Department of Health and Human Services October 6, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry.'' We are issuing this guidance document to protect public health by helping to stabilize the supply of infant formula in the United States and to maintain a consistent supply of a variety of infant formula products. Under the guidance, we intend to exercise enforcement discretion until January 6, 2023, for infant formula products that are listed in letters of enforcement discretion that FDA has issued or will issue to specific manufacturers, in response to information provided under our May 2022 ``Infant Formula Enforcement Discretion Policy: Guidance for Industry,'' which remains in effect until November 14, 2022. For those manufacturers that wish to continue to market specific products in the United States under enforcement discretion after January 6, 2023, the guidance further details additional steps that manufacturers can take toward lawful marketing of such productsand the timeline under which such steps should be takenfor FDA to consider the continued exercise of enforcement discretion. This guidance document will help infant formula manufacturers meet applicable regulatory requirements while ensuring that consumers have continued access to formulas that are currently fulfilling the needs of infants consuming such products. We are also 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 (PRA). The proposed collection pertains to the submission of information necessary to facilitate FDA's exercise of enforcement discretion, as discussed in the guidance document.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee 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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee 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.