Department of Health and Human Services July 24, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jin Su Park for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Park was convicted of one felony count under Federal law for Importing Merchandise Contrary to Law, Causing an Act to be Done and of one felony count of introducing Misbranded Drugs into Interstate Commerce, causing an Act to be Done. The factual basis supporting both of Mr. Park's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Park was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 19, 2019 (30 days after receipt of the notice), Mr. Park had not responded. Mr. Park'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 John Seil Lee for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lee was convicted of one felony count under Federal law for conspiracy to import merchandise contrary to law and to defraud the United States and of one felony count under Federal law for importing merchandise contrary to law. The factual basis supporting both of Mr. Lee's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lee was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 15, 2020 (30 days after receipt of the notice), Mr. Lee had not responded. Mr. Lee's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Alien Children (UAC) Program to provide services to UAC as required by statute and ORR policy.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Alien Children (UAC) Program to place UAC referred to federal agencies into care provider facilities and to transfer UAC within the ORR care provider network.

The Food and Drug Administration (FDA) 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 Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``COVID-19 REVISION SUPPLEMENT APPLICATION ZHS1 HSR-0 (03) HEALTHCARE SYSTEMS & VALUE RESEARCH (HSVR).'' This SEP meeting will be closed to the public.

To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), the Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the deadline and contents of submission of an annual summary. This proposed rule, if finalized, would implement the statutory requirement under provisions of the Right to Try Act for submission of an annual summary by sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.