Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Adoption and Foster Care Analysis and Reporting System
ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations that require title IV-E agencies to collect and report data to ACF on children who enter out- of-home care, their providers, and children who have a title IV-E adoption or guardianship assistance agreement to collect additional data related to Indian children.
Medicaid Program; Disproportionate Share Hospital Third-Party Payer Rule
This final rule primarily addresses recent legislative changes to the Social Security Act as a result of the Consolidated Appropriations Act, 2021 changes to the hospital-specific limit on Medicaid disproportionate share hospital (DSH) payments. This final rule affords States and hospitals more clarity on how the limit, the changes that took effect on October 1, 2021, will be calculated. Additionally, this final rule enhances administrative efficiency by making technical changes and clarifications to the DSH program.
Taylor McLaren: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Taylor McLaren for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. McLaren was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. McLaren's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. McLaren was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 8, 2024 (30 days after receipt of the notice), Mr. McLaren had not responded. Mr. McLaren's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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 (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.
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.
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' Although the public health emergency declared by the Department of Health and Human Services under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem with continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID- 19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.'' The guidance includes select updates to the guidance ``Medical Device User Fee Small Business Qualification and Certification'' which describe how FDA plans to determine if a small business is experiencing ``financial hardship'' which makes them eligible for a waiver of their registration fee. The guidance will detail what information FDA will review and consider in making this determination. This draft guidance is not final nor is it for implementation at this time.
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee (the Committee) to the list of standing advisory committees.
Administration on Disabilities, The President's Committee for People With Intellectual Disabilities
The President's Committee for People with Intellectual Disabilities (PCPID) will host a virtual meeting for its members to address issues surrounding Home and Community Based Services (HCBS) to be examined in the Committee's Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format with committee members addressing the issues and recommendations identified by PCPID workgroups proposing to be incorporated in the PCPID Report to the President.
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.
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Professions Student Loan Program, Loans for Disadvantaged Students Program, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements, OMB No. 0915-0047-Revision
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.
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 (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.
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.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
The National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2024.
Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the request for nominations for voting members excluding consumer and industry representatives, to serve on the Genetic Metabolic Diseases Advisory Committee (the Committee) in the Center for Drug Evaluation and Research. This request for nominations was announced in the Federal Register of December 13, 2023. The amendment is being made to reflect a change in the DATES portion of the document. There are no other changes.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register of December 22, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled, ``Master Protocols for Drug and Biological Product Development.'' The Agency is taking this action in response to requests 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 (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.
Submission for Office of Management and Budget Review; Healthy Marriage and Responsible Fatherhood Performance Measures and Additional Data Collection (Office of Management and Budget #0970-0566)
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), is requesting an extension with changes to its approved collection and reporting of performance measures about program operations, services, and clients served through the Healthy Marriage (HM) and Responsible Fatherhood (RF) grant programs. In an effort to gain a great understanding of how HMRF programs influence program participants and staff at an individual level, ACF proposes to add one open field to the quarterly narrative reports to capture information about the experiences of HMRF participants and/or staff. ACF is requesting to extend approval, with the implementation of this change, for 3 years.
Confidentiality of Substance Use Disorder (SUD) Patient Records
The United States Department of Health and Human Services (HHS or ``Department'') is issuing this final rule to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the Confidentiality of Substance Use Disorder (SUD) Patient Records. This final rule also makes certain other modifications to increase alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to improve workability and decrease burden on programs, covered entities, and business associates.
Submission for Office of Management and Budget Review; Administration for Children and Families Generic for Engagement Efforts (New Umbrella Generic)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to request approval from the Office of Management and Budget (OMB) to establish a new umbrella generic clearance to request information while engaging individuals and groups who could provide valuable information to inform ACF programs and work, including but not limited to those who are served or have been served by ACF, those with expertise in ACF program areas, and individuals invested in the outcomes of ACF research and evaluation. These engagement activities often need to be conducted quickly, to allow for sufficient time to inform project direction and decision-making. Additionally, planning for engagement activities is most often on a quick timeline and the standard timeline to comply with a full request under the Paperwork Reduction Act (PRA) often inhibits the ability to collect information to inform these activities. Therefore, an umbrella generic is necessary to allow for quick turnaround requests for similar information collections related to these activities.
Advisory Committee on Training in Primary Care Medicine and Dentistry Meeting Cancellation
This is to notify the public that the March 25-26, 2024, meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry is cancelled.
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