Development of a Research-Ready Pregnancy and Newborn Biobank in California Population-based biobanks are a critical resource for identifying disease mechanisms and developing screening tests for biomarkers associated with certain disorders. The California Department of Public Health has been banking newborn specimens statewide since 1982 (N~14 million) and maternal prenatal specimens for a portion of the state since 2000 (N~1 million), creating one of the largest, if not the largest single biological specimen banks with linked data in the world. With the fast pace of new knowledge in genetics and laboratory methods, the demand for specimens and data from researchers around the world now far surpasses the Department's ability to fill them. The goal of this infrastructure development project is to create an efficient, high throughput, low cost newborn screening and prenatal/maternal screening specimen biobank and linked data base that could be used by large numbers of researchers around the world for a wide range of studies through the following aims: (1) establishment of highly efficient protocols and procurement and integration of automated systems for pulling and processing specimens;(2) development of an integrated specimen tracking system into the Department's existing web-based Screening Information System;(3) development of a computerized system to track application requests for specimens and data;and (4) development of a linked screening program-vital records database that is organized into a life course, client based system. These aims will be accomplished through expansion of the Department's award-winning Screening Integration System to include web-based tracking of specimens and research requests, and use of an innovative machine-learning record matching application for high-performance linkages. After the 2 year grant period is completed, the California Research Ready Biospecimen Bank will be able to provide researchers with valuable biological specimens in a timely, cost-effective manner, thereby enabling a dramatic expansion of epidemiological research nationwide. The continuity of the system will be ensured by codifying human subjects-sensitive policies and procedures into Departmental regulations and by charging researchers modest fees for specimens, data and other research services. PUBLIC HEALTH RELEVANCE: Development of a research-ready pregnancy and newborn biobank in California This proposal funds infrastructure development to create a research-ready, efficient, high- throughput, and low-cost prenatal and newborn biobank in California. Specimens spanning 28 years will be linked to existing records of fetal death, live birth, death, prenatal and newborn screening to develop a rich, client-based, cross-generational, life- course database. Specimens and linked data from the California Research-Ready Biospecimen Bank will be made available to researchers in the U.S. and around the world to enable a broad and expanded array of studies.