February 1, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the assessment of risk evaluation and mitigation strategies (REMS) entitled ``REMS Assessment: Planning and Reporting; Draft Guidance for Industry.'' The draft guidance is one of several guidance documents being developed to fulfill performance goals under the fifth authorization of the prescription drug user fee program, the Prescription Drug User Fee Act V. This draft guidance describes how to develop a REMS Assessment Plan; specifically, how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals. The draft guidance recommends assessing the REMS using both process measures and outcome measures and provides examples of metrics by assessment categories, as well as data sources that may be utilized to evaluate the performance of the REMS. The draft guidance also discusses considerations for assessing the impact of REMS on patient access to the drug or its burden to the healthcare delivery system. Finally, this draft guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.

The Department of Education (Department) issues these final regulations to adjust the Department's civil monetary penalties (CMPs) for inflation. This adjustment is required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Inflation Adjustment Act). These final regulations provide the 2019 annual inflation adjustments being made to the penalty amounts in the Department's final regulations published in the Federal Register on January 16, 2018 (2018 final rule).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Immunogenicity Testing of Therapeutic Protein ProductsDeveloping and Validating Assays for Anti-Drug Antibody Detection.'' This guidance provides recommendations to facilitate industry's development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance applies to assays for the detection of anti-drug antibodies (ADAs) and may also apply to some peptides, oligonucleotides, and combination products on a case-by-case basis. The guidance includes recommendations regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. This guidance finalizes the revised draft guidance for industry entitled ``Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products'' issued in April 2016 and includes a revised title.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Form 15058, Application for Security Summit Membership.

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during November 2018, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), amending authorization to export LNG, and vacating prior authorization. These orders are summarized in the attached appendix and may be found on the FE website at https://www.energy.gov/ fe/listing-doefe-authorizationsorders-issued-2018-0. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons who are no longer subject to the prohibitions imposed pursuant to Executive Order 13661 of March 14, 2014, ``Blocking Property of Additional Persons Contributing to the Situation in Ukraine'', and Executive Order 13662 of March 20, 2014, ``Blocking Property of Additional Persons Contributing to the Situation in Ukraine.''

The Environmental Protection Agency (EPA) is proposing to approve the Massachusetts regional haze progress report submitted as a State Implementation Plan (SIP) revision on February 9, 2018. This revision addresses the requirements of the Clean Air Act and its implementing regulations that states submit periodic reports describing progress toward reasonable progress goals established for regional haze and a determination of adequacy of the state's existing regional haze SIP. Massachusetts' progress report notes that Massachusetts has implemented the measures in the regional haze SIP due to be in place by the date of the progress report and that visibility in the federal Class I areas affected by emissions from Massachusetts is improving and has already met the applicable reasonable progress goals for 2018. The EPA is proposing approval of Massachusetts' determination that the Commonwealth's regional haze SIP is adequate to meet these reasonable progress goals for the first implementation period, which extends through 2018, and requires no substantive revision at this time.

Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving a portion of an Oklahoma State Implementation Plan (SIP) submittal that pertains to the good neighbor provision requirements of the CAA with respect to interstate transport of air pollution which will interfere with maintenance of the 1997 ozone National Ambient Air Quality Standards (NAAQS). The good neighbor provision requires, in part, that each state, in its SIP, prohibit emissions that will interfere with maintenance of a new or revised NAAQS in another state. In this action, EPA is approving the Oklahoma SIP submittal as having met the interfere with maintenance requirement of the good neighbor provision for the 1997 ozone NAAQS in accordance with section 110 of the CAA.

The Copyright Royalty Judges announce receipt of two notices of intent to audit the 2015, 2016, and 2017 statements of account submitted by commercial webcasters and broadcasters Entercom Communications Corp. and iHeartMedia concerning royalty payments each made pursuant to two statutory licenses.

The Internal Revenue Service (IRS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Credit for Federal Tax Paid on Fuels.

NMFS has received a request from the U.S. Navy (Navy) to amend NMFS' Marine Mammal Protection Act (MMPA) regulations authorizing the take of marine mammals incidental to Navy training and testing activities conducted in the Atlantic Fleet Training and Testing (AFTT) Study Area from November 2018 to November 2023 to cover seven years of the Navy's activities, instead of five. Section 316 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (2019 NDAA), signed into law on August 13, 2018, amended the MMPA to extend the maximum period for MMPA incidental take regulations under section 101(a)(5)(A) from five to seven years for military readiness activities. The Navy's activities qualify as military readiness activities pursuant to the MMPA, as amended by the NDAA for Fiscal Year 2004. The Navy proposes no changes to their specified activities, mitigation measures, monitoring, or reporting and requests that NMFS amend the final rule issued on November 14, 2018, to authorize incidental take of marine mammals for the two additional years now allowed under the statute. NMFS invites the public to provide information, suggestions, and comments on the Navy's application.