Department of Health and Human Services February 14, 2024 – Federal Register Recent Federal Regulation Documents

ACL is issuing this final rule to modernize the implementing regulations of the Older Americans Act of 1965 (``the Act'' or OAA). These changes advance the policy goals of the Act as articulated by Congress, including equity in service delivery, accountability for funds expended, and clarity of administration for ACL and its grantees. This final rule ultimately facilitates improved service delivery and enhanced benefits for OAA participants, particularly those in greatest economic need and greatest social need consistent with the statute.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYTROFA 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 biological product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for the PORTICO TRANSCATHETER AORTIC VALVE IMPLANT 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 medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REACTIV8 SYSTEM 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 medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SIMPLIFY CERVICAL ARTIFICIAL DISC 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 claim that medical device.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ross Lucien 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. Lucien was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Lucien's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lucien 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 December 20, 2023 (30 days after receipt of the notice), Mr. Lucien had not responded. Mr. Lucien's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed collection. The request consists of several forms that will allow the Unaccompanied Children (UC) Program to implement a new set of hearings (``Risk Determination Hearings''), which will serve as due process protections for children in ORR care.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Kalpen D. Patel from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Patel was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Mr. Patel was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Patel responded to the notice by submitting correspondence to FDA, but he did not request a hearing. Mr. Patel's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORGAN CARE SYSTEM LIVER (OCS LIVER) 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.