Department of Health and Human Services May 2023 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 352
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Intent To Award a Single-Source Supplement To Provide the National Aging Network With Timely, Relevant, High-Quality Opportunities To Further Enhance Training and Technical Assistance, Visibility, and Cultural Adaptions Related to Chronic Disease Self-Management Education (CDSME) Programs
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging (NCOA) for the Chronic Disease Self-Management Education (CDSME) Resource Center. The purpose of this program is to leverage and expand upon chronic disease self- management education efforts across the nation; work collaboratively in partnership with the aging and disability network and other stakeholders to advance the development of technical assistance, education, and resources to increase public awareness about chronic disease self-management tools to better manage chronic conditions like diabetes, chronic pain, arthritis and depression; increase the number of older adults and adults with disabilities who participate in evidence-based CDSME and self-management support programs; and support the integration and sustainability of evidence-based CDSME and self- management support programs within community integrated health networks.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Evaluation of Programs Supporting the Mental Health of the Health Professions Workforce, OMB No. 0915-xxxx-New
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.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Interdisciplinary, Community-Based Linkages
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL or Committee).
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report, OMB No. 0915-0172-Revision
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; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA, Agency, or we) is announcing the establishment of a docket to solicit public comments on the identification, assessment, and control of N-nitrosamine (nitrosamine) drug substance-related impurities (NDSRIs) that may be considered by the Agency in its regulation of these types of impurities in drug products. This notice identifies scientific and regulatory considerations regarding the identification, assessment, and control of NDSRIs, including areas that may benefit from collaborative efforts, and requests comments on these topics. This notice is not intended to communicate FDA's regulatory expectations on these issues but is instead intended to seek input from the public to inform scientific and/or regulatory approaches as appropriate.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System, OMB No. 0915-0298-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA is submitting a request for public comment on redesigned Maternal and Child Health Bureau (MCHB) Performance Measures for Discretionary Grant Information System (DGIS) forms. The purpose of the redesigned DGIS forms is to facilitate higher quality data collection and develop streamlined, clear DGIS metrics to support communications about the range of HRSA's maternal and child health (MCH) programs. Proposed revisions include eliminating 52 forms, adding 25 new forms, and revising 23 existing forms. In addition, three forms have not undergone substantive revisions since the previously approved Office of Management and Budget (OMB) package and are included in the time burden estimate. HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the Information Collection Request (ICR).
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Survey of Syringe Services Programs (NSSSP). This data collection which proposes assess and monitor SSP operational characteristics and services, funding resources, community relations, and key operational and programmatic successes and challenges, and support timely analysis and dissemination of national program evaluation survey findings.
Q9(R1) Quality Risk Management; 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 ``Q9(R1) Quality Risk Management.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is a targeted revision of the 2006 guidance for industry ``Q9 Quality Risk Management'' and addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-based decision-making, and high levels of subjectivity in risk assessments and QRM outputs. The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality. The guidance replaces the draft guidance ``Q9(R1) Quality Risk Management'' issued on June 15, 2022.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Submission for OMB Review; 2024 National Survey of Early Care and Education (OMB #: 0970-0391)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the 2024 National Survey of Early Care and Education (NSECE) to be conducted October 2023 through July 2024. The objective of the 2024 NSECE is to document the nation's use and availability of early care and education (ECE) services, building on the information collected in 2012 and 2019 to describe the ECE landscape in the U.S. The 2024 NSECE will collect information on families with children under age 13 years, on ECE providers that serve families with children from birth to 13 years in the U.S., and on the workforce providing these services.
National Heart, Lung, and Blood Institute; Notice of Proposed Reorganization
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) will host a public hearing to enable discussion of the Institute's proposal to reorganize the Division of Lung Disease (DLD). The proposed reorganization aims to ensure effective oversight, alignment of expertise, and translation of knowledge within and across research areas in the lung disease field. It establishes a new branch structure that will strategically position leadership over DLD programs, balance workload, and enhance depth/ succession planning for ingrained operational sustainability. There will be no impact on the National Center on Sleep Disorders Research as a result of the restructuring. The online forums will allow members of the public to review the reorganization proposals and submit comments.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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. On June 15, 2023, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Notice of Meeting for the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. 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 information on the progress of the ISUDCC Working Groups, discussion of the ISUDCC Reauthorization, and sections 1262 and 1263 of the Consolidated Appropriations Act, 2023, commonly known as the Mainstreaming Addiction Treatment (MAT) Act and Medication Access and Training Expansion (MATE) Act. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC).
Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality
This proposed rule would advance CMS' efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The proposed rule would specifically address standards for timely access to care and States' monitoring and enforcement efforts, reduce burden for some State directed payments and certain quality reporting requirements, add new standards that would apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and specify the scope and nature of ILOS, specify medical loss ratio (MLR) requirements, and establish a quality rating system for Medicaid and CHIP managed care plans.
Medicaid Program; Ensuring Access to Medicaid Services
This proposed rule takes a comprehensive approach to improving access to care, quality and health outcomes, and better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These proposed improvements seek to increase transparency and accountability, standardize data and monitoring, and create opportunities for States to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during January, February, and March 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.
Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Environmental Defense Fund, et al., proposing that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods.
Determination That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; Application and Other Forms Used by the National Health Service Corps Scholarship Program, the NHSC Students to Service Loan Repayment Program, and the Native Hawaiian Health Scholarship Program
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.
Findings of Research Misconduct
Findings of research misconduct have been made against Johnny J. He, Ph.D. (Respondent), who is a Professor, Department of Microbiology and Immunology, Rosalind Franklin University of Medicine and Science (RFUMS). Respondent engaged in research misconduct in research reported in grant applications submitted for U.S. Public Health Service (PHS) funds, specifically U01 DA056010-01 and DP1 DA056160-01 submitted to the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), R01 AG078019-01 submitted to the National Institute on Aging (NIA), NIH, and R35 NS127233-01 submitted to the National Institute of Neurological Disorders and Stroke (NINDS), NIH. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on April 17, 2023, and are detailed below.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory 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.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award for the one grant recipient funded in fiscal year (FY) 2018 under the Clinical Support System for Serious Mental Illness (CSS-SMI) Notice of Funding Opportunity (NOFO) SM-18-020. The grant recipient may receive up to $2,846,283. The grant recipient's project period will be extended by 12 months until July 8, 2024. The supplemental funding will be used to maintain a national center that provides technical assistance to providers, programs, and communities across the nation to address evidence-based treatment and recovery support programs for individuals living with serious mental illness (SMI).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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.
Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, investigators, and other stakeholders entitled ``Decentralized Clinical Trials for Drugs, Biological Products, and Devices.'' This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this draft guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.
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.
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