Department of Health and Human Services June 9, 2023 – Federal Register Recent Federal Regulation Documents

Proposed Information Collection Activity; Medical Health Assessment Form and Public Health Investigation Forms, Tuberculosis and Non-Tuberculosis Illness (Office of Management and Budget 0970-0509); Correction
Document Number: 2023-12334
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) published a document in the Federal Register of June 1, 2023, concerning request for comments on a 3-year extension of the Mental Health Assessment Form (formerly the Health Assessment Form) and Public Health Investigation Forms, Active Tuberculosis (TB) and Non-TB Illness (Office of Management and Budget (OMB) #0970-0509, expiration December 31, 2023). The published notice contained an incorrect title and a typo in the Description section.
Medicare Program; Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage
Document Number: 2023-12308
Type: Rule
Date: 2023-06-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final action establishes a policy concerning the treatment of patient days associated with persons enrolled in a Medicare Part C (also known as ``Medicare Advantage'') plan for purposes of calculating a hospital's disproportionate patient percentage for cost reporting periods starting before fiscal year (FY) 2014 in response to the Supreme Court's ruling in Azar v. Allina Health Services, 139 S. Ct. 1804 (June 3, 2019).
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
Document Number: 2023-12293
Type: Notice
Date: 2023-06-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2024, expiration date.
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2023-12326
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2023-12325
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2023-12324
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2023-12379
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-12361
Type: Notice
Date: 2023-06-09
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 Feeding My Baby and Me: Infant Feeding Practices Study III (FMB&M-IFPS III). This study is designed to understand the current state of mothers' intentions, behaviors, feeding decisions, and practices from pregnancy through their child's first two years of life.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-12360
Type: Notice
Date: 2023-06-09
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enterprise Laboratory Information Management System (ELIMS). This data collection is used by CDC to record specimen metadata and patient data related to test order requests submitted by external partners (SPHLs, International organizations, Federal institutions, hospitals, doctor's offices, etc.) to the CDC Infectious Diseases testing laboratories.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-12359
Type: Notice
Date: 2023-06-09
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health/Public Safety Strategies to Reduce Drug Overdose Data Collection. This data collection is designed to collect data on overdose prevention efforts that involve Public Health/Public Safety sectors or to address justice-involved populations at increased risk of overdose.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-12358
Type: Notice
Date: 2023-06-09
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, Menthol-Flavored Tobacco Products Policy Evaluation, which aims to collect data on menthol-flavored tobacco product use, any tobacco use, quit rates, and product switching behaviors among adults 18 years of age and older.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-12357
Type: Notice
Date: 2023-06-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-12356
Type: Notice
Date: 2023-06-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2023-12377
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2023-12376
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2023-12375
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2023-12374
Type: Notice
Date: 2023-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Drug Interaction Studies With Combined Oral Contraceptives; Guidance for Industry; Availability
Document Number: 2023-12370
Type: Notice
Date: 2023-06-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Clinical Drug Interaction Studies With Combined Oral Contraceptives.'' This guidance is intended to help sponsors of investigational new drug applications and new drug applications evaluate the need for drug-drug interaction (DDI) studies with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and risk mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. The guidance finalizes the draft guidance ``Clinical Drug Interaction Studies With Combined Oral Contraceptives'' issued on November 23, 2020.
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