August 22, 2022 – Federal Register Recent Federal Regulation Documents

The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold online and in-person public meetings.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).

We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species and marine mammals. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).

To announce a list of senior executives who comprise a standing roster that will serve on IRS's Fiscal Year 2022 Senior Executive Service (SES) Performance Review Boards.

This temporary final rule would implement a special activities provision of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021. The Coast Guard is establishing three temporary safety zones for the safe splashdown and recovery of reentry vehicles launched by Space Exploration Technologies Corporation (SpaceX) in support of the National Aeronautics and Space Administration (NASA) from August 16, 2022 until September 30, 2022. These three temporary safety zones are located within the Captain of the Port Sector Mobile area of responsibility offshore of Pensacola, Panama City, and Tallahassee, Florida. This rule would prohibit U.S. flagged vessels from entering any of the temporary safety zones unless authorized by the Captain of the Port Sector Mobile or a designated representative. Foreign-flagged vessels would be encouraged to remain outside the safety zones. This action is necessary to protect vessels and waterway users from the potential hazards created by reentry vehicle splashdowns and recovery operations in the U.S. Exclusive Economic Zone (EEZ). It is also necessary to provide for the safe recovery of reentry vehicles, and any personnel involved in reentry services, after the splashdown.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension without change to an existing information collection requirement regarding the Implementation of Section 280 of OMB Circular A-11``Improving Customer Experience''.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to Attentive Energy, LLC (Attentive Energy) to incidentally harass marine mammals during marine site characterization surveys associated with high resolution geophysical (HRG) equipment off the coast of New Jersey and New York in the area of Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf Lease Area OCS-A 0538. There are no changes from the proposed authorization in this final authorization.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, Centralized Institutional Review for the CDC Expanded Access Investigational New Drug (EA-IND) for Use of Tecovirimat (TPOXX[supreg]) for Treatment of Human Non-Variola Orthopoxvirus Infections. This proposed project is essential to CDC's Monkeypox emergency response and is designed to assist healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the EA-IND.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued two consecutive IHAs to the U.S. Army Corps of Engineers (Corps) to incidentally harass marine mammals during in-water construction activities associated with the Sand Island Pile Dikes Repairs Project in the Columbia River. There are no changes from the proposed authorizations in these final authorizations.

The National Endowment for the Arts (NEA), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. 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. Currently, the NEA is soliciting comments concerning the proposed information collection for the Regional and State Arts Agency American Rescue Plan (ARP) Funding Survey. Copies of the ICR, with applicable supporting documentation, may be obtained by vising www.Reginfo.gov.