Department of Health and Human Services October 28, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Recommendations for Hepatitis C Screening Among Adults-2019; Request for Comment
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the opening of a public docket to obtain public comment on proposed new recommendations for hepatitis C virus (HCV) infection screening for adults, including pregnant women. The new recommendations are intended for U.S. healthcare providers and will include supporting scientific evidence of the effectiveness and economic value of screening to diagnose current HCV infection among adults and pregnant women in the United States.
Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier
This final rule rescinds the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. This final rule also removes the definitions for the ``Controlling health plan'' (CHP) and ``Subhealth plan'' (SHP).
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.
Watson Laboratories, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.
Prospective Grant of an Exclusive Patent License: The Development of an Anti-GPC3 Radionuclide Immunoconjugate for the Treatment of GPC3-Expressing Cancers
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Xsto BioSciences, Inc. (Xsto), located in San Carlos, California.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid 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 self-fitting air-conduction hearing aid's 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.
InvaGen Pharmaceuticals, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Trandolapril Tablets; Opportunity for a Hearing
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research. The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the National Center for Toxicological Research. At least one portion of the meeting will be closed to the public.
Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size
The Food and Drug Administration (FDA or we) is issuing this final rule to revise the type size labeling requirements when front-of- pack (FOP) labeling is used to meet the calorie declaration requirements for articles of food sold from glass-front vending machines. We are taking this action to reduce the regulatory burden on industry, increase flexibility for the labeling of certain articles of food sold from glass-front vending machines, and ensure that consumers continue to have visible FOP calorie information for articles of food at the point of purchase.
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