National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis with Harvard School of Public Health, Department of Nutrition, 665 Huntington Avenue, Boston, MA 02115-6021 for services to evaluate body fatness in early adulthood, adult weight change, and risk of breast cancer in an international pooling project of prospective studies. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The World Cancer Research Fund concluded in 2010 that body fatness during later adulthood is a convincing cause of postmenopausal breast cancer and that adult weight gain probably increases the risk of postmenopausal breast cancer. The evidence is less consistent for premenopausal breast cancer. The report concluded that body fatness during later adulthood probably decreases the risk of premenopausal breast cancer but made no conclusion regarding the association between adult weight gain and risk of premenopausal breast cancer. No explicit statements were made about the influence of body fatness during early adulthood. As a result, the NCI is interested in examining the associations of 1) body fatness in early adulthood and 2) adult weight change with risk of both premenopausal and postmenopausal breast cancer. In addition, the NCI wishes to explore whether these associations differ by estrogen and progesterone receptor status since there is accumulating evidence that breast cancer incidence and mortality patterns, risk factors, and molecular pathology differ by hormone receptor status. The National Cancer Institute (NCI) has recently completed analyses similar to those described above in a single U.S.-based prospective study of postmenopausal breast cancer and found provocative, potentially important results. However, the results for estrogen receptor-negative and progesterone receptor-negative breast cancer were limited by small numbers of these diagnoses, and no premenopausal women had been recruited for the cohort. Therefore, NCI is interested in replicating and expanding its results in a substantially larger dataset that includes both premenopausal and postmenopausal breast cancer. In addition, NCI is interested in exploring these associations in cohorts worldwide to take advantage of heterogeneity in adult fatness, adult weight change, usual physical activity, and energy balance. The Contractor shall conduct statistical analyses to examine associations of body fatness in early adulthood and adult weight gain with risk of breast cancer. Analyses will be conducted for all breast cancer, by estrogen and progesterone receptor status, and by menopausal status. Standardized criteria will be used to define the outcomes, exposures, and covariates across all studies. Also the Contractor shall examine associations between adult weight change and risk of breast cancer, overall and by estrogen and progesterone receptor status. Analyses will be conducted separately for premenopausal and postmenopausal breast cancer. To NCI's knowledge, there is only one cohort consortium, the Pooling Project of Prospective Studies of Diet and Cancer which is directed by Harvard, that has available at present 1) prospectively collected data on body weight in early and later adult life, height, and accepted breast cancer risk factors from multiple cohort studies conducted throughout the world, 2) at least 20,000 confirmed breast cancer outcomes identified during follow-up of cohort participants, and 3) estrogen receptor and progesterone receptor status on over 70% of the breast cancer outcomes. This consortium includes studies from all over the world. The cohorts send in data to Harvard, and Harvard staff harmonizes the data and analyze the data. Only Harvard staff is allowed access to the data based on data transfer agreements. This notice is not a request for competitive quotation. However, if any interested party especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The responses and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11:00 AM EST, on September 19, 2013. All responses and questions must be in writing and faxed 240-276-5401 or emailed to Jonathan Rudd, Contract Specialist via electronic mail at jonathan.ruddj@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through www.sam.gov. Reference: NCI- 130150-JR on all correspondence.
