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 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 Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (the SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

EPA issued a notice in the Federal Register of April 13, 2018, concerning the cancellations voluntarily requested by the registrant and accepted by the Agency but that have not yet become effective. This notice is being issued to amend the cancellation order, as supported by the current registrant and requested by a distributor, by extending the effective date of the cancellation for the two spirodiclofen registrations (EPA Registration No. 264-830 and 264-831).

The Environmental Protection Agency (EPA) is providing notice of the availability of preliminary lists of units eligible for second- round allocations of emission allowances for the 2020 control periods from the new unit set-asides (NUSAs) established under the Cross-State Air Pollution Rule (CSAPR) trading programs. EPA has posted spreadsheets containing the lists on EPA's website. EPA will consider timely objections to the lists before determining the amounts of the second-round allocations.

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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs). GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.

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 National Traffic and Motor Vehicle Safety Act (Safety Act) prohibits the sale, manufacture for sale, import or introduction into interstate commerce of a motor vehicle or item of motor vehicle equipment, unless fully compliant with all applicable Federal motor vehicle safety standards (FMVSS). The FMVSS set a threshold of performance that a vehicle or equipment item must attain, at a minimum, to meet the need for safety. The Safety Act also requires a manufacturer or distributor of a motor vehicle or motor vehicle equipment to certify that the vehicle or equipment complies with applicable FMVSS. This notice reestablishes NHTSA's longstanding position that the FMVSS test conditions and procedures apply to NHTSA's compliance testing, and that manufacturers are not required to ensure that their vehicles are designed in such a manner as to ensure that the vehicles are capable of being tested pursuant to such standards as a condition of self-certification. This notice also discusses NHTSA's enforcement with respect to vehicles with novel or innovative designs that preclude them from being tested for FMVSS compliance using NHTSA's FMVSS test procedures. This notice supersedes prior contrary statements the Agency has madeincluding those in NHTSA's 2016 letter of interpretation to Google, Inc.stating that manufacturers could not validly certify FMVSS compliance unless NHTSA could verify compliance using the FMVSS test procedures.

The Environmental Protection Agency (EPA) is issuing this notice to advise the public of upcoming changes to the Region 4 Library. Region 4 will be reducing the size of its library space, decreasing the amount of print materials maintained in its collection, and ceasing all on-site library support services. The library will retain a small, targeted collection of reference material on-site which will be accessible by appointment only to EPA staff and the public (For appointments, see contact information below). In addition, EPA staff and the public will continue to have remote access to the full suite of library services available at EPA through the Andrew W. Breidenbach Environmental Research Center (AWBERC) Library, located in Cincinnati, Ohio. The AWBERC Library can be reached by email (CI_AWBERC_Library@epa.gov) or by phone (513-569-7703). For more information about the EPA National Library Network and its information resources and services, visit https://www.epa.gov/ libraries.

The Department of Commerce (Commerce) preliminarily determines that certain steel nails (nails) from the People's Republic of China (China) were sold in the United States at less than normal value (NV) during the period of review (POR) August 1, 2018 through July 31, 2019. We invite interested parties to comment on these preliminary results.

The Federal Housing Finance Agency (FHFA) is publishing an Advance Notice of Proposed Rulemaking (ANPR) requesting public comment on a variety of questions related to potential changes to the regulation establishing housing goals for Fannie Mae and Freddie Mac (Enterprises). FHFA will consider public comments received on these questions in order to inform rulemaking that is planned for 2021 to establish single-family and multifamily housing goals benchmark levels for 2022 and beyond, and to make other changes to the Enterprise housing goals regulation, as appropriate.

The Food Safety and Inspection Service (FSIS) is announcing the availability of and requesting comment on a guideline for meat and poultry establishments interested in donating products to non-profit organizations. FSIS has received several questions from meat and poultry establishments and non-profit organizations on this subject and has decided to address the major concerns associated with donation in this guideline. FSIS encourages establishments to donate meat and poultry products to non-profit organizations, when possible, to reduce food loss and waste.

The Food and Drug Administration (FDA or Agency) has determined that DOBUTREX (dobutamine hydrochloride), equivalent (eq) 12.5 milligram (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Consumer Product Safety Commission (CPSC) is announcing an opportunity for public comment on a new proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register for each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed survey to evaluate consumer awareness of infant sleep product warning labels. The Commission will consider all comments received in response to this notice before submitting this collection of information to the Office of Management and Budget (OMB) for approval.

The FAA is proposing to adopt a new airworthiness directive (AD) for certain serial-numbered Leonardo S.p.a. (Leonardo) Model A109S and AW109SP helicopters. This proposed AD would require installing a placard in the baggage compartment, revising the existing Rotorcraft Flight Manual (RFM) for your helicopter, and inspecting the installation of the terminal lugs. Depending on the outcome of the inspection, this proposed AD would require restoring the installation of the terminal lugs. This proposed AD would also require modifying the helicopter to shim the baggage fairing assy (fwd up) away from the circuit breaker panel and incorporating protective coverings. This proposed AD was prompted by reports of several occurrences of fire ignition and smoke in the baggage compartment. The actions of this proposed AD are intended to address an unsafe condition on these products.