Department of Health and Human Services February 2019 – Federal Register Recent Federal Regulation Documents
Results 351 - 400 of 650
Meeting of the National Vaccine Advisory Committee
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.
Public Warning and Notification of Recalls; Guidance for Industry and FDA Staff; Availability
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
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
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
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.
Proposed Information Collection Activity; Youth Empowerment Information, Data Collection, and Exploration on Avoidance of Sex (IDEAS) (New Collection)
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
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
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
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.
Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.'' This guidance reflects the Agency's current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive- compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films. This guidance finalizes the draft guidance entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment'' issued in April 2018.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Cover Sheet
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.
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