Department of Health and Human Services April 2021 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 254
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2021-08084
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-08083
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-08082
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Data Collection for the Engaging Fathers and Paternal Relatives: A Continuous Quality Improvement Approach in the Child Welfare System Project (New Collection)
Document Number: 2021-08025
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing to conduct data collection activities for the Engaging Fathers and Paternal Relatives: A Continuous Quality Improvement Approach in the Child Welfare System (Fathers and Continuous Learning in Child Welfare [FCL]) Project. This evaluation is a descriptive study of child welfare agencies' use of a continuous quality improvement process called the Breakthrough Series Collaborative (BSC) to implement strategies to improve father and paternal relative engagement in the child welfare system. The project is designed to examine the use of the BSC methodology to strengthen fathers' and paternal relatives' engagement with children involved in child welfare and to add to the evidence base on engagement strategies for fathers and paternal relatives in child welfare.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement, OMB No. 0906-XXXX-NEW
Document Number: 2021-08017
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 or any other aspect of the ICR.
Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure
Document Number: 2021-08016
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Services Act requires that RWHAP Part A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals with HIV/AIDS identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary authority to waive this requirement if certain requirements are met. HRSA is proposing to simplify the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C'' (accessible at the following link) https://hab.hrsa.gov/sites/default/ files/hab/Global/13-07waiver.pdf. This notice seeks to make public the proposed policy and provide an opportunity for public comment before its implementation. In a separate notice entitled, Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement, OMB No. 0906-XXXX-NEW, HRSA is inviting comments on the data collection changes associated with this proposed policy change.
Meeting of the COVID-19 Health Equity Task Force
Document Number: 2021-08002
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on April 30, 2021. The purpose of this meeting is to consider interim recommendations specific to mental and behavioral health across the life course. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/healthequitytaskforce/ prior to the meeting.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290-Extension
Document Number: 2021-07996
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.
Advisory Committee for Women's Services (ACWS); Notice of Meeting
Document Number: 2021-07994
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07981
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB No. 0906-0017, Revision
Document Number: 2021-07971
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2021-07970
Type: Notice
Date: 2021-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
Document Number: 2021-07860
Type: Rule
Date: 2021-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-07979
Type: Notice
Date: 2021-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, 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. The meeting will be webcast live via the World Wide Web.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2021-07896
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-07895
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-07894
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-07893
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07892
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2021-07891
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2021-07890
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-07889
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-07888
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07887
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-07883
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2021-07881
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07840
Type: Notice
Date: 2021-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 American Academy of Pediatrics (AAP) Neurodevelopmental Extension for Community Health Outcomes (ECHO)program on Children with Fetal Alcohol Spectrum Disorders (FASD). The purpose of this information collection is to monitor and evaluate the American Academy of Pediatrics (AAP) Neurodevelopmental Extension for Community Health Outcomes (ECHO) Program on Children with Fetal Alcohol Spectrum Disorders (FASD). The intent of the project is to improve practicing pediatrician capacity for identification and care of children with neurodevelopmental disorders, particularly prenatal exposure to alcohol, in the medical home.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07839
Type: Notice
Date: 2021-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 SimpleReport Mobile Application. SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07838
Type: Notice
Date: 2021-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments. This new data collection is for viral hepatitis (VH) case reporting data collected from the National Notifiable Diseases Surveillance System (NNDSS) which provides the primary population-based data used to describe the epidemiology of VH in the United States and for annual reporting of surveillance, prevention, and epidemiology performance measures via an Annual Performance Report.
Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments
Document Number: 2021-07837
Type: Notice
Date: 2021-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.'' The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07836
Type: Notice
Date: 2021-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the Chronic Disease Self- Management Questionnaire. The questionnaire used for this study will assess Chronic Disease Self-Management participant health behaviors and overall health before and after a six-week workshop.
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Withdrawal of Proposed Exemptions
Document Number: 2021-07760
Type: Notice
Date: 2021-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (HHS or ``The Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. This Notice announces HHS's and the Food and Drug Administration's (FDA or ``the Agency'') withdrawal of the proposed exemptions for the 83 class II devices and 1 unclassified device. The comment period for the proposed class II and unclassified device exemptions closed on March 15, 2021. HHS and FDA are withdrawing the proposed exemptions after reviewing the Notice, its comments, inquiries to FDA, and other relevant information, and determining that the proposed exemptions and bases for them are flawed.
Medical Devices; Class I Surgeon's and Patient Examination Gloves
Document Number: 2021-07759
Type: Notice
Date: 2021-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (HHS or ``the Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or ``the Agency'') have reviewed the prior determination, including the record supporting it, and believe that the determination is flawed. This notice explains the basis for HHS and FDA's current view that the seven types of reserved class I devices identified in the January 15, 2021, Notice require a premarket notification, and explains why the reasoning supporting the prior determination was unsound. HHS and FDA are seeking comment on the matters discussed in this notice and will issue a future notice in the Federal Register containing a final determination regarding the class I medical gloves listed in the January 15, 2021, Notice.
Submission for OMB review; 30-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction
Document Number: 2021-07754
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on April 9, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.
Submission for OMB Review; OPRE Data Collection for Supporting Youth To Be Successful in Life (SYSIL) (New Collection)
Document Number: 2021-07752
Type: Notice
Date: 2021-04-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting approval from the Office of Management and Budget (OMB) for a new data collection. The Supporting Youth to be Successful in Life study (SYSIL) will build evidence on how to end homelessness among youth and young adults with experience in the child welfare system by continuing work with an organization who conducted foundational work as part of the Youth At-Risk of Homelessness project (OMB Control Number: 0970-0445). SYSIL will provide important information to the field by designing and conducting a federally led evaluation of a comprehensive service model for youth at risk of homelessness.
Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services
Document Number: 2021-07762
Type: Proposed Rule
Date: 2021-04-15
Agency: Department of Health and Human Services
The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise the rules issued on March 4, 2019, establishing standards for compliance by family planning services projects authorized by Title X of the Public Health Service Act. Those rules have undermined the public health of the population the program is meant to serve. The Department proposes to revise the 2019 rules by readopting the 2000 regulations, with several modifications needed to strengthen the program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-07746
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-07745
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-07735
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2021-07712
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-07711
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2021-07710
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-07709
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-07708
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Evaluation of LifeSet (New Collection)
Document Number: 2021-07688
Type: Notice
Date: 2021-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) is proposing a new information collection activity to assess the impact and implementation of LifeSet, a program that provides services and supports to young adults ages 17 to 21 with previous child welfare involvement. Data collection efforts will include accessing administrative data from the child welfare agency, program, and other private and governmental databases; surveys of young adults (participants and those receiving services as usual); interviews and focus groups with program and child welfare agency administrators and staff; interviews and focus groups with young adult program participants; and interviews with other program stakeholders.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022
Document Number: 2021-07556
Type: Proposed Rule
Date: 2021-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the proposed rule includes a proposed forecast error adjustment for FY 2022, proposes updates to the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), proposes to rebase and revise the SNF market basket, proposes to implement a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a methodology to recalibrate the PDPM parity adjustment. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a proposal to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2021-07641
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Document Number: 2021-07639
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Mark Reinhard: Final Debarment Order
Document Number: 2021-07638
Type: Notice
Date: 2021-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mark Reinhard from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Reinhard was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reinhard was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Reinhard has not responded to the notice. Mr. Reinhard's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2021-07622
Type: Notice
Date: 2021-04-14
Agency: Department of Health and Human Services
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.