Department of Health and Human Services November 7, 2023 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is issuing a final order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. QCA is a metabolite of carbadox that FDA has judged does not present a carcinogenic risk. FDA is revoking the approved method for carbadox based on its determination that the method is inadequate to monitor the residue of carcinogenic concern in compliance with FDA's operational definition of no residue because there is no established relationship between the concentration of QCA residues as measured by the approved method and the concentration of the residue of carcinogenic concern.

This notice fulfills an obligation under the Public Health Service Act (PHSA), which 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 common agreement developed under the PHSA. This notice is for publishing an updated version of the Common Agreement, version 1.1.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.