Neuroscience

HHS Comment Deadline: Draft Report on Pain Management Best Practices – Updates, Gaps, Inconsistencies, and Recommendations

The Department of Health and Human Services (HHS) is seeking public comments on the draft report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations, which proposes updates to best practices and recommendations for pain management, including chronic and acute pain.

The Task Force is required to propose updates on best practices and recommendations to address gaps or inconsistencies for pain management, including chronic and acute pain, and submit such updates and recommendations to relevant Federal agencies and the general public. The duties of the Task Force are to:

  • Identify, review, determine, and propose updates to gaps or inconsistencies between best practices for pain management, taking into consideration:
    • Existing pain management research and other relevant research;
    • Recommendations from relevant conferences and existing evidence-based guidelines;
    • Ongoing efforts at the state and local level and by medical professional organizations to develop improved pain management strategies;
    • The management of high-risk populations who receive opioids in the course of medical care, other than for pain management;
    • The 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the CDC; and
    • Private sector, State, and local government efforts related to pain management and prescribing pain medication.
  • Provide the public with at least ninety (90) days to submit comments on any proposed updates and recommendations.
  • Develop a strategy for dissemination of information on best practices for pain management to stakeholders, if appropriate.

The Draft Report highlights the progress made towards identifying, reviewing, and determining whether there are gaps in or inconsistencies between best practices for pain management (including chronic and acute pain) developed or adopted by Federal agencies. It includes the Task Force's proposed updates to best practices and recommendations on addressing gaps or inconsistencies. On September 26, 2018, the Task Force voted on the proposed updates and recommendations that would be provided to the public for comment. The proposed updates and recommendations are included in the Draft Report. Once the ninety (90) day comment period concludes, the Task Force will consider comments received and compile a Final Recommendations Report with its proposed updates and recommendations.

The goal of this Request for Comment is to solicit feedback on the Draft Report, which includes the Task Force's proposed updates and recommendations. The Task Force invites comment on the full range of issues that may be relevant to the proposed updates and recommendations.

Comments may be submitted electronically, either by email or at Regulations.gov, or in written form. More information regarding the task force and the comment submission process can be found at this Federal Register notice.

 

NASEM Symposium: Evidence-Based Interventions to Address the Underrepresentation of Women in Science, Engineering, and Medicine

The National Academies of Sciences, Engineering, and Medicine (NASEM) Committee On Women In Science, Engineering, and Medicine (CWSEM) is organizing a symposium to be centered around evidence-based interventions to address the underrepresentation of women in science, engineering, and medicine.

The scientific, engineering, and medical communities have been working towards improved representation of women in science, technology, engineering, mathematics, and medicine (STEMM) for decades. While progress has been made, women (particularly women of color) remain underrepresented in many scientific, engineering, and medical fields, and at many levels in education and career stages. This symposium will seek to understand institutional barriers to implementing practices for improving the representation of women in STEMM, so that those barriers can be removed or overcome. This event will re-visit the major themes of the 2007 National Academies report, Beyond Bias and Barriers, and will examine policies, practices, and strategies that have demonstrated effectiveness in opening doors to women’s participation and success in STEMM fields. 

This event is free to attend, and requires registration prior to attendance. 

NIH Workshop: Rare Disease Day

The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), announces the 2019 Rare Disease Day at NIH. The event will feature interactive panel discussions on collective research models for rare diseases, patient registries, rare cancer research initiatives, and "no disease left behind, no patient left behind." New this year will be a presentation of the first ever Zebbie award for the NCATS Rare Diseases are Not Rare! Challenge. Other highlights include posters and exhibits by rare disease groups and researchers as well as artwork, videos and NIH Clinical Center tours.

Guest speakers include NCATS Director Christopher P. Austin, M.D.; NIH Clinical Center CEO James K. Gilman, M.D.; and NCATS Office of Rare Diseases Research Director Anne R. Pariser, M.D.

Admission is free and open to the public. In association with Global Genes®, participants are encouraged to wear their favorite pair of jeans.

The day will start with a welcome session, and then move into 4 different panel sessions, each targeted at addressing a sector of rare disease treatment and research. Interested persons should register online. More information regarding the event, including a tentative agenda, can be found at this NIH page

VA Meeting: Rehabilitation Research and Development Service Scientific Merit Review Board, Brain Health and Injury Subcommittee

The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the subcommittee for Brain Health and Injury of the Rehabilitation Research and Development Service Scientific Merit Review Board will meet.

The purpose of the Board is to review rehabilitation research and development applications and advise the Director, Rehabilitation Research and Development Service, and the Chief Research and Development Officer on the scientific and technical merit, the mission relevance, and the protection of human and animal subjects.

The subcommittee meeting will be open to the public for approximately one-half hour at the start of each meeting to cover administrative matters and to discuss the general status of the program.

During the closed portion of each the subcommittee meeting, discussion and recommendations will include qualifications of the personnel conducting the studies (the disclosure of which would constitute a clearly unwarranted invasion of personal privacy), as well as research information (the premature disclosure of which would likely compromise significantly the implementation of proposed agency action regarding such research projects).

Members of the public may attend in person. For more information regarding the meeting and attendance policies, see this Federal Register notice.

VA Meeting: Rehabilitation Research and Development Service Scientific Merit Review Board, Spinal Cord Injury/Disorders & Neuropathic Pain Subcommittee

The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Spinal Cord Injury/Disorders & Neuropathic Pain subcommittee of the Rehabilitation Research and Development Service Scientific Merit Review Board will meet.

The purpose of the Board is to review rehabilitation research and development applications and advise the Director, Rehabilitation Research and Development Service, and the Chief Research and Development Officer on the scientific and technical merit, the mission relevance, and the protection of human and animal subjects. A portion of the meeting open to the public, though no public comments will be taken. 

During the closed portion of the subcommittee meeting, discussion and recommendations will include qualifications of the personnel conducting the studies (the disclosure of which would constitute a clearly unwarranted invasion of personal privacy), as well as research information (the premature disclosure of which would likely compromise significantly the implementation of proposed agency action regarding such research projects). 

Members of the public may attend in person. For more information regarding the meeting and attendance policies, see this Federal Register notice.

VA Meeting: Sensory Systems & Communication Disorders and Chronic Medical Conditions and Aging Subcommittees

The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Sensory Systems & Communication Disorders and Chronic Medical Conditions and Aging subcommittees of the Rehabilitation Research and Development Service Scientific Merit Review Board will meet.

The purpose of the Board is to review rehabilitation research and development applications and advise the Director, Rehabilitation Research and Development Service, and the Chief Research and Development Officer on the scientific and technical merit, the mission relevance, and the protection of human and animal subjects. A portion of the meeting open to the public, though no public comments will be taken. 

During the closed portion of the subcommittee meeting, discussion and recommendations will include qualifications of the personnel conducting the studies (the disclosure of which would constitute a clearly unwarranted invasion of personal privacy), as well as research information (the premature disclosure of which would likely compromise significantly the implementation of proposed agency action regarding such research projects). 

Members of the public may attend in person. For more information regarding the meeting and attendance policies, see this Federal Register notice.

DOL Comment Deadline: National Health Emergency Demonstration Grants to Address the Opioid Crisis

The Department of Labor (DOL) is providing the general public with the opportunity to comment on proposed data collection instruments that will be used in the implementation evaluation of the National Health Emergency Demonstration Grants to Address the Opioid Crisis. 

This notice provides the opportunity to comment on proposed data collection instruments that will be used in the implementation evaluation: Key informant interview protocols, survey of key informants (state- and local-level administrators) and a program participant interview guide.

1. Key informant interview protocol. The protocol will be used during site visits to the grantees to collect information from administrators and staff at the state- and local-level, and with partner organizations and employers at either the state or local level. Issues to be covered include the state and local community context, strategies and approaches to service delivery, target populations and recruiting, the role of various partners in grant and subgrant activities, successes and challenges, preliminary outcomes, promising practices, and other topics.

2. Survey of key informants. This short questionnaire for key informants (administrators and staff at the state- and local-level) includes basic background information, such as their highest education level and experience, and brief questions about their perspectives on the opioid crisis and the state's partnerships to address the crisis.

3. Program participant interview guide. The guide will be used for individual or group discussions with approximately 10 program participants in each state. Topics will include participant background, service receipt, participants' views on the quality and effectiveness of the workforce services received, and their current or anticipated labor market experiences as a result of the services.

 Desired Focus of Comments: Currently, the Department of Labor is soliciting comments concerning the above data collection for the Implementation Evaluation of the National Health Emergency (NHE) Demonstration Grants to Address the Opioid Crisis. DOL is particularly interested in comments that do the following:

  • Evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
  • Evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions;
  • Enhance the quality, utility, and clarity of the information to be collected; and
  • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology—for example, permitting electronic submissions of responses.

Comments may be submitted electronically or in written form. For more information regarding the information collection and the comment submission process, please see this Federal Register notice

FDA Comment Deadline: Definition of the Term “Biological Product”

The Food and Drug Administration (FDA or the Agency) is seeking comments on a proposed rule to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.

Comments on this proposal may be submitted electronically at Regulations.gov or by mail. More information on the proposal and the comment submission process can be found at this Federal Register notice