February 19, 2019 – Federal Register Recent Federal Regulation Documents

Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing antidumping duty (AD) and countervailing duty (CVD) orders on rubber bands from the People's Republic of China (China).

EPA is making available for review and comment the data received from respondents of a voluntary survey, ``2018 Clean Water Act Hazardous Substances Survey'' (OMB Control No. 2050-0220). This data is being made available consistent with the preamble to the proposed action ``Clean Water Act Hazardous Substances Spill Prevention'' published on June 25, 2018. The data collected through the voluntary survey is available in Regulations.gov at Docket ID: EPA-HQ-OLEM-2017- 0444.

The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on April 3-4, 2019. A sample of agenda items to be discussed during the public session includes: A discussion on medical-related events; a discussion on the ACMUI's recommendations and comments on revision 10 of the draft Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] and SIR_Spheres[supreg] Licensing Guidance; a discussion on the summary of changes to the NRC's requirements regarding medical use of byproduct material; a discussion of the ACMUI's recommendations related to the appropriateness of the required reporting and notification of a medical event; a presentation from Lucerno Dynamics on the detection of nuclear medicine injection infiltrations; and a discussion on the ACMUI's recommendations and comments on the draft Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance. The agenda is subject to change. The current agenda and any updates will be available at https://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2019.html or by emailing Ms. Kellee Jamerson at the contact information below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry.'' The guidance document provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. The issuance of this guidance fulfills the statutory requirement set forth in a certain section of the 21st Century Cures Act (Cures Act). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2017.

The National Toxicology Program (NTP) announces a workshop titled ``Converging on Cancer'' on April 29-30, 2019, to bring together researchers working in the area of cancer biology, assay development, mixtures toxicology, in silico modeling, and cancer risk assessment. The objectives of the workshop are to identify technologies and models that can be used in a systems toxicology approach for cancer risk assessment. Specific applications to understanding the joint effects of multiple chemical exposures will be discussed. The workshop will consist of plenary sessions (webcast), breakout discussion sessions, and a poster session. This workshop is open to the public. Members of the public can register to attend the workshop in person as observers or view the plenary proceedings via webcast.

By Federal Register notice on July 31, 2018 the National Park Service (NPS) and the Federal Aviation Administration (FAA) invited interested persons to apply to fill one current and three future openings on the National Parks Overflights Advisory Group (NPOAG) to represent air tour operator concerns, general aviation, and Native American interests. This notice informs the public of the selection made for the vacancies representing air tour operator concerns and Native American interests and invites persons interested in serving on the NPOAG to apply for current openings representing Native American concerns and general aviation.

This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.

In accordance with the Federal Advisory Committee Act, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.

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

FMCSA announces its decision to grant the American Pyrotechnics Association (APA) an exemption from the hours-of-service (HOS) regulations that require a motor carrier to install and require each of its drivers to use an electronic logging device (ELD) to record the driver's HOS. APA requested the exemption for APA member companies currently holding an exemption from the HOS 14-hour rule during the Independence Day season. These member companies will continue to use paper records of duty status (RODS) in lieu of an ELD during the designated Independence Day periods. FMCSA has determined that the terms and conditions of the exemption ensure a level of safety equivalent to, or greater than, the level of safety achieved without the exemption.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

We are superseding Airworthiness Directive (AD) 2018-11-16 for all Engine Alliance (EA) GP7270 and GP7277 turbofan engines with a certain engine fan hub assembly. AD 2018-11-16 required a one-time eddy current inspection (ECI) of the engine fan hub blade slot bottom and blade slot front edge for cracks, a visual inspection of the engine fan hub assembly for damage, and removal of parts if damage or defects are found that are outside serviceable limits. This AD retains these requirements, but expands the population of affected engine fan hub assemblies and revises the compliance time for the inspections. This AD was prompted by the FAA's determination that inspections need to be expanded to all EA GP7270 and GP7277 turbofan engines. We are issuing this AD to address the unsafe condition on these products.

FMCSA announces its decision to deny applications from 32 individuals who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting 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 operate a commercial motor vehicle (CMV) from operating CMVs in interstate commerce.

EIA requests a three-year extension, with changes, of the Petroleum Marketing Program as required under the Paperwork Reduction Act of 1995. EIA's petroleum marketing survey program collects volumetric and price information needed for determining the supply of and demand for crude oil and refined petroleum products.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information collected on the FAA Form 8120-11 is reported voluntarily by manufacturers, repair stations, aircraft owner/ operators, air carriers, and the general public who wish to report suspected unapproved parts to the FAA for review. The report information is collected and correlated by the FAA, Aviation Safety Hotline Program Office, and used to determine if an unapproved part investigation is warranted.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Healthcare Improvement, Inc. PSO, PSO number P0123, of its status as a PSO, and has delisted the PSO accordingly.

The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend approval, under the Paperwork Reduction Act, of a collection of information contained in its regulation on Annual Financial and Actuarial Information Reporting. This notice informs the public of PBGC's intent and solicits public comment on the collection.