Department of Health and Human Services September 11, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib)
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that OPZELURA (ruxolitinib), approved September 21, 2021, meets the criteria for redeeming a priority review voucher.
Determination of Regulatory Review Period for Purposes of Patent Extension; TECHNEGAS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECHNEGAS 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; VOQUEZNA TRIPLE PAK-New Drug Application 215152
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOQUEZNA TRIPLE PAKnew drug application (NDA) 215152 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; VOQUEZNA DUAL PAK-New Drug Application 215153
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOQUEZNA DUAL PAKnew drug application (NDA) 215153 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.
Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
The Food and Drug Administration (FDA, Agency, or we) is classifying the whole exome sequencing constituent device 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 whole exome sequencing constituent device'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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZTALMY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZTALMY 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.
Notice of Funding Extension for Rural Behavioral Health Workforce Centers-Northern Border Region
HRSA will provide a performance period extension with supplemental funds to three fiscal year (FY) 21 award recipients with a period of performance ending on August 31, 2025. The supplemental funding will extend their current period of performance by 12 months to align with the FY 2022 award to an additional recipient, which has a period of performance from September 1, 2022, to August 31, 2025.
Notice of Supplemental Award; Autism Longitudinal Data Project
HRSA is announcing supplemental award funds through the Patient-Centered Outcomes Research Trust Fund to the current HRSA award recipient to expand activities under the Autism Longitudinal Data Project (ALDP). The funding will be used to create and share a combined de-identified dataset from the Boston Birth Cohort (BBC), Massachusetts Pregnancy to Early Life Longitudinal Data System, and Agency for Healthcare Research and Quality Social Determinants of Health database.
Submission for Office of Management and Budget Review; Children's Bureau Regional Partnership Grants Final Report Outline (NEW)
The Children's Bureau (CB) is requesting a new collection effort for the Regional Partnership Grant (RPG) program, for the use of a Regional Partnership Grants Final Report Outline to collect cumulative project information. Information from the report will aid grant recipients in meeting grant management requirements as well as to support CB in gathering information on the projects to better monitor the project's use of funds, implementation successes and challenges and program and service effectiveness.
World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders
This interim final rule updates existing regulations governing the WTC Health Program, which provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. This rulemaking expands existing eligibility criteria for enrollment of new Pentagon and Shanksville responders, caps those new members at 500, and makes various conforming amendments to the WTC Health Program regulations to align with statutory changes.
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.
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