Neuroscience

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive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 This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.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

NASEM Workshop: The Role of Nonpharmacological Approaches to Pain Management

The National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a workshop titled "The Role of Nonpharmacological Approaches to Pain Management." Given the changing landscape for pain management, the Forum on Neuroscience and Nervous System Disorders and the Global Forum on Innovation in Health Professional Education will bring together key stakeholders to discuss these treatments and integrative health models for pain management.

As a result of the national push toward the use of nonpharmacological therapies for chronic pain, increased health professionals' education and training will be needed to encourage the adoption and appropriate use of the evidence-based approaches. In addition, addressing policy barriers, such as those related to reimbursement for these treatments will be important to enable broader use and dissemination.

Workshop Objectives:

  • Review the current state of evidence on the effectiveness of nonpharmacological treatments and integrative health models for pain management, as well as available evidence on use patterns and patient interest. Examples may include acupuncture, manual therapies, physical therapy and exercise, cognitive behavioral therapy, tai chi, yoga, meditation, and neurostimulation.
  • Consider multimodal approaches and potential synergies between pharmacological and nonpharmacological approaches to pain management.
  • Consider multimodal approaches and potential synergies between devices and nonpharmacological approaches to pain management.
  • Discuss research gaps and key questions for further research.
  • Examine health professions' current approaches for educating students, trainees, and practicing clinicians on nonpharmacological pain management, and discuss potential next steps to improve training and education within and across health professions.
  • Explore policies, such as those related to reimbursement, that would enable broader dissemination and implementation of evidence-based nonpharmacological treatments when appropriate.

Members of the public may attend the workshop in person. More information is available at NASEM's website.

NSF Meeting: National Science Board

The National Science Board (NSB) of the National Science Foundation (NSF) will hold their quarterly meeting to pursue the goals and functions of NSF, as well as recommend and encourage the pursuit of national policies for the promotion of research and education in science and engineering.

The National Science Board has two important roles. First, it establishes the policies of NSF within the framework of applicable national policies set forth by the President and the Congress. In this capacity, the Board identifies issues that are critical to NSF's future, approves NSF's strategic budget directions and the annual budget submission to the Office of Management and Budget, and approves new major programs and awards. The second role of the Board is to serve as an independent body of advisors to both the President and the Congress on policy matters related to science and engineering and education in science and engineering. In addition to major reports, the NSB also publishes occasional policy papers or statements on issues of importance to U.S. science and engineering.

This meeting is open to the public. Public visitors must arrange for a visitor's badge at least 24 hours in advance by emailing your name and organizational affiliation to NSB. Find more information and an agenda on the meeting's event page.

NIH Comment Deadline: Feedback on the BRAIN Initiative

The National Institutes of Health (NIH) has issued a Request for Information (RFI) is to solicit input on how best to accomplish the ambitious vision for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative set forth in BRAIN 2025: A Scientific Vision. NIH is soliciting input from all interested stakeholders, including members of the scientific community, trainees, academic institutions, the private sector, health professionals, professional societies, advocacy groups, and patient communities, as well as other interested members of the public.

The BRAIN Initiative aims to develop new tools and technologies to understand and manipulate networks of cells in the brain. BRAIN 2025: A Scientific Vision serves as the strategic plan for the BRAIN Initiative at NIH and outlines an overarching vision, seven high level scientific priorities, and many specific goals. Designed to be achieved over at least a decade, the first five years of BRAIN 2025 emphasizes development of tools and technology, and the next five years shifts emphasis to using these tools to make fundamental discoveries about how brain circuits work and what goes wrong in disease.

Members of the public may submit responses and suggestions to the NIH online or via email. More information can be found at the NIH's website.

CCR Teleconference: Nevada State Advisory Committee

The Nevada State Advisory Committee to the U.S. Commission on Civil Rights (CCR) will meet to discuss potential findings and recommendations for report on policing practices and mental health.

The Commission maintains 51 State Advisory Committees (SACs) composed of citizen volunteers familiar with local and state civil rights issues. The committees assist the Commission through information-gathering activities to include fact-finding activity, public hearings, and the solicitation of a broad cross section of viewpoints about civil rights issues in its state and then reports on its findings and recommendations to the Commission.

This meeting is available to the public through a toll-free call-in number. Members of the public may make comments during the open period at the end of the meeting, and may submit written comments by mail, email, or fax.

Records and documents discussed during the meeting will be available online prior to and after the meeting. More information can be found at the Federal Register Notice for the meeting.

AHRQ Comment Deadline: Supplemental Evidence and Data Request on Antipsychotics for Delirium

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific evidence and data from the public to inform their review of Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program.

The EPC program is supplementing the usual manual and electronic database searches by seeking published and unpublished pertinent scientific information from the public to improve the quality of this review. The entire research protocol, including the key questions, to Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review is available online.

Submissions to this supplementary evidence and data request must be sent via email or direct mail to AHRQ on or before October 31, 2018. Materials submitted must be publicly available or able to be made public.

More information on submission criteria and the systematic review can be found at the Federal Register Notice for this request.

FDA Nomination Deadline: Device Advisory Committees and Panels

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee. 

The Device Good Manufacturing Practice Advisory Committee reviews regulations proposed for promulgation regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs (the Commissioner) regarding the feasibility and reasonableness of those proposed regulations. 

The Medical Devices Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The Committee has numerous panels which advise according to their specialty device area. 

Any interested person may nominate one or more qualified individuals for membership on one or more of the advisory panels or advisory committees. Self-nominations are also accepted. All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal or by mail to Advisory Committee Oversight and Management Staff. 

More information on the committees and panels, membership criteria, and the nomination process can be found on the Federal Register Notice for this request for nominations.