostatistical methods relating to the assays, and acquire, test, store and dispense all quality control materials and reagents required for this program, including specimens collected from HIV-infected and -uninfected human subjects. The contractor will serve laboratories associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, 55 of which are international, located in 22 countries. It is anticipated that one cost reimbursement, term type contract will be awarded for a one year base period of performance beginning on or about June 1, 2012. Options will be included to extend the term of the contract for an additional six years for a maximum period of performance of 7 years. The level of effort anticipated for support of the base period and six-one year options is 9.10 FTE/year. In addition, the Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include: Increased Level of Effort for Additional Labs: During the course of the contract it may be necessary to incorporate additional Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each option of this type will implement work commensurate with the addition of 5 Labs. More than one (1), but not more than three (3), Options may be exercised in any one year. It is estimated that an additional 0.20 full time equivalents (FTEs) will be needed to accommodate these additional Labs during the first year of activation. If the options for these Labs are exercised for continuation in subsequent years, 0.10 FTE/year will be needed. Options to add new Labs will not be exercised in the last year of the contract (Year 7). Addition of Expertise: Addition of a Quality Assessment Program for viral disease agents other than HIV and related co-pathogens. During the course of the contract it may be necessary to develop a quality assessment program for assays associated with viral disease agents other than HIV that were not anticipated at the time this solicitation was initiated, and that would directly support high priority NIAID research programs. During the contract period, one option could be activated for the addition of a Quality Assessment Program. The option may be activated in any year of the contract. Additional options to extend the Quality Assessment Program for subsequent years may be exercised as well. It is estimated that 3.10 full time equivalents (FTEs) will be needed for this Option in the first year, and in subsequent years if options are exercised for continuation. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on May 18, 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.
