December 8, 2017 – Federal Register Recent Federal Regulation Documents

On November 8, 2017, U.S. Customs and Border Protection (CBP) published a notice in the Federal Register announcing plans to make the Automated Commercial Environment (ACE) the sole electronic data interchange (EDI) system authorized by CBP for generating, transmitting, and updating daily and monthly statements for all entries except reconciliation (type 09) entries. The changes announced in that notice were to become operational on December 9, 2017. This notice announces that the date for the transition to ACE as the sole CBP- authorized EDI system for statement processing is delayed until January 6, 2018. ACE will not be the official system of records for statements until that time.

The Coast Guard is establishing a temporary safety zone for all navigable waters on the Ohio River from mile marker (MM) 326.5 to MM 327.5. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with the demolition of the Ironton-Russell Bridge. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

NMFS proposes 2018 and 2019 harvest specifications, apportionments, and Pacific halibut prohibited species catch limits for the groundfish fishery of the Gulf of Alaska (GOA). This action is necessary to establish harvest limits for groundfish during the 2018 and 2019 fishing years and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska. The intended effect of this action is to conserve and manage the groundfish resources in the GOA in accordance with the Magnuson-Stevens Fishery Conservation and Management Act.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.

The Board of Governors of the Federal Reserve System (``Board'') is proposing to amend its Regulation A to; revise the provisions regarding the establishment of the primary credit rate in a financial emergency, and to delete the provisions relating to the use of credit ratings for collateral for extensions of credit under the former Term Asset-Backed Securities Loan Facility (TALF). The proposed amendments are intended to allow the regulation to address circumstances in which the Federal Open Market Committee has established a target range for the federal funds rate rather than a single target rate, and to reflect the expiration of the TALF program.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the San Joaquin County (Bacon Island Road) highway Drawbridge across the Middle River, mile 8.6, between Bacon Island and Lower Jones Tract, CA. The deviation is necessary to allow the bridge owner to make emergency structural repairs. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Fostering Digital Health Innovation: Developing the Software Precertification Program.'' The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take into account real world evidence while incorporating principles established through international harmonization.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Department of Defense is publishing the unclassified text of an arms sales notification.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service, are proposing to renew an information collection with revisions.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Software as a Medical Device (SaMD): Clinical Evaluation.'' This guidance was prepared as part of the FDA's international convergence efforts under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The guidance, informed by global and U.S. public comments, pertains to Software as a Medical Device (SaMD) and focuses on principles of clinical evaluation, which include establishing the scientific validity, clinical performance, and analytical validity for SaMD. The guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical and Patient Decision Support Software.'' This draft guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for healthcare professionals, and patient decision support software intended for patients and caregivers who are not healthcare professionals. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' available at https://www.fda.gov/downloads/forindustry/ userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals.

We, NMFS, announce our intent to conduct a 5-year review for the endangered western distinct population segment (DPS) of Steller sea lion (Eumetopias jubatus) under the Endangered Species Act of 1973, as amended (ESA). We are required by the ESA to conduct 5-year reviews to ensure that the listing classifications of species are accurate. The 5- year review must be based on the best scientific and commercial data available at the time of the review. We request submission of any such information on the Western DPS of Steller sea lion, particularly information on the status, threats, and recovery of the species that has become available since the final listing determination in May, 1997.

The Department of Defense is removing its regulations regarding procedures for the conduct of military commissions to try certain terror suspects for war crimes because the subchapter, which contains eleven parts, is outdated and no longer in force.

The Environmental Protection Agency (EPA) is proposing to find that the St. Louis-St. Charles-Farmington, Missouri-Illinois (MO-IL) area, ``the St. Louis area,'' is attaining the 2008 ozone National Ambient Air Quality Standard (NAAQS or standard) based on 2014-2016 monitoring data. EPA is further proposing to redesignate the Illinois portion of the St. Louis area, ``the Metro-East area,'' to attainment for the 2008 ozone NAAQS because the Metro-East area meets the statutory requirements for redesignation under the Clean Air Act (CAA). (EPA will address the Missouri portion of the St. Louis area in a separate rulemaking action.) The St. Louis area includes Madison, Monroe and St. Clair Counties in Illinois (the Metro-East area), and Franklin, Jefferson, St. Charles, and St. Louis Counties and the City of St. Louis in Missouri. The Illinois Environmental Protection Agency (IEPA) submitted a request to redesignate the Metro-East area on May 8, 2017. EPA is also proposing to approve, as a revision to the Illinois State Implementation Plan (SIP), the State's plan for maintaining the 2008 ozone standard through 2030 in the St. Louis area. Finally, EPA finds adequate and is proposing to approve, as a SIP revision, the State's 2030 volatile organic compound (VOC) and oxides of nitrogen (NOX) Motor Vehicle Emission Budgets (MVEBs) for the Metro- East area.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 18, 2017, direct final rule approving the State of Ohio's request to redesignate the Fulton County nonattainment area (Fulton County) to attainment of the 2008 National Ambient Air Quality Standards for lead.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 18, 2017, direct final rule approving the Illinois regional haze progress report under the Clean Air Act as a revision to the Illinois State Implementation Plan (SIP).

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 20, 2017, direct final rule approving the Wisconsin regional haze progress report under the Clean Air Act as a revision to the Wisconsin State Implementation Plan (SIP).