The Department of Health and Human Services (HHS) provides notice 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 (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

Original title: “Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IZERVAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; IZERVAY”

The Health Resources and Services Administration (HRSA) published a Federal Register Notice on October 1, 2025, with proposed updates to the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The proposed updates specifically relate to recommendations for Screening for Cervical Cancer. Recommendations to update the Guidelines are developed under a HRSA-funded cooperative agreement, the Women's Preventive Services Initiative (WPSI), for consideration by HRSA. Under this agreement

Original title: “Update to the Women's Preventive Services Guidelines”

The Department of Health and Human Services, Administration for Children and Families proposes to amend the Child Care and Development Fund (CCDF) regulations (45 CFR part 98) to reduce costs and burden for states and territories administering the CCDF program. It proposes rescinding the requirements to limit family co-payments to 7 percent of family income, to provide some direct services through grants or contracts, to pay providers based on child's enrollment, and to pay providers prospective

Original title: “Restoring Flexibility in the Child Care and Development Fund (CCDF)”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AUGTYRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRENZAVVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MEDIBEACON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON”

Deputy Secretary of HHS and Acting CDC Director Jim O'Neill signed a decision memorandum

Original title: “CDC Acts on Presidential Memorandum to Update Childhood Immunization Schedule”

The Food and Drug Administration (FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for primidone suspension, 250 mg/5 mL.

Original title: “Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document

Original title: “Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability”

The Drug Enforcement Administration (DEA) jointly with the Department of Health and Human Services (HHS) is issuing a fourth extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2026.

Original title: “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the United Nuclear Corporation in Hematite, Missouri, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

Original title: “Decision To Evaluate a Petition To Designate a Class of Employees From United Nuclear Corporation in Hematite, Missouri, To Be Included in the Special Exposure Cohort”

The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

Original title: “FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products”

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR)s for fiscal years 2026 through 2030. In this notice, FDA is announcing the OMOR fee rates for fiscal year (FY) 202

Original title: “Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026”

This proposed rule focuses on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking. This proposed rule seeks to reduce burden, offer flexibility to both developers and providers, and support innovation through the removal and revisions of certain certification criteria and regulatory provisions. This prop

Original title: “Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROMVIMZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADZYNMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZELSUVMI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OJEMDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA”

The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting partial exemption from the premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices. Specifically, the petition requests exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition are met: radiological computer-assi

Original title: “Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices”