Department of Health and Human Services December 2, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the isocapnic ventilation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System
The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the esophageal tissue characterization system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Solicitation of Nominations for Membership To Serve on the National Advisory Council on Migrant Health
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health (NACMH or advisory committee). The NACMH advises, consults with, and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of Migrant Health Centers (MHCs) and other entities under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill seven positions on the NACMH.
National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
On April 4, 2018, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a notice of proposed rulemaking (NPRM) to amend the National Vaccine Injury Compensation Program (VICP or Program) Vaccine Injury Table (Table), consistent with the statutory requirement to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women. Specifically, the Secretary sought public comment regarding how the addition of this new category should be formatted on the Table. Through this final rule, the Secretary amends the Table to add ``and/or pregnant women'' after ``children'' to the existing language in Item XVII as proposed in the NPRM. This change will apply only to petitions for compensation under the VICP filed after the effective date of this final rule.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tropical Disease Priority Review Vouchers
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 Tropical Disease Priority Review Vouchers.
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor
The Food and Drug Administration (FDA or we) is classifying the intraoperative orthopedic strain sensor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intraoperative orthopedic strain sensor's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA, Agency, or we) 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 ``Financial Disclosure by Clinical Investigators.''
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 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).
Medical Devices; Neurological Devices; Classification of the Conditioning Tool for Eating Disorders
The Food and Drug Administration (FDA or we) is classifying the conditioning tool for eating disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the conditioning tool for eating disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache
The Food and Drug Administration (FDA or we) is classifying the trunk and limb electrical stimulator to treat headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the trunk and limb electrical stimulator to treat headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements
The Food and Drug Administration (FDA, Agency, or we) 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 provisions of the regulation requiring the manufacturer, packer, or distributor of a dietary supplement to notify us that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Notice of Meeting; National Advisory Committee on the Sex Trafficking of Children and Youth in the United States
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on December 9 and 10, 2021. The purpose of the meeting is for the Committee to review state self-assessment survey responses and finalize their January 2022 report. The members of the Committee request comments from the public to inform their ongoing work and January 2022 report. Please submit your comments to NAC@nhttac.org with the subject ``NAC Comments,'' as soon as possible and before December 6, 2021.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
