Department of Health and Human Services August 30, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Agency Emergency Information Collection Clearance Request for Public Comment
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Safety and Performance Based Pathway Device-Specific Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathwayspecifically, ``Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff'' and ``Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidance documents are not final nor are they in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Center on Law and Elder Rights-Resource Support and User Satisfaction; OMB #0985-0060
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the National Center on Law and Elder Rights- Resource Support and user Satisfaction data collection used by ACL to provide aging, disability, and related legal professionals with training and complex case consultations and support for demonstration projects regarding contractually identified priority legal topics.
Agency Information Collection Activities; Proposed Collection; Comment Request; Process Evaluation of the Aging Network and Its Return on Investment; OMB #0985-New
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a revision to the information collection requirements related to the Process Evaluation of the Aging Network and its Return on Investment.
Electronic Common Technical Document; Data Standards; Specifications for Electronic Common Technical Document Validation Criteria
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that FDA will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria.
Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10 Milligrams
The Food and Drug Administration (FDA) is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge). Breckenridge requested withdrawal of this application and has waived its opportunity for a hearing.
Announcement of the Advisory Panel on Outreach and Education (APOE) September 15, 2021 Virtual Meeting
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
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