Department of Health and Human Services July 10, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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 titled, Improving Fetal Alcohol Spectrum Disorders (FASD) Prevention and Practice through Practice and Implementation Centers and National Partnerships (PICs). The purpose of FASD PICs is to collect training evaluation data from healthcare practitioners and staff in health systems where FASD-related practice and systems changes are implemented, and from grantees of Practice and Implementation Centers and national partner organizations related to prevention, identification, and treatment of fetal alcohol spectrum disorders (FASDs).
The Use of an Alternate Name for Potassium Chloride in Food Labeling; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry entitled ``The Use of an Alternate Name for Potassium Chloride in Food Labeling,'' which was announced in the Federal Register of May 20, 2019. In the notification, FDA requested comments on the use of ``potassium chloride salt'' as an alternate common or usual name for potassium chloride. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA's review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
This document corrects the information provided for [Document Identifier: CMS-10328] titled ``Medicare Self-Referral Disclosure Protocol.''
Mesothelioma Registry Feasibility; Request for Information; Extension of Comment Period
On April 8, 2019, the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), opened a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the United States, as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment. Comments were to be received by July 8, 2019. NIOSH is extending the comment period to close on August 7, 2019, to allow stakeholders and other interested parties sufficient time to respond.
Technical Report: The NIOSH Occupational Exposure Banding Process for Chemical Risk Management
NIOSH announces the availability of Technical Report: The NIOSH Occupational Exposure Banding Process for Chemical Risk Management.
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