Health

HRSA Meeting: Advisory Commission on Childhood Vaccines

The Health Resources and Services Administration (HRSA) will hold a meeting of their Advisory Commission on Childhood Vaccines (ACCV). ACCV provides advice and recommendations to the Secretary of Health and Human Services on policy, program development, and other issues related to implementation of the National Vaccine Injury Compensation Program and concerning other matters as described under section 2119 of the Public Health Service Act.

Agenda items and meeting times are subject to change as priorities dictate. For calendar year 2020 meetings, agenda items may include, but are not limited to updates from: (1) The Division of Injury Compensation Programs; (2) Department of Justice; (3) Office of Infectious Disease and HIV/AIDS Policy (HHS); (4) Immunization Safety Office (Centers for Disease Control and Prevention); (5) National Institute of Allergy and Infectious Diseases (National Institutes of Health); and, (6) Center for Biologics, Evaluation and Research (Food and Drug Administration).

Members of the public may attend in person or via webcast. For more information on this meeting and a link to a forthcoming agenda, please see this Federal Register notice.

HRSA Meeting: Advisory Commission on Childhood Vaccines

The Health Resources and Services Administration (HRSA) will hold a meeting of their Advisory Commission on Childhood Vaccines (ACCV). ACCV provides advice and recommendations to the Secretary of Health and Human Services on policy, program development, and other issues related to implementation of the National Vaccine Injury Compensation Program and concerning other matters as described under section 2119 of the Public Health Service Act.

Agenda items and meeting times are subject to change as priorities dictate. For calendar year 2020 meetings, agenda items may include, but are not limited to updates from: (1) The Division of Injury Compensation Programs; (2) Department of Justice; (3) Office of Infectious Disease and HIV/AIDS Policy (HHS); (4) Immunization Safety Office (Centers for Disease Control and Prevention); (5) National Institute of Allergy and Infectious Diseases (National Institutes of Health); and, (6) Center for Biologics, Evaluation and Research (Food and Drug Administration).

Members of the public may attend in person or via webcast. For more information on this meeting and a link to a forthcoming agenda, please see this Federal Register notice.

NASEM Teleconference: Integrating the Science of Aging and Environmental Health Research

The National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a teleconference workshop titled "Integrating the Science of Aging and Environmental Health Research." This workshop will explore emerging research at the intersection between aging, longevity, environmental exposures, and human health. Workshop speakers will detail emerging research findings through two lenses:

  1. How environmental exposures influence or mediate aging; and
  2. How aging influences environmentally-mediated health outcomes.

Participants will also explore research opportunities and needs, enabling technologies and analytical tools, and mechanisms to anticipate and use new data to inform decisions about personal health choices, public health and medical practice, or environmental regulation.

With the global population living longer—the number of people worldwide aged 80 years or over is projected to triple by 2050—understanding the factors that influence healthy aging throughout our lifetimes is critical for protecting public health.

Scientists have long known that environment plays an important role in aging: for example, research has shown that human exposure to environmental pollutants can exacerbate age-related diseases, such as Alzheimer’s and Parkinson’s. However, many questions remain about the mechanisms through which environmental stressors influence aging, longevity, and the etiology of age-related disease. How do environmental pollutants, such as airborne particulate matter and pesticides, alter the biological processes that underlie human aging and longevity?

Members of the public may attend the teleconference with advance registration. More information is available at this NASEM website.

HRSA Meeting: Advisory Commission on Childhood Vaccines

The Health Resources and Services Administration (HRSA) will hold a meeting of their Advisory Commission on Childhood Vaccines (ACCV). ACCV provides advice and recommendations to the Secretary of Health and Human Services on policy, program development, and other issues related to implementation of the National Vaccine Injury Compensation Program and concerning other matters as described under section 2119 of the Public Health Service Act.

Agenda items and meeting times are subject to change as priorities dictate. For calendar year 2020 meetings, agenda items may include, but are not limited to updates from: (1) The Division of Injury Compensation Programs; (2) Department of Justice; (3) Office of Infectious Disease and HIV/AIDS Policy (HHS); (4) Immunization Safety Office (Centers for Disease Control and Prevention); (5) National Institute of Allergy and Infectious Diseases (National Institutes of Health); and, (6) Center for Biologics, Evaluation and Research (Food and Drug Administration).

Members of the public may attend in person or via webcast. For more information on this meeting and a link to a forthcoming agenda, please see this Federal Register notice.

HHS Webinar: Office of the National Coordinator for Health IT's Cures Act Final Rule, Q&A on Health IT for Pediatric Care and Settings

The Department of Health and Human Services (HHS), Office of the National Coordinator for Health IT (ONC), will hold a public Q&A webinar to discuss Health IT for pediatric care and settings provisions provisions within their recently released Cures Act Final Rule. The final rule will help give patients safe, secure access to their health data, spur innovation, and address industry-wide information blocking practices.

The final rule implements interoperability provisions of the bipartisan 21st Century Cures Act and promotes patient access to their health record. Putting patients in charge of their health records is a key piece of patient control in health care, and patient control is at the center of our work toward a value-based health care system.

Members of the public may attend the webinar with advance registration. More information is available at this event registration website.

FDA Comment Deadline: Patient-Focused Drug Development for Vitiligo

The Food and Drug Administration (FDA) is seeking public comments to accompany the public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment. Vitiligo is an autoimmune disease that causes the loss of skin color. The loss of color can affect skin, hair, and other areas of the body. 

The questions that will be asked of patients and patient representatives at the meeting are listed in the following section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives.

This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives. In addition to input generated through this public meeting, FDA is interested in receiving patient and patient representative input addressing these questions through written comments, which can be submitted to the public docket. When submitting comments, if you are commenting on behalf of a patient, please indicate that you are doing so and answer the following questions as much as possible from the patient's perspective.

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

HHS Webinar: Office of the National Coordinator for Health IT's Cures Act Final Rule, Q&A on Compliance Timeline

The Department of Health and Human Services (HHS), Office of the National Coordinator for Health IT (ONC), will hold a public Q&A webinar to discuss the compliance timeline of their recently released Cures Act Final Rule. The final rule will help give patients safe, secure access to their health data, spur innovation, and address industry-wide information blocking practices.

The final rule implements interoperability provisions of the bipartisan 21st Century Cures Act and promotes patient access to their health record. Putting patients in charge of their health records is a key piece of patient control in health care, and patient control is at the center of our work toward a value-based health care system.

Members of the public may attend the webinar with advance registration. More information is available at this event registration website.

FDA Comment Deadline: Patient-Focused Drug Development for Stimulant Use Disorder

The Food and Drug Administration (FDA) is hosting a public meeting titled "Patient-Focused Drug Development for Stimulant Use Disorder" and seeking comments to inform that meeting. This meeting will provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, crystal meth, or misuse of prescription stimulants such as Adderall or Ritalin. Family members, advocates, caregivers and other stakeholders are encouraged to participate and share their views on the condition. In particular, FDA is interested in hearing perspectives on the:

  • Health effects and daily impacts of their condition
  • Impact (if any) of opioid and polysubstance use on their condition
  • Treatment goals
  • Decision factors considered when seeking out or selecting a treatment

Members of the public may submit comments online at Regulations.gov, or by mail. For more information, please see this FDA meeting announcement or this Federal Register notice.

EPA Teleconference: Science Advisory Board

The Environmental Protection Agency (EPA) will hold a teleconference meeting of its Science Advisory Board (SAB). The SAB will review their workgroup reports for the following proposed rules: (1) Oil and Natural Gas Sector: Emission Standards for New, Reconstructed and Modified Sources Review and (2) National Primary Drinking Water Regulations: Proposed Lead and Copper Rule Revisions.

At the March 30, 2020 meeting of the SAB, the SAB reviewed  the scientific and technical basis of these rules and decided to provide advice and comments to EPA on the two proposed rules.

The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the scientific and technical basis for agency positions and regulations. Under the SAB's authorizing statute, the SAB “may make available to the Administrator, within the time specified by the Administrator, its advice and comments on the adequacy of the scientific and technical basis” of proposed rules.

Members of the public may attend the teleconference. More information is available at this Federal Register notice and this EPA website.

HHS Webinar: Office of the National Coordinator for Health IT's Cures Act Final Rule, Q&A on Application Programming Interfaces

The Department of Health and Human Services (HHS), Office of the National Coordinator for Health IT (ONC), will hold a public Q&A webinar to discuss application programming interfaces provisions within their recently released Cures Act Final Rule. The final rule will help give patients safe, secure access to their health data, spur innovation, and address industry-wide information blocking practices.

The final rule implements interoperability provisions of the bipartisan 21st Century Cures Act and promotes patient access to their health record. Putting patients in charge of their health records is a key piece of patient control in health care, and patient control is at the center of our work toward a value-based health care system.

Members of the public may attend the webinar with advance registration. More information is available at this event registration website.

CDC Comment Deadline: Developmental Studies to Improve the National Health Care Surveys

The Centers for Disease Control and Prevention (CDC) seeks public comment on a proposed information collection project titled Developmental Studies to Improve the National Health Care Surveys. The purpose of this generic information collection request is to conduct developmental studies on survey design and data collection activities that are part of the National Health Care Surveys (NHCS).

On April 3, 2020 (85 FR 18979), CDC extended the comment deadline from March 23, 2020, to May 3, 2020.

Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes the Secretary of Health and Human Services (DHHS), acting through the Division of Health Care Statistics (DHCS) within NCHS, shall collect statistics on the extent and nature of illness and disability of the population of the United States.

The DHCS conducts the National Health Care Surveys, a family of nationally representative surveys of encounters and health care providers in inpatient, ambulatory, and long-term care settings. This information collection request (ICR) is for the extension of a generic clearance to conduct developmental studies to improve this family of surveys. This three-year clearance period will include studies to evaluate and improve upon existing survey design and operations, as well as to examine the feasibility of, and address challenges that may arise with, future expansions of the National Health Care Surveys.

Specifically, this request covers developmental research with the following aims: (1) To explore ways to refine and improve upon existing survey designs and procedures; and (2) to explore and evaluate proposed survey designs and alternative approaches to data collection. The goal of these research studies is to further enhance DHCS existing and future data collection protocols to increase research capacity and improve health care data quality for the purpose of monitoring public health and well-being at the national, state and local levels, thereby informing the health policy decision-making process. The information collected through this generic ICR will not be used to make generalizable statements about the population of interest or to inform public policy; however, methodological findings may be reported.

This generic ICR would include studies conducted in person, via the telephone or internet, and by postal or electronic mail. Methods covered would include qualitative (e.g., usability testing, focus groups, ethnographic studies, and respondent debriefing questionnaires) and/or quantitative (e.g., pilot tests, pre-tests and split sample experiments) research methodologies. Examples of studies to improve existing survey designs and procedures may include evaluation of incentive approaches to improve recruitment and increase participation rates; testing of new survey items to obtain additional data on providers, patients, and their encounters while minimizing misinterpretation and human error in data collection; testing data collection in panel surveys; triangulating and validating survey responses from multiple data sources; assessment of the feasibility of data retrieval; and development of protocols that will locate, identify, and collect accurate survey data in the least labor-intensive and burdensome manner at the sampled practice site.

To explore and evaluate proposed survey designs and alternative approaches to collecting data, especially with the nationwide adoption of electronic health records, studies may expand the evaluation of data extraction of electronic health records and submission via continuity of care documentation to small/mid-size/large medical providers and hospital networks, managed care health plans, prison-hospitals, and other inpatient, ambulatory, and long-term care settings that are currently either in-scope or out-of-scope of the National Health Care Surveys. Research on feasibility, data quality and respondent burden also may be carried out in the context of developing new surveys of health care providers and establishments that are currently out-of-scope of the National Health Care Surveys. Specific motivations for conducting developmental studies include: (1) Within the National Ambulatory Medical Care Survey (NAMCS), new clinical groups may be expanded to include dentists, psychologists, podiatrists, chiropractors, optometrists), mid-level providers (e.g., physician assistants, advanced practice nurses, nurse practitioners, certified nurse midwives) and allied-health professionals (e.g., certified nursing aides, medical assistants, radiology technicians, laboratory technicians, pharmacists, dieticians/nutritionists). Current sampling frames such as those from the American Medical Association may be obtained and studied, as well as frames that are not currently in use by NAMCS, such as state and organizational listings of other licensed providers. (2) Within the National Study of Long-Term Care Providers, additional new frames may be sought and evaluated and data items from home care agencies, long-term care hospitals, and facilities exclusively serving individuals with intellectual/developmental disability may be tested. Similarly, data may be obtained from lists compiled by states and other organizations. Data about the facilities as well as residents and their visits will be investigated. (3) In the inpatient and outpatient care settings, the National Hospital Care Survey (NHCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) may investigate the addition of facility and patient information especially as it relates to insurance and electronic medical records.

Projects under development or in the planning stages include two projects related to opioid use: One that will investigate adding questions to NAMCS on physician understanding of guidelines for opioid use and one that will test the validation of an algorithm for identifying opioid-involved hospital visits. Another study will develop a Hospital-Based Victim Services Frame.

The National Health Care Surveys collect critical, accurate data that are used to produce reliable national estimates—and in recent years (when budget allows), state-level estimates—of clinical services and of the providers who delivered those services in inpatient, ambulatory, and long-term care settings. The data from these surveys are used by providers, policy makers and researchers to address important topics of interest, including the quality and disparities of care among populations, epidemiology of medical conditions, diffusion of technologies, effects of policies and practice guidelines, and changes in health care over time. Research studies need to be conducted to improve existing and proposed survey design and procedures of the National Health Care Surveys, as well as to evaluate alternative data collection approaches particularly due to the expansion of electronic health record use, and to develop new sample frames of currently out-of-scope providers and settings of care.

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

DOS Comment Deadline: The Use of Digital Sequence Information of Genetic Resources

The Department of State (DOS) is seeking comments from the public, academia, industry, and other stakeholders to inform US Government policy and international engagement for an ongoing process under the Convention on Biological Diversity (CBD) concerning the use of “digital sequence information (DSI) on genetic resources,” also known as genetic sequence data (GSD).

The Secretariat of the CBD released three studies on “Digital Sequence Information on Genetic Resources” that examine scope, present use, traceability, access, and current benefit-sharing schemes. These studies were commissioned to inform decisions by the Parties to the CBD and the Nagoya Protocol at the 2020 Conference of Parties to the CBD and the Conference of Parties serving as the Meeting of the Parties to the Nagoya Protocol.

DOS seeks comments on the CBD studies cited above, and also request information on practices regarding the collection, management and use of DSI or GSD; and regarding experiences with access and benefit-sharing approaches or requirements related to DSI/GSD. DOS welcomes specific examples of the actual, and potential, impacts that could occur if tracking and benefit sharing for the utilization of DSI were required by domestic legislation, and encouraged under the Nagoya Protocol or other international ABS instruments, such as the International Treaty for Plant Genetic Resources for Food and Agriculture and the Pandemic Influenza Preparedness Framework. DOS is, likewise, interested in effects on research collaborations, international sample sharing, academic and commercial research, pandemic and epidemic preparedness and response, food security, and other aspects. DOS would also welcome views on what organizations can do to effectively protect the scientific process in the context of national-level ABS approaches potentially requiring tracking and benefit sharing for the utilization of DSI/GSD.

DOS also welcomes examples of:

  1. Issues and/or examples related to the items described above or other items that could affect the scientific process;
  2. Monetary or non-monetary benefits that are facilitated by international sharing of DSI or GSD;
  3. Non-ABS challenges and barriers to sharing DSI or GSD that have significant implications for global research efforts that might merit additional attention or analysis.

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