September 25, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is reopening the comment period provided in the notice entitled ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' that appeared in the Federal Register on February 16, 2018. That notice announced the public meeting to be held on August 13 and 14, 2018, and requested comments by September 14, 2018. FDA is reopening the public meeting's comment period until November 26, 2018. The Agency is taking this action to allow interested parties additional time to submit comments.

The U.S. Nuclear Regulatory Commission (NRC) is considering the renewal of NRC source materials license SUA-1548, to authorize continued uranium in-situ recovery (ISR) operations at the sites under the Smith Ranch-Highland Uranium Project (Smith Ranch Project) (Docket No. 40-8964). The NRC has prepared an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for this licensing action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsContent and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act).

In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee on Community Banking, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on a broad range of policy issues that have particular impact on small community banks throughout the United States and the local communities they serve, with a focus on rural areas.

Notice is hereby given that the U.S. International Trade Commission has found no violation of section 337 of the Tariff Act of 1930, as amended, by respondents Sigma Designs, Inc. and Vizio, Inc. The investigation is terminated.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive.

MFP provides payments to producers with commodities that have been significantly impacted by actions of foreign governments resulting in the loss of traditional exports. This NOFA announces the availability of MFP funds for eligible producers of shelled almonds and fresh sweet cherries and makes a correction to a previously issued NOFA published on August 30, 2018, with respect to MFP funds availability for hogs. On behalf of the Commodity Credit Corporation (CCC), the Farm Service Agency (FSA) administers MFP. MFP participants will receive an MFP payment, calculated based on the eligible production multiplied by the participant's share multiplied by the MFP payment rate.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.'' This guidance document describes factors FDA considers when evaluating the benefit-risk profile of a device in comparison to a predicate device in a 510(k) when the device has the same intended use as the predicate device, and different technological characteristics that do not raise different questions of safety and effectiveness. This guidance can be helpful in situations when there is an increase in risk and increase or equivalent benefit, or a decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. We are taking this action in response to a color additive petition submitted by Glo Eyes, LLC.

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.