Department of Health and Human Services – 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 Jonathan Corbett Cosie 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. Cosie was convicted of two felony counts under Federal law for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead. The factual basis supporting Mr. Cosie's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Cosie 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 6, 2025 (30 days after receipt of the notice), Mr. Cosie had not responded. Mr. Cosie'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 Harpreet Singh 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 Mr. Singh was convicted of multiple felony offenses, which serve as the basis for this debarment, that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol; one felony count under Federal law for fraudulent importation and transportation of goods; one felony count under Federal law for conspiracy to launder money; and one felony count under Federal law for conspiracy to obstruct justice. The factual basis supporting Mr. Singh's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Singh 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 20, 2024 (30 days after receipt of the notice), Mr. Singh had not responded. Mr. Singh'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 announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GOMEKLI (mirdametinib), approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, "IHS Loan Repayment Program (LRP)."

This is to notify the public that the February 26-28, 2025, meeting of the Advisory Committee on Immunization Practices (ACIP) was cancelled and will be rescheduled.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0036, "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery." This notice announces our intent to submit this previously approved information collection, which expires February 28, 2025, to the OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.

The Department of Health and Human Services (HHS or Department) published a direct final rule entitled "Name Change From Office of Child Support Enforcement to Office of Child Support Services" in the Federal Register on December 31, 2024, which was to become effective March 3, 2025. HHS is reopening the public comment period and delaying the effective date for the purpose of reviewing any questions of fact, law, and policy that the rule may raise.

This notice announces an administrative hearing to be held on April 2, 2025, by way of video, or at the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Idaho's Medicaid SPA 24-0015.

This notice acknowledges the approval 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 Outpatient Physical Therapy programs that wish to participate in the Medicare or Medicaid programs.

On January 16, 2025, the Department of Health and Human Services published a final rule to make effective the exemptions that were previously proposed for a new Privacy Act system of records, "NIH Police Records," maintained by the National Institutes of Health (NIH), from certain requirements of the Act. That final rule was originally scheduled to take effect on February 18, 2025. This document announces that the effective date is delayed until March 21, 2025, in response to the memorandum titled "Regulatory Freeze Pending Review," issued by the President on January 20, 2025.