Department of Health and Human Services April 12, 2021 – Federal Register Recent Federal Regulation Documents

Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
Document Number: 2021-07452
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of October 13, 2020. In that notice, FDA announced a public meeting, which was held on November 16, 2020, and requested public input on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. Specifically, the Agency requested comments on the potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs. We are taking this action in response to technical difficulties submitting comments to the Federal eRulemaking portal.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2021-07435
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Child Care Improper Payments Data Collection Instructions
Document Number: 2021-07425
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families is proposing revisions to an approved information collection, Child Care Improper Payments Data Collection Instructions (OMB #0970-0323, expiration 10/ 31/2021). There are minor changes requested to the form.
Proposed Information Collection Activity; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (0970-0555)
Document Number: 2021-07420
Type: Notice
Date: 2021-04-12
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 for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Document Number: 2021-07397
Type: Notice
Date: 2021-04-12
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.
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
Document Number: 2021-07396
Type: Notice
Date: 2021-04-12
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07379
Type: Notice
Date: 2021-04-12
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 TEMPORARY HALT IN RESIDENTIAL EVICTIONS TO PREVENT THE FURTHER SPREAD OF COVID-19. The information collection originally pertained to the September 4, 2020 CDC Order of the same name that temporarily halts residential evictions of covered persons for nonpayment of rent from September 4, 2020, through December 31, 2020. The Consolidated Appropriations Act, 2021, statutorily extended CDC's Order until January 31, 2021. On January 29, 2021, the CDC Director renewed the Order until March 31, 2021. As of March 31, the Order is further extended until June 30, 2021. The Declaration in this information collection request will serve as an attestation by a tenant, lessee, or resident that they meet the criteria therein, to prevent an eviction proceeding per the Order issued by the CDC.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-07378
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07377
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next ADUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07375
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Generic Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program. The meeting will be open to the public.
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07374
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next AGDUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07373
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. The meeting will be open to the public.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program
Document Number: 2021-07343
Type: Proposed Rule
Date: 2021-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. In addition, this proposed rule includes proposals for the IRF Quality Reporting Program (QRP).
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