Department of Health and Human Services December 14, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2024, expiration date.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Submission for OMB Review; 30-Day Comment Request; Regular Clearance for Autism Spectrum Disorder (ASD) Research Portfolio Analysis, (NIMH)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Targeted Mechanism of Action Presentations in Prescription Drug Promotion
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Targeted Mechanism of Action Presentations in Prescription Drug Promotion'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
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), 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher.
David J. Kempema: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David J. Kempema for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kempema was convicted of one felony count under Federal law which FDA has determined is for conduct relating to the importation into the United States of a drug or controlled substance. The factual basis supporting Mr. Kempema's conviction is described in further detail below. Mr. Kempema was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 14, 2022 (30 days after receipt of the notice), Mr. Kempema had not responded. Mr. Kempema's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of December 14, 2022, for the final rule that appeared in the Federal Register of September 15, 2022. The direct final rule revises the ``small number of animals'' definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. This document confirms the effective date of the direct final rule.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
