Department of Health and Human Services February 5, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping
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.
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 ``Gonococcal Isolate Surveillance Project (GISP)''. The purpose of GISP is to monitor trends in antimicrobial resistance in N. gonorrhoeae strains in the United States in order to establish a scientific basis for the selection of gonococcal therapies and to allow proactive changes to treatment guidelines before widespread resistance and failures of treatment occur.
Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
This notice announces the 2018 meetings of the Physician- Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') which will be held in Washington, DC. This meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders
The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Determination of Regulatory Review Period for Purposes of Patent Extension; VIBERZI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIBERZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability; Correction
The Food and Drug Administration is correcting a notice entitled ``Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of January 23, 2018. The document announced the availability of a draft guidance for industry #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' The document was published with the incorrect docket number. This document corrects that error.
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