2018 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a reinstatement of approval of an information collection associated with the Cooperative State-Federal Brucellosis Eradication Program.

The Coast Guard is establishing a 1000-yard temporary moving safety zone around the Falcon 9 rocket in the Atlantic Ocean, in the vicinity of Port Canaveral Harbor, Cape Canaveral, FL. This safety zone is necessary to protect personnel, vessels, and the public from potential hazards associated with the control and removal of the rocket and any debris from navigable waters of the Atlantic Ocean. All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Jacksonville or a designated representative.

Our Office of the General Counsel (OGC) is responsible for processing and handling summonses and complaints in lawsuits involving judicial review of our final decisions on individual claims for benefits under titles II, VIII, and XVI of the Social Security Act (Act). This notice sets out the names and current addresses of those offices and the jurisdictions for which each office has responsibility.

Pursuant to United States Code and the Code of Federal Regulations, the Department must publish and revise at least annually in the Federal Register a list of explosives determined to be within the coverage of pertinent United States Code. The list covers not only explosives, but also blasting agents and detonators, all of which are defined as ``explosive materials'' in pertinent United States Code. The 2017 Annual List of Explosives inadvertently omitted a letter in one of the explosive materials. This notice does not make any substantive changes to the 2017 annual list; however, it corrects the list and publishes the 2018 Annual List of Explosive Materials.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the ``deemed to be a license'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued May 13, 2015, to provide new and revised Q&As.

The Board is providing notice of the aggregate global indicator amounts for purposes of a calculation for 2018, which is required under the Board's rule regarding risk-based capital surcharges for global systemically important bank holding companies (GSIB surcharge rule).

The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection: 0651-0051 (Madrid Protocol).

This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2019. This table is needed to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide.'' Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.

The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Financial Statements for Holding Companies (FR Y-9 family of reports) (OMB No. 7100-0128), the Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations (FR Y-7N family of reports) (OMB No. 7100-0125), the Bank Holding Company Report of Insured Depository Institutions' Section 23A Transactions with Affiliates (FR Y-8) (OMB No. 7100-0126), the Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11 family of reports) (OMB No. 7100-0244), the Domestic Finance Company Report of Consolidated Assets and Liabilities (FR 2248) (OMB No. 7100-0005), the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314 family of reports) (OMB No. 7100-0073), the Quarterly Savings and Loan Holding Company Report (FR 2320) (OMB No. 7100-0345), the Weekly Report of Selected Assets and Liabilities of Domestically Chartered Commercial Banks and U.S. Branches and Agencies of Foreign Banks (FR 2644) (OMB No. 7100-0075), and the Consolidated Report of Condition and Income for Edge and Agreement Corporations (FR 2886b) (OMB No. 7100-0086).

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Procurement Solicitation Package (FR 1400; OMB No. 7100-0180).

The Secretary of Homeland Security, pursuant to the Homeland Security Act of 2002, has temporarily extended the applicability and enforcement of certain regulations governing conduct on Federal property that is under the administrative jurisdiction and control of U.S. Customs and Border Protection (CBP) along the southwest border. This temporary administrative extension enables DHS to protect and secure Federal property along the southwest border within the control of CBP's San Diego Field Office, Tucson Field Office, Laredo Field Office and El Paso Field Office, and to carry out DHS's statutory obligations to protect and secure the nation's borders. The Federal property subject to this notice is limited to the specific geographic area within the administrative control of CBP along the length of the U.S. border with Mexico.

We are announcing the end of the ``single decisionmaker'' test, consistent with our notice in the Federal Register in 2016, in which we said that we would end the test by December 28, 2018. This notice also extends the separate ``prototype'' test until its cessation in June 2020.