Department of Health and Human Services October 7, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Endocrinologic and Metabolic 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 Endocrinologic and Metabolic 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.
Meeting of the Advisory Committee on Interdisciplinary, Community Based Linkages
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community Based Linkages (ACICBL) will hold public meetings for the 2020 calendar year (CY). Information about ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records
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.
Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, August 20, 2019. The document announced a ``Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1.'' The document was published with the incorrect contact name, phone number, and email address in the FOR FURTHER INFORMATION CONTACT section. This document corrects those errors.
Submission for OMB Review; Trafficking Victim Assistance Program Data Collection (OMB #0970-0467)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to reinstate a previously approved information collection with revisions to information collected on clients enrolled in the Trafficking Victim Assistance Grant Program.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2020
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2020. The calendar year 2020 AIC threshold amounts are $170 for ALJ hearings and $1,670 for judicial review.
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter 14Recall Plan.''
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
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