Department of Health and Human Services March 19, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Administration on Children, Youth and Families; Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Administration on Children, Youth and Families (ACYF). The reorganization has no impact on existing delegations of authority. The reorganization within the ACYF Office of the Commissioner amends the functions of the Office of Management Services and creates the Office of Budget. Within the Children's Bureau (CB), it creates the Division of Performance Measurement and Improvement. It removes the Office of Data Analysis, Research and Evaluation from the Office of the Commissioner and transfers the functions to the Division of Performance Measurement and Improvement. Within the Family and Youth Services Bureau (FYSB), it renames the Division of Adolescent Development and Support to the Division for Optimal Adolescent Development and elevates the Runaway Homeless Youth office to the Division of Runaway and Homeless Youth. It also creates the Division of Evaluation, Data and Policy. Lastly, it renames the Division of Family Violence Prevention to the Division of Family Violence Prevention and Services.
March 10 Through April 30, 2020, Public Meetings; Postponement, Cancellation, or Remote Only
The Food and Drug Administration is announcing that certain meetings involving the Center for Drug Evaluation and Research (CDER) from March 10 through April 30, 2020, are postponed, cancelled, or modified to take place remotely.
Meeting of the Advisory Committee on Organ Transplantation
The Advisory Committee on Organ Transplantation (ACOT) meeting will be held by webinar and conference call, rather than in-person as previously announced, due to unforeseen circumstances. The webinar link, conference call-in number, registration information, and meeting materials can be accessed through the registration link posted on the ACOT website at https://www.organdonor.gov/about-dot/acot/ meetings.html.
Brenda Elise Edwards: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mrs. Edwards was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mrs. Edwards was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of January 2, 2020 (30 days after receipt of the notice), Mrs. Edwards had not responded. Mrs. Edwards's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this action.
Stephen Kalinoski: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Kalinoski was convicted of a felony for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kalinoski was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Kalinoski failed to respond. Mr. Kalinoski's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Gerald Tighe: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gerald Tighe from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Tighe was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Tighe was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Tighe failed to respond. Mr. Tighe's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Development of a Shared System REMS; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 1, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
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