Department of Health and Human Services June 13, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Agency Information Collection Activities: Proposed Collection; Comment Request
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 clearance process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low- burden, and uncontroversial," 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 may be submitted under that umbrella. This notice is intended to advise the public of our intent to reinstate OMB's approval of our generic umbrella (CMS-10398, OMB control number 0938-1148) and all of the individual generic collection of information requests that fall under that umbrella. This notice also provides the public with general instructions for obtaining documents that are associated with such collections and for submitting comments.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.
Medicare and Medicaid Programs: Application by the DNV Healthcare USA, Inc. for Continued CMS-Approval of Its Critical Access Hospital Accreditation Program
This notice acknowledges the receipt of an application from the DNV Healthcare USA, Inc. for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs: Application by the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program
This notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, dba QUAD A, for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Implement Maternal, Infant, and Early Childhood Home Visiting Program 2022 Legislative Changes: Assessment of Administrative Burden; Correction
The Health Resources and Services Administration published a document in the Federal Register of May 28, 2024, concerning an Information Collection Request titled "Implement Maternal, Infant, and Early Childhood Home Visiting Program 2022 Legislative Changes: Assessment of Administrative Burden." The document contained an incorrect "Total Estimated Annualized Burden Hours." The published Federal Register Notice had an estimated average burden per response of 27 hours for the "State and Jurisdiction [Maternal, Infant, and Early Childhood Home Visiting (MIECHV)] Funding Recipient Survey," with the total burden hours for the form being 1,512 hours. The published total estimated burden for the collection was 1,628 hours. This document corrects the estimate so that the average burden per response for the State and Jurisdiction MIECHV Funding Recipient Survey is 14 hours per response, 784 hours for the total estimated burden hours, and 900 hours for the collection.
Jonathan R. Shaver: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Jonathan R. Shaver 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. Shaver 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. Shaver was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 16, 2024 (30 days after receipt of the notice), Mr. Shaver has not responded. Mr. Shaver's failure to respond and request a hearing constitutes a waiver of Mr. Shaver's right to a hearing concerning this matter.
Richard B. Smith III: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Richard B. Smith III 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. Smith was convicted of two felony counts under Federal law, only one of which serves as the basis of this debarment: receiving misbranded drugs in interstate commerce and delivering for pay. The factual basis supporting Mr. Smith's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Smith 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 November 29, 2023 (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 matter.
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