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

Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities
Document Number: 2019-01698
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2019-01696
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
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.
Request for Information (RFI): Improving Efficiency, Effectiveness, Coordination, and Accountability of HIV and Viral Hepatitis Prevention, Care, and Treatment Programs
Document Number: 2019-01695
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
Both the National HIV/AIDS Strategy (NHAS) and the National Viral Hepatitis Action Plan (NVHAP) expire in 2020. The Department of Health and Human Services (HHS) Office of HIV/AIDS and Infectious Disease Policy (OHAIDP), in collaboration with federal partners, is leading development of the next iterations of these two separate and distinct national strategies. To help inform the next iterations of the NHAS and NVHAP, HHS seeks input from external stakeholders for improving efficiency, effectiveness, coordination, and accountability of HIV and viral hepatitis prevention, care, treatment, and cure policies, services, and programs.
Meeting of the National Vaccine Advisory Committee
Document Number: 2019-01694
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
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.
Proposed Information Collection Activity; Comment Request Proposed Projects: Domestic Victims of Human Trafficking Program
Document Number: 2019-01691
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meetings
Document Number: 2019-01681
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2019-01680
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meetings
Document Number: 2019-01679
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-01678
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2019-01677
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-01676
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-01675
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Meeting
Document Number: 2019-01674
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meeting
Document Number: 2019-01673
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meetings
Document Number: 2019-01672
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Public Warning and Notification of Recalls; Guidance for Industry and FDA Staff; Availability
Document Number: 2019-01603
Type: Notice
Date: 2019-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: 2019-01597
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
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.
Agency Information Collection Request: 30-Day Public Comment Request
Document Number: 2019-01596
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
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.
Agency Information Collection Request: 30-Day Public Comment Request
Document Number: 2019-01595
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services
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.
National Library of Medicine; Notice of Closed Meetings
Document Number: 2019-01586
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2019-01585
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2019-01584
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2019-01583
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-01582
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-01581
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-01580
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-01579
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2019-01578
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-01577
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2019-01576
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Meeting
Document Number: 2019-01575
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Youth Empowerment Information, Data Collection, and Exploration on Avoidance of Sex (IDEAS) (New Collection)
Document Number: 2019-01566
Type: Notice
Date: 2019-02-08
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Pilot Project Program Under the Drug Supply Chain Security Act; Program Announcement
Document Number: 2019-01561
Type: Notice
Date: 2019-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the start of the Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program is voluntary and will be open to pharmaceutical distribution supply chain members to apply to the program. FDA will ensure that participation reflects the diversity of the supply chain, including large and small entities from all industry sectors. This notice establishes the DSCSA Pilot Project Program and includes instructions for submitting a request to participate and expectations for program participants.
Request for Nomination From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees
Document Number: 2019-01555
Type: Notice
Date: 2019-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products
Document Number: 2019-01529
Type: Notice
Date: 2019-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.