Department of Health and Human Services June 5, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Submission for Office of Management and Budget (OMB) Review; Annual Report on Children in Foster Homes and Children in Families Receiving Payments in Excess of the Poverty Income Level From a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #: 0970-0004)
The Office of Family Assistance (OFA), Administration for Children and Families (ACF) is requesting a three-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #: 0970-0004, expiration 6/30/2024). There are no changes requested to the form.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food.
Healthcare Infection Control Practices Advisory Committee; Cancellation of Meeting
This is to notify the public that the June 6-7, 2024, meeting of the Healthcare Infection Control Practices Advisory Committee is cancelled.
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions." The draft guidance document and BIMO Technical Conformance Guide provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by FDA's Center for Biologics Evaluation and Research (CBER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, BIMO inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by CBER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of BLA and NDA content for the planning and conduct of CBER BIMO inspections, using the electronic Common Technical Document.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions related to Medical Device Recall Authority.
Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting Reports (Office of Management and Budget#: 0970-0409)
The Administration for Children and Families (ACF), Office of Early Childhood Development (ECD) is requesting revisions to the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program: Guidance for Submitting Reports (Office of Management and Budget (OMB)#: 0970-0409; expiration March 31, 2026) and a 3-year extension of approval.
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Processes and Practices Applicable to Bioresearch Monitoring Inspections." The draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA's Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The draft guidance is intended to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.
Notice of Meeting
The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on "Evaluation and Coordinating Center for the AHRQ/PCORI Learning Health System Embedded Scientist Training and Research Centers (U18)"
Proposed Information Collection Activity; Child and Family Services Reviews (OMB #0970-0214)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the activities associated with the Child and Family Services Reviews information collection (Office of Management and Budget (OMB) #0970-0214, expiration January 31, 2025). There are no changes requested to the collection.
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.
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