Department of Health and Human Services December 30, 2024 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is publishing its Scientific Integrity Policy to increase access to and raise awareness of the Policy.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E11A Pediatric Extrapolation." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides a comprehensive and systematic approach to pediatric extrapolation during drug development. Notably, the guidance discusses approaches to safety extrapolation and defining extrapolation as a continuum. The guidance also includes approaches to study designs and statistical methodologies, including modeling and simulation, for developing and implementing pediatric extrapolation. The guidance is intended to provide approaches that can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The guidance replaces the draft guidance "E11A Pediatric Exploration" issued on August 29, 2022.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTAMPZA ER 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 drug product.

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.

This document corrects technical errors in the final rule that appeared in the October 15, 2024, Federal Register titled "Medicare Program: Appeal Rights for Certain Changes in Patient Status." It also corrects technical errors in the final rule that appeared in the May 7, 2019, Federal Register titled "Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures."

The Health Resources and Services Administration (HRSA) published a Federal Register Notice on October 22, 2024, with proposed updates to the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The proposed updates specifically relate to recommendations for Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation Services for Breast and Cervical Cancer Screening. Recommendations to update the Guidelines are developed by the Women's Preventive Services Initiative (WPSI) for consideration by HRSA. WPSI convenes expert health professionals to conduct rigorous reviews of the evidence following the National Academy of Medicine standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, and external reviews and it develops draft recommendations for HRSA's consideration. After consideration of public comment, HRSA has accepted the recommendations as revised and detailed in this notice. Under applicable law, non- grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, Health and Human Services, and the Treasury have previously issued regulations describing how group health plans and health insurance issuers apply the coverage requirements. Please see https://www.hrsa.gov/womens-guidelines for additional information.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,500,000, with an expected total funding of approximately $7,500,000 over a 5-year period, to the University of Oslo (UiO). This award will protect Americans and people worldwide from public health threats by building capacity within their respective countries to strengthen public health preparedness; early pathogen detection to mitigate the impact of global disease outbreaks and public health; and bolstering rapid response to global health emergencies.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces four separate awards to fund Agence Nationale de S[eacute]curit[eacute] Sanitaire, Kementerian Kesehatan RI, Pakistan National Institute of Health, and Tanzania Ministry of Health. For Guinea Agence Nationale de S[eacute]curit[eacute] Sanitaire, the award is for approximately $2,000,000, with an expected total funding of approximately $10,000,000. For Kementerian Kesehatan RI, the award is for approximately $1,500,000, with an expected total funding of approximately $7,500,000. For Pakistan National Institute of Health, the award is for approximately $700,000, with an expected total funding of approximately $3,500,000. For Tanzania Ministry of Health, the award is for approximately $2,000,000, with an expected total funding of approximately $10,000,000. The total 5-year period amount for the four recipients is $31,000,000. The awards will protect Americans and people worldwide from public health threats by building capacity within their respective countries to strengthen public health preparedness; early pathogen detection to mitigate the impact of global disease outbreaks and public health; and bolstering rapid response to global health emergencies.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology. The HITAC will hold public meetings throughout 2025. See list of public meetings below.

This collection relates to survey instruments to be administered in conjunction with technical assistance (TA) delivered to legal and judicial staff who participate in strategic planning workshops and attorneys and judicial trainings with a Children's Bureau TA provider. This is a revision and extension to Office of Management and Budget (OMB) #0970-0576) to remove instruments that are no longer in use, revise the title of the collection, and to revise the name of the TA provider in the instruments still in use.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs 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.

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.