BAA Announcement: Opportunity to Use Women’s Health Initiative Resources – BAA-NHLBI-WH-05-21

Notice Number: NOT-HL-06-102

Key Dates
Release Date: August 5, 2005

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

The purpose of this Notice is to announce the NHLBI's intention to issue a Broad Agency Announcement (BAA) on or about January 9, 2006. The BAA will solicit proposals to maximize the scientific yield from the biologic resource and associated participant exposure and outcome data generated by the Women's Health Initiative (WHI) since 1993 through research studies which will be applied to the WHI biological resource. This Notice encourages Prospective Offerors who believe they have sufficient expertise and resources to conduct such research studies to begin considering submitting a proposal for the BAA. It is anticipated that 8-10, two-year contracts will be awarded.

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 http://www.whi.org on or about December 1, 2005. The NHLBI anticipates awarding contracts 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.

Inquiries

Inquiries may be directed to:

Betty Nordan
Contracting Officer
Contracts Operations Branch, NHLBI, NIH
Women's Health Initiative
Rockledge Bldg. 2, Ste. 6016, MSC 7902
6701 Rockledge Dr.
Bethesda, MD 20892-7902
Phone: (301) 435-6672
Fax: (301) 480-3338
Email: nordanb@nhlbi.nih.gov


Weekly TOC for this Announcement
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