June 2021 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is approving, under the Clean Air Act (CAA), a revision to Indiana's State Implementation Plan (SIP) to address changes to its air emissions monitoring rules for Portland cement plants. Indiana revised its rules for Portland cement plants to update the monitoring of particulate matter (PM) emissions to allow an additional monitoring option. This additional monitoring option is consistent with EPA's recent revisions to Federal requirements for Portland cement plants. EPA proposed to approve this action on March 25, 2021 and received no comments.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

With the issuance of this final rule, the Drug Enforcement Administration places 1-(4-methoxyphenyl)-N-methylpropan-2-amine (para- methoxymethamphetamine, PMMA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PMMA.

The Environmental Protection Agency (EPA) is taking final action to approve revisions to the Mendocino County Air Quality Managment District (MCAQMD or ``District'') portion of the California State Implementation Plan (SIP). These revisions concern the District's prevention of significant deterioration (PSD) permitting program for new and modified stationary sources of air pollution. We are approving these local rules pursuant to requirements under part C of title I of the Clean Air Act as amended in 1990 (CAA or the ``Act'').

The Environmental Protection Agency (EPA) is taking final action to approve a revision to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD or ``the District'') portion of the California State Implementation Plan (SIP). This revision concerns emissions of oxides of nitrogen (NOX) and particulate matter (PM) from indirect sources associated with new development projects as well as NOX and PM emissions from certain transportation and transit development projects. We are approving a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act).

The Environmental Protection Agency (EPA) is approving a revision to the Illinois State Implementation Plan (SIP) to amend requirements applicable to certain coal-fired electric generating units (EGUs) in the Illinois Administrative Code, also known as the Multi- Pollutant Standards (MPS) Rule. On January 23, 2020, the Illinois Environmental Protection Agency (IEPA) submitted a request to amend the provisions of the MPS Rule in the Illinois regional haze SIP. EPA is approving the revision because it will result in a significant decrease in emissions of Oxides of Nitrogen and Sulfur Dioxide, meets the applicable requirements of the Clean Air Act (CAA), and does not interfere with any applicable requirement concerning attainment and reasonable further progress.

The FAA proposes to supersede Airworthiness Directive (AD) 2019-01-08, which applies to certain The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes. AD 2019-01-08 requires modifications for galley mounted attendant seat fittings. Since the FAA issued AD 2019-01-08, the FAA determined that additional airplanes are subject to the unsafe condition. This proposed AD would retain the requirements of AD 2019-01-18 and expand the applicability to include additional airplanes. The FAA is proposing this AD to address the unsafe condition on these products.

This rule amends the National List of Allowed and Prohibited Substances (National List) section of the U.S. Department of Agriculture's (USDA) organic regulations to implement recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB). This rule adds the following allowed substances to the National List: Oxalic acid dihydrate as a pesticide for organic apiculture (beekeeping); pullulan for use in organic handling in products labeled, ``Made with organic (specified ingredients or food group(s));'' and collagen gel as a nonorganic nonagricultural substance for use as a casing in organic handling when organic forms of collagen gel are not commercially available.

NMFS implements the measures of the New England Fishery Management Council's Omnibus Deep-Sea Coral Amendment. This action protects deep-sea corals from the impacts of commercial fishing gear on Georges Bank and in the Gulf of Maine. These management measures are intended to reduce, to the extent practicable, impacts of fishing gear on deep-sea corals in New England while balancing the continued operations of commercial fisheries.

This action proposes to amend Class D and Class E airspace in the south Florida area, by updating the geographic coordinates of the following airports; Fort Lauderdale-Hollywood International Airport, Miami-Opa Locka Executive Airport, (formerly Opa Locka Airport), North Perry Airport, Pompano Beach Airpark, Miami International Airport, Homestead ARB, Boca Raton Airport, Miami Executive Airport (formerly Kendall-Tamiami Executive Airport). This action would also update the geographic coordinates of the Fort Lauderdale Very High Frequency Omnidirectional Range Collocated with Distance Measuring Equipment (VOR/DME), and the QEEZY Locator Outer Marker (LOM). This action would also make an editorial change replacing the term Airport/Facility Directory with the term Chart Supplement in the legal descriptions of associated Class D and E airspace. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

The Department of Veterans Affairs (VA) is amending its regulations concerning the VA Homeless Providers Grant and Per Diem (GPD) Program. These amendments provide GPD with increased flexibility to: Respond to the changing needs of homeless veterans; repurpose existing and future funds more efficiently; and allow recipients the ability to add, modify, or eliminate components of funded programs. This rule updates these regulations to better serve our homeless veteran population and the recipients who serve them.

The Animal and Plant Health Inspection Service issued a final rule on December 31, 2012, to establish regulations under which research facilities and dealers, exhibitors, intermediate handlers, and carriers must meet certain requirements for contingency planning and training of personnel. Implementation of the final rule was stayed on July 31, 2013, so that the agency could conduct additional review to further consider the impact of contingency plan requirements on regulated entities. Since that time, we have conducted such a review, and the 2021 Congressional Appropriations Act has required us to propose to lift the stay. We are therefore proposing to lift the stay and make minor revisions to the requirements in order to update compliance dates and clarify intent. The lifting of the stay and proposed revisions would better ensure that entities responsible for animals regulated under the Animal Welfare Act are prepared to safeguard the health and welfare of such animals in the event of possible emergencies or disasters.

The National Endowment for the Humanities (NEH) is proposing to issue regulations to implement the Program Fraud Civil Remedies Act of 1986 (PFCRA). The PFCRA authorizes certain Federal agencies, including NEH, to impose civil penalties and assessments through administrative adjudication against any person who makes, submits, or presents a false, fictitious, or fraudulent claim or written statement to NEH. The proposed rule will establish the procedures that NEH will follow in implementing the PFCRA, as well as specify the hearing and appeal rights of persons subject to penalties and assessments under the PFCRA.

The FDIC is inviting comment on a proposed rule to amend Interagency Guidelines for Real Estate Lending Policies (Real Estate Lending Standards). The purpose of the proposed rule is to align the Real Estate Lending Standards with the community bank leverage ratio (CBLR) rule, which does not require electing institutions to calculate tier 2 capital or total capital. The proposed rule would allow a consistent approach for calculating the ratio of loans in excess of the supervisory loan-to-value limits (LTV Limits) at all FDIC-supervised institutions, using a methodology that approximates the historical methodology the FDIC has followed for calculating this measurement without requiring institutions to calculate tier 2 capital. The proposed rule would also avoid any regulatory burden that could arise if an FDIC-supervised institution subsequently decides to switch between different capital frameworks.

The Environmental Protection Agency (EPA), Office of Research and Development (ORD), gives notice of a virtual meeting of the Board of Scientific Counselors (BOSC) Executive Committee (EC) to conduct a consultation on equity and barriers to environmental justice.

This document corrects technical and typographical errors in the proposed rule that appeared in the May 10, 2021 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.''

The Coast Guard is establishing a special local regulation on the waters of the Gulf of Mexico, in the vicinity of Lido Beach, Florida, during the Sarasota Powerboat Grand Prix. Approximately 70 boats and jet skis, traveling at speeds in excess of 100 miles per hour are expected to participate. Additionally, it is anticipated that 100 spectator vessels will be present along the race course. The special local regulation is necessary to protect the safety of race participants, participant vessels, spectators, and the general public on certain navigable waters of the Gulf of Mexico, Lido Beach, Florida during the event. The special local regulation will establish an enforcement area where all persons and vessels, except those persons and vessels participating in the high speed boat races, are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area without obtaining permission from the Captain of the Port St. Petersburg or a designated representative.

The Coast Guard is establishing a series of temporary safety zones on the waters of Boothbay Harbor, Maine. These safety zones are necessary to provide for the safety of participant vessels and the general public during Tall Ships Boothbay Harbor, 2021, an event allowing for public tours of tall ships (large sailing vessels) from various countries while at the docks of Boothbay Harbor, Maine. When enforced, this rule will prohibit persons and vessels from entering into the safety zone unless authorized by the Captain of the Port Northern New England or a designated representative.

On December 19, 2019, Holtec Decommissioning International, LLC (HDI) submitted to the U.S. Nuclear Regulatory Commission (NRC) a letter enclosing the post-shutdown decommissioning activities report (PSDAR) for the Indian Point Nuclear Generating, Unit Nos. 1, 2, and 3 (Indian Point Energy Center (IPEC)), contingent upon the transfer of the IPEC licenses to HDI. The PSDAR, which includes the site-specific decommissioning cost estimate (DCE), provides an overview of HDI's planned activities, schedule, projected costs, and environmental impacts for the decommissioning of the IPEC. The IPEC license transfer transaction closed on May 28, 2021. Accordingly, the NRC is noticing receipt of the PSDAR and making it available for public comment. The NRC will hold a public meeting in the vicinity of the IPEC to discuss the PSDAR's content and receive comments. The date, time, and location of the meeting will be provided in a future Federal Register notice.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft regulatory guide (DG), DG-4029, ``Use of Plant Parameter Envelope in Early Site Permit Applications.'' DG-4029 is a new regulatory guide that proposes guidance for nuclear power plant applicants that elect to use the plant parameter envelope (PPE) concept to assume certain design parameters for an early site permit (ESP) application when a specific reactor technology has not been selected for a proposed site. It incorporates the PPE portions of NRC Review Standard (RS)-002, ``Processing Applications for Early Site Permits.'' The issuance of this DG allows the NRC staff to withdraw the outdated guidance in RS-002 while retaining the PPE information in it for future use by prospective ESP applicants.

The Commission hereby gives notice of the scheduling of the final phase of antidumping investigation Nos. 731-TA-1550-1553 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of polyester textured yarn from Indonesia, Malaysia, Thailand, and Vietnam, provided for in subheadings 5402.33.30 and 5402.33.60 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be sold at less-than-fair- value.

On December 14, 2020, the Department of Health and Human Services published in the Federal Register a final rule (``Rule'') establishing the 340B Drug Pricing Program (340B Program) Administrative Dispute Resolution (ADR) Board (hereafter, ``the Board''). See 85 FR 80632 (Dec. 14, 2020). According to the Rule, the purpose of the 340B Program's ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibitions on diversion or duplicate discounts. The Rule states that Board members from the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) must have relevant expertise and experience in drug pricing or drug distribution. The Rule also states that Board members from the Office of the General Counsel (OGC) must have expertise and experience in handling complex litigation. From the 340B ADR Board, the HRSA Administrator will select three voting members, one from each of the three HHS operating/staff divisions involved (i.e., CMS, HRSA, OGC) to form 340B ADR Panels that will review claims and, pursuant to delegated authority from the Secretary, make certain final agency decisions. All previous appointments to the Board are revoked. Based on recommendations from OGC, CMS, and HRSA, I hereby appoint the following Board members, who shall serve a term of two years, to be extended for additional terms upon agreement by the member and the head of his or her operating/staff division. Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services; Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services; Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health Resources and Services Administration, Department of Health and Human Services; CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of Regional Operations, Health Resources and Services Administration, Department of Health and Human Services; CDR Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Adele Pietrantoni, Office of Program Operations and Local Engagement, Division of Drug and Health Plan Operations, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member; and Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member.