Department of Health and Human Services December 16, 2021 – Federal Register Recent Federal Regulation Documents
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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the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other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 FDA is issuing this draft guidance to promote clarity regarding references to the terms ``device'' and ``counterfeit device'' in guidance, regulatory documents, communications, and other public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 This draft guidance is not final nor is it in effect at this time.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.
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