2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical and Patient Decision Support Software.'' This draft guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for healthcare professionals, and patient decision support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 This draft guidance is not final nor is it in effect at this time.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commissions to try certain terror suspects for war crimes because the subchapter, which contains eleven parts, is outdated and no longer in force.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).

Due to adverse comments, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for ``Approval of Missouri Air Quality Implementation Plans; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard'' published in the Federal Register on October 11, 2017. The direct final rule was an approval of a State Implementation Plan (SIP) revision from the State of Missouri for the 2010 Nitrogen Dioxide (NO2) National Ambient Air Quality Standard (NAAQS). Section 110 of the CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

The Bureau of Land Management (BLM) is promulgating a final rule (2017 final delay rule) to temporarily suspend or delay certain requirements contained in the rule published in the Federal Register on November 18, 2016, entitled, ``Waste Prevention, Production Subject to Royalties, and Resource Conservation'' (2016 final rule) until January 17, 2019. The BLM has concerns regarding the statutory authority, cost, complexity, feasibility, and other implications of the 2016 final rule, and therefore intends to avoid imposing likely considerable and immediate compliance costs on operators for requirements that may be rescinded or significantly revised in the near future. The 2017 final delay rule does not substantively change the 2016 final rule, but simply postpones implementation of the compliance requirements for certain provisions of the 2016 final rule for 1 year.

In the event of an appropriations lapse, the Office of the Federal Register (OFR) would be required to publish documents directly related to the performance of governmental functions necessary to address imminent threats to the safety of human life or protection of property. Since it would be impracticable for the OFR to make case-by- case determinations as to whether certain documents are directly related to activities that qualify for an exemption under the Antideficiency Act, the OFR will place responsibility on agencies submitting documents to certify that their documents relate to emergency activities authorized under the Act.

This regulation establishes a tolerance for residues of ziram in or on hazelnut. United Phosphorus, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This document corrects two errors in the preamble of a document that appeared in the Federal Register on November 29, 2017.

The Board of Overseers of the Malcolm Baldrige National Quality Award (Board) will meet in open session on Wednesday, December 6, 2017. The purpose of this meeting is to review and discuss the work of the private sector contractor, which assists the Director of the National Institute of Standards and Technology (NIST) in administering the Malcolm Baldrige National Quality Award (Award), and information received from NIST and from the Chair of the Judges Panel of the Malcolm Baldrige National Quality Award in order to make such suggestions for the improvement of the Award process as the Board deems necessary. Details on the agenda are noted in the SUPPLEMENTARY INFORMATION section of this notice.

The Coast Guard is modifying the operating schedule that governs the Marine Parkway (Gil Hodges) Bridge across Jamaica Bay (Rockaway Inlet), mile 3.0, at Queens, NY. This temporary interim rule is necessary to accomodate Metropolitan Transportation Authority's (MTA) (the owner of the Marine Parkway Bridge) unexpected emergency repairs requiring a complete closure of the Bridge and an extension of time for their completion. The active deviation allows for opening of the bridge with two-hours of advance notice and expires at the 180th day. Existing federal regulations do not allow back-to-back deviations.

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

The FDIC, 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 the renewal of the existing information collection, as required by the Paperwork Reduction Act of 1995. Currently, the FDIC is soliciting comment on renewal of the information collection described below.

We propose special conditions for the BHTI Model 525 helicopter. This helicopter will have a novel or unusual design feature associated with fly-by-wire flight control system (FBW FCS) functions that affect the pilot awareness of the flight control modes while operating the helicopter. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed 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.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is expanding the approximately 2.25 million-acre ``Outer Coastal Plain'' viticultural area of southeastern New Jersey by approximately 32,932 acres. The Outer Coastal Plain AVA includes all or portions of Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Monmouth, Ocean, and Salem counties. The established viticultural area and the expansion area are not located within any other established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.

On October 31, 2017, the Department of Commerce (Department) published in the Federal Register the preliminary determination of the less-than-fair-value investigation of carbon and alloy steel wire rod (wire rod) from Spain. The Department is amending its preliminary determination to correct a significant ministerial error.