Department of Health and Human Services January 4, 2021 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress. The proposed survey will be used to determine what food defense activities, if any, State, local, territorial, and/or tribal (SLTT) agencies have completed to date. The information will be compared to the initial baseline data collected by State(s) in 2018.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

The Food and Drug Administration (FDA or Agency) is issuing an order permanently debarring Jerrod Nichols Smith 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. Smith was convicted of multiple felony counts under Federal law for conduct that relates to the regulation of a drug product under the Federal, Food, Drug, and Cosmetic Act (the FD&C Act). Mr. Smith 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 September 27, 2020 (30 days after receipt of the notice), Mr. Smith had not responded. Mr. Smith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

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 Joseph A. Rowan 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 Joseph A. Rowan was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Rowan was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of August 6, 2020 (30 days after receipt of the notice), Mr. Rowan had not responded. Mr. Rowan's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.