Department of Health and Human Services April 13, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Findings of Research Misconduct
Findings of research misconduct have been made against Carlo Spirli, Ph.D. (Respondent), who was an Assistant Professor of Medicine, Department of Digestive Diseases, Yale University (YU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK079005 and P30 DK034989. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on March 28, 2023, and are detailed below.
Submission for Office of Management and Budget (OMB) Review; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Implementation Plan Guidance for Development and Implementation and Implementation and Expansion Grantees
The Administration for Children and Families (ACF), Office of Early Childhood Development (ECD) is requesting Office of Management and Budget (OMB) approval of Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Implementation Plan Guidance for Tribal Home Visiting Development and Implementation Grants (DIG) and Tribal Home Visiting Implementation and Expansion Grants (IEG).
Notice of Expiration of Certain Notifications of Enforcement Discretion Issued in Response to the COVID-19 Nationwide Public Health Emergency
This document is to inform the public that four Notifications of Enforcement Discretion (``Notifications'') issued by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) regarding how the Privacy, Security, and Breach Notification Rules (``HIPAA Rules'') promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act will be applied to certain violations during the COVID-19 nationwide public health emergency (``COVID-19 PHE''), will expire upon expiration of the COVID-19 PHE, which is currently scheduled for 11:59 p.m. on May 11, 2023. Accordingly, upon expiration of the COVID-19 PHE, the Notifications will not provide a basis for OCR to exercise enforcement discretion with respect to imposing penalties for violations of the HIPAA Rules. OCR will continue to exercise enforcement discretion consistent with the Notifications for violations of the HIPAA Rules that occurred during the period that each Notification was in effect. In addition, OCR is affording covered health care providers a 90- calendar day transition period to come into compliance with the HIPAA Rules with respect to their provision of telehealth using non-public facing remote communication technologies.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for the 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.
Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. This final order exempts two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.
Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs'' (Revision 2). This draft guidance (Revision 2) revises the Revision 1 draft guidance of the same name, which was announced in the Federal Register on October 10, 2018. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA).
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin I/S studies. This guidance revises the October 2018 draft guidance entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.''
Over-the-Counter Monograph Order Requests: Format and Content; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Monograph Order Requests (OMORs): Format and Content.'' This draft guidance provides recommendations on the format and content of the information that a requestor should provide in an over-the-counter (OTC) monograph order request (OMOR) and identifies relevant guidance documents to assist requestors in preparing their OMORs.
Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments
The Food and Drug Administration (FDA or Agency) is announcing a request for information and comments on the development of an FDA Data and Technology Strategic Plan. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 30, 2023. This plan will define and shape the future course of FDA's data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate Agency and center strategies.
Submission for Office of Management and Budget Review; Procedures for Requests From Tribal Lead Agencies To Use Child Care and Development Fund Funds for Construction or Major Renovation of Child Care Facilities
The Administration for Children and Families (ACF) is proposing to collect data for the Procedures for Requests from Tribal Lead Agencies to use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities. This information collection was previously approved by the Office of Management and Budget (OMB). The Office of Child Care is proposing to reinstate the information collection with changes.
Agency for Healthcare Research and Quality; Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
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