Department of Health and Human Services November 29, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled ``Food Labeling: Nutrient Content Claims; Definition of Term `Healthy' '' that appeared in the Federal Register of September 29, 2022. We are taking this action in response to a request from stakeholders to extend the comment period to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry.'' The guidance document informs members of the medical and scientific community and other interested persons notice that, at this time, we intend to exercise enforcement discretion with respect to the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies under limited circumstances described in the guidance. The guidance announced in this notice finalizes the draft guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies'' dated March 2016, and supersedes the guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies'' dated July 2013.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jennings Ryan Staley for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Staley was convicted of one felony count under Federal law for Importation Contrary to Law. The factual basis supporting Mr. Staley's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Staley was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Staley provided notice to FDA that he acquiesced to the debarment; FDA received that notice on October 6, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.