Department of Health and Human Services July 25, 2019 – Federal Register Recent Federal Regulation Documents
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Modified Risk Tobacco Product Applications for VLNTM
The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for VLNTM King and VLNTM Menthol King, combusted, filtered cigarettes, submitted by 22nd Century Group, Inc.
21st Century Cures: Announcing the Establishment of the BEST Resource Taxonomy; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to receive comments from interested parties (including academic institutions, regulated industry, and patient groups) on the Agency's publication of a glossary of terms which is part of the BEST (Biomarkers, EndpointS, and other Tools) Resource Taxonomy. FDA has developed a web page that describes the BEST Resource Taxonomy and links out to the official National Library of Medicine web page for the BEST glossary of terms. Comments on the BEST Resource Taxonomy will help FDA enhance its utility and may assist FDA in developing future versions of this resource and identifying best methods for conveying information about biomarkers, endpoints, and other drug development tools to the general public.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Monitoring and reporting for the Overdose Data to Action Cooperative Agreement.'' This new data collection effort is to collect information from grantees funded under the Overdose Data to Action (CDC-RFA-CE19-1904) funding opportunity. The information collected will be used to monitor the progress on set performance activities, and progress towards stated grant objectives.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2020
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2019, and will remain in effect through September 30, 2020.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of the DP18-1801 Healthy Schools Program. This evaluation will examine three selected DP18-1801 Healthy Schools Program (DP18-1801) grantees to provide a comprehensive picture of implementation activities, context, successes and challenges, key partnerships, lessons learned, and impact on program outcomes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
The Food and Drug Administration (FDA or we) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications
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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