A -- Opportunity to Use Women's Health Initiative Resources

This is not a Request for Proposals. This provides advance notice that a Broad Agency Announcement (BAA) will be available on or about January 9, 2006. The BAA will seek proposals to maximize the scientific yield from the biologic resource and associated participant exposure and outcome data generated by the Women's Health Initiative since 1993. The Women's Health Initiative includes some 161,000 women in a set of overlapping clinical trials of post-menopausal hormone therapy, low fat dietary pattern, and calcium and vitamin D supplementation, as well as an observational study. In general the BAA will seek the application of technologies that enable comprehensive yet efficient investigation of sets of markers associated with disease outcomes, or of modulators and mediators that might substantively explain the pathway of exposure or treatment effects on disease outcomes. For example, genomic studies might include whole-genome, tag SNP, or haplotype approaches, and/or studies of sets of functional genes with related effects on an outcome. Studies that combine information from genes and gene products in the form of blood proteins could help to elucidate pathways. Studies on serum or plasma might include multiplex assays of panels of markers, for example adipokines or cytokines, which allow a large number of markers to be tested using a modest amount of sample. Focused studies on a more limited number of candidate genes or candidate markers that need to be confirmed in a large dataset, and for which their validation has potential public health implications, will also be considered. In order to conserve sample, consideration should be given to pooling approaches, or case-only approaches, as appropriate. The primary disease outcomes will be cardiovascular diseases, breast cancer, colorectal cancer, and fractures. Detailed information on the WHI program will be found at www.whi.org on or about December 1, 2005. The NHLBI anticipates awarding approximately 8-10 contracts for a two year period of performance based on technical merit, available funds, and programmatic balance. Prospective Offerors are invited to attend a pre-proposal conference on February 27, 2006 from 1:00-3:00 pm, at the Natcher Building on the NIH Campus in Bethesda, Maryland. NHLBI staff will explain the purpose of the initiative, provide instructions about the proposal process and answer questions. Questions provided by February 20, 2006 will be answered at the conference. Offeror institutions are urged to send a representative to this conference. All attendees, as well as anyone who cannot attend the pre-proposal conference, will be given access, through an NHLBI web site, to any distributed materials, questions and answers, and a summary of the discussion. These materials and additional information about the meeting will be posted with the BAA. Attendance is not a pre-requisite for proposal submission and will not be considered a factor in proposal evaluation.