2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2024, expiration date.

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Eastern Kern Air Pollution Control District (EKAPCD or ``the District'') portion of the California State Implementation Plan (SIP). In this action, we are approving one rule submitted by the EKAPCD, governing the issuance of permits for stationary sources, focusing on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or ``the Act'').

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Statistical Approaches to Establishing Bioequivalence.'' This draft guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. When finalized, this guidance will replace FDA's 2001 guidance for industry of the same name.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.'' For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, ``ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence),'' issued in November 2017.

The U.S. Department of Commerce (Commerce) determines that Metalco S.A. (Metalco), the sole company subject to the 2020-2021 administrative review of the antidumping duty order on corrosion- resistant steel products from the People's Republic of China (China), is part of the China-wide entity because it did not demonstrate its eligibility for a separate rate. The period of review (POR) is July 1, 2020, through June 30, 2021.

The U.S. Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping duty (AD) and countervailing duty (CVD) orders with October anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning a revision to a regulatory reporting requirement for national banks and federal savings associations titled, ``Company-Run Annual Stress Test Reporting Template and Documentation for Covered Institutions with Total Consolidated Assets of $250 Billion or More under the Dodd-Frank Wall Street Reform and Consumer Protection Act.''

The National Archives and Records Administration (NARA) publishes notice of certain Federal agency requests for records disposition authority (records schedules). We publish notice in the Federal Register and on regulations.gov for records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on such records schedules.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) proposes to renew an information collection.

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC), through a letter dated June 1, 2021. The SIP submittal proposes to revise SIP requirements regarding the installation, maintenance, and termination of ambient air sulfur dioxide (SO2) monitors near large industrial SO2 emitting sources in the State. EPA is proposing to approve these changes to the Tennessee Air Pollution Control Regulations (TAPCR) related to the control of SO2 emissions into the SIP because they are consistent with the Clean Air Act (CAA or Act).

Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed new collection, and allow 60 days for public comment in response to the notice.

The Department of Energy (DOE) invites public comment on a renewal of a collection of information for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.

Under the authority of the Northern Pacific Halibut Act of 1982, this final rule implements a permitting system for the Pacific halibut commercial and recreational charter halibut fisheries in International Pacific Halibut Commission (IPHC) regulatory Area 2A (Washington, Oregon, and California). This action also establishes a regulatory framework for the Area 2A Pacific halibut directed commercial fishery that, consistent with the allocations and coastwide season dates set by the IPHC, allows NMFS to annually determine dates and times the fishery will be open and set harvest limits for those periods of time. These permitting and management activities for Area 2A were previously performed by the IPHC; through this final rule, NMFS will now implement these Area 2A-specific permitting and management activities.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). The OCC may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment on the renewal of its information collection titled ``Joint Standards for Assessing the Diversity Policies and Practices of Entities Regulated by the Agencies and Diversity Self-Assessment Template for OCC-Regulated Entities.'' The OCC also is giving notice that it has sent the information collection to OMB for review.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice announces a $688.00 calendar year (CY) 2023 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2023 and on or before December 31, 2023.

The President's Commission on White House Fellowships (PCWHF) was established by an Executive Order in 1964. The PCWHF is an advisory committee composed of Special Government Employees appointed by the President. Name of Committee: President's Commission on White House Fellowships Mid-Year Meeting. Date: January 20, 2023. Time: 8 a.m.-5:30 p.m. Place Eisenhower Executive Office Building, 1650 Pennsylvania Ave. NW, Washington, DC 20500. Agenda: The Commission holds a mid-year meeting to talk with current Fellows on how their placements are going and discuss preparation for future events.

According to the provisions of section 10 of the Federal Advisory Committee Act, notice is hereby given that a virtual meeting of the Federal Prevailing Rate Advisory Committee will be held on Thursday, December 15, 2022. There will be no in-person gathering for this meeting.

The U.S. Nuclear Regulatory Commission (NRC) is issuing an environmental assessment (EA) and finding of no significant impact (FONSI) under the National Environmental Policy Act of 1969 (NEPA) and NRC's regulations. This EA summarizes the results of the NRC staff's environmental review, which evaluates the potential environmental impacts of approving an alternate disposal request in response to a request from STP Nuclear Operating Company (STPNOC) for Renewed Facility Operating Licenses NPF-76 and NPF-80 for South Texas Project, Units 1 and 2 (STP). Specifically, the alternate disposal request, if approved, would allow the licensee to dispose of very-low-level waste (VLLW) generated during day-to-day operations at the STP reactor site at Texas Class 1 or Class 2 industrial landfills.