Department of Health and Human Services December 2024 – Federal Register Recent Federal Regulation Documents
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Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from the holder of those ANDAs. The basis for the withdrawal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.
Submission for Office of Management and Budget Review; Tribal Child Support Direct Funding Request: 45 CFR 309 (Office of Management and Budget #0970-0218)
The Office of Child Support Services (OCSS) is requesting a review by the Office of Management and Budget (OMB) of revisions to the Tribal Child Support Direct Funding Request: (OMB #0970-0218). These revisions are necessary to align this collection with updates resulting from a final rule: Employment and Training Services for Noncustodial Parents in the Child Support Program, which will require tribes to amend tribal plans if they elect to participate in employment and training services for non-custodial parents in the child support program.
Submission for Office of Management and Budget Review; State Plan for Child Support Collection and Establishment of Paternity Title IV-D of the Social Security Act
The Office of Child Support Services (OCSS) is requesting review by the Office of Management and Budget (OMB) of revisions to the State Plan for Child Support Collection and Establishment of Paternity Under Title IV-D of the Social Security Act (State Plan; OMB # 0970- 0017). These revisions are necessary to align this collection with updates resulting from a final rule: Employment and Training Services for Noncustodial Parents in the Child Support Program which will require states to amend State Plans if they elect to participate in employment and training services for non-custodial parents in the child support program.
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA or we) is establishing January 1, 2028, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2025, and on or before December 31, 2026. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes.
Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products," published in the Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.
Statement of Organization, Functions, and Delegations of Authority
This document announces that the Establishment of the Advanced Research Projects Agency for Health (ARPA-H) is being amended to reflect a revised organizational structure for ARPA-H that aligns with current statutory requirements. See 42 U.S.C. 290c(a)(2).
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Dermatologic and Ophthalmic 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 Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2026, expiration date.
Proposed Information Collection Activity; Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance (Office of Management and Budget #0970-0527)
The Children's Bureau (CB), Administration for Children and Families (ACF), Administration for Children, Youth and Families (ACYF), U.S. Department of Health and Human Services (HHS), is requesting an extension with changes to the approved information collection: Regional Partnership Grants (RPG) National Cross-Site Evaluation and Evaluation Technical Assistance (Office of Management and Budget (OMB) #0970- 0527). The proposed information collection will be used in a national cross-site evaluation of the seventh cohort of CB's RPG. The cross-site evaluation will use a survey, interviews, focus groups, and data on participant enrollment, services, and outcomes.
Name Change From Office of Child Support Enforcement to Office of Child Support Services
In an effort to make child support regulations consistent with recent rulemaking and updated Tribal child support processes and reporting, this direct final rule (DFR) makes technical updates reflect the current name of the child support program, Office of Child Support Services (OCSS). This is a conforming update to align with the Federal Register notice changing the office's name in the Statement of Organization, Functions, and Delegations of Authority that was published on June 5, 2023, and updates based on the Elimination of the Tribal Non-Federal Share Requirement final rule issued on February 12, 2024.
Final Scientific Integrity Policy of the U.S. Department of Health and Human Services
The Department of Health and Human Services (HHS) is publishing its Scientific Integrity Policy to increase access to and raise awareness of the Policy.
M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." 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 discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence.
E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled "Shortages Data Collection" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEXOBRID 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
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.
Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment
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."
Proposed Information Collection Activity: Unaccompanied Children Bureau Assessments for Children and Sponsors (Office of Management and Budget #: 0970-NEW)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on the proposed information collection, including proposed changes. The request consists of several forms that will allow the Unaccompanied Children Bureau (UCB) to continue conducting statutorily mandated assessments of unaccompanied children in ORR care and custody as well as their sponsors. These assessments allow ORR to understand the status and needs of the child and their potential sponsor; assessment findings inform all decisions concerning the child's care while in ORR custody and eventual reunification with a sponsor.
Update to the Health Resources and Services Administration-Supported Women's Preventive Services Guidelines
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.
Proposed Information Collection Activity; National Youth in Transition Database (NYTD) and Youth Outcomes Survey (Office of Management and Budget #0970-0340)
The Administration for Children and Families (ACF) is requesting a three-year extension of the National Youth in Transition Database (NYTD) and Youth Outcomes Survey (Office of Management and Budget (OMB)#: 0970-0340, expiration date May 31, 2025). There are no changes requested to the form.
Notice of Award of a Single Source Cooperative Agreement To Fund University of Oslo (UiO).
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.
Notice of Award of a Sole Source Cooperative Agreement To Fund Burkina Faso Ministry of Health, Direction of Disease Control Epidemics and Pandemics (DLMEP), Pasteur Institute of Ivory Coast (ICPI), National Public Health Institute of Liberia (NPHIL), Nigeria Center for Disease Control (NCDC), Senegal Ministry of Health and Social Action, and Sierra Leone Ministry of Health (MoH)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces seven separate awards to fund Burkina Faso Ministry of Health, Direction of Disease Control Epidemics and Pandemics in Cameroon, Pasteur Institute of Ivory Coast in Cote d'Ivoire, National Public Health Institute of Liberia in Liberia, Nigeria Center for Disease Control in Nigeria, Senegal Ministry of Health and Social Action in Senegal, and Ministry of Health in Sierra Leone. For Burkina Faso Ministry of Health, the award is for approximately $1,000,000, with an expected total funding of approximately $5,000,000. For Direction of Disease Control Epidemics and Pandemics, the award is for approximately $500,000, with an expected total funding of approximately $2,500,000. For Pasteur Institute of Ivory Coast (IPCI), the award is for approximately $2,000,000, with an expected total funding of approximately $10,000,000. For National Public Health Institute of Liberia (NPHIL), the award is for approximately $1,000,000 with an expected total funding of approximately $5,000,000. For Nigeria Center for Disease Control (NCDC), the award is for approximately $500,000 with an expected total funding of approximately $2,500,000. For Senegal Ministry of Health and Social Action, the award is for approximately $500,000 with an expected total funding of approximately $2,500,000. For Sierra Leone Ministry of Health (MoH), the award is for approximately $1,000,000, with an expected total funding of approximately $5,000,000. The total 5-year period amount for the seven recipients is $32,500,000, subject to the availability of funds. 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.
Notice of Award of a Sole Source Cooperative Agreement To Fund Guinea Agence Nationale de Sécurité Sanitaire (ANSS), Kementerian Kesehatan RI, Pakistan National Institute of Health, and Tanzania Ministry of Health (MoH)
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.
Health Information Technology Advisory Committee Schedule of Meetings
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.
Proposed Information Collection Activity; Evaluation of the Center for Legal and Judicial Innovation and Advancement (CLJIA) (Previously Evaluation of the Child Welfare Capacity Building Collaborative) (Office of Management and Budget #0970-0576)
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.
Notice of Award of a Single Source Cooperative Agreement To Fund Ponce Health Sciences Foundation, Inc.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $5,000,000, with an expected total funding of approximately $25,000,000 over a 5-year period, to Ponce Health Sciences Foundation, Inc. The award will support surveillance and research studies for endemic and emerging arboviruses in Puerto Rico.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application 218276 S-004 for FABHALTA (iptacopan) Oral Capsules in the Treatment of Adults With C3G
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with new animal drug applications and veterinary master files.
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