Department of Health and Human Services September 16, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Geriatric Information in Human Prescription Drug and Biological Product Labeling.'' This draft guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling. The goal of this draft guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs and biological products in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients. This draft guidance provides additional examples of geriatric use statements in labeling and examples of when the labeling regulations authorize FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection. We are withdrawing the guidance for industry entitled ``Content and Format for Geriatric Labeling'' (October 2001) and replacing it with this draft guidance.

The Department of Health and Human Services, National Institutes of Health published a Final rule; technical amendments document in the Federal Register on September 1, 2020. That document requires a correction in the SUPPLEMENTARY INFORMATION section.

HRSA is providing notice of a technical issue in the collection of public comments responding to a previous Federal Register notice, dated August 20, 2020, submitted to the American Academy of Pediatrics through its publicly available web-based portal during the period from August 20-27, 2020. After receiving no comments during this timeframe, a routine test found that the database that records public comments was not connected to the comment form on the web page. This technical issue has been resolved and the system is functional and collecting comments. HRSA encourages members of the public who may have previous submitted comments to resubmit and is extending the time period for public comments in response to proposed updates to the Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''). The Bright Futures Periodicity Schedule is part of the HRSA-supported preventive service guidelines for infants, children, and adolescents under, and is maintained, in part, through a national cooperative agreement, the Bright Futures Pediatric Implementation Program.