September 12, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.

The New Mexico Environment Department (NMED) has submitted updated regulations for receiving delegation and approval of a program for the implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA and amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA and amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA and amended between August 30, 2013 and January 15, 2017, as adopted by the NMED. The delegation of authority under this action does not apply to sources located in Bernalillo County, New Mexico, or to sources located in areas defined as Indian Country. The EPA is providing notice that it is updating the delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping duty investigation Nos. 731-TA-1422-1423 (Preliminary) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether there is a reasonable indication that 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 strontium chromate from Austria and France, provided for in subheadings 2841.50.91 and 3212.90.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value. Unless the Department of Commerce (``Commerce'') extends the time for initiation, the Commission must reach a preliminary determination in antidumping duty investigations in 45 days, or in this case by October 22, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by October 29, 2018.

Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.

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 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.

This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4383-DR), dated August 10, 2018, and related determinations.

This notice amends the notice of an emergency declaration for State of Hawaii (FEMA-3399-EM), dated August 22, 2018, and related determinations.

The U.S. Nuclear Regulatory Commission (NRC) is revising its guidance about administrative licensing procedures and agency policies for reviewing nuclear materials licensing requests. The NRC is requesting public comment on draft NUREG-1556, Volume 20, ``Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures.'' The document has been updated from the original version to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by the NRC staff when reviewing NRC materials licensing requests.

These amended special conditions are issued for the Boeing Model 777 series airplanes. This amendment states that the Boeing Model 777 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This NOFO details the application procedures and requirements to obtain remaining grant funding for eligible positive train control (PTC) system projects of the Consolidated Rail Infrastructure and Safety Improvements (CRISI) Program as provided by the Consolidated Appropriations Act, 2018, (2018 Appropriation). The funding in this NOFO remains from the 2018 Appropriation after DOT selected applications submitted in response to an initial NOFO for PTC systems deployment published on May 18, 2018. The opportunity described in this notice is made available under Catalog of Federal Domestic Assistance (CFDA) number 20.325, ``Consolidated Rail Infrastructure and Safety Improvements.''

This proposed rule would implement a recommendation from the Processed Pear Committee (Committee) to decrease the assessment rate established for ``summer/fall'' varieties of pears for canning for the 2018-2019 and subsequent fiscal periods. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.

Notice is hereby given of temporary approval of revisions to the mandatory Complex Institution Liquidity Monitoring Report (FR 2052a; OMB No. 7100-0361) by the Board of Governors of the Federal Reserve System (Board) pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB), per OMB Regulations on Controlling Paperwork Burdens on the Public. The temporary approval is valid until March 31, 2019.