May 9, 2019 – Federal Register Recent Federal Regulation Documents

The Surface Transportation Board (STB or Board) adopts a new procedure for water carriers operating in the noncontiguous domestic trade to electronically publish, file, and keep tariffs available for public inspection.

In accordance with the U.S. Code, and the provisions of the Federal Advisory Committee Act (FACA) and its implementing regulations issued by the U.S. General Services Administration (GSA), the Secretary of Labor is renewing the charter for the Advisory Committee on Veterans' Employment, Training, and Employer Outreach (ACVETEO).

We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the North Dakota regulatory program (North Dakota program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). This amendment, proposed by North Dakota, makes numerous rule changes to the North Dakota Administrative Code for surface coal mining and reclamation operations based on statutory changes that were made during North Dakota's 2015 Legislative Session. The statutory changes added a definition of ``commercial leonardite'' (oxidized lignite) and excluded commercial leonardite from the statutory definition of ``coal.'' The statutory changes also added the phrase ``and commercial leonardite'' and ``or commercial leonardite'' to many other sections of North Dakota's reclamation statute. The statutory changes necessitated a number of similarly related changes to North Dakota's administrative rules. Finally, some of North Dakota's proposed rule revisions include minor non-substantive grammatical, codification, and statutory citation cross-reference changes. North Dakota's revisions are intended to improve operational efficiency. OSMRE does not have any corresponding statutes or regulations about leonardite, and the changes are consistent with OSMRE policy about leonardite. As such, North Dakota's proposed statutory and regulatory changes add specificity about the regulation of leonardite beyond that contained in SMCRA and the Federal regulations, and we are approving them. OSMRE's approval of North Dakota's proposed statutory and regulatory changes are solely for purposes of complying with SMCRA and may not be viewed as waiving any property interests that the United States may have in leonardite deposits that are part of the federal coal estate in certain lands in North Dakota.

The U.S. Copyright Office is correcting a final rule that appeared in the Federal Register on April 9, 2019. The document incorrectly numbered paragraphs governing the filing fees of certain documents that can be filed with the Copyright Office.

FMCSA announces receipt of applications from six individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to control a commercial motor vehicle (CMV) to drive in interstate commerce. If granted, the exemptions would enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.

FMCSA requests comments on a petition submitted by the American Bus Association, Inc. (ABA) and the United Motorcoach Association, Inc. (UMA) requesting a determination that certain vehicle inspection requirements for ground transportation operators imposed by the San Francisco International Airport (SFO) on passenger-carrying motor vehicles in interstate commerce are preempted by Federal law. FMCSA requests comments in response to this petition.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Ohio (FEMA- 4424-DR), dated 04/08/2019. Incident: Severe Storms, Flooding, and Landslides. Incident Period: 02/05/2019 through 02/13/2019.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a public meeting on Friday, May 24, 2019; 1:30 p.m. to discuss Legal Financial Obligation (LFO) report.

The National Park Service is soliciting comments on the significance of properties nominated before April 27, 2019, for listing or related actions in the National Register of Historic Places.

The Coast Guard announces that the Fifth District, Chief of Prevention Division has issued a certificate of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for the towing vessel CAPE CANAVERAL, Official Number (O.N.) 1293905, Master Boat Builders Hull Number 461. We are issuing this notice because its publication is required by statute. Due to its construction, purpose and service, the towing vessel CAPE CANAVERAL cannot fully comply with the light, shape, or sound signal provisions of the 72 COLREGS without interfering with the vessel's design and construction. This notification of issuance of a certificate of alternative compliance promotes the Coast Guard's marine safety mission.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of California (FEMA- 4431-DR), dated 05/01/2019. Incident: Severe Winter Storms, Flooding, Landslides, and Mudslides. Incident Period: 02/13/2019 through 02/15/2019.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Mississippi (FEMA-4429-DR), dated 04/23/2019. Incident: Severe Storms, Straight-line Winds, Tornadoes, and Flooding. Incident Period: 02/22/2019 through 03/29/2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.'' This draft guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of their regulatory submissions to provide certain information to FDA so that FDA can internally track the submissions. The purpose of this guidance is to provide instructions on how to document that a submission includes RWE.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postapproval Pregnancy Safety Studies.'' When finalized, the purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA (i.e., pregnancy safety studies). This draft guidance, when finalized, will represent the current thinking of FDA on postapproval pregnancy safety studies. This draft guidance is intended to help industry develop more comprehensive and scientifically sound studies to assess the safety of drug and biological products during pregnancy in the postmarketing setting. The previous guidance for industry entitled ``Establishing Pregnancy Exposure Registries,'' issued on August 23, 2002, has been withdrawn.

The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on June 10, 2019, to discuss: (1) The revisions to the ACMUI bylaws and (2) the draft report of the ACMUI Regulatory Guide 8.39 Subcommittee. This report will include the subcommittee's comments and recommendations on Phase 1 of the revisions to Regulatory Guide 8.39, ``Release of Patients Administered Radioactive Material.'' A phased approach is being conducted by the NRC staff to comprehensively update Regulatory Guide 8.39. Phase 1 of the revision provides licensees with more detailed instructions to patients before and after they have been administered radioactive material than what is currently provided in Regulatory Guide 8.39. Meeting information, including a copy of the agenda and handouts, will be available at https:// www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2019.ht ml. The agenda and handouts may also be obtained by contacting Ms. Kellee Jamerson using the information below.

We are superseding Airworthiness Directive (AD) 2016-16-01, which applied to certain Airbus SAS Model A330-200 Freighter, -200, and -300 series airplanes. AD 2016-16-01 required an inspection of affected structural parts in the cargo and cabin compartments to determine if proper heat treatment has been done, and replacement or repair if necessary. This AD retains the requirements of AD 2016-16-01 and requires inspection of additional locations of the cabin compartment structure. This AD was prompted by a report of a manufacturing defect (i.e., improperly heat-treated materials) that affects the durability of affected parts in the cargo and cabin compartments. We are issuing this AD to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-8 and 747-8F series airplanes. This AD was prompted by reports of damaged vapor seals, block seals, and heat shield seals on the outboard pylons between the engine strut and aft fairing. This AD requires installing new aft fairing vapor seals, heatshield seals, heatshield seal retainers, block seals, and outboard lateral restraint access panels. We are issuing this AD to address the unsafe condition on these products.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection as part of our continuing efforts to reduce paperwork and respondent burden.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

We are notifying the public that we propose to make changes to the import requirements in the U.S. Department of Agriculture (USDA) Plants for Planting Manual for imports of Dianthus spp. (carnation) cuttings from Kenya. Currently, Dianthus spp. cuttings from Kenya require mandatory postentry quarantine within the United States. We are proposing to allow Dianthus spp. cuttings from Kenya to be imported into the United States without postentry quarantine, subject to certain conditions. These changes to the USDA Plants for Planting Manual would relieve restrictions on Dianthus spp. cuttings from Kenya while continuing to address the possible introduction of quarantine pests through the importation of such cuttings. We are making these changes available to the public for review and comment.