The Food and Drug Administration (FDA) is seeking comments to accompany the public meeting titled “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases. For more information on meeting content, please see this FDA draft agenda.
The MDCC is a federal advisory committee established in accordance with the Muscular Dystrophy Community Assistance, Research, and Education Amendments of 2001 (MD-CARE Act; Public Law 107-84). The MD-CARE Act was reauthorized in 2008 by Public Law 110-361, and again in 2014 by Public Law 113-166. The MD-CARE Act specifies that the committee membership be composed of 2/3 governmental agency representatives and 1/3 public members. They are seeking nominations for four non-federal, public members at this time, due to turnover of committee membership.
Nominations are encouraged for new or reappointment of non-federal public members who can provide the public and/or patient perspectives to discussions of issues considered by the Committee. Self-nominations and nominations of other individuals are both permitted.
The Food and Drug Administration (FDA) is opening a public docket to solicit input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations, in establishing strategic priorities for the Office of Minority Health and Health Equity (OMHHE). This will help the FDA ensure that important health concerns are carefully considered in establishing priorities.
FDA's OMHHE serves to promote and protect the health of diverse populations through research and communication of science that addresses health disparities and health equity. Established in 2010, OMHHE provides leadership and policy direction for FDA regarding issues relating to the health of racial and ethnic minority, underrepresented, and underserved populations. OMHHE's stakeholders reflect the diversity of the US population, including individuals of low socioeconomic status and historically underrepresented populations.
The Substance Abuse and Mental Health Services Administration (SAMHSA), in cooperation with the Office of National Drug Control Policy, will hold a meeting of their Interdepartmental Substance Use Disorders Coordinating Committee. The Committee is charged with the following duties:
- Identify areas for improved coordination of activities, if any, related to substance use disorders, including research, services, supports, and prevention activities across all relevant federal agencies;
- Identify and provide to the Secretary recommendations for improving federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment, and recovery services;
- Analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies;
- Make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in items (1) through (3) above;
- Make recommendations to the Secretary regarding public participation in decisions relating to substance use disorders and the process by which public feedback can be better integrated into such decisions; and
- Make recommendations to ensure that substance use disorder research, services, supports, and prevention activities of the Department of Health and Human Services and other federal agencies are not unnecessarily duplicative.
Members of the public may attend in person. More information is available at this SAMHSA website.
The National Institutes of Health (NIH), National Center for Advancing Translational Sciences and Clinical Center, will hold the 2020 Rare Disease Day at NIH to raise awareness about rare diseases, the people they affect, and NIH research collaborations underway to address scientific challenges and to advance new treatments.
The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Chemical Sciences and Technology, will hold a workshop for its project titled "Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing." The goal of this workshop is to identify and discuss potential innovative technologies that could realistically be implemented in the next 5-10 years. Three workshop sessions will explore innovations in manufacturing drug products, drug substances, and control and analytics. A later workshop will focus on technical and regulatory issues associated with the identified innovations.
This project has been tasked with identifying emerging and upcoming technologies—for example, product technologies, manufacturing processes, control and testing strategies, and platform technologies—that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration.
The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Health Sciences Policy, will hold a workshop titled "An Examination of Emerging Bioethical Issues in Biomedical Research." The workshop will bring together stakeholders to discuss potential ethical issues that may arise from new and emerging trends in biomedical research (including behavioral and social research) and society. The workshop will identify a range of current and emerging bioethical issues—both in basic and clinical research—and explore a broad-range of stakeholder perspectives. Input will be sought from a variety of perspectives which may include patients/participants/individuals, bioethicists, academic and industry researchers, clinicians, and government representatives. The workshop will describe the state of the emerging science and potential pressing, recurring, emerging, and/or anticipated future bioethical issues in biomedical research and society that fall within the scope of the research and policy activities of the NIH.
Potential topics on the agenda may include:
- Use of digital technologies, artificial intelligence, and machine learning in biomedical research and clinical care;
- Emerging ethical challenges for sharing data from human research participants and use of human biospecimens;
- Health equity and health disparities in research, including:
- Recognizing and addressing barriers to participation in research and clinical care across diverse populations and groups
- Understanding the impact of cultural and social context on health and disease
- Equitable distribution of the benefits and burdens of research;
- Innovative study designs, including crowdsourcing of research and citizen science;
- Novel approaches for enhancing bioethics infrastructure and training;
- New means for assessing and enhancing scientific workforce diversity; and/or
- Innovative solutions for enhancing research oversight infrastructure.
Given the broad scope of bioethical issues in research and the difficulty in addressing all possible issues in a single workshop, the following topics fall outside the scope of this workshop as they are being addressed in multiple other venues: gene editing, gene drives, human-animal chimera research, human fetal tissue research, neuroethics, and animal care and welfare.
Registration for in-person attendance has been filled, but members of the public may register for the webcast or for the in-person waitlist. For more information about this workshop, please see this NASEM website.
The Centers for Disease Control and Prevention (CDC) will hold a meeting of its Advisory Committee on Immunization Practices. Agenda items include updates on the Ebola vaccine, the 2019 novel coronavirus, the influenza vaccine, the rabies vaccine, the dengue vaccine, and on polio.
The Advisory Committee on Immunization Practices comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States. The recommendations stand as public health guidance for safe use of vaccines and related biological products.
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Evolving Role of Artificial Intelligence in Radiological Imaging." The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. The purpose of the workshop is to work with interested stakeholders to identify the benefits and risks associated with use of AI in radiological imaging. FDA also plans to discuss best practices for the validation of AI-automated radiological imaging software and image acquisition devices. Validation of device performance with respect to the intended use is critical to assess safety and effectiveness.
The Food and Drug Administration (FDA) is announcing a public meeting titled “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases. For more information on meeting content, please see this FDA draft agenda.
The Centers for Disease Control and Prevention (CDC) invites the general public and other Federal agencies the opportunity to comment on a proposed information collection project titled Enterprise Laboratory Information Management System which is a system used to record specimen metadata and patient data related to test order requests submitted by external partners (state public health laboratories, International organizations, federal institutions, hospitals, doctor's offices, etc.) to the CDC Infectious Diseases testing laboratories.
The Department of Health and Human Services (HHS), National Toxicology Program (NTP), will hold a teleconference meeting of its Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities.
The preliminary agenda topics include:
- Evolving the paradigm: In vivo to in vitro extrapolation
- Nano/microplastics and health effects: Novel agents bring novel challenges
- Traffic-related air pollution and hypertensive disorders of pregnancy: Disease as a toxicology focus
- NTP studies of per- and poly-fluoroalkyl substances: Understanding human translation