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

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

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

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

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

The Food and Drug Administration's (FDA or the Agency) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5 MILLIMETERS (MM)) 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 Administration for Children and Families' (ACF) Office of Community Services (OCS) is requesting from OMB a three-year extension of the Social Services Block Grant (SSBG) Post-Expenditure Report, Pre- Expenditure Report, and Intended Use Plan (OMB #0970-0234). OCS is proposing to make minor editorial modifications to some column titles in the Pre- and Post-Expenditure Reports, for clarification.

OCSS eliminates the non-Federal share of program expenditures requirement for Tribal child support programs, including the 90/10 and 80/20 cost sharing rates. Based upon the experiences of and consultations with Tribes and Tribal organizations, we have determined that the non-Federal share requirement limits growth, causes disruptions, and creates instability.

This document corrects technical and typographical errors in the final rule that appeared in the November 16, 2023 issue of the Federal Register, entitled ``Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program'' (referred to hereafter as the ``CY 2024 PFS final rule''). The effective date was January 1, 2024.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE.'' The draft guidance, when finalized, will provide recommendations for collecting a representative sample for products subject to DWPE under an import alert due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. When finalized, the draft guidance will also help foreign manufacturers and other processors of fish and fishery products subject to DWPE introduce evidence to FDA to support a request to have products removed from DWPE.

The Department of Health and Human Services (HHS) is issuing a final rule establishing standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This final rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule finalizes the regulations as proposed in the Notice of Proposed Rule Making (NPRM) of August 16, 2023, with minor technical edits based on comments received.

This document corrects technical and typographical errors in the final rule with comment period that appeared in the Federal Register on November 22, 2023, titled ``Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction'' (referred to hereafter as the ``CY 2024 OPPS/ASC final rule with comment period'').

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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season. The meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Global Public Health Data Innovation Performance Monitoring. This data collection is designed to help government decision makers gather timely, accurate, and comprehensive public health data to effectively prevent, detect, and respond to public health threats.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC., proposing that we amend our color additive regulations to provide for the safe use of butterfly pea flower extract in ready-to-eat cereals, crackers and snack mixes, and chips at levels consistent with good manufacturing practice.

This final rule will improve the electronic exchange of health care data and streamline processes related to prior authorization through new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). This final rule will also add new measures for eligible hospitals and critical access hospitals (CAHs) to report under the Medicare Promoting Interoperability Program and for MIPS eligible clinicians to report under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS). These policies, taken together, will reduce overall payer and provider burden and improve patient access to health information while continuing CMS's drive toward interoperability in the health care market.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Marble Therapeutics, Inc. (``Marble''), headquartered in Boston, MA.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $8,000,000, with an expected total funding of approximately $50,000,000 over a 5-year period, to the Pan-American Health Organization (PAHO). The award will support strengthening immunization systems; ensuring polio free certification status; maintaining measles, rubella, and neonatal tetanus elimination; and prevention of other vaccine-preventable diseases (VPDs) in the Americas region. This award builds upon and continues work previously supported by PAHO through a cooperative agreement under CDC-RFA-GH-1901, ``Cooperative Agreement with the Pan American Health Organization: Protecting and Strengthening Immunization Programs in the Americas.''

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $500,000, for Year 1 funding to Kisumu County GovernmentDepartment of Health Services, $8,000,000, for Year 1 funding to Servi[ccedil]os Provincial de Sa[uacute]de Gaza, $2,500,000, for Year 1 funding to Servi[ccedil]os Provincial de Saude Nampula and $800,000 for Year 1 funding to MHSA. These awards will achieve and sustain HIV/TB epidemic control through sustainable high-quality comprehensive HIV prevention and treatment services, health service delivery models, and health systems in Kenya, Mozambique and West Africa-Senegal. Funding amounts for years 2-5 will be set at continuation.

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.

The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUAs) (the Authorizations) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

HRSA expects the availability of additional funds for the RWHAP Part C Early Intervention Services (EIS) Program due to relinquishments, reductions, closeouts, and unawarded fiscal year (FY) 2023 new service area competition funds in the estimated amount of $4.2 million and intends to distribute these supplemental funds across the current cohort of RWHAP Part C EIS recipients. The amount is subject to change depending on the availability of additional funds.

AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.

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

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 17, 2026.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Capacity Building Assistance Program: Data Management, Monitoring, and Evaluation. The goal of the study is to allow CDC to evaluate the CDC cooperative agreement program entitled CDC-RFA-PS19- 1904 in order to improve the evaluation design and methods used to capture PS19-1904 outcomes, and to increase access and use of PS19-1904 data for continuous quality improvement and performance reporting.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Import Permit. The goal of the information collection is to support the Public Health Service (PHS) Act and prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards (``Potential Hazards'') to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.

Notice is hereby given for the meeting on February 27, 2024, of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings . The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 29, 2023; overview of CSAP strategic planning activities; presentations on substance use prevention priorities; Council discussion and public comments.

This final rule modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This includes making flexibilities put forth during the COVID-19 Public Health Emergency (PHE) permanent, as well as expanding access to care and evidence-based treatment for OUD. The final rule also removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from the regulations pursuant to the ``Consolidated Appropriations Act, 2023''.

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.

HRSA published a notice in the Federal Register on October 12, 2023, concerning the 2024 calendar year meetings of the Advisory Commission on Childhood Vaccines (ACCV). The meeting times have changed. The 2024 ACCV meetings will be held from 1 p.m. eastern time (ET)-4 p.m. ET instead of from 10 a.m.-4 p.m.

The Agency for Healthcare Research and Quality (AHRQ) Center for Quality Improvement and Patient Safety (CQuIPS) Division of Quality Measurement and Improvement (QMI) invites public comment in response to this Request for Information (RFI). The AHRQ Quality Indicators (QI) program maintains inpatient quality indicators (https:// qualityindicators.ahrq.gov/measures/IQI_TechSpecTechSpec) and patient safety indicators (https://qualityindicators.ahrq.gov/measures/ PSI_TechSpec), several of which are relevant to maternal health care. Specifically, the QI program maintains measures of obstetric trauma, birth trauma, and cesarean delivery calculated at the hospital level using administrative data. However, severe maternal morbidity during an inpatient stay may result from a host of complications, such as sepsis, cardiac failure, stroke, respiratory distress, and renal failure. While state-level rates of severe maternal morbidity are available from AHRQ (https://datatools.ahrq.gov/hcup-fast-stats/?tab=special- emphasis&dash=92), experts have noted some shortcomings of this measure. This RFI seeks comments on the usability, feasibility, and likely uptake of a measure of severe maternal morbidity to be validated, refined, and maintained by the QI program, with the goal of providing data for maternal health service improvements. While a measure of severe maternal morbidity is currently available from AHRQ and the Health Resources and Service Administration (HRSA), several experts have suggested that this algorithm could benefit from refinements.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on January 29, 2024. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 21, 2023. The document announced the availability of a final guidance for industry entitled ``Development of Monoclonal Antibody Products Targeting SARS- CoV-2 for Emergency Use Authorization.'' The document was published with an incorrect docket number. This document corrects that error.

This document corrects technical errors in the final rule that appeared in the November 13, 2023 Federal Register titled ``Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements'' (referred to hereafter as the ``CY 2024 HH PPS final rule'').

The Office of Human Services Emergency Preparedness and Response (OHSEPR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension for approval of the following information collection: OHSEPR Disaster Human Services Case Management Intake Assessment, Resource Referral, and Case Management Plan; OMB No.: 0970-0619. This information collection was originally approved for 6 months through an emergency approval.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry.'' The guidance document provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety assessment, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.'' The purpose of this guidance is to provide FDA's expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled ``Collection of Race and Ethnicity Data in Clinical Trials'' issued on October 26, 2016.

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in turkey feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.