Department of Health and Human Services August 25, 2020 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Case Plan Requirement, Title IV-E of the Social Security Act
The Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collectionCase Plan Requirement, Title IV-E of the Social Security Act, (OMB #0970-0428, expiration 3/31/2021). ACF is reporting a change to the information collectionthe burden estimates in the previously-approved request were based on the children in foster care as the respondent instead of the agency completing the case plan. The burden estimates, therefore, are adjusted accordingly.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), 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 award of the priority review voucher. FDA has determined that EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions-Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
The Food and Drug Administration (FDA) 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.
Meeting of the Advisory Committee on Infant Mortality
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.
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