Department of Health and Human Services August 31, 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