December 11, 2018 – Federal Register Recent Federal Regulation Documents

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 hearing to hear testimony on the civil rights issues related to legal financial obligations in Tennessee.

The Bureau of Industry and Security (BIS) is seeking public comments on the impact that implementation of the Chemical Weapons Convention (CWC), through the Chemical Weapons Convention Implementation Act and the Chemical Weapons Convention Regulations (CWCR), has had on commercial activities involving ``Schedule 1'' chemicals during calendar year 2018. The purpose of this notice of inquiry is to collect information to assist BIS in its preparation of the annual certification to the Congress on whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms are harmed by such implementation. This certification is required under Condition 9 of Senate Resolution 75 (April 24, 1997), in which the Senate gave its advice and consent to the ratification of the CWC.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pesticide Active Ingredient Production (EPA ICR No. 1807.09, OMB Control No. 2060-0370), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Metallic Mineral Processing Plants (EPA ICR Number 0982.12, OMB Control Number 2060- 0016), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

NMFS announces 26 inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.

This is a Notice of the Presidential declaration of a major disaster for the State of California (FEMA-4407-DR), dated 11/12/2018. Incident: Wildfires. Incident Period: 11/08/2018 and continuing.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4399-DR), dated 10/23/2018. Incident: Hurricane Michael. Incident Period: 10/07/2018 through 10/19/2018.

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Virginia (FEMA-4401-DR), dated 10/15/2018. Incident: Hurricane Florence. Incident Period: 09/08/2018 through 09/21/2018.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the Federal Register Notice 82 FR 50428 regarding nationwide priorities for cessation. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4400-DR), dated 11/01/2018. Incident: Hurricane Michael. Incident Period: 10/09/2018 through 10/23/2018.

Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, the Federal Retirement Thrift Investment Board (FRTIB) is proposing to establish a new system of records. Records contained in this system will be used to educate participants about various aspects of the TSP.

The Environmental Protection Agency (EPA) is approving the removal of outdated rules in the Code of Federal Regulations (CFR) for the State of Oregon because they are duplicative or obsolete. Removal of such material from the air program subparts is designed to improve cost effectiveness and usability of the CFR. The EPA is also approving non-substantive revisions to reflect updated citations and correcting a typographical error. This final action makes no substantive changes to the Oregon State Implementation Plan and imposes no new requirements.

This action proposes to amend three domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways (V-113, V-137, and V-485) in the western United States. The modifications are necessary due to the planned decommissioning of Priest, CA, VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Priest, CA, VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-128 and V-144 in the vicinity of Kankakee, IL. The modifications are necessary due to the planned decommissioning of the Kankakee, IL (IKK), VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Kankakee VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by reports indicating there is a possibility of excessive error in the signal generated by the angle of attack (AOA) transducer. This proposed AD would require replacing certain AOA transducers. We are proposing this AD to address the unsafe condition on these products.

We propose to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes. This proposed AD was prompted by reports of corrosion in the solder joints of the upper and lower front relay box connectors to the printed circuit board. This proposed AD would require replacement of the existing relay boxes with modified boxes. We are proposing this AD to address the unsafe condition on these products.

The Federal Trade Commission (``FTC'' or ``Commission'') requests public comment on its Identity Theft Rules. The Commission is soliciting comment as part of the FTC's systematic review of all current Commission regulations and guides.

Under section 211 of the Clean Air Act, the Environmental Protection Agency (EPA) is required to set renewable fuel percentage standards every year. This action establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in the year 2019. Relying on statutory waiver authority that is available when the projected cellulosic biofuel production volume is less than the applicable volume specified in the statute, EPA is establishing volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel that are below the statutory volume targets. We are also establishing the applicable volume of biomass-based diesel for 2020.

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This AD was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. This AD requires inspecting for and removing all sealant blocking the drainage holes on the belly fairing forward and middle access panels. We are issuing this AD to address the unsafe condition on these products.