| Bench to Bedside: Integrating Sex and Gender to Improve Human Health |
Training Initiative |
FDA |
OD/DPCPSI/ORWH |
Bench to Bedside: Integrating Sex and Gender to Improve Human Health was developed in partnership with the Food and Drug Administration (FDA) Office of Women’s Health (OWH). This online course gives users a thorough and up-to-date understanding of sex and gender influences on health and disease so users can apply this knowledge when conducting research and interpreting evidence for clinical practice. Course material showcases examples from basic science through clinical trials and translation into practice to ensure participants understand the importance of considering the influence of sex and gender throughout the research spectrum and beyond. Through its six modules, the course focuses on key health conditions on which sex and gender have an impact. The six modules that compose the course are Immunology, Cardiovascular disease, Pulmonary disease, Neurology, Endocrinology, and Mental Health. |
| Best Pharmaceuticals for Children Act (BPCA) Working Group |
Committee, Work group, Advisory group, or Task Force |
FDA |
NICHD |
The overarching goals of BPCA are to encourage the pharmaceutical industry to perform pediatric studies to improve labeling for patented drug products used in children by granting an additional 6 months of patent exclusivity and authorize NIH, through Section 409I, to prioritize needs in various therapeutic areas and sponsor clinical trials of off-patent drug products that need further study in children, as well as training and other research that addresses knowledge gaps in pediatric therapeutics. The Data Monitoring Committee subgroup provides safety oversight for all studies conducted under BPCA. The Research Oversight Committee provides programmatic support to project lead for the BPCA clinical program, which includes the oversight prioritization, concept developments, and study implementation for the Pediatric Trials Network. |
| BioCompute Object Project |
Committee, Work group, Advisory group, or Task Force |
FDA |
NCI |
The BioCompute Object (BCO) Project is a community-driven initiative to build a framework for standardizing and sharing computations and analyses generated from High-throughput sequencing (HTS -- also referred to as next-generation sequencing or massively parallel sequencing). The project has since been standardized as IEEE 2791-2020, and the project files are maintained in an open source repository. The July 22nd, 2020 edition of the Federal Register announced that the FDA now supports the use of BioCompute (officially known as IEEE 2791-2020) in regulatory submissions, and the inclusion of the standard in the Data Standards Catalog for the submission of HTS data in NDAs, ANDAs, BLAs, and INDs to CBER, CDER, and CFSAN. Originally started as a collaborative contract between the George Washington University and the Food and Drug Administration, the project has grown to include over 20 universities, biotechnology companies, public-private partnerships and pharmaceutical companies including Seven Bridges and Harvard Medical School. The BCO aims to ease the exchange of HTS workflows between various organizations, such as the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers, and academic researchers. Due to the sensitive nature of regulatory filings, few direct references to material can be published. However, the project is currently funded to train FDA Reviewers and administrators to read and interpret BCOs, and currently has 4 publications either submitted or nearly submitted. |
| Biodosimetry Trans-NIH Working Group and Special Journal Issue |
Committee, Work group, Advisory group, or Task Force |
ASPA, BARDA, FDA |
NIAID |
This collaboration highlights regulatory and scientific approaches in research and advancement of biodosimetry tests in both NIAID and BARDA portfolios |
| Biomarkers of Exposure and Effect in Agriculture (BEEA) |
Research Initiative |
CDC |
NCI |
National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) are collaborating to characterize exposure to glyphosate, permethrin, and other pesticides by measuring urinary metabolites among participants in the Biomarkers of Exposure and Effect in Agriculture (BEEA) study. |
| Biomarkers of Exposure and Effect in Agriculture (Water Contaminants) |
Research Initiative |
CDC |
NCI |
National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) and the US Geological Survey (USGS) are collaborating on a study to characterize exposure to water contaminants by measuring urinary nitrate excretion, and drinking water concentrations of nitrate, pesticides, and other chemicals, as well as hormone activity among a subset of participants in the Biomarkers of Exposure and Effect in Agriculture (BEEA) study. |
| Biomedical Advanced Research Development Agency (BARDA) |
Other |
BARDA |
OD, OD/OM |
Provide Contract Property Support for R&D Contracts containing government furnished equipment |
| Biosafety and Biosecurity Innovation Initiative Working Group for the Executive Order on Strengthening the Bioeconomy |
Committee, Work group, Advisory group, or Task Force |
ASPR, CDC, FDA, ONS |
OD/OM, OD/OM/ORS, OD/OSP |
BBII-IWG is tasked with launching the Biosafety and Biosecurity Innovation Initiative which seeks to reduce biological risks associated with the Bioeconomy. BBII-IWG is tasked with writing a "plan for biosafety and biosecurity for the bioeconomy." |
| Biosafety in Biomedical and Microbiological Laboratories |
Resource Development |
CDC |
OD/OM, OD/OM/ORS |
The purpose is to update guidance for biosafety and biosecurity for biomedical laboratories, and update the BMBL. |
| Blood, Organ, and Tissue Senior Executive Council (BOTSEC) |
Committee, Work group, Advisory group, or Task Force |
OASH |
NHLBI, NIAID |
The Blood, Organ, and Tissue Senior Executive Council (BOTSEC) is an advisory forum for senior leadership from the Department of Health and Human Services (HHS) organizational components, as well as liaison representatives from Department of Defense and Veterans’ Health Administration, that are involved in blood, organ, and tissue safety and availability. The HHS Assistant Secretary for Health serves as the Council Chair, and the Office of the Assistant Secretary for Health (OASH) Senior Advisor for Blood and Tissue Policy serves as the BOTSEC Executive Director. |