Department of Health and Human Services June 30, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Submission for OMB Review; Head Start Program Performance Standards (OMB #0970-0148)
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collection requirements under the Head Start Program Performance Standards (OMB #0970-0148). There are no changes to the information collection.
Determination of Regulatory Review Period for Purposes of Patent Extension; OXBRYTA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OXBRYTA 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; BALVERSA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BALVERSA 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; AXONICS SACRAL NEUROMODULATION SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AXONICS SACRAL NEUROMODULATION SYSTEM 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; FETROJA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FETROJA 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; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products
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 postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
The Food and Drug Administration (FDA) is correcting a notice announcing receipt of a petition requesting exemption from the premarket notification requirements. The document was published with an incorrect docket number. This document corrects that error.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2021.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA, Agency, 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.
Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG), proposing that the color additive regulations be amended to provide for the safe use of gardenia blue powder in various foods.
Determination of Regulatory Review Period for Purposes of Patent Extension; POLIVY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POLIVY 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 patents which claims that human biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
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 information collection associated with FDA's MedWatch adverse experience reporting (AER) program.
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. This SACATM meeting will be a virtual meeting only and available to the public for remote viewing. Registration is required to access the virtual meeting and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ 32822.
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