May 2021 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing a temporary safety zone for all navigable waters of the Lake of the Ozarks at mile marker 1 approximately 500 feet southwest of the Bagnell Dam. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA has issued one Authorization for biological products as requested by Eli Lilly and Company and one Authorization for a biological product as requested by Janssen Biotech, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Equal Employment Opportunity Commission (EEOC or Commission) announces that it is submitting to the Office of Management and Budget (OMB) a request for a three-year extension without change of the State and Local Government Information Report (EEO-4) as described below.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of West Virginia (FEMA-4605-DR), dated 05/20/2021. Incident: Severe Storms and Flooding. Incident Period: 02/27/2021 through 03/04/2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Tobacco Product User Fees: Responses to Frequently Asked Questions.'' This draft guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The purpose of this Notice is to solicit comments about this assessment process, instructions, and data collections. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The purpose of this Notice is to solicit comments about this assessment process, instructions, and data collections. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.'' The existing post-approval studies final guidance, entitled ``Procedures for Handling Post-Approval Studies Imposed by PMA Order,'' was issued in June 2009. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time.

The Coast Guard is proposing to establish temporary special local regulations for certain waters of Back River. This action is necessary to provide for the safety of life on these navigable waters located in Baltimore County, MD, during activities associated with an air show event from July 9, 2021, through July 11, 2021. This proposed rulemaking would prohibit persons and vessels from entering the regulated area unless authorized by the Captain of the Port Maryland- National Capital Region or the Coast Guard Event Patrol Commander. We invite your comments on this proposed rulemaking.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed extension of the standardized Research Performance Progress Report (RPPR), prior to the submission of the information collection request (ICR) to OMB for approval.

The Payette National Forest is withdrawing the Notice of Intent (NOI) that was published in the Federal Register on April 22, 2009 to prepare an Environmental Impact Statement (EIS) for the Wildlife Conservation Strategy Forest Plan Amendment.

The Environmental Protection Agency (EPA) is taking final action to approve the State of Utah's Source Category Exemptions Revisions as submitted on November 5, 2019. The EPA is taking this action pursuant to section 110 of the Clean Air Act (CAA).

On September 15, 2017, DoD published a Federal Register Notice (FRN) to implement a new workforce-shaping pilot program that provides the science and technology reinvention laboratory (STRL) lab directors the authority to dynamically shape the mix of technical skills and expertise in the workforces of such laboratories to achieve one or more of the objectives in section 1109(a) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016. The suite of workforce-shaping tools available to STRL lab directors includes flexible-length and renewable-term technical appointments, modified re- employed annuitant authority, and modified voluntary early retirement and separation incentive authorities. Updates are necessary to clarify that subsequent changes to this authority are applicable. For example, section 1112 of the NDAA for FY 2019 amends this authority to allow flexible-length and renewable-term technical appointments for current DoD term employees. In addition to updating other legislative references, this notice clarifies application of probationary/trial periods and career tenure to flexible-length and renewable-term technical appointments and subsequent conversion to career or career- conditional appointments.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Beryllium Rocket Motor Fuel Firing (EPA ICR Number 1125.09, OMB Control Number 2060- 0394), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through July 31, 2021. Public comments were previously requested, via the Federal Register, on May 12, 2020 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.