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

Results 51 - 100 of 254
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-08573
Type: Notice
Date: 2021-04-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of the Director, National Institutes of Health Notice of Meeting
Document Number: 2021-08554
Type: Notice
Date: 2021-04-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-08553
Type: Notice
Date: 2021-04-26
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2021-08551
Type: Notice
Date: 2021-04-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-08548
Type: Notice
Date: 2021-04-26
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.
Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal Use); Correction
Document Number: 2021-08241
Type: Proposed Rule
Date: 2021-04-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting a notification entitled ``Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal Use)'' that appeared in the Federal Register of November 27, 2020. The document was published with the incorrect docket number. This document corrects that error.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-08538
Type: Notice
Date: 2021-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-08515
Type: Notice
Date: 2021-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Model Informed Drug Development Approaches for Immunogenicity Assessments; Public Workshop
Document Number: 2021-08487
Type: Notice
Date: 2021-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, in collaboration with the Center for Drug Evaluation and Research, is announcing the following public workshop entitled ``Model Informed Drug Development Approaches for Immunogenicity Assessments.'' The purpose of this public workshop is to discuss the best practices and future directions of quantitative methods for predicting immunogenicity of biological products. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
Document Number: 2021-08480
Type: Notice
Date: 2021-04-23
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 (PRA).
Office of The Director, National Institutes of Health Notice of Closed Meeting
Document Number: 2021-08476
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-08475
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Guidance Documents Related to Coronavirus Disease 2019; Availability
Document Number: 2021-08474
Type: Notice
Date: 2021-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
Document Number: 2021-08470
Type: Notice
Date: 2021-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2021-08467
Type: Notice
Date: 2021-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and are available on FDA's website at the links indicated.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062-Revision
Document Number: 2021-08454
Type: Notice
Date: 2021-04-23
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, below, or any other aspect of the ICR.
Award of a Single-Source Supplement for the National Center for Benefits Outreach and Enrollment
Document Number: 2021-08452
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source supplemental to the current cooperative agreement held by the National Council on Aging (NCOA) for the National Center for Benefits Outreach and Enrollment (NCBOE). The purpose of the NCBOE is to provide technical assistance to states, Area Agencies on Aging, Aging and Disability Resource Centers and service providers who conduct outreach and low-income benefits enrollment assistance, particularly to older individuals with greatest economic need for federal and state programs. The administrative supplement for FY 2021 will be for $3,009,007, bringing the total award for FY 2021 to $14,509,007.
Single-Source Supplement for the Amputee Coalition of America, Inc. for the National Limb Loss Resource Center Cooperative Agreement
Document Number: 2021-08449
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Amputee Coalition of America, Inc. for the National Limb Loss Resource Center (NLLRC). The purpose of this project is to expand on current grant activities occurring across communities. These activities include programs that promote independence, community living, and the adoption of healthy behaviors that promote wellness and prevent and/or reduce chronic conditions associated with limb loss and increase partnerships and collaborations with ACL programs that will benefit all people living with limb loss or limb differences. The administrative supplement for FY 2021 will be for $487,857 bringing the total award for FY 2021 to $3,883,387.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-08437
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2021-08436
Type: Notice
Date: 2021-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Mine Safety and Health Research Advisory Committee (MSHRAC)
Document Number: 2021-08429
Type: Notice
Date: 2021-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a virtual meeting. It is open to the public, limited only by web conference lines (500 web conference lines are available).
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Dose Reconstruction Review (SDRR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-08428
Type: Notice
Date: 2021-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Reviews (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH). 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.
General Mills, Inc.; Filing of Food Additive Petition
Document Number: 2021-08235
Type: Proposed Rule
Date: 2021-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by General Mills, Inc., proposing that the food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in yogurt at a level higher than is currently permitted.
Privacy Act of 1974; Matching Program
Document Number: 2021-08044
Type: Notice
Date: 2021-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and each State-Based Administering Entity (AE), titled ``Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act.''
National Vaccine Injury Compensation Program: Rescission of Revisions to the Vaccine Injury Table
Document Number: 2021-08478
Type: Rule
Date: 2021-04-22
Agency: Department of Health and Human Services
This action rescinds in its entirety the rule entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,'' published in the Federal Register on January 21, 2021 (January 21, 2021 Final Rule).
Proposed Collection; 60-Day Comment Request Inclusion Enrollment Report Form (OD)
Document Number: 2021-08407
Type: Notice
Date: 2021-04-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Meeting of the COVID-19 Health Equity Task Force; Correction
Document Number: 2021-08403
Type: Notice
Date: 2021-04-22
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register on April 19, 2020 giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on April 30, 2021. In accordance with 41 CFR 102-3.150(b), less than 15 calendar days' notice is being given for this meeting due to the exceptional circumstances of the COVID-19 pandemic, the urgent need for the Task Force's advice during the COVID-19 pandemic, and scheduling difficulties. 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 prior to the meeting: www.minorityhealth.hhs.gov/healthequitytaskforce/.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-08377
Type: Notice
Date: 2021-04-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Notice of Meeting
Document Number: 2021-08353
Type: Notice
Date: 2021-04-22
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on May 5 and 6, 2021. The purpose of the meeting is for the Committee to discuss state efforts in implementing the recommendations described in its interim report, ``Best Practices and Recommendations for States,'' progress in states responding to the Committee's State Self-Assessment Survey, and plans for the Committee's final report. The members of the Committee request any examples and comments from the public to inform their work and have also requested input pertaining to the recommendations in its interim report, as well as the State Self-Assessment Survey. Please submit your examples and/or comments to NAC@nhttac.org with the subject ``NAC Comments'' as soon as possible and before May 1, 2021.
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2021-08334
Type: Notice
Date: 2021-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-08333
Type: Notice
Date: 2021-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Early Head Start-Child Care Partnerships Sustainability Study
Document Number: 2021-08258
Type: Notice
Date: 2021-04-21
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) seeks approval to collect information for the Early Head Start-Child Care Partnerships Sustainability Study.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-08252
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-08251
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-08250
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Interstate Administrative Subpoena and Notice of Interstate Lien (OMB #0970-0152)
Document Number: 2021-08249
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Interstate Administrative Subpoena and Notice of Interstate Lien forms (OMB #0970-0152, expiration 7/31/ 2021). There are no changes requested to these forms.
National Library of Medicine Notice of Closed Meetings
Document Number: 2021-08247
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2021-08246
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2021-08245
Type: Notice
Date: 2021-04-21
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: 2021-08244
Type: Notice
Date: 2021-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Acquisition Regulations; Buy Indian Act; Procedures for Contracting; Reopening and Extension of Comment Period
Document Number: 2021-07455
Type: Proposed Rule
Date: 2021-04-21
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service (IHS) is reopening and extending the comment period for the proposed rule entitled ``Acquisition Regulations; Buy Indian Act; Procedures for Contracting.'' This action is being taken in response to requests from stakeholders to extend the comment period to allow additional time for interested persons to submit comments on the proposed rule.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-08275
Type: Notice
Date: 2021-04-20
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.
Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
Document Number: 2021-08117
Type: Notice
Date: 2021-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention, within the Department of Health and Human Services, announces the changes in assisted reproductive technology (ART) data validation selection process; data validation approach; and data discrepancy reporting. The proposed changes to ART data validation were published in the Federal Register on October 20, 2020 (85 FR 66566); public comments and recommendations were requested, and no comments were received. This notice describes changes to the data validation process that will be implemented effective for calendar year 2022.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-08094
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: 2021-08093
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-08092
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-08091
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-08090
Type: Notice
Date: 2021-04-20
Agency: Department of Health and Human Services, National Institutes of Health