Department of Health and Human Services 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 3,097
Proposed Collection; 60-Day Comment Request; Generic Clearance for National Cancer Institute (NCI) NCI Resources, Software and Data Sharing Forms (National Cancer Institute)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen
The Food and Drug Administration (FDA or we) is classifying the manual percutaneous surgical set assembled in the abdomen 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 manual percutaneous surgical set assembled in the abdomen'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 New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute), as well as developing new OIG Special Fraud Alerts.
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States; Correction
This document corrects technical errors in the final rule that appeared in the November 19, 2021 Federal Register entitled, ``Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States.''
Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Inspection of Injectable Products for Visible Particulates.'' Visible particulates in injectable products can jeopardize patient safety. This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The draft guidance also clarifies that meeting an applicable U.S. Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
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 collections of information describing mitigation strategies to protect food against intentional adulteration.
Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), in the Office of the Director, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups.
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.'' FDA is issuing this draft guidance to promote clarity regarding references to the terms ``device'' and ``counterfeit device'' in guidance, regulatory documents, communications, and other public documents. This draft guidance is not final nor is it in effect at this time.
Meeting of the Council on Graduate Medical Education
In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2022 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/advisory- committees/graduate-medical-edu/.
Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training and Primary Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2022 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisory-committees/primarycare-dentist/ index.html.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; National Center on Law and Elder Rights-Resource Support and User Satisfaction; OMB# 0985-0060
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the National Center on Law and Elder Rights-Resource Support and User Satisfaction [OMB# 0985-0060].
Expedited OMB Review and Public Comment: Recordkeeping for New Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start
An Interim Final Rule with Comment Period (IFC) was published on November 30, 2021 that established the COVID-19 vaccination requirements whereby all Head Start staff, certain contractors, and volunteers must be vaccinated for COVID-19 by January 31, 2022. The Office of Head Start, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the following new recordkeeping requirements for Head Start programs: (1) Collect and maintain records on the vaccination status of staff, certain contractors, and volunteers in Head Start and Early Head Start programs, and (2) develop and maintain a written COVID-19 protocol for testing individuals granted vaccine exemptions including granting such exemptions. We also invite comments on the impact of this new requirement on the current requirement for Head Start programs to maintain, including regularly update, program policies and procedures for personnel (associated burden approved under OMB #: 0970-0148).
Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
The Food and Drug Administration (FDA or we) is classifying the traumatic brain injury eye movement assessment aid 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 traumatic brain injury eye movement assessment aid'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.
Submission for OMB Review; Low Income Home Energy Assistance Program (LIHEAP) Performance Data Form (OMB #0970-0449)
The Administration for Children and Families (ACF) is requesting reinstatement of the Low Income Home Energy Assistance Program (LIHEAP) Performance Data Form (Office of Management and Budget (OMB) #0970-0449, expiration date March 31, 2021) with changes. Changes include additional reporting items to collect Module 2 (Performance Measures) data on the impacts of supplemental federal LIHEAP funds, and other minor changes to the most recent version of this form.
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 (the 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.
National Vaccine Injury Compensation Program; List of Petitions Received
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 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.
Julia Fees: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Julia Fees 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 Ms. Fees was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Ms. Fees' conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Fees was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of September 12, 2021 (30 days after receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Jeffrey A. Styron: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeffrey A. Styron for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Styron was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Styron was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 29, 2021 (30 days after receipt of the notice), Mr. Styron has not responded. Mr. Styron's failure to respond and request a hearing constitutes a waiver of Mr. Styron's right to a hearing concerning this matter.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle
The Food and Drug Administration (FDA or we) is classifying the endoscopic transhepatic venous access needle 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 endoscopic transhepatic venous access needle'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 Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
The Food and Drug Administration (FDA or we) is classifying the nonimplanted nerve stimulator for functional abdominal pain relief 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 nonimplanted nerve stimulator for functional abdominal pain relief'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.
Meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) will hold public meetings for the 2022 calendar year (CY). Information about ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.
Meeting of the National Advisory Council on Nurse Education and Practice
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold public meetings for the 2022 calendar year (CY). Information about NACNEP, agendas, and materials for these meetings can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/.
Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
The Food and Drug Administration (FDA or Agency) is proposing to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, which is an unclassified, preamendments device. FDA is summarizing its proposed findings regarding the degree or risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from the use of the device.
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based, in part, on the recommendations of the Orthopaedic and Rehabilitation Devices Panel, regarding the classification of spinal spheres for use in intervertebral fusion procedures.
Advisory Committee on Immunization Practices (ACIP); Meeting
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID). This virtual meeting is open to the public via Zoom, limited only by the space available, which is 500 seats. Pre-registration is required by accessing the link below in the addresses section.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model; Correction
This document corrects a typographic error that appeared in the final rule published in the Federal Register on November 8, 2021 entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
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 information collection associated with expanded access to investigational drugs for treatment use.
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