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

Establishment of the Office of Climate Change and Health Equity
Document Number: 2021-18794
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Document Number: 2021-18789
Type: Notice
Date: 2021-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Curative Inc. for the Curative SARS-Cov-2 Assay. FDA revoked the Authorization on July 15, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Curative Inc. on June 16, 2021. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2021-18777
Type: Notice
Date: 2021-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. FDA revoked the Authorizations for the decontamination and bioburden reduction systems for personal protective equipment on June 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. FDA revoked the umbrella Authorizations issued to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators manufactured in China (China FFR Authorization), and to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators (Imports FFR Authorization) on June 30, 2021, under the FD&C Act. The revocations, which each include an explanation of the reasons for the revocation, are reprinted in this document.
Updating CDC's Contraception Guidance Documents: U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use
Document Number: 2021-18769
Type: Notice
Date: 2021-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On August 19, 2021 the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published a notice to obtain comment on CDC's contraception recommendations. Two guidance documents, U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC) and U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), provide evidence-based recommendations to assist health care providers when counseling patients on contraceptive choice and use. The notice did not include the mailing address to submit public comment. This notice provides the mailing address for the public.
Submission for OMB Review; 30-Day Comment Request; Evaluation of Office of Acquisitions System (OASYS) and FFRDC Contract Administration System (FCAS) Vendor Portals National Cancer Institute (NCI)
Document Number: 2021-18767
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Intent To Award a Supplement for the Lifespan Respite Program: Special Projects To Strengthen Program Development, Implementation and Sustainability
Document Number: 2021-18748
Type: Notice
Date: 2021-08-31
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 Center for Health Policy Development.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18728
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2021-18727
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2021-18726
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: 2021-18725
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-18694
Type: Notice
Date: 2021-08-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on May 25, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision
Document Number: 2021-18688
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for the 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.
Submission for OMB Review; Monitoring and Compliance for ORR Care Provider Facilities (0970-0564)
Document Number: 2021-18660
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow the Unaccompanied Children (UC) Program to monitor its care provider facilities for compliance with federal and state laws and regulations, licensing and accreditation standards, ORR policies and procedures, and child welfare standards. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection.
Submission for OMB Review; Legal Services for Unaccompanied Children (0970-0565)
Document Number: 2021-18658
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow the Unaccompanied Children (UC) Program to provide legal services to UC. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. This is a time sensitive request because all of these forms are already in use and must continue to be in use in order for the UC Program to meet its statutory obligations.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2021-18075
Type: Notice
Date: 2021-08-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2021-18649
Type: Notice
Date: 2021-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2021-18647
Type: Notice
Date: 2021-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Emergency Information Collection Clearance Request for Public Comment
Document Number: 2021-18636
Type: Notice
Date: 2021-08-30
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 proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Safety and Performance Based Pathway Device-Specific Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-18592
Type: Notice
Date: 2021-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathwayspecifically, ``Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff'' and ``Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidance documents are not final nor are they in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Center on Law and Elder Rights-Resource Support and User Satisfaction; OMB #0985-0060
Document Number: 2021-18590
Type: Notice
Date: 2021-08-30
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the National Center on Law and Elder Rights- Resource Support and user Satisfaction data collection used by ACL to provide aging, disability, and related legal professionals with training and complex case consultations and support for demonstration projects regarding contractually identified priority legal topics.
Agency Information Collection Activities; Proposed Collection; Comment Request; Process Evaluation of the Aging Network and Its Return on Investment; OMB #0985-New
Document Number: 2021-18588
Type: Notice
Date: 2021-08-30
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a revision to the information collection requirements related to the Process Evaluation of the Aging Network and its Return on Investment.
Electronic Common Technical Document; Data Standards; Specifications for Electronic Common Technical Document Validation Criteria
Document Number: 2021-18587
Type: Notice
Date: 2021-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that FDA will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria.
Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10 Milligrams
Document Number: 2021-18586
Type: Notice
Date: 2021-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge). Breckenridge requested withdrawal of this application and has waived its opportunity for a hearing.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-18564
Type: Notice
Date: 2021-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of the Advisory Panel on Outreach and Education (APOE) September 15, 2021 Virtual Meeting
Document Number: 2021-18472
Type: Notice
Date: 2021-08-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Medicare Program; National Expansion Implementation for All Remaining States and Territories of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports
Document Number: 2021-18543
Type: Notice
Date: 2021-08-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the implementation dates for all remaining states and territories for the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-18541
Type: Notice
Date: 2021-08-27
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 CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for revision to the previously approved project used to monitor and evaluate performances and practices among national laboratories for M. tuberculosis susceptibility testing.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-18540
Type: Notice
Date: 2021-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-18539
Type: Notice
Date: 2021-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-18538
Type: Notice
Date: 2021-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Data Collection for the Integrating Financial Capability and Employment Services Project (New Collection)
Document Number: 2021-18520
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Integrating Financial Capability and Employment Services Project. The objective of this project is to better understand financial capability interventions offered in the context of delivering employment and training services for low-income adults. This descriptive study intends to use this information to build more evidence about the extent, forms, and practices of incorporating financial capability interventions into organizations delivering employment and training services for low-income adult populations, and to help establish a basis for future research and evaluation in this area. This project will focus on organizations delivering employment and training services that also offer financial capability services to low-income adults.
Proposed Information Collection Activity; Head Start Family and Child Experiences Survey (FACES) (OMB #0970-0151)
Document Number: 2021-18519
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new wave of the Head Start Family and Child Experiences Survey (FACES) as well as a follow-up to a special data collection fielded in the fall of 2021.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-18508
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-18507
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-18506
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2021-18505
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-18501
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-18493
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-18492
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18491
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2021-18454
Type: Notice
Date: 2021-08-27
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 Board of Scientific Counselors, National Center for Health Statistics BSC, NCHS). This meeting is open to the public.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-18452
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18451
Type: Notice
Date: 2021-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Evaluation of the Family Unification Program-Extension (OMB #0970-0514)
Document Number: 2021-18438
Type: Notice
Date: 2021-08-27
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) requests an extension to continue data collection for the Evaluation of the Family Unification Program (FUP) (OMB #0970-0514). Information collection activities requested include interviews, focus group discussions, program data, and administrative data collection.
Advisory Committee on Immunization Practices (ACIP); Amended Notice of Meeting
Document Number: 2021-18453
Type: Notice
Date: 2021-08-26
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. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Notice of Meetings
Document Number: 2021-18428
Type: Notice
Date: 2021-08-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-18403
Type: Notice
Date: 2021-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
National Institute of Dental & Craniofacial Research; Amended Notice of Meeting
Document Number: 2021-18401
Type: Notice
Date: 2021-08-26
Agency: Department of Health and Human Services, National Institutes of Health