Department of Health and Human Services July 2023 – Federal Register Recent Federal Regulation Documents
Results 201 - 242 of 242
Extension of Temporary Suspension of Dogs Entering the United States From Countries With a High Risk of Rabies
In order to protect the United States against the potential reintroduction of the dog-maintained rabies virus variant (DMRVV) into the United States, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces an extension of the current temporary suspension of the importation into the United States of dogs from countries at high-risk for enzootic rabies (DMRVV high-risk countries). This suspension includes dogs that have been in any DMRVV high-risk countries during the previous six months.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products
The Food and Drug Administration (FDA, Agency, or we) 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.
Medical Imaging 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 Medical Imaging 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.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT or Committee). ACOT provides advice and recommendations to the Secretary of HHS (Secretary) on proposed Organ Procurement and Transplantation Network policies and such other matters as the Secretary determines. The Secretary also may seek the advice of the Committee on other proposed policies.
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 Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks. This data collection is used to collect standardized data during investigations of outbreaks of cyclosporiasis, thereby increasing the likelihood that outbreaks will be recognized, and sources will be identified.
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 National Wastewater Surveillance System for COVID-19 and other infectious disease targets of public health concern. The proposed information collection project aims to collect pathogen and public health target concentration in wastewater, wastewater target variant sequencing data, sewershed spatial files, and associated sewershed-level case data from participating jurisdictions in the United States to inform infectious disease prevention and control efforts.
Findings of Research Misconduct
Findings of research misconduct have been made against William M. Armstead, Ph.D. (Respondent), who was a Research Associate Professor of Anesthesiology and Critical Care, Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania (UPENN). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS090998-01A1, R21 NS095321, and T32 NS043126 and National Institute of Child Health and Human Development (NICHD), NIH, grant R01 HD057355. The research was included in grant applications for PHS funds, specifically R35 NS116805-01, R01 NS121149-01, and R01 NS090998-02, -03, -04, and -05 submitted to NINDS, NIH, and R01 HL139506-01 submitted to the National Heart, Lung, and Blood Institute (NHLBI), NIH. The administrative actions, including debarment for a period of seven (7) years, were implemented beginning on June 19, 2023, and are detailed below.
National Committee on Vital and Health Statistics; Meeting
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to attend in person or virtually by following the instructions posted on the website: https://ncvhs.hhs.gov/meetings/full-committee- meeting-14/. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting.
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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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; Public Comment Request; SHIP-SMP Survey of One-on-One Assistance, (OMB Control Number 0985-0057)
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the ``SHIP-SMP Survey of One-on-One Assistance''.
Announcing the Intent To Award a Sole-Source Supplement for the Christopher and Dana Reeve Foundation
The Administration for Community Living (ACL) is announcing the award of a sole-source supplement for the National Paralysis Resource Center (PRC) as a result of the 2023 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation and offers important programmatic opportunities for persons with disabilities and older adults. The NPRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans' program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY 2023 will be in the amount of $1,300,000, bringing the total award for FY 2023 to $10,000,000.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Maternity and Obstetrics Management Strategies Program, OMB No. 0915-xxxx-NEW.
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 Request. 30-Day Public Comment Request
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Corps Supplemental Funding Evaluation OMB No. 0915-xxxx-New
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: Submission to OMB for Review and Approval; Public Comment Request; HRSA Telehealth Outcome Measures-OMB No. 0915-0311-Extension
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 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.
Proposed Information Collection Activity; Information Comparison With Insurance Data
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Federal Office of Management and Budget (OMB) to extend approval of the Information Comparison with Insurance Data, with minor changes, for an additional three years. The current OMB approval (OMB No.: 0970-0342) expires January 31, 2024.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement in scope of the parent award for one grant recipient funded in FY 2020 under the National Peer-Run Training and TA Center for Addiction Recovery Peer Support grant, Notice of Funding Opportunity (NOFO) TI-20-004. The recipient may receive up to $941,960. The recipient has a project end date of August 30, 2024.
Supplemental Evidence and Data Request on Breastfeeding and Health Outcomes for Infants and 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 Breastfeeding and Health Outcomes for Infants and 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.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Injury Prevention and Control
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, National Center for Injury Prevention and Control (BSC, NCIPC). The BSC, NCIPC consists of up to 18 experts in pertinent disciplines involved in injury and violence prevention.
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
The CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This is a hybrid meeting, accessible both in person and virtually. It is open to the public, limited only by the space available and the number of audio conference lines and internet conference accesses. Time will be available for public comment. The public is also welcomed to submit written comments in advance of the meeting, to the contact person listed in the addresses section 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 combined number of audio conference lines and internet conference accesses is 200.
Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules
This final rule amends the civil money penalty (CMP) regulations of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to: incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations.
Request for Public Comment: 60-Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule'' Office of Management and Budget (OMB) Control Number 0917-0030. This previously approved information collection project was last published in the Federal Register (84 FR 42935) on August 19, 2019, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces the IHS's intent to submit the collection, which expires August 31, 2023, to OMB for approval of an extension with modifications, and to solicit comments on specific aspects of the information collection.
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.
Inflation Reduction Act (IRA) Revised Program Guidance
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' revised guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction Act-related guidance; all can be viewed on the dedicated Inflation Reduction Act section of the CMS website.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
This is the first of two notices planned for the coming months informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of April 28, 2023. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website and includes HPSAs which are proposed for withdrawal but currently remain designated. HRSA is extending the transition time communicated in the notice published on July 7, 2022, for jurisdictions and facilities to prepare for potential loss of HPSA designations. HPSA designations that are currently proposed for withdrawal will remain in this status until they are re-evaluated in preparation for the publication of the January 2, 2024, HPSA Federal Register notice. If these HPSAs do not meet the requirements for designation by the data pull scheduled for November 15, 2023, they will be withdrawn with the publication of a second Federal Register notice planned for January 2, 2024.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
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).
Cardiovascular and Renal 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 Cardiovascular and Renal 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.
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