Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

Pursuant to section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's Notices of Funding Opportunities (NOFOs) in fiscal year (FY) 2024. Changes to FY NOFOs will be based on the previously published programs: Environmental Regulatory Enhancement (ERE), HHS-2021-ACF-ANA-NR-1907; Native American Language Preservation and Maintenance-Esther Martinez Immersion (EMI), HHS-2021-ACF-ANA-NB-1958; Native American Language Preservation and Maintenance (P&M), HHS-2021-ACF-ANA-NL-1924; Social and Economic Development Strategies (SEDS), HHS-2021-ACF-ANA-NA-1906; Social and Economic Development Strategies-Alaska (SEDS-AK), HHS-2021-ACF-ANA-NK- 1902.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Charging for Investigational Drugs Under an IND: Questions and Answers.'' This guidance addresses frequently asked questions related to the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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.

HRSA published documents in the Federal Register of October 24, 2023, and January 5, 2024, concerning updates to the Bright Futures Periodicity Schedule as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents. These documents contained minor errors related to updates to two footnotes, including an error in the text of footnote 15 and an error in the description of footnote 21. These minor corrections align with information provided to the public on the Bright Futures web page and referenced by HRSA in the October 24, 2023, Federal Register notice that sought public comment on the proposed updates to the Bright Futures Periodicity Schedule. These corrections do not change the clinical recommendations in the Bright Futures Periodicity Schedule or the associated requirement for certain group health plans and health insurance issuers to provide coverage without cost-sharing under section 2713 of the Public Health Service Act.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Use of Data Monitoring Committees in Clinical Trials.'' This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees,'' issued in March 2006. This draft guidance is not final nor is it in effect at this time.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) PRGLAC Implementation Working Group of Council is charged with monitoring and reporting on implementation of the recommendations from the PRGLAC. This includes monitoring and reporting on implementation, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical trials.