December 21, 2020 – Federal Register Recent Federal Regulation Documents

The United States Patent and Trademark Office (USPTO or Office) revises the rules of practice in inter partes review (IPR), post-grant review (PGR), and the transitional program for covered business method patents (CBM) (collectively post-grant trial) proceedings before the Patent Trial and Appeal Board (PTAB or Board) to allocate the burdens of persuasion in relation to motions to amend and the patentability of substitute claims proposed therein. In light of Federal Circuit case law, and to better ensure the predictability and certainty of post-grant trial proceedings before the Board, the Office revises the rules of practice governing motions to amend, to expressly assign to the petitioner the burden of showing the unpatentability of substitute claims proposed in a motion to amend. In addition, the Office revises the rules to expressly assign to the patent owner the burden of showing that a motion to amend complies with certain statutory and regulatory requirements for such a motion. Notwithstanding the adversarial nature of the proceedings and the burdens described above, however, the Office further revises its rules to expressly provide that the Board itself may, in the interests of justice, exercise its discretion to grant or deny a motion to amend only for reasons supported by readily identifiable and persuasive evidence of record in the proceeding. The Office anticipates the Board will exercise its discretion in the interests of justice only in rare circumstances. In doing so, the Board may make of record only readily identifiable and persuasive evidence in a related proceeding before the Office or evidence that a district court can judicially notice. Where the Board exercises its discretion in such circumstances, the parties will have an opportunity to respond.

The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Missouri on January 15, 2019, and supplemented by letter on June 14, 2019. Missouri requests that the EPA remove a rule related to control of emissions from the solvent cleanup operations in the Kansas City, Missouri area from its SIP. This removal does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is in accordance with the requirements of the Clean Air Act (CAA).

The Coast Guard is establishing a temporary safety zone on the navigable waters within a 1,700 foot radius of the barge M. J. VERROCHI located in Narragansett Bay, Quonset, RI. The safety zone is needed to protect personnel, vessels, and the marine environment from the potential hazards created by dredging operations that include drilling and blasting. When enforced, entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Southeastern New England or designated representative.

The Federal Housing Finance Agency (FHFA) is issuing a final rule on the 2021 housing goals for Fannie Mae and Freddie Mac (the Enterprises). The Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (the Safety and Soundness Act) requires FHFA to establish annual housing goals for mortgages purchased by the Enterprises. The housing goals include separate categories for single- family and multifamily mortgages on housing that is affordable to low- income and very low-income families, among other categories. The final rule establishes benchmark levels for each of the housing goals for 2021.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Rolls-Royce Deutschland Ltd & Co KG (RRD) Trent 1000-A2, 1000-AE2, 1000-C2, 1000-CE2, 1000-D2, 1000-E2, 1000-G2, 1000-H2, 1000- J2, 1000-K2 and 1000-L2 model turbofan engines. This proposed AD was prompted by the manufacturer's analysis which determined that cracks may initiate in the front seal fins and cause cracks in the low- pressure turbine (LPT) disk. This proposed AD would require repetitive inspection of the seal fins and, depending on the results of the inspection, replacement of the LPT disk before further flight. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus Helicopters Model AS332L, AS332L1, AS332C, and AS332C1 helicopters. This proposed AD was prompted by the failure of a second stage planet gear installed in the main gearbox (MGB). This proposed AD would require identifying the part number of each second stage planet gear assembly installed in the MGB, replacing an MGB having certain second stage planet gear assembly part numbers with a serviceable MGB, modifying the helicopter by installing a full flow magnetic plug (FFMP), repetitively inspecting the FFMP and the MGB bottom housing and conical housing for metal particles, analyzing any metal particles that are found, and applying corrective actions if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA is superseding Airworthiness Directive (AD) 2019-23- 05, which applied to all Dassault Aviation Model MYSTERE-FALCON 900 airplanes. AD 2019-23-05 required revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. This AD continues to require revising the existing maintenance or inspection program, as applicable, to incorporate those new or more restrictive airworthiness limitations, and also requires revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations; as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address the unsafe condition on these products.

Ch[eacute]rie R. Kiser has filed a Petition for Reconsideration (Petition) on behalf of Global Tel*Link Corporation (GTL) in Federal Communications Commission (FCC) WC Docket No. 12-375.

The FAA proposes to adopt a new airworthiness directive (AD) for certain MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2C11 (Regional Jet Series 550), and CL-600-2D24 (Regional Jet Series 900) airplanes. This proposed AD was prompted by a report that some piccolo ducts for the wing anti-ice system have bleed holes that do not conform to requirements. This proposed AD would require, depending on airplane configuration, inspection for the presence of affected wing anti-ice system piccolo ducts and corrective actions, or replacement of affected piccolo ducts with new piccolo ducts. The FAA is proposing this AD to address the unsafe condition on these products.

NMFS announces final specifications for the 2021 commercial golden tilefish fishery and projected specifications for 2022. This action also implements temporary emergency measures for the golden tilefish fishery at the request of the Mid-Atlantic Fishery Management Council. This action establishes allowable harvest levels and other management measures to prevent overfishing while allowing optimum yield, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the Tilefish Fishery Management Plan. The emergency measures allow a limited one-time carryover of up to 5 percent of unharvested fishing quota from the 2020 fishing year into the 2021 fishing year.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposed revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. FDA is proposing this action because these regulations are obsolete or no longer necessary to achieve public health goals. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive Orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment to its regulations that would alter financial assurance mechanisms approved by the NRC for the decommissioning of nuclear power plants and other nuclear facilities. Specifically, this action would amend provisions for parent company and self company guarantees that require bond ratings issued by credit rating agencies. This action would implement the provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, which directed agencies to amend their regulations to remove any reference to or reliance on credit ratings. Applicants and licensees who are required to provide decommissioning financial assurance may be affected. The NRC is soliciting public comment on potential approaches for amending the regulations and invites stakeholders and interested persons to participate. The NRC plans to hold a public meeting during the comment period to facilitate stakeholder participation.

The Department of Defense (DoD) is codifying the National Industrial Security Program Operating Manual (NISPOM) in regulation. The NISPOM establishes requirements for the protection of classified information disclosed to or developed by contractors, licensees, grantees, or certificate holders (hereinafter referred to as contractors) to prevent unauthorized disclosure. In addition to adding the NISPOM to the Code of Federal Regulations (CFR), this rule incorporates the requirements of Security Executive Agent Directive (SEAD) 3, ``Reporting Requirements for Personnel with Access to Classified Information or Who Hold a Sensitive Position.'' SEAD 3 requires reporting by all contractor cleared personnel who have been granted eligibility for access to classified information. This NISPOM rule provides for a single nation-wide implementation plan which will, with this rule, include SEAD 3 reporting by all contractor cleared personnel to report specific activities that may adversely impact their continued national security eligibility, such as reporting of foreign travel and foreign contacts. NISP Cognizant Security Agencies (CSAs) shall conduct an analysis of such reported activities to determine whether they pose a potential threat to national security and take appropriate action. Finally, the rule also implements the provisions of Section 842 of Public Law 115-232, which removes the requirement for a covered National Technology and Industrial Base (NTIB) entity operating under a special security agreement pursuant to the NISP to obtain a national interest determination as a condition for access to proscribed information.

NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to construction activities including marine structure maintenance, pile replacement, and select waterfront improvements at Naval Station Norfolk (NAVSTA Norfolk) over the course of five years (2021-2026). As required by the Marine Mammal Protection Act (MMPA), NMFS is proposing regulations to govern that take, and requests comments on the proposed regulations. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.

The United States Environmental Protection Agency (EPA or Agency) is taking final action to amend the Federal regulations to withdraw human health criteria (HHC) for toxic pollutants applicable to waters in the State of Maine. EPA is taking this action because Maine adopted, and EPA approved, HHC that the Agency determined are protective of the designated uses for these waters. This final rule amends the Federal regulations to withdraw certain HHC applicable to Maine that the Agency had promulgated, as described in the September 3, 2020 proposed rule. The withdrawal of these certain federally promulgated HHC will enable Maine to implement its EPA-approved HHC, submitted on April 24, 2020, and approved on June 23, 2020, as applicable criteria for Clean Water Act (CWA or the Act) purposes.

The Farm Credit Administration (FCA or we) is repealing the regulatory requirement that production credit associations (PCAs) amortize their loans in 15 years or less, while requiring Farm Credit System (FCS or System) associations to address amortization through their credit underwriting standards and internal controls. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session.

This final rule corrects editorial errors and improves the clarity of certain provisions in the Hazardous Materials Regulations and PHMSA program and procedural regulations. The intended effect of this rulemaking is to enhance the accuracy and reduce misunderstandings of the regulations. The amendments contained in this final rule are non-substantive changes and do not impose new requirements.