Department of Health and Human Services February 2021 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces a temporary exception from expulsion for unaccompanied noncitizen children to its Order issued October 13, 2020 suspending the right to introduce certain persons from countries where a quarantinable communicable disease exists.

The Food and Drug Administration (FDA, the Agency, or we) has determined that NYMALIZE (nimodipine), oral solution, 3 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nimodipine, oral solution, 3 mg/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).'' This is a revision to the second edition of this final guidance, which issued in May 2020, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the December 2, 2020, court order that postponed the effective date of the final rule entitled ``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'' to January 14, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by March 16, 2021.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

This document corrects a typographical error in the final rule that appeared in the December 28, 2020 Federal Register (hereinafter referred to as the CY 2021 PFS final rule). The effective date was January 1, 2021.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Federally-recognized Indian Tribes/American Indian and Alaska Native (AI/AN) Tribes, Tribal organizations, Tribal-serving organizations, Tribal Colleges and Universities, and AI/ANserving institutions of higher education to guide the development of a new Center for Indigenous Innovation and Health Equity (Center). This is NOT a solicitation for proposals or proposal abstracts.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a request for emergency clearance of the information collection titled Requirement for Negative Pre-Departure Covid-19 Test Result or Documentation of Recovery from Covid-19 for all Airline or other Aircraft Passengers arriving into the United States from any foreign country. This collection accompanies a CDC Order of the same name and is designed to prohibit the introduction into the United States of any airline passenger departing from the any foreign country unless the passenger: (1) Has a negative pre-departure test result for COVID-19 (Qualifying Test), or (2) has written or electronic documentation of recovery from COVID-19 in the form of a positive viral test result and a letter from a licensed health care provider or public health official stating that the passenger has been cleared for travel.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Supplemental Measurements for Exploratory Research Regarding Exposure During Activities Conducted on Synthetic Turf Fields with Tire Crumb Rubber Infill.'' The purpose of the proposed study is to evaluate and characterize human exposure potential to polyaromatic hydrocarbons during play on synthetic turf fields with tire crumb rubber infill.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Native Hawaiian and Pacific Islander (NHPI) communities and NHPI serving organizations to guide the development of a new Center for Indigenous Innovation and Health Equity (Center). This is NOT a solicitation for proposals or proposal abstracts.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on February 26, 2021. The purpose of this meeting is to introduce Task Force members and to outline the charges as directed by Executive Order 13995, Ensuring an Equitable Pandemic Response and Recovery. This meeting is open to the public. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Information about the meeting will be posted on the HHS Office of Minority Health website: https://minorityhealth.hhs.gov/ prior to the meeting. Pre- registration for the meeting must be completed by 5 p.m. ET, Wednesday, February 24, 2021.