December 16, 2015 – Federal Register Recent Federal Regulation Documents

This rulemaking is required by a Public Law enacted on December 16, 2014. This law requires the United States Patent and Trademark Office (``Office'' or ``USPTO'') Director to establish regulations and procedures for application to and participation in the USPTO Law School Clinic Certification Program. This law removed the ``pilot'' status of the USPTO's existing law school clinic certification program. The program allows students enrolled in a participating law school's clinic to practice patent and trademark law before the USPTO under the direct supervision of a faculty clinic supervisor by drafting, filing, and prosecuting patent or trademark applications, or both, on a pro bono basis for clients who qualify for assistance from the law school's clinic. In this way, these student practitioners gain valuable experience drafting, filing, and prosecuting patent and trademark applications that would otherwise be unavailable to students while in law school. The program also facilitates the provision of pro bono services to trademark and patent applicants who lack the financial resources to pay for legal representation. The proposed rules incorporate the requirements and procedures developed and implemented during the pilot phase of the program.

This guidance relates to Section 1332 of the Patient Protection and Affordable Care Act (ACA) and its implementing regulations. Section 1332 provides the Secretary of Health and Human Services and the Secretary of the Treasury with the discretion to approve a state's proposal to waive specific provisions of the ACA (a State Innovation Waiver), provided the proposal meets certain requirements. In particular, the Secretaries can only exercise their discretion to approve a waiver if they find that the waiver would provide coverage to a comparable number of residents of the state as would be provided coverage absent the waiver, would provide coverage that is at least as comprehensive and affordable as would be provided absent the waiver, and would not increase the Federal deficit. If the waiver is approved, the state may receive funding equal to the amount of forgone Federal financial assistance that would have been provided to its residents pursuant to specified ACA programs, known as pass- through funding. State Innovation Waivers are available for effective dates beginning on or after January 1, 2017. They may be approved for periods up to 5 years and can be renewed. The Departments promulgated implementing regulations in 2012. This document provides additional information about the requirements that must be met, the Secretaries' application review procedures, the amount of pass-through funding, certain analytical requirements, and operational considerations.

The Department of State, pursuant to its regulations and in the interest of the security of the United States, temporarily modifies Category XI of the United States Munitions List (USML).

Environmental Protection Agency (EPA) is reopening the public comment period for a proposed rule published October 22, 2015. On November 23, 2015, EPA received a request from the National Tribal Air Association to extend the public comment period an additional 120 days from the closing date of November 23, 2015 and from the Fond du Lac Band of Lake Superior Chippewa for an unspecified period of time. EPA is, therefore, reopening the comment period for an additional 30 days after November 23, 2015.

We are proposing to consolidate the regulations governing bovine tuberculosis, and those governing brucellosis. As part of this consolidation, we are proposing to transition the tuberculosis and brucellosis programs away from a State classification system based in disease prevalence. Instead, States and Tribes would implement animal health plans that identify sources of the diseases within the State or Tribal lands and specify mitigations to address the risk posed by those sources. The consolidated regulations would also set forth standards for surveillance, epidemiological investigations, and affected herd management that must be incorporated into each animal health plan, with certain limited exceptions; would provide revised conditions for the interstate movement of cattle, bison, and captive cervids; and would provide revised conditions for APHIS approval of tests, testing laboratories, and testers for bovine tuberculosis or brucellosis. Finally, we are proposing to revise the bovine tuberculosis- and brucellosis-related import requirements for cattle and bison to make these requirements clearer and assure that they more effectively mitigate the risk of introduction of these diseases into the United States.

This regulation amends the existing exemption from the requirement of a tolerance for residues of the microbial pesticide Bacillus subtilis strain MBI600 to change the name to Bacillus amyloliquefaciens strain MBI600 (antecedent Bacillus subtilis strain MBI600) in or on all food commodities, including residues resulting from post-harvest uses, when applied or used in accordance with good agricultural practices. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to the existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus amyloliquefaciens strain MBI600.

The Federal Motor Carrier Safety Administration (FMCSA) amends the Federal Motor Carrier Safety Regulations (FMCSRs) to establish: Minimum performance and design standards for hours-of-service (HOS) electronic logging devices (ELDs); requirements for the mandatory use of these devices by drivers currently required to prepare HOS records of duty status (RODS); requirements concerning HOS supporting documents; and measures to address concerns about harassment resulting from the mandatory use of ELDs. The requirements for ELDs will improve compliance with the HOS rules.