|
Asia-Pacific Economic Cooperation (APEC) Cervical Cancer Initiative
|
Meeting/ Workshop
|
OGA
|
NCI
|
In November and December 2020, following the launch of the Global Strategy to Accelerate the Elimination of Cervical Cancer, the US National Cancer Institute together with the APEC Health Working Group and the APEC Life Sciences Innovation Forum, organized the APEC Policy Dialogue (Day 1 and Day2) and the APEC Technical Webinar. These meetings brought together multisectoral stakeholders from APEC economies to discuss and to highlight the importance of the Global Strategy to Accelerate Cervical Cancer Elimination, HPV Vaccination and Screening in APEC during the COVID-19 Pandemic, Strengthening Health Systems and Research Priorities to Deliver on the Promise of Cervical Cancer Elimination, and Control of HPV Disease in HIV+ Women. These meetings were also supported by the University of Malaya of Malaysia and VCS Foundation Ltd of Australia.
|
|
Assessment of Inhalation Exposures to Indoor and Occupational Aerosols
|
Research Initiative
|
CDC
|
NIEHS
|
The primary goal of this collaboration is to study inhalation exposures to indoor and occupational aerosols, with a current focus on characterizing the health hazards associated with exposure to common fungal contaminants. NIOSH uses a specially developed exposure system to conduct subchronic toxicology studies following repeated exposure to molds identified by the NTP as a public health concern. Subprojects under this IAA are examining the association of exposure to mycotoxins and health by analyzing indoor air samples, developing biomarkers of exposure and response, and using genomic sequencing methodologies to assess fungal diversity associated with the built environment.
|
|
Assisted Outpatient Treatment for Individuals with Serious Mental Illness
|
Research Initiative
|
HRSA, SAMHSA, ASPE
|
NIMH
|
This collaboration supports the development and implementation of a rigorous and objective cross-site impact evaluation of an Assisted Outpatient Treatment Grant Program for Individuals with Serious Mental Illness. The Department of Health and Human Services, Assistant Secretary for Planning and Evaluation (ASPE) has primary responsibility for the solicitation, management, and implementation of the evaluation contract in consultation with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute of Mental Health (NIMH). The Center for Behavioral Health Statistics and Quality (CBHSQ), an entity within SAMHSA that serves as a focal point for data collection, analysis, and the dissemination of critical public health data, provides consultation on the cross-site evaluation of the Assisted Outpatient Treatment grant program. ASPE, in consultation with the NIMH, brings expertise in evaluation design and implementation that benefits SAMHSA in its priority of having a rigorous multi-site evaluation. The initial Phase I Implementation Evaluation was completed in FY 2017. Results of the Implementation Evaluation were used to inform the design and data collection plan for the Phase II Outcome Evaluation, which began in FY 2019.
|
|
Autoimmune Diseases Coordinating Committee
|
Committee, Work group, Advisory group, or Task Force
|
CDC, FDA, HRSA
|
NIAID, CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR
|
The purpose of the Autoimmune Diseases Coordinating Committee (ADCC) is to provide a forum for the coordination of research efforts in autoimmunity and autoimmune diseases among various stakeholders including the National Institutes of Health (NIH), other federal agencies such as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and private organizations with an interest in autoimmune diseases. The ADCC meets twice yearly to discuss a broad range of basic, preclinical, and clinical endeavors.
|
|
Bacteriophage Interest Group (Monthly Meeting)
|
Meeting/ Workshop
|
BARDA, FDA
|
NIAID
|
The purpose of this monthly meeting is to allow the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA) and the Food and Drug Administration (FDA) staff to hear seminars on bacteriophage therapy and discuss progress in this area.
|
|
Bacteriophage Therapy: Intraagency meeting
|
Meeting/ Workshop
|
FDA
|
NIAID
|
The purpose of this meeting is to exchange information regarding phage therapy with other United States Government (USG) stakeholders. The meeting is planned for summer 2021.
|
|
Bench to Bedside: Integrating Sex and Gender to Improve Human Health
|
Resource Development
|
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) Data Monitoring Committee
|
Committee, Work group, Advisory group, or Task Force
|
FDA
|
NICHD, NCI, NHLBI
|
This group provides safety oversight for all studies conducted under BPCA.
|
|
Bi-Weekly Assay subgroup for SARS-CoV-2
|
Committee, Work group, Advisory group, or Task Force
|
CDC, FDA, BARDA, FDA
|
NIAID
|
The objective is to share assay development activities within the government Labs
|
|
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. [1] 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.[2] 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.
|