Department of Health and Human Services March 3, 2022 – Federal Register Recent Federal Regulation Documents

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: The necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Eduardo Navarro 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. Navarro was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Mr. Navarro was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 24, 2021 (30 days after receipt of the notice), Mr. Navarro had not responded. Mr. Navarro's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring George Kuiper 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. Kuiper was convicted of multiple felony offenses: One count of smuggling, one count of conspiracy to smuggle goods into the United States and to introduce into interstate commerce unapproved drugs, and one count of introduction into interstate commerce of unapproved drugs. The factual basis supporting Mr. Kuiper's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kuiper 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 December 8, 2021 (30 days after receipt of the notice), Mr. Kuiper had not responded. Mr. Kuiper's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.