Department of Health and Human Services November 26, 2024 – Federal Register Recent Federal Regulation Documents

This notice fulfills an obligation under the Public Health Service Act (PHSA). The act requires the National Coordinator for Health Information Technology to publish on the Office of the National Coordinator for Health Information Technology's public internet website, and in the Federal Register, the trusted exchange framework and common agreement developed under the PHSA. This notice is for publishing an updated version of the Common Agreement (Version 2.1).

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices." This guidance provides information regarding FDA recommendations and general principles to be referenced by holders of premarket approval applications (PMAs) and humanitarian device exemptions (HDE) for class III devices sterilized by ethylene oxide (EtO) whose products are affected by the potential, actual, or temporary stop or reduction of operations at a sterilization facility, if they wish to have FDA consider whether the exercise of enforcement discretion relating to the implementation of certain types of sterilization site changes is appropriate. FDA is issuing this guidance to provide an enforcement discretion policy to help proactively address manufacturing limitations or supply chain issues due to disruptions caused by closures or potential closures of sterilization facilities that use EtO as a medical device sterilant during the time in which manufacturers are transitioning to compliance with certain new requirements. FDA believes that the enforcement discretion policy described in this guidance may help address concerns during this time related to potential sterile medical device impacts affecting certain devices sterilized by EtO, help mitigate possible interruptions in sterile device processing, and help maintain adequate supplies of finished sterile medical devices. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 National Notifiable Diseases Surveillance System. This data collection provides the official source of statistics in the United States for nationally notifiable conditions.