2018 – Federal Register Recent Federal Regulation Documents

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 collection of information using Form FDA 3794, entitled ``Generic Drug User Fee Cover Sheet.''

The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the ultrasound cyclodestructive device, a postamendments class III device (regulated under product code LZR), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these devices from class III to class II (special controls) and reduce regulatory burdens as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.

This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.

The Office of the United States Trade Representative (USTR) is providing notice of the Fiscal Year (FY) 2019 (Oct. 1, 2018 through Sept. 30, 2019) in-quota quantity of the tariff-rate quotas for imports of certain sugars, syrups and molasses (also known as refined sugar), specialty sugar, and sugar-containing products.

The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of North Carolina on November 17, 2017, through the North Carolina Department of Environmental Quality, Division of Air Quality (DAQ), for the purpose of removing 26 counties from North Carolina's expanded inspection and maintenance (I/M) program, which was previously approved into the SIP for use as a component of the State's Nitrogen Oxides (NOX) Budget and Allowance Trading Program. The EPA has determined that North Carolina's November 17, 2017, SIP revision is approvable because it is consistent with the Clean Air Act (CAA or Act) and with the EPA's regulations.

OGIS and the Office of Information Policy (OIP), U.S. Department of Justice, announce a second 2018 meeting of the Chief FOIA Officers Council.

In this document, the Environmental Protection Agency (``EPA'' or ``Agency'') is notifying the public that the Agency has found that the 2017 motor vehicle emissions budgets (``budgets'') for volatile organic compounds (``VOCs'') and nitrogen oxides (``NOX'') submitted by the New Jersey Department of Environmental Protection for the 2008 national ambient air quality standard (``NAAQS'') for ozone are adequate for transportation conformity purposes for the New Jersey portions of the New York-Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone nonattainment area. The transportation conformity rule) requires that the EPA conduct a public process and make an affirmative decision on the adequacy of these budgets before they can be used by metropolitan planning organizations in conformity determinations. As a result of this finding, upon the effective date of this notification of adequacy, the North Jersey Transportation Planning Authority must use these budgets in future transportation conformity determinations. The budgets are contained in New Jersey's December 22, 2017, state implementation plan submittal for the 2008 8-hour ozone NAAQS and are associated with the reasonable further progress milestone demonstration.

The Department of Veterans Affairs (VA) adopts as final, with no changes, a proposed rule amending the definition of domiciliary care to encompass VA's Mental Health Residential Rehabilitation Treatment Program (MH RRTP). This rule aligns regulations with VA's administrative decision in 2005 to designate MH RRTP as a type of domiciliary care. We also proposed clarifying that domiciliary care provides temporary, not permanent, residence to affected veterans. We provided a 60-day comment period on this proposed rule and received 4 comments, all of which were generally supportive of the proposed changes. We make no changes based on public comments and adopt the proposed rule as final.

The Pipeline and Hazardous Materials Safety Administration, in coordination with the Federal Railroad Administration, is issuing this final rule to remove requirements pertaining to electronically controlled pneumatic brake systems on high-hazard flammable unit trains. This final action is based on the Department of Transportation's determination that the requirements are not economically justified.

We are superseding Airworthiness Directive (AD) 2017-14-03 for Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters. AD 2017-14-03 required an inspection and reduced the retirement lives of certain landing gear components. This new AD retains the requirements of AD 2017-14-03, reduces the retirement lives of additional landing gear components, and requires repeating the inspection. This AD was prompted by a revised analysis of the fatigue life of the landing gear. The actions of this AD are intended to prevent an unsafe condition on these products.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued, from August 28, 2018 to September 10, 2018. The last biweekly notice was published on September 11, 2018.

Based on an affirmative final determination by the Department of Commerce (Commerce) and the International Trade Commission (the ITC), Commerce is issuing the antidumping duty order on forged steel fittings from Taiwan.

Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given that the next meeting of the Children's Health Protection Advisory Committee (CHPAC) will be held October 11- October 12, 2018, at Holiday Inn Washington-Capitol 550 C Street SW, Washington, DC 20024. The CHPAC advises the Environmental Protection Agency on science, regulations, and other issues relating to children's environmental health.

This notice announces the availability, and opportunity for public review, and comment, of a Draft Supplemental Environmental Impact Statement (SEIS), which examines the potential impacts of a proposal by the GSA, to reconfigure and expand the existing San Ysidro Land Port of Entry (LPOE) located at the United States (U.S.)-Mexico border in the City of San Diego community of San Ysidro, in San Diego County, California. The Draft SEIS describes the reason the project is being proposed; the alternatives being considered; the potential impacts of each of the alternatives on the existing environment; and the proposed avoidance, minimization, and/or mitigation measures related to those alternatives. As the lead agency for this undertaking, GSA is acting on behalf of its major tenant at this facility, the Department of Homeland Security's Customs and Border Protection.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Consolidated Superfund Information Collection Request'' (EPA ICR No. 1487.14, OMB Control No. 2050-0179) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through May 31, 2019. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding the Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453.

On September 10, 2018, the United States Court of International Trade (CIT or Court) sustained the final remand results pertaining to the countervailing duty (CVD) investigation on certain cold-rolled steel flat products from the Republic of Korea covering the period January 1, 2014, through December 31, 2014. The Department of Commerce (Commerce) is notifying the public that the final judgement in this case is not in harmony with the Amended Final Determination of the CVD investigation and that Commerce is amending the Amended Final Determination with respect to the CVD rate assigned to POSCO.

The Department of Commerce (Commerce) determines that imports of polyethylene terephthalate (PET) resin from Pakistan are being sold in the United States at less than fair value (LTFV), as provided in section 735 of the Tariff Act of 1930, as amended (the Act).