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

Part G of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS) is hereby amended to reflect a reorganization of the Indian Health Service (IHS). The purpose of this reorganization proposal is to update the current approved IHS, Office of the Director (GA), Congressional and Legislative Affairs Staff (GA1) and the Office of Quality (GAP) in their entirety and replace with the following:

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committees regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status, and, therefore, encourages nominations of appropriately qualified candidates from all groups.

The Food and Drug Administration (FDA) is announcing the transfer of regulatory responsibility for medical maggots and medicinal leeches to the Center for Biologics Evaluation and Research (CBER). These products are currently regulated by the Center for Devices and Radiological Health (CDRH). FDA is transferring regulatory responsibility of these products to CBER because these products are living organisms that more closely align with products regulated by CBER. This action affects only Center assignment and does not change requirements applicable to these products.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 29, 2024. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 28, 2024. The document indicated that FDA was withdrawing approval of the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 087774 for phenylbutazone capsules, 100 mg; and 088602 for pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 08540. Additionally, ANDAS 075631 for ketorolac tromethamine injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, EQ 5 mg base/mL; 076828 haloperidol lactate injectable, EQ 5 mg base/ mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals, LLC, timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled "National Agriculture and Food Defense Strategy Survey" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second annex to "E6(R3) Good Clinical Practice" published June of 2023. This annex provides additional considerations for the application of good clinical practices to a variety of trial designs and data sources. Specifically, this draft guidance discusses trials with decentralized and pragmatic elements and real-world data sources. This draft guidance highlights the importance of quality by design and focusing efforts and resources on critical aspects of the trials that might impact the safety of participants and the reliability of results. The draft guidance is intended to encourage innovation in trial design and provides flexible, modern, and clear good clinical practices for conducting trials, while avoiding unnecessary complexities.

This document withdraws a notice of proposed rulemaking that appeared in the Federal Register on February 2, 2023, regarding coverage of certain preventive services under the Affordable Care Act.

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

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research's (CDER), Office of Surveillance and Epidemiology (OSE) and Office of New Drugs (OND) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on November 20, 2014.

The Administration for Children and Families (ACF) published a document in the Federal Register on December 4, 2024, concerning minor adjustments made to the organization of the Office of Child Care (OCC) in adding a Regional Operations Division. The document contained an incorrect code.

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 for public comment.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing departmentwide system of records, "Federal Advisory Committee Membership Files," System No. 09-90-0059. The modifications include, among other things, adding records about any prospective guest speakers at Federal advisory committee meetings who disclose financial interests and professional relationships related to the matter they will be speaking on, and changing the name of the system of records to "Federal Advisory Committee/Subgroup Member, Subscriber/Registrant, and Guest Speaker Records."

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data from programs delivered by Sexual Risk Avoidance Education (SRAE) grant recipients on behalf of the SRAE National Evaluation. The generic mechanism will allow ACF to rapidly respond to research and evaluation opportunities that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The opportunities may relate to innovative implementation strategies and program components in use by SRAE grant recipients as they arise, and in particular, for youth subpopulations served by grant recipients. The purpose of the data collections submitted under the generic will be to inform ACF programming by building evidence about what innovations work to improve programming and outcomes across the SRAE grant recipients and the youth they serve.

ORR is correcting an interim rule (IFR) that was published in the Federal Register on November 27, 2024 with an effective date of December 27, 2024. The Investigations of Child Abuse and Neglect IFR provides standards and processes for ORR to apply when it conducts investigations into allegations of child abuse and neglect that occur in certain care provider facilities funded by ORR to provide residential and other services for unaccompanied children; describes a process for appeal and review of substantiated allegations; and establishes an ORR Central Registry to list individuals with certain findings of child abuse and neglect that have been substantiated and sustained after exhausting the appeal and review process.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT or Council) has scheduled a public meeting. Information about ACBSCT and the agenda for the meeting can be found on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/ advisory-council.

In accordance with subsection (k)(2) of the Privacy Act of 1974, as amended (the Privacy Act or the Act), the Department of Health and Human Services (HHS or Department) is exempting a new system of records maintained by the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Unaccompanied Children Bureau (UCB), System No. 09-80-0323, "ORR Unaccompanied Children Bureau (UCB) Child Abuse or Neglect Investigation Records and Central Registry," from certain requirements of the Privacy Act.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Department of the Treasury (Treasury), Internal Revenue Service (IRS), "Verification of Household Income and Family Size for Insurance Affordability Programs and Exemptions." The new matching program will commence under a new agreement when the agreement for the existing matching program expires in April 2025.