Background The Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), was formed in 1986 to address the national research needs created by the advent and spread of the HIV/AIDS epidemic. The mission of DAIDS is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), supporting the development of therapies for HIV infection and its complications, supporting prevention strategies and the development of vaccines. The DAIDS Vaccine Research Program (VRP) supports basic, preclinical, and clinical research of candidate vaccines. VRP activities include (1) oversight of grants, contracts, and cooperative agreements that support preclinical and clinical vaccine research, (2) evaluation of the safety and efficacy of vaccine candidates, (3) promotion of research programs to discover novel vaccine strategies for the treatment and prevention of HIV, and (4) work with the pharmaceutical industry and the U.S. Food and Drug Administration (FDA) to facilitate the evaluation and approval of new vaccines. Project Requirements The scope of activities to be carried out under this contract involves both QA/QC and operational activities and includes: (A) maintenance of a PBMC bank and EQA reagent repository (B) establishment of a PBMC EQA program to assess the ability of laboratories to reliably process, freeze, store, and ship viable and functional PBMC (C) preparation and distribution of proficiency panels and reagents to laboratories that conduct enzyme-linked immunosorbent spot (ELISpot) assays and evaluation of test results (D) preparation and distribution of materials and reagents to laboratories that perform intracellular cytokine staining (ICS), novel T cell assays, and/or other flow cytometry based assays, and evaluation of test results (E) acquisition, establishment, and characterization of unique clade-specific HIV virus panels, or other viral isolate panels, as needed, to help ensure assay quality and validity of new assay platforms (F) creation and maintenance of a central web database for the above activities (G) advice on Food and Drug Administration (FDA) regulatory, compliance, and statistical issues and coordination of optimization efforts among laboratories to develop validation programs for novel T or B cell functional assays (H) establishment and support of an Independent External Advisory Group (I) provide expertise to develop/implement a proficiency panel to access pre-existing vaccine vector immunity (J) support the development of antibody characterization assays. To accomplish these aims, the Contractor's laboratory shall be Clinical Laboratory Improvement Amendments (CLIA)-certified (www.cms.hhs.gov/clia) and when necessary have local Institutional Review Board (IRB) approval for its activities. It is anticipated that a cost-reimbursement, term type contact will be awarded. The period of performance will be for one year beginning approximately August 30, 2010 through August 29, 2011. Options will be included to extend the term of the contract for an additional 6 years. The requirement will be the delivery of 12.35 full time equivalents (FTE) per year for the base period (Year 1) and 12.35 FTE per year for Option periods 1-6. In addition, the Government may exercise options during Years 2-7 of the contract for increased services for the delivery of additional FTEs as follows: Options 7-12: For additional FTEs to provide for support for 1-3 laboratory sites per year to the PBMC QA Program. It is estimated that an additional .50 FTEs per year will be needed to accommodate these additional sites. Options 13-18: For additional FTEs to provide support for 1-3 laboratory sites per year to the ELISpot EQA program. It is estimated that .65 FTEs per year will be needed to accommodate these additional sites. Options 19-24: For additional FTEs to provide for support for 1-3 laboratory sites per year for flow cytometry-based assays. It is estimated that .75 FTEs per year will be needed to accommodate these additional sites. Options 25-30: For increased FTEs to expand the panel of characterized HIV isolates. It is estimated that 2.00 FTEs per year will be needed to expand the panel of characterized HIV isolates. Options 31-36: For increased FTEs to expand the panel of other viral isolates. It is estimated that 2.50 FTEs per year will be needed to expand the panel of other viral isolates. Options 37-42 For increased FTEs to expand develop/implement a proficiency panel to assess pre-existing vaccine vector immunity. It is estimated that 2.75 FTEs per year will be needed for this work. Options 43-48: For increased FTEs to support the development of antibody characterization assays. It is estimated to be 2.60 FTEs per year will be needed for this work. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about September 10, 2009, 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.
