Department of Health and Human Services January 31, 2018 – Federal Register Recent Federal Regulation Documents
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Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Determination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LENVIMA 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.
Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.
Final National Occupational Research Agenda for Manufacturing
NIOSH announces the availability of the final National Occupational Research Agenda for Manufacturing
Determination of Regulatory Review Period for Purposes of Patent Extension; DUAVEE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUAVEE 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Application 207501
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207501 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 as approved under NDA 207501.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN XT TRANSCATHETER HEART VALVE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN XT TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KEYTRUDA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOBI-C CERVICAL DISC PROSTHESIS 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 medical device.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
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 Information Collection for U.S. Tuberculosis Follow-up Worksheet for Newly-Arrived Persons with Overseas Tuberculosis ClassificationsCDC is proposing a TB follow-up worksheet to capture domestic TB examination data for persons arriving to the U.S. with overseas TB classifications.
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