Department of Health and Human Services August 3, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Agency Information Collection Request. 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.'' This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS) database.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2023; Changes to the Requirements for the Director of Food and Nutrition Services and Physical Environment Requirements in Long-Term Care Facilities
This final rule updates payment rates; forecast error adjustments; diagnosis code mappings; the Patient Driven Payment Model (PDPM) parity adjustment; the SNF Quality Reporting Program (QRP); and the SNF Value-Based Purchasing (VBP) Program. It also establishes a permanent cap policy to smooth the impact of year-to-year changes in SNF payments related to changes in the SNF wage index. We also announce the application of a risk adjustment for the SNF Readmission Measure for COVID-19 beginning in FY 2023. We are finalizing changes to the long-term care facility fire safety provisions referencing the National Fire Protection Association (NFPA)[supreg] Life Safety Code, and Director of Food and Nutrition Services requirements.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
NIH Request for Information (RFI) on NIH-Wide Strategic Plan for Research on the Health of Women
The Office of Research on Women's Health (ORWH) is updating the National Institutes of Health (NIH) Strategic Plan for Research on the Health of Women. NIH is publishing this Notice to solicit input from the basic, clinical, and translational scientists; advocacy and patient communities; and the public on topics under consideration for the next strategic plan.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 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 Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) Special Exposure Cohort Petitions. This information collection project permits respondents to submit petitions to HHS requesting the addition of classes of employees to the Special Exposure Cohort under EEOICPA.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and Gas Extraction. This project is designed to evaluate oil and gas extraction workers' sleep, fatigue, and other related factors, and their relationship to risks associated with the industry.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-BUTINACA; Adinazolam; Bromazolam; Protonitazene (Propoxynitazene); Etazene (Etodesnitazene); Etonitazepyne (N-Pyrrolidino etonitazene); 2-Methyl-AP-237; Alpha-PiHP; 3-Methylmethcathinone (3-MMC); Zopiclone; Request for Comments
The Food and Drug Administration (FDA or Agency) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).
Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisins present in swine feed. This action is in response to a food additive petition filed by Biomin GmbH.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Advisory Committee; Blood Products Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products 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 Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2024, expiration date.
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