Neuroscience

FDA Comment Deadline: Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

The Food and Drug Administration (FDA) is seeking public comments to accompany an upcoming public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.

Given the substantial interest in this topic and Congressional interest in fostering the development of appropriate hemp products under the 2018 Farm Bill, while also preserving FDA's ability to protect the public health, FDA is holding a public hearing. The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products. FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.

Members of the public may submit comments via mail, fax, or at Regulations.gov. More information is available at this Federal Register notice

CDC Nomination Deadline: Board of Scientific Counselors and the National Center for Injury Prevention and Control

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership to two groups: the Board of Scientific Counselors (BSC) and the National Center for Injury Prevention and Control (NCIPC). The BSC and NCIPC nominations are sought for experts in the fields of surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for preventing injury and violence.

All nominations should be emailed to the CDC. More information is available at this Federal Register notice.

FDA Comment Deadline: Youth Tobacco Cessation: Science and Treatment Strategies

The Food and Drug Administration (FDA) is seeking public comments to accompany the upcoming public scientific workshop entitled “Youth Tobacco Cessation: Science and Treatment Strategies.” The purpose of the workshop is to discuss the unique challenges associated with youth tobacco addiction and cessation, and the current science regarding youth tobacco use and addiction as well as treatment strategies to support youth tobacco cessation.

Nearly all tobacco product use begins during youth and young adulthood, there was an alarming increase in tobacco product use among adolescents, primarily driven by e-cigarette use. Youth tobacco use raises a number of health concerns including risk of addiction to nicotine early on in life, potential harm to the developing adolescent brain, and exposure to chemicals, including carbonyl compounds and volatile organic compounds known to have adverse health effects. The full range of possible health effects is not yet completely understood.

This public scientific workshop will gather scientific information and stimulate discussion about the current science regarding youth tobacco use and addiction, and treatment strategies to support youth tobacco cessation with a focus on e-cigarette cessation. This is because e-cigarettes are the tobacco products most commonly used by youth and there continues to be a rampant rise in use. The workshop is intended to explore the challenges of treating youth tobacco addiction and promoting cessation. In particular, the workshop will highlight differences in treatment strategies needed in youth as opposed to adults.

The workshop will include presentations and panel discussions regarding substantive scientific information specifically relating to the unique factors impacting youth tobacco use and addiction and challenges associated with youth tobacco cessation. Topics to be addressed include (1) the basic science of tobacco addiction in adolescents, (2) current state of behavioral and pharmacotherapy cessation strategies in adolescents (e.g., clinical trial experience to date, use of technology and social media, impact of social factors), and (3) the development of strategies to generate robust evidence to address youth tobacco cessation (e.g., clinical trial design, measures of adolescent addiction, selection of endpoints, subpopulation and co-morbidity considerations, and patient recruitment and retention). 

Members of the public may submit comments via mail, fax, or Regulations.gov. More information is available at this Federal Register notice

FDA Meeting: Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

The Food and Drug Administration (FDA) is announcing a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.

Given the substantial interest in this topic and Congressional interest in fostering the development of appropriate hemp products under the 2018 Farm Bill, while also preserving FDA's ability to protect the public health, FDA is holding a public hearing. The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products. FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.

Members of the public may attend in person or via webcast with advance registration. More information is available at this Federal Register notice.

NIH Meeting: National Advisory Mental Health Council

The National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Advisory Mental Health Council will hold their 256th meeting. The Council advises on matters relating to mental health research, research training, and programs of the NIMH.

Members of the public may attend the meeting in person with advanced registration or via webcast. More information is available at the NIH's website or the event registration's website.

SAMHSA Meeting: Advisory Committee for Women's Services

The Substance Abuse and Mental Health Services Administration (SAMHSA) will hold a meeting of their Advisory Committee for Women's Services. The meeting will include discussions on assessing SAMHSA's current strategies, including the mental health and substance use needs of the pregnant and parenting women population. Additionally, the Committee will be speaking with the Assistant Secretary for Mental Health and Substance Use regarding priorities and directions around behavioral health services and access for women and children.

The meeting is open to the public and will be held virtually only. The meeting may be accessed by telephone or WebEx with advance registration. More information is available at this Federal Register notice.

NIH Meeting: Interagency Pain Research Coordinating Committee

The National Institutes of Health (NIH) will hold a meeting of its Interagency Pain Research Coordinating Committee (IPRCC). The meeting will include discussions of committee business items including information about the NIH HEAL Initiative and an update on the Pain Management Best Practices Interagency Task Force.

The Interagency Pain Research Coordinating Committee (IPRCC) is a Federal advisory committee created by the Department of Health and Human Services to enhance pain research efforts and promote collaboration across the government, with the ultimate goals of advancing the fundamental understanding of pain and improving pain-related treatment strategies.

Members of the public may attend in person or via teleconference. More information is available at this Federal Register notice.

NIH Meeting: National Advisory Neurological Disorders and Stroke Council

The National Institutes of Health (NIH), National Institute of Neurological Diseases and Stroke (NINDS), will hold the 205th meeting of the National Advisory Neurological Disorders and Stroke Council

The Council advises the Director of the NINDS on research activities and policies. The Council provides the final review for all applications for research grants, training grants, and career development awards assigned to the NINDS, as well as for other requests for support for which Council approval is required by law. The Council also provides clearance for concepts for new NINDS research initiatives involving set-aside funds.

Members of the public may attend in person. More information is available at this NIH website.

Duke students submit public comment on CMS proposed rulemaking regarding cost-sharing reduction payments and Silver Loading

Duke SciPol.org – Students in the Duke University Science Regulation (SciReg) Lab submitted a public comment today in response to a Centers for Medicare and Medicaid Services (CMS) proposed rule on various technical and financial changes related to the health insurance Exchanges established by the Patient Protection and Affordable Care Act.