Neuroscience

AHRQ Nominations: US Preventive Services Task Force

The Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services is announcing a forthcoming nomination deadline for members of the US Preventive Services Task Force (USPSTF). The USPSTF, an independent body of experts in prevention and evidence- based medicine, works to improve the health of all Americans by making evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. The recommendations made by the USPSTF address clinical preventive services for adults and children, and include screening tests, counseling services, and preventive medications.

The USPSTF was first established in 1984 under the auspices of the US Public Health Service. Currently, the USPSTF is convened by the Director of AHRQ, and AHRQ provides ongoing scientific, administrative, and dissemination support for the USPSTF's operation. USPSTF members serve four year terms. New members are selected each year to replace those members who are completing their appointments.

To qualify for the USPSTF and support its mission, an applicant or nominee should, at a minimum, demonstrate knowledge, expertise and national leadership in the following areas:

  1. The critical evaluation of research published in peer-reviewed literature and in the methods of evidence review;
  2. Clinical prevention, health promotion and primary health care; and
  3. Implementation of evidence-based recommendations in clinical practice including at the clinician-patient level, practice level, and health-system level.

Additionally, the Task Force benefits from members with expertise in the following areas:

  • Public health
  • Health equity and the reduction of health disparities
  • Application of science to health policy
  • Behavioral medicine
  • Communication of scientific findings to multiple audiences including health care professionals, policy makers and the general public
  • Candidates with experience and skills in any of these areas should highlight them in their nomination materials

Nominations should be submitted in writing by mail, or electronically by email. More information about nomination criteria and the nomination process can be found at this Federal Register notice.

FDA Comment Deadine: Enforcement Policy for Certain Marketed Tobacco Products

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comment on a draft guidance for industry entitled “Enforcement Policy for Certain Marketed Tobacco Products.” FDA is issuing this draft guidance to provide information regarding FDA's enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE) order. This policy extends to new tobacco products created by modifying the quantity of a provisional tobacco product in a pending substantial equivalence report that become subject to NSE orders.

The draft guidance also provides information on FDA's enforcement policy for when FDA receives from an applicant a request for supervisory review under 21 CFR 10.75 within 30 calendar days of the issue date of the NSE order. The draft guidance provides that for these new tobacco products, FDA intends to offer copies of those final scientific reviews that supported the basis of the Agency's decision to the applicant concurrent with the NSE order for provisional tobacco products. 

FDA is issuing this draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Enforcement Policy for Certain Marketed Tobacco Products".

Comments on this draft guidance may be submitted electronically through this portal at Regulations.gov, or via mail. For more information regarding the draft guidance and the comment submission process, please see this Federal Register notice

FDA Comment Deadline: Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation — Nonclinical Testing and Clinical Considerations

The Food and Drug Administration (FDA) is announcing a forthcoming comment deadline on a draft guidance titled "Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Nonclinical Testing and Clinical Considerations."

Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This draft guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies. This draft guidance is not final nor is it in effect at this time.

The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life. On November 21, 2014, the Center for Devices and Radiological Health (CDRH) held an open public workshop with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of implanted BCI devices. FDA considered the input provided during this workshop to develop this guidance document. This guidance document provides clinical study design and nonclinical testing recommendations associated with BCI devices.

This is a leapfrog guidance: A type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leapfrog guidance represents the Agency's initial thinking and our recommendations may change as more information becomes available.

Comments on this draft guidance may be submitted through this online portal at Regulations.gov, or via mail in written form. For more information on the draft guidance or the comment submission process, please see this Federal Register notice.

FDA Comment Deadline: Smoking Cessation and Related Indications — Developing Nicotine Replacement Therapy Drug Products

The Food and Drug Administration (FDA) is announcing the comment period for a draft guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy [NRT] Drug Products.” This draft guidance reflects the FDA's current recommendations regarding overall development programs to support the approval of NRT drug products for smoking cessation and related chronic indications.

There are several FDA-approved prescription and nonprescription NRT drug products for cessation of smoking cigarettes, but the Agency encourages the development of additional NRT drug products, which could help more smokers quit. In November 2017, FDA published a notice in the Federal Register requesting comments on the Agency's approach to evaluating the safety and efficacy of NRT drug products, including how they should be used and labeled (82 FR 56759; Docket No. FDA-2017-N-6529). The Agency hosted a public hearing in January 2018 to obtain input from stakeholders on these issues. This draft guidance takes into consideration the feedback received and is intended to serve as a focus for continued discussions among the Agency, pharmaceutical sponsors, the academic community, and the public on this topic.

The draft guidance focuses on drug development and trial design issues that are specific to the study of NRT drug products. NRT drug products are typically studied and labeled for use as adjuncts to behavioral self-help materials and to date have involved single treatment regimens that begin on the patient's quit day. Alternate treatment regimens (e.g., pretreatment before quit day, quitting by gradual reduction (reduce to quit), using multiple NRT drug products together) are discussed in the guidance.

As outlined in the guidance, NRT drug products can be developed for smoking cessation and/or reduction in risk of relapse. NRT drug products that first have demonstrated efficacy for at least one of these indications can also include additional information in labeling by demonstrating efficacy in certain secondary endpoints. Sponsors can evaluate reduction in the urge to smoke or relief of cue-induced craving in former smokers, as secondary endpoints. Additionally, sponsors that can demonstrate, via a secondary endpoint, that the drug product provides relief of withdrawal symptoms in smokers who are not trying to quit smoking, may be able to include labeling instructions to address situations when such individuals are required to abstain and therefore experience withdrawal symptoms (e.g., while traveling on an airplane).

FDA is aware of the serious risks associated with smoking and is committed to facilitating the development of therapies to support smoking cessation efforts. Both the regulatory pathway for an NRT drug product and the amount of nonclinical or clinical data needed to support approval will depend on the characteristics of the proposed NRT drug product relative to an approved NRT drug product. This guidance outlines general considerations for NRT drug development and trial design, and FDA encourages sponsors to contact FDA for feedback on their proposed development plans. Sponsors developing an over-the-counter drug product should bear in mind that it is often not possible to answer all regulatory questions in a single trial, and additional sequential steps may be needed.

Comments on this draft guidance may be submitted electronically, through this portal on Regulations.gov, or through mail in written form. For more information regarding this draft guidance and the comment submission process, please see this Federal Register notice.

HHS Meeting: Interagency Autism Coordinating Committee

The Department of Health and Human Services (HHS) announces a forthcoming meeting of the Interagency Autism Coordinating Committee (IACC).

The purpose of the IACC meeting is to discuss business, agency updates, and issues related to autism spectrum disorder (ASD) research and services activities.

The meeting will be open to the public and will be accessible by webcast and conference call. A registration link will be posted prior to the meeting. For more information regarding the details of the meeting, and the forthcoming registration link, please see this IACC notice.

FDA Comment Deadline: Modifications to Compliance Policy for Certain Deemed Tobacco Products

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comment on a draft guidance for industry entitled “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” The draft guidance discusses changes to the compliance policies for pre-market review requirements for certain deemed tobacco products and describes how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have pre-market authorization.

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

FDA Comment Deadline: Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

The Food and Drug Administration (FDA ) is announcing an opportunity for public comment on an experimental study on measuring consumer comprehension of displays of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act was signed into law. This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the FD&C Act.

In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA's tobacco product authority. The deemed products include electronic nicotine delivery systems, cigars, waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (final deeming rule) (81 FR 28973).

Among other requirements, section 904(e) of the FD&C Act requires FDA to establish, and periodically revise as appropriate, a list of HPHCs, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. Section 904(d)(1) of the FD&C Act further requires that this list be published in a format that is understandable and not misleading to a lay person.

FDA has undertaken a rigorous science-based research approach to ensure that the Section 904(d) list is not misleading to lay persons. As part of this research, FDA is seeking to conduct an experimental/quantitative study (4,500 online surveys), consisting of adult and youth (aged 13-17) participants to evaluate the best way to convey information about HPHCs in tobacco products and tobacco smoke, by brand and by quantity in each brand and subbrand, in a format that is understandable and not misleading to a lay person. Participants will view sample formats and complete an online survey that will include questions regarding their understanding of the HPHC information presented to them. The purpose of the research is to gain insight on consumer comprehension of, and preferences regarding, HPHC presentations that will inform the Agency's efforts in connection with publishing the Section 904(d) list.

For this study, potential participants will be recruited by a market research firm that maintains an internet panel, and information will be collected through self-administered, online screening tests and surveys of youth aged 13-17 and adults aged 18 and older. Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be requested to complete a screening test to determine eligibility for participation in the study, estimated to take approximately 3 minutes (0.05 hour) per screening test, for a total of 260 hours for screening activities. Respondents who qualify for the study will be directed to the survey. Approximately 4,500 participants (1,500 youth and 3,000 adults) will complete the survey, estimated to take 20 minutes (0.33 hour) per survey, for a total of 1,500 hours for completion of both adult and adolescent samples. The length of time to complete the screening test and survey are based on the research firm's experience that panel members answer approximately 2.5 questions per minute. This data collection will take place one time in 2019. Thus, the total estimated burden is estimated to be 1,760 hours.

Comments on this study may be submitted electronically, through this portal at Regulations.gov, or through mail. For more information on the study and the comment submission process, please see this Federal Register notice

CDC Comment Deadline: Paul Coverdell National Acute Stroke Program Reporting System

The Centers for Disease Control and Prevention (CDC) invites the public to comment on a proposed information collection project titled Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.

Stroke is the fifth leading cause of death in the United States and results in approximately 130,000 deaths per year. Additionally, approximately 800,000 stroke events are reported each year, including approximately 250,000 recurrent strokes. However, many strokes are preventable, or patient outcomes post-stroke can be improved through coordinated care that begins at stroke onset and is delivered in a timely manner.

Stroke outcomes depend upon the rapid recognition of signs and symptoms of stroke, prompt transport to a treatment facility, and early rehabilitation. Improving outcomes requires a coordinated systems approach involving pre-hospital care, emergency department and hospital care, post-stroke rehabilitation, prevention of complications, and ongoing secondary prevention. Each care setting has unique opportunities for improving the quality of care provided and access to available professional and clinical care at the local level within a coordinated state-based system of care.

Through the Paul Coverdell National Acute Stroke Program (PCNASP), CDC has been continuously working to measure and improve acute stroke care using well-known quality improvement strategies coupled with frequent evaluation of results. PCNASP awardees are state health departments who work with participating hospitals, Emergency Medical Services (EMS) agencies, and other healthcare partners (e.g., post-stroke recovery facilities) in their jurisdictions to improve quality of care for stroke patients. State-based efforts include identifying effective stroke treatment centers, building capacity and infrastructure to ensure that stroke patients are routed to effective treatment centers in a timely manner, and improving transitions of care from the hospital to the next care setting.

During initial cooperative agreement cycles, PCNASP awardees focused on improving in-hospital quality of care (QoC) with technical assistance provided by CDC. Through lessons learned during this process and other supporting evidence in the field, it has become evident that it is also important to examine pre- and post-hospital transitions of care to link the entire continuum of stroke care when improving QoC for stroke patients.

The PCNASP's current five-year cooperative agreement started on July 1, 2015 and includes nine awardees and their selected partners (hospitals, EMS agencies, other healthcare facilities). This current funding period reflects additional emphasis on pre-hospital quality of care as well as the post-hospital transition of care setting from hospital to home or other healthcare facility. With technical assistance provided by CDC, awardees have worked on identifying and using data systems to systematically collect and report data on all three phases of the stroke care continuum and on hospital capacity.

PCNASP currently has OMB approval for the collection of pre-hospital (EMS), in-hospital, and post-hospital patient care data, as well as hospital inventory data. CDC plans to request a revision of this currently approved collection, with an extension of three years.

In-hospital patient care data continues to align with standards set by The Joint Commission (TJC) and the American Heart Association's Get With The Guidelines (GWTG) program. There are no changes to the estimated burden for the collection of in-hospital data. The average burden per response remains 30 minutes for awardees, for a total of 18 hours annually.

Data collection methods for pre- and post-hospital care data are being revised to allow for information collection through existing data systems, including GWTG and the National Emergency Medical Services Information System (NEMSIS). CDC has been working with awardees and the American Heart Association to identify areas of alignment and new collaboration to reduce the burden of this data collection. The changes also reflect the different methods that awardees use to collect this data, which depends on their state's access to data sources. These changes will ultimately reduce the overall burden of pre-hospital data collection by using existing data systems to automatically transmit data from EMS partners or hospitals to awardees. The average burden per response will vary from 30 minutes to two hours. Thus, the burden for pre-hospital data is being reduced from 96 to 60 burden hours annually.

Similarly, the burden for post-hospital data is reduced from 38 to 22 burden hours annually, because data collection will occur using GWTG or another similar mechanism, and data will be transmitted automatically to awardees. The average burden per response will vary from 30 minutes to two hours per quarter for post-hospital data collection.

Primary data collection of hospital inventory data is being collected to understand the capacity and infrastructure of the hospitals that admit and treat stroke patients. Each hospital reports inventory information to its PCNASP awardee annually. The average burden per response remains 30 minutes for hospitals. In addition, each PCNASP awardee prepares an annual aggregate hospital inventory file for transmission to CDC. The average burden of reporting hospital inventory information for each PCNASP awardee remains eight hours per response. The number of respondents is increasing from 315 to 378 hospital partners due to increased participation in PCNASP. Thus, the burden for hospital inventory data is increasing from 230 to 261 hours annually.

These requested changes will result in a net decrease in total average burden from 382 to 361 hours. All patient, hospital, and EMS provider data that is submitted to CDC by PCNASP awardees will be de-identified and occur through secure data systems. Proposed data elements and quality indicators may be updated over time to include new or revised items based on evolving recommendations and standards in the field to improve the quality of stroke care.

The OMB is particularly interested in comments that will help:

  1. Evaluate whether the proposed collection of information 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 of the proposed collection of information, including the validity of the methodology and assumptions used;
  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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
  5. Assess information collection costs.

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

HRSA Meeting: National Advisory Council on the National Health Service Corps

The Health Resources and Services Administration (HRSA) will hold a meeting of their National Advisory Council on the National Health Service Corps

The Council's responsibilities include to:

  • Serve as a forum to identify the priorities for the NHSC and bring forward and anticipate future program issues and concerns.
    • Do this through ongoing communication with program staff, professional organizations, communities and program participants.
  • Function as a sounding board for proposed policy changes by using the varying levels of expertise represented on the Council to advise on specific program areas.
  • Develop and distribute white papers and briefs that clearly state issues and/or concerns relating to the NHSC with specific recommendations for necessary policy revisions.

Members of the public may attend in person or via webcast. More information is available at this HRSA website.

CDC Nomination Deadline: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP). The SEP provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC), and the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR) regarding the concept review, scientific and technical merit of grant and cooperative agreement assistance applications, and contract proposals relating to the causes, prevention, and control of diseases, disabilities, injuries, and impairments of public health significance; exposure to hazardous substances in the environment; health promotion and education; and other related activities that promote health and well-being.

Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of National Center for Injury Prevention and Control (NCIPC), National Center for Environmental Health (NCEH) and ATSDR SEP objectives. Reviewers with expertise in research for injury and violence prevention are sought to serve on the NCIPC SEPs, for research and evaluation related, but not limited to the following program fields: Child abuse and neglect, opioid use disorder and overdose, polysubstance use and impaired driving, suicide/self-directed violence, intimate partner violence, mechanisms of injury and violence research, motor vehicle injury, older adult falls, elder maltreatment, sexual violence, substance use and abuse, traumatic brain injury, teen dating violence, and youth violence related to NCIPC research priorities.

Reviewers with expertise in the following research fields for prevention and reduction of adverse effects related to environmental hazards are sought to serve on the NCEH and ATSDR SEPs for research and evaluation related, but not limited to: Amyotrophic Lateral Sclerosis (ALS), perfluoroalkyl substances (PFAS) contamination in drinking water, environmental health, newborn screening, environmental pollutants (air/water), toxic substances most commonly found at facilities on the National Priorities List (NPL), chemical releases, natural disasters, and other potential NCEH or ATSDR research priorities.

In addition, reviewers with expertise in the following general and methodological fields are sought to serve on the NCIPC, NCEH and ATSDR SEPs: Economic evaluation, epidemiology, etiology of disease, community participatory research, implementation and translation science, intervention research, policy evaluation, research evaluation, qualitative research design, quantitative research design, statistics, and surveillance.

Members and Chairs shall be selected by the Secretary, HHS, or other official to whom the authority has been delegated, on an “as needed” basis in response to specific applications being reviewed with expertise to provide advice. Members will be selected from authorities in the various fields of prevention and control of diseases, disabilities, and injuries. Members of other chartered HHS advisory committees may serve on the panel if their expertise is required. Consideration is given to professional training and background, points of view represented, and upcoming applications to be reviewed by the committee.

All nominations should be submitted by mail. For more information regarding the nominations and the submission process, please see this Federal Register notice

FDA Comment Deadline: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information regarding reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This comment period is open to the public. Comments may be submitted electronically through this portal at Regulations.gov, or by mail. For more information regarding the content discussed above and the comment submission process, please see the full Federal Register notice.

CDC Comment Deadline: Partnership Opportunity To Identify Products for Fentanyl Exposure in Personal Protective Equipment Information Database

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), is reopening a comment opportunity from October 18, 2018 (83 FR 52834), regarding the availability of a Partnership Opportunity to Identify Products for Fentanyl Exposure in Personal Protective Equipment Information Database (PPE-Info).  

PPE-Info is a collection of national personal protective equipment (PPE) information. The database provides PPE standards setting organizations, manufacturers, suppliers, purchasers, and end users with the ability to conduct general- or advanced-criteria searches of (1) relevant standards, (2) associated product types, (3) target occupational groups, (4) basic conformity assessment specifications, and (5) additional pertinent information. PPE-Info is the only U.S. database that is maintained with comprehensive information about national PPE standards and select product information. Using this collection of information, PPE-Info currently offers the following capabilities:

  • Identification of PPE standards, searchable by PPE type, hazard category, Standards Development Organization, Standard Occupational Classification (SOC) code, standard type, and standard status, with basic- and advanced-search functions;
  • A PPE-Selection Logic Tool for potential Ebola exposure; and
  • Identification of 3rd party testing laboratories whose scope of accreditation includes testing to the identified standard.

Members of the public may submit comments online at Regulations.gov or by mail. For more information regarding the reopened comment period and the submission process, please see this Federal Register notice.