Department of Health and Human Services August 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 305
HRSA-Initiated Supplemental Funding to the Supporting Maternal Health Innovation Program
HRSA is providing supplemental funds not to exceed $1,500,000 to the Supporting Maternal Health Innovation Program, also referred to as the Maternal Health Learning and Innovation Center (MHLIC), in fiscal year (FY) 2023 to provide support and capacity building to HRSA's new maternal health award recipients under the State Maternal Health Innovation (MHI) Program (HRSA-23-108).
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
The Food and Drug Administration (FDA or Agency) 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 reporting requirements associated with extralabel drug use in animals.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
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.
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.'' This guidance clarifies the enhanced drug distribution security requirements listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, this guidance outlines and makes recommendations on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. This guidance finalizes the draft guidance of the same title issued on June 4, 2021.
Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
The Food and Drug Administration (FDA or Agency) 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 information collection provisions of the dispute resolution procedures for science-based decisions on products regulated by the Center for Veterinary Medicine (CVM).
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program for drugs and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD) and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug that are not subject to the IND regulations. This guidance finalizes the draft guidance of the same title issued on December 9, 2021.
Supporting Healthy Start Performance Project
HRSA will provide supplemental award funds to the current SHSPP recipient, in fiscal year 2023 to provide new and continued support to Healthy Start grant recipients.
Medicaid Program and CHIP; Mandatory Medicaid and Children's Health Insurance Program (CHIP) Core Set Reporting
This document establishes requirements for mandatory annual State reporting of the Core Set of Children's Health Care Quality Measures for Medicaid and the Children's Health Insurance Program (CHIP), the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid, and the Core Sets of Health Home Quality Measures for Medicaid.
Request for Public Comment; 60-Day Information Collection: Application for Participation in the IHS Scholarship Program
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Application for Participation in the IHS Scholarship Program,'' Office of Management and Budget (OMB) Control No. 0917-0006. The IHS is requesting OMB to approve an extension for this collection, which expires on October 31, 2023.
Meeting of the National Advisory Council on Migrant Health
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Migrant Health (NACMH) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on NACMH's website at https:// www.hrsa.gov/advisory-committees/migrant-health.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Satisfaction Surveys
The Food and Drug Administration (FDA or Agency) 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.
Availability of Five Draft Toxicological Profiles and One Draft Interaction Profile
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on drafts of five updated toxicological profiles, and one draft interaction profile: Creosote, Nickel, 1,2-Dichloroethene, Vinyl acetate, Acrylonitrile, and the Interaction Profile for Selected Metallic Ions. This action is necessary as this is the opportunity for members of the public and organizations to submit comments on drafts of the profiles. The intended effect of this action is to ensure that the public can note any pertinent additional information or reports on studies about the health effects of these six profiles for review.
Proposed Requirements for Tobacco Product Manufacturing Practice; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule entitled ``Requirements for Tobacco Product Manufacturing Practice'' published in the Federal Register of March 10, 2023, by 30 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 (the 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.
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic ActCompliance Policies.'' This guidance describes FDA's compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction
This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy- related changes. This final rule also revises our regulations on the counting of days associated with individuals eligible for certain benefits provided by section 1115 demonstrations in the Medicaid fraction of a hospital's disproportionate patient percentage (DPP) used in the disproportionate share hospital (DSH) calculation.
Advisory Board on Radiation and Worker Health, Subcommittee on Procedures Reviews, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces a meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, Center for Preparedness and Response
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). The BSC, CPR consists of 11 experts in fields associated with business, crisis leadership, emergency response and management, informatics, laboratory science, medicine, mental and behavioral health, public health law, public health practice, risk communication, and social science.
Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is soliciting nominations for membership on the Lead Exposure and Prevention Advisory Committee (LEPAC). The LEPAC is composed of 15 members that are Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure.
Clinical Laboratory Improvement Advisory Committee
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public, limited only by the in-person space available. The public is also welcome to view the meeting by joining the audio conference (information below). Time will be available for public comment, and the public is also welcome to submit written comments in advance of the meeting (see the public participation section below).
Government-Owned Inventions; Availability for Licensing
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.
Supplemental Evidence and Data Request on Diagnosis and Management of Obsessive Compulsive Disorders in Children
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Diagnosis and Management of Obsessive Compulsive Disorders in Children, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container
The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity and standard of fill of container for canned tuna. This action partially responds to a citizen petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (doing business as Chicken of the Sea International). We tentatively conclude that this action, if finalized, will promote honesty and fair dealing in the interest of consumers.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Correction
On August 11, 2023, CMS published a notice in the Federal Register that sought comment on a collection of information concerning CMS-10305 (OMB control number 0938-1115) entitled ``Medicare Part C and Part D Data Validation.'' The point of contact for policy questions is incorrect. This document corrects the error.
Advisory Committee on Immunization Practices
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.
Notice of Opportunity for Public Comment on Proposal To Withdraw Approval of New Drug Application for PEPAXTO, Equivalent to 20 Milligrams Base per Vial
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA, the Agency) is proposing to withdraw approval of PEPAXTO (melphalan flufenamide) for injection, equivalent to (EQ) 20 milligrams (mg) BASE/VIAL, once every 28 days, new drug application (NDA) 214383, held by Oncopeptides AB (Oncopeptides). This notice is intended to provide an opportunity for public comment on CDER's proposed withdrawal of PEPAXTO, in accordance with the expedited withdrawal of approval procedures described in the Federal Food, Drug and Cosmetic Act (FD&C Act).
Notice of Award of a Single-Source Cooperative Agreement To Fund icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $6,000,000, for Year 1 funding to icddr,b. The award will support high quality public health research and surveillance activities to further strengthen the ability of the Government of Bangladesh and other global partners to detect, prevent, and respond to disease threats. Funding amounts for years 2-5 will be set at continuation.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Program Evaluation for PS22-2208 Component 2. This information collection request is designed to monitor and evaluate the PS22-2208 Component 2 funding opportunity's overall goal of supporting syringe services program (SSP) subrecipients in meeting the needs of people who use drugs (PWUD) and reducing infectious disease and other harms related to drug use during the 5- year PS22-2208 Cooperative Agreement.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Standardized Work Plan Form for Use With Applications to the Bureau of Health Workforce Research and Training Grants and Cooperative Agreements OMB No. 0906-0049-Extension
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 (the 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.
Proposed Collection; 30 Day Comment Request Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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