A -- Toward Maximizing the Scientific Value of the Biologic Specimens from the Women's Health Initiative II

BACKGROUND The NIH has supported collection of blood samples and clinical data from participants in the three clinical trials and the observational study of the Women's Health Initiative (WHI) since 1993. This well-characterized population provides a rare and valuable scientific resource maintained under contracts between NHLBI and the WHI centers. Promoting optimal use on a national scale of such a resource requires a large and concerted effort which may exceed the research capacities of individual study locations, and of WHI as a whole. The NHLBI and the researchers it supports have a responsibility to the public in general, and the scientific community in particular, to encourage the most rapid scientific progress possible using these resources. In order to take full advantage of such resources and to maximize their research value, it is important that samples and data collected with public funds be made available, with the least amount of restrictions, to the largest possible number of qualified investigators in a timely manner. NHLBI and NIH programs were reviewed to determine whether existing projects will satisfy the requirement, and the proposed activity was discussed with key staff in NHLBI and other NIH Institutes to determine that this BAA does not replicate other efforts. The WHI resource is unique in its scope, focus on diseases of older women, ethic and racial diversity, and in particular in that it includes several large randomized controlled clinical trials which are capable of yielding information that cannot be obtained from observational studies. Care will be taken to ensure that the investigations under this BAA will not duplicate those already performed by the WHI investigators and their colleagues. The original WHI study population included 161,808 postmenopausal women in the United States, 68,132 (42%) of whom were randomized to one or more components of the clinical trial (CT), and 93,676 (58%) of whom were enrolled in the observational study (OS) between 1993 and 1998. Recruitment criteria included being 50-79 years of age, being post-menopausal, and planning to live in the area of a given Clinical Center (CC) for three years, with specific exclusionary criteria for the Dietary Modification (DM) and Hormone Therapy (HT) Trial components. Specific study goals were set for ethnic distribution (20% minority women in the CT) and age distribution (30% for 50-59 years of age; 45% for 60-69; 25% for 70-79). The original cohort was followed until March 31, 2005, after which subjects were invited to enroll in the WHI Extension Study from 2005 to 2010. As of August 2006 there were 115,273 women (77% of eligibles) enrolled in the Extension Study, during which ascertainment of outcomes (including activities of daily life) has continued together with limited exposure data on use of hormone therapy, calcium/vitamin D supplements, and 24-hour recall of food intake (in a subset). ACQUISITION PLAN This acquisition will employ a Broad Agency Announcement (BAA) to seek proposals that will maximize the scientific yield from the biologic resource and associated participant exposure and outcome data in the Women?s Health Initiative (WHI), by soliciting the best ideas for laboratory-based research studies to apply to the WHI biologic resource. This second solicitation follows on a first solicitation issued in January, 2006. That BAA solicitation resulted in the award of 12 contracts, each of a 2-year duration, awarded in January 2007. WHI collected extensive information on multiple outcomes, including any disease leading to overnight hospitalization, cancers, self-report of a number of additional conditions, measures of cognition/dementia, sleep, and functional status, amongst others. For this second BAA solicitation, proposals utilizing the data on any of the phenotypes or groups of phenotypes will be considered. It is anticipated that the research programs funded by this BAA will include applications of genomics, proteomics, and other laboratory investigations to the existing frozen samples of DNA, serum, plasma, red blood cells, and urine. The BAA will not fund new data collection and will make use of existing biologic specimens. In general, the BAA seeks innovative technologies that enable comprehensive, yet efficient, investigation of sets of markers associated with disease outcomes or treatment effects, or of groups of mediators that might substantively explain the pathway of exposure or treatment effects on disease. For example, genomic studies might include whole-genome and haplotype approaches and 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 a panel of markers, for example adipokines or cytokines, which allow a large number of markers to be tested using a modest amount of sample. On the other hand, focused studies on a more limited number of candidate genes or candidate markers will be considered if there are reasonably strong data supporting large effects from these individual markers that need to be confirmed in a large dataset, and their validation has potential public health implications. Broad Agency Announcements (BAA) are used by agencies to fulfill their requirements for scientific study and experimentation directed towards advancing the state-of-the art or increasing knowledge or understanding rather than focusing on a specific solution. Proposals received under this BAA will be evaluated in accordance with evaluation criteria as specified in the solicitation, through a peer review process. Proposals will not be evaluated against a specific Government need, as in the case of a conventional request for proposals (RFP), as they are not submitted in accordance with a common work statement. In addition to the mechanism envisaged by this BAA, investigators may also gain access to the WHI data (including study data not related to the biologic resource) through an established ancillary study mechanism by collaborating with one or more WHI investigators. A portion of the biologic resource not reserved for the BAA is otherwise reserved, and therefore studies that are not suitable for funding through the BAA may be proposed for funding through a variety of other mechanisms. Such ancillary studies are reviewed by the relevant WHI committees and by the National Heart Lung and Blood Institute (NHLBI), and if approved can be eligible for funding from NIH and non-NIH sources outside of the BAA. Procedures for establishing collaboration can be found on www.whiscience.org. NHLBI anticipates awarding between 14 and 16 2-year contracts in mid January 2009. Awards will be made based on the weighted evaluation factors of technical merit, programmatic balance, and funds availability. It is anticipated that the individual award amounts will vary depending on the scope and capacity of the technical objectives for the award. For example, lower award costs may be made for more focused or limited investigations, and higher award costs may be for consortia proposing more comprehensive investigations. At the sole discretion of the NHLBI, meritorious proposal that cannot be funded within the amount currently available under this BAA may be forwarded to other National Institutes of Health (NIH) Institutes for their consideration. Cost reimbursement type contracts are planned for this acquisition because the programs being solicited will be basic research into highly technical areas of medical/scientific interest where there has been little work performed in the past. It is expected that only minimal information concerning the specific requirements of the work will be provided by the government in the BAA. It will be necessary for the contractors to develop their own research programs including research hypotheses and methods based on highly specialized knowledge and expertise. The contractors will need to have considerable medical/scientific expertise in order to carry out the work to achieve the highly sophisticated research and technical objectives of the programs. EVALUATION PLAN The primary basis for selecting proposals submitted in response to this BAA shall be technical excellence, importance to agency programs, and funds availability. The technical evaluation of proposals will be conducted through a peer review process in accordance with established criteria. The evaluation criteria shall evaluate the Offeror?s scientific and technical approach, adequacy of the technical approach, the Offerors? capabilities, and the qualifications, capabilities experience, and availability of proposed key personnel. NHLBI program and administrative staff will determine importance to agency programs and availability of funds. In addition, past performance of the Offeror and the extent of small disadvantaged business concerns in performance of the program will also be evaluated in accordance with FAR 15.304. This sources sought announcement is published to notify the contracting community of this upcoming project and is meant to inform of its breadth and scope. This is NOT a request for proposals. The NAICS code for this requirement is 541710 e.g. Research and Development in the Physical, Engineering, and Life Sciences. If your institution is a small business and would like to submit a capabilities statement to inform this office of how your business may fulfill some portion of this requirement, you are welcome to send two (2) copies thereof to this Office. Do not include budget information.