Department of Health and Human Services February 8, 2019 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services (HHS) announces the next two meetings of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. These meetings will be held online via webinar and are open to the public. The Committee will discuss the nation's proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will deliberate recommendations regarding the proposed Healthy People 2030 objectives, activities designed to implement the disease prevention and health promotion goals and objectives for the nation, and graphics for communicating key Healthy People 2030 elements. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held of the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public via teleconference; a public comment session will be held during the meeting.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Public Warning and Notification of Recalls.'' The guidance establishes guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of recalls under federal regulations. The intent of the guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled. The guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), at the U.S. Department of Health and Human Services (HHS), proposes data collection activities as part of the Youth Empowerment IDEAS study. The goal of this project is to collect data that will inform educational topics and strategies for an optimal-health sexual risk avoidance (SRA) approach to reducing teen pregnancy and improving youth well-being. The project will identify strategies, skills, messages, and themes that are most likely to resonate with youth. The project will inform hypotheses on how to increase the effectiveness of sex education approaches so that more youth avoid the risks associated with teen sex, and teen pregnancy rates are reduced. To support these efforts, we seek OMB approval to collect survey information from a nationally-representative sample of youth and young adults age 14-24 and a nationally-representative sample of parents of teens ages 14-18.

The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for vacancies which become available on November 1, 2019, for the 4-year term of November 1, 2019 to October 31, 2023.