Department of Health and Human Services March 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.'' This guidance provides recommendations regarding the use of restricted delivery systems to limit unintentional ingestion of oral liquid drug products (e.g., oral solution, oral suspension) by children. The recommendations in this guidance apply broadly to oral liquid drug and biological products. FDA's recommendations are intended to minimize the potential for harm due to unintentional ingestions.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Charles Jeffrey Edwards from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Edwards was convicted, as defined in the FD&C Act, of two felony counts under federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Edwards was given notice of the proposed permanent debarment and was given an opportunity to request a hearing within the timeframe prescribed by regulation to show why he should not be debarred. As of November 15, 2019 (30 days after receipt of the notice), Mr. Edwards had not responded. Mr. Edwards's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

In response to recently issued OPM guidance to agencies on reducing non-essential travel, this notice announces a change to a meeting of the National Advisory Council for Healthcare Research and Quality.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's document entitled ``Tobacco Products: Required Warnings for Cigarette Packages and Advertisements,'' which establishes new required cigarette health warnings for cigarette packages and advertisements.

The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.

In accordance with section 351a of the Public Health Service Act, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS; hereafter referred to as HHS/CDC) has initiated a review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety (HHS select agents and toxins). This review was initiated within two years of the completion of the previous review. In reviewing the list, HHS/CDC is considering whether to propose amending the HHS list of select agents and toxins.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jagen Lewicki 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. Lewicki was convicted, as defined in the FD&C Act, of one felony count under Federal law for conspiracy to distribute Human Growth Hormone (HGH) imported from China for a purpose other than the treatment of a disease or other recognized medical condition, the use of which had been authorized by the Secretary of Health and Human Services, and not pursuant to an order of a physician, in violation of the FD&C Act. The factual basis supporting this felony conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lewicki was given notice of the proposed debarment and, in accordance with the FD&C Act and FDA's regulations, was given an opportunity to request a hearing to show why he should not be debarred. As of October 28, 2019 (30 days after receipt of the notice), Mr. Lewicki had not responded. Mr. Lewicki's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Richard Jodoin for a period of 5 years from importing any drug into the United States. FDA bases this order on a finding that Mr. Jodoin was convicted, as defined in the FD&C Act, of one felony count under Federal law for unlawfully importing and attempting to import a controlled substance into the United States. The factual basis supporting the conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Jodoin was given notice of the proposed debarment and, in accordance with the FD&C Act, was given an opportunity to request a hearing to show why he should not be debarred. As of November 9, 2019 (30 days after receipt of the notice), Mr. Jodoin had not responded. Mr. Jodoin's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA or Agency) has determined that the potassium chloride drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products, if all other legal and regulatory requirements are met.