Neuroscience

DOS Meeting: Implications of Access and Benefit-Sharing Regimes on Global Health and Biomedical Research

The Department of State (DOS) will hold a meeting to discuss the implications of Access and Benefit-Sharing (ABS) regimes on global health and biomedical research. In particular, DOS will focus on the effects of Nagoya Protocol and other ABS implementation on public health systems. This is the seconf of two meetings on this topic; the first meeting will occur on June 25, 2019.

Specific issues of focus include: International research collaborations, international pathogen sample sharing, infectious disease research, including influenza, Zika and other diseases, pandemic and epidemic preparedness and response, medical countermeasure product development efforts, investor interest in vaccine development, and other aspects.

DOS would also welcome views on what the World Health Organization, other United Nations bodies, and non-governmental organizations can do to effectively protect public health equities in the context of the Nagoya Protocol and other national level ABS implementation. DOS also welcomes examples of:

  1. Monetary or non-monetary benefits to the global public health system that are facilitated by international sharing of pathogens, biospecimens, pathogen genetic sequence data, and/or relevant metadata.
  2. Influenza-specific issues and/or examples related to the items described above or other items that could affect global influenza pandemic preparedness and response or efforts to combat seasonal influenza.
  3. Non-ABS challenges and barriers with sharing pathogens internationally or that otherwise have significant implications for global pandemic or epidemic preparedness and response efforts that might merit additional attention or analysis.

Members of the public may attend in person. More information is available at this Federal Register notice and at this DOS website.

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

SAMHSA Teleconference: Interdepartmental Serious Mental Illness Coordinating Committee

The Substance Abuse and Mental Health Services Administration (SAMHSA) will hold a teleconference meeting of its Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC).

The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in serious mental illness (SMI) and serious emotional disturbance (SED), research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and support for adults with SMI or children with SED.

In addition, the ISMICC will evaluate the effect federal programs related to serious mental illness have on public health, including public health outcomes such as (A) rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment; (B) increased rates of employment and enrollment in educational and vocational programs; (C) quality of mental and substance use disorders treatment services; or (D) any other criteria as may be determined by the Secretary.

Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED. Not later than one year after the date of enactment of the 21st Century Cures Act, and five years after such date of enactment, the ISMICC shall submit a report to Congress and any other relevant federal department or agency.

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

FDA Comment Deadline: Clinical Utility and Safety Concerns Associated with Higher Ranges of Opioid Analgesic Dosing in the Outpatient Setting

The Food and Drug Administration (FDA) is seeking public comments to accompany a forthcoming meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. At the meeting, FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. FDA is also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.

FDA frequently hears from patients and healthcare providers that higher-dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids.

To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk-management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities.

In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

Members of the public may submit comments online at Regulations.gov. More information is available at this Federal Register notice.

HHS Nomination Deadline: Advisory Council on Alzheimer's Research, Care, and Services

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Planning and Evaluation, invites nominations to the Advisory Council on Alzheimer's Research, Care, and Services. HHS is soliciting nominations for five new non-Federal members of the Advisory Council to replace the five members whose terms will end September 30, 2019. 

The Advisory Council on Alzheimer's Research, Care, and Services meets quarterly to discuss programs that impact people with Alzheimer's disease and related dementias and their caregivers. The Advisory Council makes recommendations to Congress and the Secretary of Health and Human Services about ways to reduce the financial impact of Alzheimer's disease and related dementias and to improve the health outcomes of people with these conditions. The Advisory Council also provides feedback on a National Plan for Alzheimer's disease. On an annual basis, the Advisory Council evaluates the implementation of the recommendations through an updated National Plan. The National Alzheimer's Project Act, Public Law 111-375 (42 U.S.C. 11225), requires that the Secretary of Health and Human Services (HHS) establish the Advisory Council on Alzheimer's Research, Care, and Services. The Advisory Council is governed by provisions of Public Law 92-463 (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

Members of the public may submit nominations by mail or email. More information is available at this Federal Register notice.

EPA Nomination Deadline: Pesticide Program Dialogue Committee

The Environmental Protection Agency (EPA) is inviting nominations from a diverse range of qualified candidates to be considered for appointment to the Pesticide Program Dialogue Committee (PPDC). The PPDC is chartered to provide policy advice, information, and recommendations to the EPA on a wide variety of pesticide regulatory developments and reform initiatives, evolving public policy, and program implementation issues associated with evaluating and reducing risks from pesticide use.

To maintain the representation outlined by the charter, nominees will be selected to represent: Environmental/public interest and animal rights groups; farm worker organizations; pesticide industry and trade associations; pesticide user, grower, and commodity groups; federal/state/local and tribal governments; academia; and public health organizations. 

Members of the public may submit nominations by email or mail. More information is available at this Federal Register notice.

NASEM Meeting: Committee on Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Population Health and Public Health Practice, will hold the third meeting of the Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. The committee will hear from programs that integrate opioid and infectious disease treatment and prevention into their practice. The experiences of the panelists and their respective organizations will help to inform the committee’s deliberations, based on the Statement of Task.

The session on June 27, 2019, will only be available to the public via teleconference. Members of the public may attend the June 28, 2019, session either in person or via webcast. 

Members of the public may attend with advance registration. More information, including the agenda, is available at this NASEM website.

EPA Meeting: Board of Scientific Counselors, Executive Committee

The Environmental Protection Agency (EPA), Office of Research and Development, will hold a meeting of the Executive Committee of its Board of Scientific Counselors. The Board of Scientific Counselors is a federal advisory committee that provides advice and recommendations to EPA's Office of Research and Development on technical and management issues of its research programs.

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

HHS Teleconference: Pain Management Best Practices Inter-Agency Task Force

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health, will hold a teleconference meeting of its Pain Management Best Practices Inter-Agency Task Force. The purpose of this meeting is for the Task Force to collaborate with the Centers for Medicaid and Medicare Services to discuss payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues. This meeting was initially scheduled for June 12 but was later postponed to June 26 (84 FR 27640). 

The Task Force is charged with developing an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to Medication-Assisted Treatment.

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

SAMHSA Teleconference: Interdepartmental Serious Mental Illness Coordinating Committee

The Substance Abuse and Mental Health Services Administration (SAMHSA) will hold a teleconference meeting of its Interdepartmental Serious Mental Illness Coordinating Committee. Particularly, the Focus Area 2 (Access and Engagement: Make It Easier to Get Good Care), Focus Area 3 (Treatment and Recovery: Close the Gap Between What Works and What Is Offered), Focus Area 4 (Increase Opportunities for Diversion and Improve Care for People With SMI and SED Involved in the Criminal and Juvenile Justice Systems) and Focus Area 5 (Develop Finance Strategies to Increase Availability and Affordability of Care) workgroups will meet. Focus Areas are described in the SAMHSA report "The Way Forward: Federal Action for a System That Works for All People Living With SMI and SED and Their Families and Caregivers." 

Members of the public may access the teleconference. More information is available at this SAMHSA website.

NASEM Workshop: Brain Health Across the Lifespan

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Population Health and Public Health Practice, will hold a workshop titled "Brain Health Across the Lifespan." The workshop will explore issues related to brain health throughout the life span, from birth through old age. Workshop presentations will explore the following questions:

  • What are accepted definitions of brain health and resilience?
  • What are the key elements to measure status of brain health and its resilience across the life span?
  • What additional research questions can be addressed to increase our understanding of brain plasticity throughout the life span?

Members of the public may attend in person with advance registration. More information is available at this NASEM website.

DOS Meeting: Implications of Access and Benefit-Sharing Regimes on Global Health and Biomedical Research

The Department of State (DOS) will hold a meeting to discuss the implications of Access and Benefit-Sharing (ABS) regimes on global health and biomedical research. In particular, DOS will focus on the effects of Nagoya Protocol and other ABS implementation on public health systems. This is the first of two meetings on this topic; the second meeting will occur on September 20, 2019.

Specific issues of focus include: International research collaborations, international pathogen sample sharing, infectious disease research, including influenza, Zika and other diseases, pandemic and epidemic preparedness and response, medical countermeasure product development efforts, investor interest in vaccine development, and other aspects.

DOS would also welcome views on what the World Health Organization, other United Nations bodies, and non-governmental organizations can do to effectively protect public health equities in the context of the Nagoya Protocol and other national level ABS implementation. DOS also welcomes examples of:

  1. Monetary or non-monetary benefits to the global public health system that are facilitated by international sharing of pathogens, biospecimens, pathogen genetic sequence data, and/or relevant metadata.
  2. Influenza-specific issues and/or examples related to the items described above or other items that could affect global influenza pandemic preparedness and response or efforts to combat seasonal influenza.
  3. Non-ABS challenges and barriers with sharing pathogens internationally or that otherwise have significant implications for global pandemic or epidemic preparedness and response efforts that might merit additional attention or analysis.

Members of the public may attend in person. More information is available at this Federal Register notice and at this DOS website.