Department of Health and Human Services February 15, 2018 – Federal Register Recent Federal Regulation Documents

Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03174
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZONTIVITY
Document Number: 2018-03170
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZONTIVITY 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; BRIDION
Document Number: 2018-03137
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIDION 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; AVEED
Document Number: 2018-03136
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AVEED 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.
Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
Document Number: 2018-03135
Type: Rule
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use 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 non-absorbable, hemostatic gauze for temporary internal use'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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 205858
Document Number: 2018-03134
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYDELIG based on new drug application (NDA) 205858 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 and that NDA.
Regulatory Classification of Pharmaceutical Co-Crystals; Guidance for Industry; Availability
Document Number: 2018-03133
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This guidance finalizes the draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals'' published in August 2016.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADDYI
Document Number: 2018-03130
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADDYI 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; FETZIMA
Document Number: 2018-03129
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FETZIMA 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-03128
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORKAMBI
Document Number: 2018-03127
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORKAMBI 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; SYLVANT
Document Number: 2018-03126
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SYLVANT 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 biological product.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-03110
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-03109
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03108
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2018-03106
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-03105
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, Administration for Children and Families
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