Neuroscience

SAMHSA Comment Deadline: Extension to Collect the Treatment Episode Data Set and Client-Level Mental Health Admission and Update/Discharge Data

The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting an extension to collect the Treatment Episode Data Set (TEDS) data collection, which expires on March 31, 2019. TEDS is a compilation of client-level substance use treatment admission and discharge data submitted by states on clients treated in facilities that receive state funds. SAMHSA is also requesting an extension to collect the client-level mental health admission and update/discharge data (MH-TEDS/MH-CLD) submitted by states on clients treated in facilities that receive state funds.

TEDS/MH-TEDS/MH-CLD data are collected to obtain information on the number of admissions and updates/discharges at publicly funded substance use treatment and mental health services facilities and on the characteristics of clients receiving services at those facilities. TEDS/MH-TEDS/MH-CLD also monitor trends in the demographic, substance use, and mental health characteristics of admissions.

Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

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

FDA Comment Deadline: Eliminating Youth Electronic Cigarette and Other Tobacco Product Use–The Role for Drug Therapies

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing and seeking public comments to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.

On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan. This plan focuses on three key strategies: Prevention of youth access to tobacco products, curbing the marketing of tobacco products aimed at youth, and educating teens about the dangers of using any tobacco products. FDA recently launched an expansion of its “The Real Cost” campaign to educate youth on the dangers of e-cigarette use and increased enforcement actions to address this critically important public health concern.

In addition to the prevention of initiation, which will be the cornerstone of any successful effort to curb youth e-cigarette use, FDA is also exploring additional approaches to address youth e-cigarette use. One such approach may be the development of drug therapies, as part of multimodal treatment strategies, including behavioral interventions, to support tobacco product cessation. To date, research on youth tobacco product cessation has been limited and focused on smoking (i.e., combustible products) cessation. One recent review found a paucity of data on either behavioral or drug therapies for smoking cessation in young people (age less than 20 years) and concluded that “there continues to be a need for well-designed, adequately powered, randomized controlled trials of interventions for this population of smokers” (Ref. 4). FDA is not aware of any research examining either drug or behavioral interventions for the cessation of youth or adult e-cigarette use. In contrast, there is a large body of research on adult smoking cessation, and multiple drugs for smoking cessation are approved for the adult population, including a variety of prescription and over-the-counter nicotine replacement therapy (NRT) products, as well as the prescription drugs varenicline and bupropion hydrochloride sustained release.

FDA is holding a public hearing to obtain the public's perspectives on the potential role drug therapies may play in the broader effort to eliminate youth e-cigarette and other tobacco product use, as well as the appropriate methods and study designs for evaluating youth e-cigarette cessation therapies and the safety and efficacy of such therapies. The Agency has determined that a public hearing is the most appropriate way to ensure public engagement on this issue, which is of great importance to the public health. FDA believes it is critical to obtain input across the medical and research fields, the pharmaceutical and tobacco industries, and among public health stakeholders (including adolescents) regarding approaches to eliminate youth e-cigarette and other tobacco product use, including exploring whether there is a need for drug therapies to support youth e-cigarette cessation, and if so, how FDA can support the development of such therapies.

Considering the broad range of activities focused on this public health issue, FDA is interested in the public's view on approaches to eliminating e-cigarette and other tobacco product use among youth. Although FDA welcomes all feedback on any public health, scientific, regulatory or legal considerations relating to this topic, we particularly encourage commenters to consider the following questions as they prepare their comments or statements. Responses to questions should include supporting scientific justification.

  1. FDA notes that the factors driving e-cigarette use among youth likely differ from those in the adult population. How might such differences impact the need for, or use of, drug therapies for e-cigarette cessation among youth?
  2. FDA is interested in whether there is a population of youth e-cigarette users who would be likely to benefit from the use of drug therapies for e-cigarette cessation. What age groups (older adolescent vs. younger adolescent), patterns in tobacco use (duration and frequency of use), and clinical features (level of addiction, presence/absence of comorbidities including psychiatric disease) might characterize this population? What types of products (NRT vs. non-NRT; prescription vs. over-the-counter) might be useful?
  3. Describe the scientific, clinical, and societal factors that could either encourage or impede the conduct of clinical trials designed to evaluate drugs intended for youth e-cigarette cessation. What approaches could be used to encourage research and overcome barriers to research?
  4. What methods and study designs are appropriate for assessing drug therapies for youth e-cigarette cessation? What are the appropriate control groups? What are the most informative endpoints and the best assessment tools to evaluate these endpoints?
  5. Acknowledging that to date research has been limited, are there data available from the adult experience with smoking cessation that could potentially be leveraged in the effort to develop drug therapies for youth e-cigarette cessation? Have any drug therapies demonstrated potential to help adults discontinue e-cigarette use? Are there differences between adolescents and adults that impact the ability to extrapolate efficacy findings from the adult population to the adolescent population? Could existing NRT products be useful for youth e-cigarette cessation?
  6. While this hearing is focused on the topic of e-cigarette use among youth, as e-cigarettes are currently the most commonly used form of tobacco in this population, FDA also welcomes comments regarding the potential need for drug therapies to support cessation of other tobacco products, including combustible products (i.e., cigarettes or cigars) and smokeless tobacco products, among youth and the issues impacting the development of such therapies.

Members of the public can submit comments by mail or at Regulations.gov. More information can be found at this Federal Register notice.

BIS Comment Deadline: Review of Controls for Certain Emerging Technologies

The Department of Commerce's Bureau of Industry and Security (BIS) controls the export of dual-use and less sensitive military items, including the Commerce Control List (CCL). Certain emerging technologies may not yet be listed on the CCL and thus have not been evaluated for their national security impacts. This advance of notice proposed of rulemaking (ANPRM) seeks public comment on criteria for identifying emerging technologies that are essential to U.S. national security. 

The representative general categories of technology for which Commerce currently seeks to determine whether there are specific emerging technologies that are essential to the national security of the United States include:

  1. Biotechnology, such as: 
    1. Nanobiology;
    2. Synthetic biology;
    3. Genomic and genetic engineering; or
    4. Neurotech.
  2. Artificial intelligence (AI) and machine learning technology, such as:
    1. Neural networks and deep learning (e.g., brain modelling, time series prediction, classification);
    2. Evolution and genetic computation (e.g., genetic algorithms, genetic programming);
    3. Reinforcement learning;
    4. Computer vision (e.g., object recognition, image understanding);
    5. Expert systems (e.g., decision support systems, teaching systems);
    6. Speech and audio processing (e.g., speech recognition and production);
    7. Natural language processing (e.g., machine translation);
    8. Planning (e.g., scheduling, game playing);
    9. Audio and video manipulation technologies (e.g., voice cloning, deepfakes);
    10. AI cloud technologies; or
    11. AI chipsets.
  3. Position, Navigation, and Timing (PNT) technology.
  4. Microprocessor technology, such as:
    1. Systems-on-Chip (SoC); or
    2. Stacked Memory on Chip.
  5. Advanced computing technology, such as:
    1. Memory-centric logic. 
  6. Data analytics technology, such as:
    1. Visualization;
    2. Automated analysis algorithms; or
    3. Context-aware computing.
  7. Quantum information and sensing technology, such as
    1. Quantum computing;
    2. Quantum encryption; or
    3. Quantum sensing.
  8. Logistics technology, such as
    1. Mobile electric power;
    2. Modeling and simulation;
    3. Total asset visibility; or
    4. Distribution-based Logistics Systems (DBLS).
  9. Additive manufacturing (e.g., 3D printing);
  10. Robotics such as:
    1. Micro-drone and micro-robotic systems;
    2. Swarming technology;
    3. Self-assembling robots;
    4. Molecular robotics;
    5. Robot compliers; or
    6. Smart Dust.
  11. Brain-computer interfaces, such as
    1. Neural-controlled interfaces;
    2. Mind-machine interfaces;
    3. Direct neural interfaces; or
    4. Brain-machine interfaces.
  12. Hypersonics, such as:
    1. Flight control algorithms;
    2. Propulsion technologies;
    3. Thermal protection systems; or
    4. Specialized materials (for structures, sensors, etc.).
  13. Advanced Materials, such as:
    1. Adaptive camouflage; 
    2. Functional textiles (e.g., advanced fiber and fabric technology); or
    3. Biomaterials.
  14. Advanced surveillance technologies, such as:​
    1. Faceprint and voiceprint technologies.

BIS welcomes comments on: (1) How to define emerging technology to assist identification of such technology in the future; (2) criteria to apply to determine whether there are specific technologies within these general categories that are important to U.S. national security; (3) sources to identify such technologies; (4) other general technology categories that warrant review to identify emerging technology that are important to U.S. national security; (5) the status of development of these technologies in the United States and other countries; (6) the impact specific emerging technology controls would have on U.S. technological leadership; (7) any other approaches to the issue of identifying emerging technologies important to U.S. national security, including the stage of development or maturity level of an emerging technology that would warrant consideration for export control.

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

FDA Comment Deadline: Rare Diseases – Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings.

Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.

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

FDA Meeting: Community Use of Naloxone Products

The FDA will hold a joint meeting with the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss strategies to increase the availability of naloxone products intended for use in the community.

The committees will be asked to consider various options for increasing access to naloxone, a medicine used to block the effects of opioids, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients.

Members of the public may attend the meeting in person or via webcast. Members of the public may also present data, information, or views, orally or in writing, or submit comments by mail or at Regulations.gov. More information is available at the FDA's website

NIH Meeting: Cures Acceleration Network (CAN) Review Board

The Cures Acceleration Network (CAN) Review Board of the National Center for Advancing Translational Sciences (NCATS) within the NIH will meet to advise and provide recommendations for identifying significant barriers to successful translation of basic science into clinical application.

Authorized to reduce significant barriers to successful translation and accelerate the development of high-need cures, the Cures Acceleration Network (CAN) provides NCATS with flexibility in how it funds projects. Implementation of this authority is guided by the CAN Review Board, which advises and provides recommendations to the NCATS director on the policies, programs and procedures for carrying out the duties of the Office of the Director and on identifying significant barriers to successful translation of basic science into clinical application. The CAN Review Board also discusses concept clearances for potential NCATS initiatives.

This meeting of the NCATS Cures Acceleration Network Review Board will feature presentations by NCATS leadership and invited guests. NCATS staff will present proposed initiative concepts for CAN Review Board consideration.

The meeting is open to the public and will be webcast. Further information can be found on the meeting agenda and Federal Register Notice, both linked from the meeting website.

CDC Meeting: Board of Scientific Counselors, National Center for Injury Prevention and Control

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). 

The Board will: (1) Conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases, and other impairments; (2) assist States and their political subdivisions in preventing and suppressing communicable and non-communicable diseases and other preventable conditions and in promoting health and well-being; and (3) conduct and assist in research and control activities related to injury. The Board of Scientific Counselors makes recommendations regarding policies, strategies, objectives, and priorities; and reviews progress toward injury prevention goals and provides evidence in injury prevention-related research and programs. The Board also provides advice on the appropriate balance of intramural and extramural research, the structure, progress and performance of intramural programs. The Board is designed to provide guidance on extramural scientific program matters, including the: (1) Review of extramural research concepts for funding opportunity announcements; (2) conduct of Secondary Peer Review of extramural research grants, cooperative agreements, and contracts applications received in response to the funding opportunity announcements as it relates to the Center's programmatic balance and mission; (3) submission of secondary review recommendations to the Center Director of applications to be considered for funding support; (4) review of research portfolios, and (5) review of program proposals.

The Board of Scientific Counselors will discuss science matters to include research strategies needed to guide the Center's focus on reducing opioid overdose and to review the recommendations from the opioid prescribing for acute and chronic pain workgroup. Agenda items are subject to change as priorities dictate.

This meeting is open to members of the general public. More information regarding registration and attendance can be found at this Federal Register notice.

House Hearing: Implementing the 21st Century Cures Act – An Update from the Office of the National Coordinator

The House Committee on Energy and Commerce, Subcommittee on Health, will hold a hearing titled "Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator". 

The 21st Century Cures Act (Cures) was signed into law on December 13, 2016. Enactment of Cures was the culmination of a bipartisan, multi-year effort by Congress to modernize the cycle of discovery, development, and delivery of innovative medical products.

On November 30, 2017, the Subcommittee on Health held its first Cures implementation hearing, focusing on research and development. Since that time, additional Cures oversight hearings have focused on the law’s mental health initiatives and provisions being implemented by the Food and Drug Administration and the National Institutes of Health. This hearing will complete the oversight of Cures implementation for the 115th Congress by focusing on the Office of the National Coordinator for Health Information Technology (ONC). Members will have the opportunity to learn more about health information technology and the work ONC has done in implementing Cures.

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

HHS Meeting: Interdepartmental Serious Mental Illness Coordinating Committee

The Substance Abuse and Mental Health Services Administration within the Department of Health and Human Services (HHS) announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED), including federal coordination, strategies, data evaluation, and recommendations for action. Committee members will also discuss federal implementation of ISMICC recommendations.

The ISMICC meeting is open to the public and members of the public can attend the meeting via telephone or webcast only. More information is available at this Federal Register notice.

Crashing the boards: Neuroscientist Maureen Condic brings a different voice to NSF oversight body

Science – On Wednesday, the National Science Foundation (NSF) will welcome the first cohort of members appointed by President Donald Trump to its oversight body, the National Science Board. Most of the seven fit the mold of senior academic leaders, prominent scientists, and corporate research managers who typically sit on the 24-member board. But Maureen Condic is somewhat different.