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.

FDA Comment Deadline: Modernizing the Food and Drug Administration's Data Strategy

The Food and Drug Administration (FDA) is seeking public comments to accompany the following public meeting (which was rescheduled to June 30, 2020) entitled “Modernizing FDA's Data Strategy.” The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.

On April 29, 2020 (85 FR 23832), FDA extended the comment deadline from April 30, 2020, to July 30, 2020.

FDA is gathering scientific and technical information to help inform its development of an Agency-wide, strategic approach to modernizing its data strategy, including data quality, data stewardship, data exchange, and data analytics. The Agency has determined that a public meeting and an open public docket will encourage public input and engagement in this important topic.

In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data, and analytics—to advance FDA's public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is responsive to novel technologies and rapidly increasing workloads.

To achieve these goals, FDA intends to develop a modernized Agency-wide, strategic approach not only to technology, but to data itself. Data is at the heart of FDA's work as a science-based Agency, and we anticipate ongoing, rapid increases in the amount and complexity of the data that informs FDA's regulatory decision-making process and how we advance our public health mission.

The Agency welcomes any relevant scientific and technical information related to FDA's consideration of the following topics:

  1. Standards and policy, including:
    1. How can FDA best use policy and common data standards to help ensure the effective and efficient use of data assets?
    2. What are the consequences/issues as we move from “static point-in-time data sets” to updating digital data streams for analyses?
    3. As we move into increased sharing and integrated data sets, how might FDA manage data in a way that avoids unnecessary duplication?
  2. Data security, privacy, and management including:
    1. How can FDA modernize its data strategy to continue ensuring privacy and security of data?
    2. What should FDA do to promote the management and organization of data assets across the Agency, as the amount and complexity of data (e.g., in regulatory submissions to FDA) is rapidly increasing?
  3. Data strategies and data sharing, including:
    1. How can FDA's data strategy facilitate broader goals of integration and interoperability of health care data, and scientific data/virtual patient data generated using scientific models?
    2. How can FDA design its data strategy to reflect a global marketplace and promote clarity to data providers like regulated industry and other stakeholders?
    3. How can FDA design its data strategy and policy development to facilitate appropriate data access, data sharing within the Agency and via data sharing agreements, as well as the appropriate reuse and repurposing of data to advance Agency regulatory science priorities?
    4. For stakeholders, including regulated industry, that submit data to FDA, how can FDA enhance the efficiency of the preparation and submission of data to FDA?

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

CDC Comment Deadline: Developing a Workplace Supported Recovery Program: A Strategy for Assisting Workers and Employers With the Nation's Opioid and Substance Use Disorder Epidemics

The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces an opportunity for the public to provide input on a NIOSH plan to develop resources and conduct research on the topic of Workplace Supported Recovery. Workplace Supported Recovery programs (WSRPs) assist workers and employers facing the nation's crisis related to the misuse of opioids and other drugs, and related substance use disorders.

On April 13, 2020 (85 FR 20505), CDC extended the comment deadline from April 27, 2020, to July 27, 2020.

The United States is in the midst of a drug overdose epidemic. More than 70,000 Americans died of drug overdoses in 2017, more than any year on record. Two-thirds of drug overdoses involved an opioid. About 44 percent of adults with a substance use disorder are employed full-time and an additional 10 percent are employed part-time. A 2017 National Safety Council survey found that 70 percent of employers reported experiencing the negative effects of prescription drug misuse at the organizational level, noting recruitment issues related to positive drug tests, absenteeism, injuries, and overdoses within the workplace. Misuse of any drug, including prescription drugs, may impact the ability of a person to function safely in the workplace and may also hinder return to work following an injury or illness, negatively affecting their livelihood.

The effects of substance use and misuse are not isolated to work or home environments, and the potential for developing a substance use disorder may be preceded by injuries that happen in the workplace, with the consequences affecting both an individual's working life as well as their home life. Regardless of the circumstances that may have led to substance misuse, employment is a key goal among individuals in recovery. Work can also provide a sense of purpose and the income needed to participate in community life, and the workplace offers social networks that provide support and friendship. By using Total Worker Health® principles, NIOSH is developing solutions to help workers and employers facing the drug crisis in their communities. To that end, NIOSH is interested in developing resources and conducting research on the topic of Workplace Supported Recovery.

In a Workplace Supported Recovery program (WSRP), employers use evidence-based policies and programs to reduce the risk factors associated with initiating substance misuse and the progression to a substance use disorder and take steps to assist workers in recovery in staying at work or returning to work. WSRP efforts could potentially include, but would not necessarily be limited to, the following:

  • Preventing work-related injuries and illnesses;
  • Promoting the use of alternatives to opioids for pain relief associated with a workplace injury or illness;
  • Preventing initiation of misuse;
  • Developing return-to-work plans for employees after medical treatment;
  • Supporting second chance employment, a process that allows for workers in recovery to rejoin the workforce after a job loss related to drug misuse;
  • Providing accommodations, including access to medication-based or medication-assisted treatment (MAT) together with individual counseling;
  • Offering peer support groups; and
  • Peer coaching.

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