Department of Health and Human Services February 22, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming joint public advisory committee meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices. The Committee will also provide advice and recommendations to the FDA on research programs in the Office of Blood Research and Review. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Determination of Regulatory Review Period for Purposes of Patent Extension; ESBRIET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ESBRIET 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LYMPHOSEEK
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYMPHOSEEK 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; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 reporting and recordkeeping requirements of our regulations concerning new animal drugs for investigational use.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Medical Device Labeling Regulations.
Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 38 new drug applications (NDAs) and 43 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Determination of Regulatory Review Period for Purposes of Patent Extension; OFEV
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OFEV 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; Proposed Collection; Comment Request; Medical Device Recall Authority
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection related to Medical Device Recall Authority.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on administrative practices and procedures; formal evidentiary public hearing.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System 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.
Announcement of Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of $15,000,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 450 beds in an expedited manner.
Predictive Models for Acute Oral Systemic Toxicity; Notice of Meeting; Registration Information
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces the workshop ``Predictive Models for Acute Oral System Toxicity.'' Workshop attendees will discuss development of in silico models for acute oral system toxicity and the next steps to encourage appropriate use of these models in regulatory contexts. Interested persons may attend in person or view the meeting remotely by webcast. Registration is requested to attend in person and required to view the webcast. Information about the workshop and registration links are available at https://ntp.niehs.nih.gov/go/atwksp- 2018.
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