Department of Health and Human Services August 9, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Clozapine Risk Evaluation and Mitigation Strategy
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee (the Committees). The general function of the Committees 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.
Notice of Supplemental Award; Infant-Toddler Court Program-National Resource Center
HRSA is providing up to $1,750,000 in supplemental award funds in federal fiscal year (FY) 2024 to the current recipient of the Infant-Toddler Court Program (ITCP)National Resource Center (NRC) award, to expand activities to help lead nationwide improvements to child welfare and early childhood systems.
Notice of Supplemental Award; Early Childhood Developmental Health Systems Program
HRSA is providing supplemental award funds in federal fiscal year (FY) 2024 to the current recipient of the Early Childhood Developmental Health Systems Program (ECDHS) cooperative agreement (HRSA-22-091), to support existing activities relating to early childhood developmental health services.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the Environmental Health Specialists Network (EHS-Net) Program. The goal of this food safety research program is to collect data in retail food establishments that will identify and address environmental factors associated with retail-related foodborne illness and outbreaks.
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 Adverse Health Outcomes Associated with Medical Tourism Surveillance System. This information collection project will help CDC detect outbreaks and trends in cases to identify prevention measures and improve awareness of risks associated with medical tourism.
Pre-Market Animal Food Ingredient Review Programs; Request for Comments
The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs to determine if changes are needed to promote their efficiency. Specific questions and information requests are included in this notice to help guide input from stakeholders and other members of the public.
Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This draft guidance describes FDA's interim AFIC process and explains one way FDA intends to work with firms that are developing animal food ingredients after the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and generally recognized as safe (GRAS) Notification programs. The new AFIC process will provide an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process will also allow for public awareness of and input on such ingredients. In addition, this draft guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases." This guidance is intended to assist sponsors in identifying an optimized dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials. In addition, this guidance does not address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytics, microbiota, or cancer vaccines, nor does it specifically address pediatric drug development. However, some of the principles outlined may be applicable to these therapeutic modalities or to dosage optimization for pediatric patients. This guidance finalizes the draft guidance of the same title "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" issued on January 23, 2023.
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Behavioral Risk Factor Surveillance System (BRFSS). BRFSS is an annual state-based health survey that produces information on health risk behaviors, health conditions, and preventive health practices that are associated with chronic diseases, infectious diseases, and injury.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 extension without change of the information collection project "Nursing Home Survey on Patient Safety Culture Database," OMB No. 0935-0195.
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bacillus Calmette-Gu[eacute]rin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment." The purpose of this guidance is to assist sponsors in the development of drug and biological products for the treatment of patients with bacillus Calmette-Gu[eacute]rin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). This draft guidance reflects proposed revisions to the final guidance entitled "BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment," published in February 2018, and incorporates changes based on review experience as well as the evolving landscape of drug development in bladder cancer, as noted by external experts.
Submission for OMB Review; Child Abuse and Neglect Background Checks for Child Care and Early Education Project (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF) is proposing an information collection activity for the Child Abuse and Neglect Background Checks for Child Care and Early Education (CAN Checks for CCEE) Project. The goal of the project is to better understand how states and territories use findings from CAN registry background checks, as required by the Child Care and Development Block Grant Act of 2014 (CCDBG), to make child care employment eligibility determinations. The study will also be used to understand state and territory variation, facilitators, and challenges in implementing CAN registry background checks; and explore any resulting within- or across-state/territory equity implications.
HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology (HHSAR Case 2023-001)
The Department of Health and Human Services (HHS) is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to implement requirements to procure health information technology (health IT) that meets standards and implementation specifications (standards) adopted by the Office of the National Coordinator for Health Information Technology (ONC) in the following parts: Acquisition of Information Technology and Solicitation Provisions and Contract Clauses.
Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #293 entitled "FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients." This draft guidance, when finalized, will communicate FDA's enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication (OP) after the expiration of the Agency's memorandum of understanding (MOU) with AAFCO. The current MOU, which expires in October 2024, will not be renewed.
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