Neuroscience

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.

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

CDC Comment Deadline: Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

Tobacco use is the leading cause of preventable disease, disability, and death in the United States. The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; therefore, rapid elimination of their use will dramatically reduce this burden.

Cigarette smoking alone causes more than 480,000 deaths each year, including more than 41,000 secondhand smoke related deaths, and costs the country over $300 billion annually in health care spending and lost productivity. Cigarette smoking is causally linked to numerous types of cancer, respiratory and cardiovascular diseases, diabetes, eye disease, complications to pregnancy and reproduction, and compromises the immune system.

Any form of tobacco product use is unsafe for youth, irrespective of whether it is smoked, smokeless, or electronic. Since brain development continues through the early to mid-20s, the use of products containing nicotine, including e-cigarettes, can be harmful to youth and young adults. Specifically, the use of these products can disrupt the growth of brain circuits that control attention, learning, and susceptibility to addiction. In 2018, nearly 4.9 million United States middle and high school students currently used (≥1 day in past 30 days) at least one type of tobacco product, with e-cigarettes being the most commonly used tobacco product. Flavors are a major factor contributing to the use of these products among young people; 85% of youth e-cigarette users report using flavors. The use of e-cigarettes may also lead to future cigarette smoking among some youth. In addition to e-cigarettes, youth also use several other types of tobacco products, and disparities in use of these products exist across population groups.

CDC is seeking input to inform future activities to advance tobacco control practices to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities. The information gathered will be used to inform activities that encompass technical assistance and guidance to state tobacco control programs and collaborative work with national governmental and nongovernmental partners, who share CDC's goals to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

CDC is specifically interested in receiving information on the following issues:

  1. What innovative strategies are working in communities to prevent tobacco use among youth, especially in terms of flavored tobacco products and e-cigarettes?
  2. How can CDC best educate all community members about the harmful effects of secondhand smoke exposure?
  3. How can CDC support state and local health departments and their partners to improve community engagement with populations most at risk for tobacco use?
  4. What innovative strategies are effective in communities to decrease tobacco use in population groups that have the greatest burden of tobacco use and secondhand smoke exposure?
  5. What science, tools, or resources does the public health sector need CDC to develop in order to enhance and sustain tobacco prevention and control efforts?

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

FDA Meeting: Tobacco Products Scientific Advisory Committee

The Food and Drug Administration (FDA) is announcing a forthcoming meeting of the Tobacco Products Scientific Advisory Committee. The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The Committee will convene for two sessions. 

The first session will convene on February 6, 2019, during which the Committee will discuss an amendment to the modified risk tobacco product applications (MRTPAs), submitted by Swedish Match North America for the following snus smokeless tobacco products:

  • MR0000020: General Loose;
  • MR0000021: General Dry Mint Portion Original Mini;
  • MR0000022: General Portion Original Large;
  • MR0000024: General Classic Blend Portion White Large-12ct;
  • MR0000025: General Mint Portion White Large;
  • MR0000027: General Nordic Mint Portion White Large-12ct;
  • MR0000028: General Portion White Large; and
  • MR0000029: General Wintergreen Portion White Large.

The second session will convene, after the first session has concluded, on February 6, 2019, and continue on February 7, 2019. During the second session the Committee will discuss the MRTPA, submitted by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC for the following smokeless tobacco product:

  • MR0000108: Copenhagen Snuff Fine Cut.

This meeting will be open to the public to attend in person. Persons interested in attending the meeting can find more information regarding location and the committee itself at this Federal Register notice.

NIH Comment Deadline: Laboratory Animal Welfare – Draft Report on Recommendations To Reduce Administrative Burden on Researchers

The National Institutes of Health (NIH) is seeking input on the draft report by the 21st Century Cures Act Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The draft report is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Department of Agriculture and the Food and Drug Administration. It describes the proposed actions that the working group has identified to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.

This request for information is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, to seek input on the draft report by the 21st Century Cures Act, Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research.

Input is sought on the draft report of the Working Group and others within the federal government and the proposed recommendations to reduce the administrative burden associated with research activities with laboratory animals while maintaining appropriate protections and scientific integrity.

Comments must be submitted electronically to this portal. More information on the submission of comments and the draft report itself can be found at this Federal Register notice

TSA Comment Deadline: Requested Revision of Current Public Collection of Information – Law Enforcement/Federal Air Marshal Service Physical and Mental Health Certification

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR) that the TSA intends to submit for revision. The ICR describes the nature of the information collection and its expected burden. The collection involves a certification form that applicants for the Law Enforcement/Federal Air Marshal Service are required to complete regarding their mental health history.

TSA is soliciting comments to—

  1. Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
  2. Evaluate the accuracy of the agency's estimate of the burden;
  3. Enhance the quality, utility, and clarity of the information to be collected; and
  4. Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments can be submitted electronically or by mail. More information regarding the submission process can be found at this Federal Register notice.

FDA Comment Deadline: Determination of Regulatory Review Period for Purposes of Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM (EXABLATE) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device EXABLATE. EXABLATE is indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the EXABLATE device. Subsequent to this approval, the USPTO received a patent term restoration application for EXABLATE (U.S. Patent No. 6,612,988) from Brigham and Women's Hospital, Inc. and InSightec, Ltd., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 1, 2017, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of EXABLATE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,158 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments, either through the online portal or by mail. For more information regarding this comment deadline and the extension of the regulatory review period, please see this Federal Register notice

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

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January meeting, the Research Subcommittee will be taking charge of the theme.

The topics covered will include: Non-pharmacological interventions, pragmatic trials, and maximizing the quality of life for people living with dementia. The meeting will also include updates on work from the previous meetings and federal workgroup updates.

Members of the public may attend this meeting in person or via webcast. More information regarding the meeting of this advisory council can be found at this Federal Register notice

NIH Nomination Deadline: Interagency Pain Research Coordinating Committee

The Department of Health and Human Services (HHS) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee. Once filled, the Committee will:

  1. Develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration;
  2. Identify critical gaps in basic and clinical research on
    1. The symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain;
    2. The diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and
    3. Risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain;
  3. Make recommendations to the Director of NIH
    1. To ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;
    2. On how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and
    3. On how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.

Membership on the committee will include six (6) non-Federal members from among scientists, physicians, and other health professionals and six (6) non-Federal members of the general public who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions. Members will serve overlapping three year terms. It is anticipated that the committee will meet at least once a year.

Nominations for this committee may be submitted through the IPRCC webform. More information regarding the committee and the nomination/selection processes can be found at this Federal Register notice.

FDA Comment Deadline: Submission for Office of Management and Budget Review–Experimental Study of Cigarette Warnings

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In this study, adolescent current cigarette smokers, adolescent non-smokers who are susceptible to initiation of cigarette smoking, young adult current cigarette smokers and non-smokers, and older adult current cigarette smokers and non-smokers will be recruited from an existing internet panel of more than 1.2 million people and screened for inclusion into the study. Participants who meet the inclusion criteria will be randomized into 1 of 17 conditions. In each condition, respondents will view one cigarette warning. In the 16 treatment conditions, participants will view 1 cigarette health warning, containing a textual warning statement accompanied by a concordant color graphic depicting the negative health consequences of smoking described in the statement. In the control condition, participants will be randomized to view one of the four current Surgeon General's warnings, representing the current state of cigarette warnings in the United States. In all conditions, participants will view their assigned warnings both on a mock cigarette package and in a mock cigarette advertisement, presented in a randomized order.

There will be three sessions. During Session 1, participants will complete a baseline assessment about their beliefs about the negative health consequences of cigarette smoking. Next, they will be exposed to the stimuli (i.e., the warning based on condition assignment) and complete a set of items assessing (a) if the information presented in the warning was new; (b) self-reported learning from the warning; (c) if the warning was easy to understand; (d) if the warning was perceived to be a fact or an opinion; (e) if the warning was informative; (f) if the warning grabbed their attention; and (g) if the warning made them think about the health risks of cigarette smoking. During Session 2 (1 to 2 days after Session 1), participants will be exposed to the same stimuli again (i.e., the warning based on condition assignment from Session 1) and complete a set of items assessing beliefs about the negative health consequences caused by cigarette smoking. During Session 3 (approximately 14 days after Session 2), participants will complete a delayed post-test on beliefs about the negative health consequences caused by cigarette smoking and items assessing recall of the warning.

Prior to the main data collection, 2 sequential pretests, each with 50 participants, will take place to ensure correct programming of Session 1 and to identify any issues with the study design and implementation.

Study outcomes include comparisons to assess the extent to which exposure to new cigarette health warnings, relative to the text-only Surgeon General's warnings, provide new information, increase self-reported learning, change beliefs about the negative health consequences of cigarette smoking, increase thinking about the risks of smoking, and the extent to which the warnings are informative, easy to understand, factual, attention grabbing, and recalled.

This study is open to comments from members of the general public. Written comments must be submitted by fax or email. For more information regarding this study and previous comments on the subject matter, please see this Federal Register notice.