July 17, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Federal Transit Administration (FTA) and Metro (the designated Metropolitan Planning Organization, or MPO, for the Portland region) issue this early scoping notice for a MAX tunnel project (Project). Metro is exploring ways to improve transit time and reliability to and through the Portland Central City. The purpose of this early scoping notice is to advise other agencies and the public of the intent to further study the feasibility of a tunnel under downtown Portland. The Project would improve regional transit service by addressing current and projected travel time, reliability, and resiliency issues for trips to and across Portland's downtown core. Early scoping for the feasibility study is occurring within the context of the Council on Environmental Quality's regulations for complying with the National Environmental Policy Act (NEPA).

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection resulting from focus groups about drug products as used by FDA.

This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

The Department of Defense (DoD) is publishing this notice to announce that it is establishing the Table Rock Lake Oversight Committee (``the TRLOC'').

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Office of Population Affairs (OPA) announces the award of a single-source grant in response to an unsolicited proposal from the University of Northern Colorado, Greely, Colorado. The proposal submitted was not solicited either formally or informally by any federal government official.

The FAA is amending three jet routes and seven VHF Omnidirectional Range (VOR) Federal airways in the vicinity of Omaha, Nebraska, to correct the state abbreviation for the Omaha VOR/Tactical Air Navigation (VORTAC) navigation aid (NAVAID). The Omaha VORTAC is located in Mineola, Iowa; however, the state abbreviation for the location of the Omaha VORTAC included in the Air Traffic Service (ATS) routes is listed as ``NE''. Specifically, this action changes the state abbreviation for the Omaha VORTAC listed in the jet route J-21, J-41, and J-151, and VOR Federal airway V-6, V-8, V-138, V-159, V-172, V-181, and V-307, descriptions from ``NE'' to ``IA'' to match the information contained in the FAA's aeronautical database and the charted ATS route depictions on the associated charts. No air traffic services are affected by this action.

NMFS has received a request from the Alaska Department of Transportation and Public Facilities (ADOT&PF) for authorization to take marine mammals incidental to two years of activity related to ferry berth improvements and construction in Tongass Narrows, near Ketchikan, AK. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue two consecutive incidental harassment authorizations (IHAs) to incidentally take marine mammals during the specified activities. The marine construction associated with the proposed activities will occur during two distinct year-long phases, and incidental take associated with these phases would be authorized in separate, consecutive IHAs. NMFS is also requesting comments on a possible one-year renewal for each IHA that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.

This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-423, and V-428 due to the planned decommissioning of the Ithaca, NY, VOR/DME navigation aid which provides navigation guidance for segments of the routes. The Ithaca VOR/DME is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

On October 26, 2018, the Montana Department of Environmental Quality (MDEQ) submitted a request to the EPA for redesignation of the East Helena, Montana 1971 sulfur dioxide (SO2) National Ambient Air Quality Standards (NAAQS) nonattainment area (NAA) to attainment, and to approve a State Implementation Plan (SIP) revision for a maintenance plan of the East Helena area. After review and analysis of Montana's submittal, the EPA is proposing to redesignate the East Helena, Montana SO2 nonattainment area to attainment for the 1971 primary 24-hour and annual, and secondary 3- hour SO2 NAAQS, and to approve Montana's SIP revision for continued maintenance and attainment of the 1971 primary 24-hour and annual, and secondary 3-hour SO2 NAAQS in East Helena, Montana.

This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-91, V-123, V-431, V-489, and V-496 due to the planned decommissioning of the Glens Falls, NY, VORTAC navigation aid which provides navigation guidance for segments of the routes. The Glens Falls VORTAC is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions to Colorado Regulation Number 4 (Reg. No. 4), ``Sale and Installation of Wood-Burning Appliances and the Use of Certain Wood Burning Appliances During High Pollution Days,'' submitted by the State on May 2, 2016 and May 14, 2018. The revisions update definitions, emission standards, certification and labeling requirements, and citation references to maintain consistency with the EPA's 2015 Standards of Performance for New Residential Wood Heaters. The EPA is taking this action in accordance with the Clean Air Act (CAA).

This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-148 and V-345 in the vicinity of Hayward, WI, and remove V-177 in the vicinity of Ely, MN, and Hayward, WI. The VOR Federal airways modifications and removal are necessary due to the planned decommissioning of the Ely, MN, and Hayward, WI, VOR navigation aids (NAVAIDs), which provide navigation guidance for portions of the affected air traffic service (ATS) routes. The Ely and Hayward VORs are being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

The National Aeronautics and Space Administration (NASA) is correcting a document that appeared in the Federal Register on July 10, 2019, concerning request for public comment on the Agency's proposed implementation of new reporting requirements regarding harassment among recipients of NASA financial assistance. The document that published was an incorrect version. This document is the correct version.

The Environmental Protection Agency (EPA) is updating a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying to OCS sources located within 25 miles of states' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by section 328(a)(1) of the Clean Air Act (CAA). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which Maryland is the designated COA. The State of Maryland's requirements discussed in this document, and listed in the appendix to the Federal OCS air regulations, are approved for incorporation into the compilation of state provisions that is incorporated by reference.