Department of Health and Human Services July 17, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Platform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry "Platform Technology Designation Program for Drug Development" that appeared in the Federal Register of May 29, 2024. In the notice of availability for the draft guidance, FDA requested comments on the proposed collection of information. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)
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 the supplemental application (Supplement-5) for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024, meets the criteria for redeeming a priority review voucher.
Proposed Information Collection Activity; Child Support Portal Registration (Office of Management and Budget #: 0970-0370)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) approve the "Child Support Portal Registration," with minor revisions, for an additional three years. The OCSS Child Support Portal ("Portal") contains applications to help state child support agencies administer their programs. Authorized Portal users must register with OCSS to access Portal applications and provide OCSS with certain Portal application preferences. The current OMB approval expires on February 28, 2025.
Agency Information Collection Revision 30-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 reinstatement for public comment.
Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and have earned an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current information needed to disburse the payment. This advisory provides information to QPs on how to update their Medicare billing information so that CMS can disburse APM Incentive Payments.
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