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07/26/2018 Public Inspection Issue

The following documents are on file at the Office of the Federal Register (OFR) and will be published in the Federal Register on the dates listed.

Regular Filing documents are routinely placed on file at 8:45 a.m. Eastern Time, for publication in the next day’s Federal Register.

Special Filing documents are filed at other times and/or dates prior to publication.

See About Public Inspection for more information.

Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text. If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507.

Please note that most of the original documents filed with the Office of the Federal Register contain calculated effective dates, comment dates, and other applicable dates. We calculate and insert those dates after the documents go on file. You can consult the Table of Effective Dates & Time Periods to determine the calendar date of a calculated date contained in a Public Inspection document.

Special Filing Table of Contents

Public Inspection documents are unpublished documents. Click here to learn more about Public Inspection.

Special Filing documents are filed at various times and/or dates prior to publication.

Special Filing updated at 04:15 PM, on Thursday, July 26, 2018

Centers for Medicare & Medicaid Services

Proposed Rules

Medicare Program:

Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Requests for Information on Promoting Interoperability and Electronic Health Care Information, Price Transparency, and Leveraging Authority for the Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model
Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; etc.

Editorial Note: Due to technical issues, the Office of the Federal Register made changes to this document after placement on public inspection. The changes reflected in this version were updated as of 2:01 p.m., on July 18, 2018.

Commerce Department

Education Department

Proposed Rules

Proposed Priorities, Requirements, Definitions, and Selection Criteria--Expanding Opportunity Through Quality Charter Schools Program:

Grants to Charter Management Organizations for the Replication and Expansion of High-Quality Charter Schools

Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program, and William D. Ford Federal Direct Loan Program

Federal Election Commission

Notices

Meetings; Sunshine Act

Health and Human Services Department

Rules

Adoption of the Methodology for the HHS-operated Permanent Risk Adjustment Program under the Patient Protection and Affordable Care Act for the 2017 Benefit Year

National Credit Union Administration

Notices

Meetings; Sunshine Act

National Oceanic and Atmospheric Administration

Rules

Atlantic Highly Migratory Species:

Atlantic Bluefin Tuna Fisheries

Nuclear Regulatory Commission

Notices

Meetings; Sunshine Act

Postal Service

Notices

Meetings; Sunshine Act

Regular Filing Table of Contents

Public Inspection documents are unpublished documents. Click here to learn more about Public Inspection.

Regular Filing documents are routinely placed on file at 8:45 a.m. Eastern Time, for publication in the next day’s Federal Register.

Regular Filing updated at 08:45 AM, on Thursday, July 26, 2018

Advisory Council on Historic Preservation

Notices

Program Comment:

General Services Administration on Select Envelope and Infrastructure Repairs and Upgrades to Historic Public Buildings

Agricultural Research Service

Notices

Exclusive Licenses; Approvals:

Methods for Synthesizing Graphene from a Lignin Source

Agriculture Department

Animal and Plant Health Inspection Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Emergency Management Response System
Importation of Apples from China
Importation of Papayas from Peru

Census Bureau

Notices

Requests for Nominations:

Census Scientific Advisory Committee
National Advisory Committee on Racial, Ethnic, and Other Populations

Centers for Disease Control and Prevention

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Meetings:

Advisory Committee to the Director, Health Disparities Subcommittee
Board of Scientific Counselors, National Center for Injury Prevention and Control
National Center for Health Statistics, ICD-10 Coordination and Maintenance Committee

Coast Guard

Rules

Drawbridge Operations:

Jamaica Bay, Queens, NY
Willamette River at Portland, OR

Safety Zones:

Kanawha River, Nitro, WV
Lower Mississippi River, Natchez, MS

Commerce Department

Committee for Purchase From People Who Are Blind or Severely Disabled

Notices

Procurement List; Additions and Deletions

Defense Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Charter Renewals:

Army Education Advisory Committee

Education Department

Notices

Privacy Act; Matching Program

Energy Department

Environmental Protection Agency

Rules

National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List:

Deletion of the Davenport and Flagstaff Smelters Superfund Site
Deletion of the Old Esco Manufacturing Superfund Site
Partial Deletion of the Peters Cartridge Factory Superfund Site

Proposed Rules

National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List:

Deletion of the Old Esco Manufacturing Superfund Site
Partial Deletion of the Peters Cartridge Factory Superfund Site

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

NSPS for Portland Cement Plants

Environmental Impact Statements; Availability, etc.:

Weekly Receipts

Privacy Act; Systems of Records

Requests for Nominations:

Clean Air Scientific Advisory Committee Ozone Review Panel

Federal Aviation Administration

Rules

Airworthiness Directives:

Pacific Aerospace Limited Airplanes

Amendment of Class D and E Airspace; Revocation of Class E Airspace:

Kansas City, MO

Amendment of Class E Airspace:

Ionia, MI

Revocation of Class E Airspace:

Clarendon, TX

Proposed Rules

Airworthiness Directives:

Gulfstream Aerospace Corporation Airplanes

Amendment of Class E Airspace:

Wooster, OH

Federal Communications Commission

Proposed Rules

Jurisdictional Separations and Referral to the Federal-State Joint Board

Notices

Certification of State Telecommunications Relay Services Programs

Federal Energy Regulatory Commission

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Applications:

Public Utility District No. 1 of Lewis County, WA

Combined Filings

Environmental Assessments; Availability, etc.:

Columbia Gas Transmission, LLC , Line 8000 Replacement Project

Filings:

Miller, Paul J.

Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations:

Hudson Shore Energy Partners LLC
Lorenzo Wind, LLC

Requests under Blanket Authorizations:

Columbia Gas Transmission, LLC

Federal Railroad Administration

Notices

Addressing Electrode-Induced Rail Pitting from Pressure Electric Welding

Federal Reserve System

Notices

Notice of Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities

Federal Trade Commission

Notices

Early Termination of Waiting Period under Premerger Notification Rules

Food and Drug Administration

Notices

Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:

Metaxalone Tablets, 640 Milligrams

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019

Generic Drug User Fee Rates for Fiscal Year 2019

Guidance:

Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
Peripheral Vascular Atherectomy Devices--Premarket Notification Submissions
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

Withdrawal of Approval of Abbreviated New Drug Applications:

ICU Medical, Inc., et al.

Food and Nutrition Service

Notices

Food Distribution Program:

Value of Donated Foods from July 1, 2018, through June 30, 2019

Foreign-Trade Zones Board

Notices

Subzone Applications:

MAS US Holdings, Inc., Foreign-Trade Zone 93, Raleigh/Durham, NC

Forest Service

Notices

New Fee Sites

Health and Human Services Department

Notices

Meetings:

President's Council on Sports, Fitness, and Nutrition

Homeland Security Department

Rules

Privacy Act of 1974:

Implementation of Exemptions; Department of Homeland Security/ALL-039 Foreign Access Management System of Records

Interior Department

International Trade Administration

Notices

Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Aluminum Extrusions from the People's Republic of China
Certain New Pneumatic Off-the-Road Tires from India
Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled into Modules, from the People's Republic of China
Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China
Seamless Refined Copper Pipe and Tube from the People's Republic of China

Meetings:

Annual U.S. Industry Program at the International Atomic Energy Agency General Conference

Justice Department

Notices

Proposed Consent Decrees:

Clean Water Act

Labor Department

Notices

Orders:

Procedures for Appointment of Individuals to Department of Labor Appellate Boards

Procedures for Appointment of Individuals to Department of Labor Advisory Committees

Land Management Bureau

Notices

Environmental Impact Statements; Availability, etc.:

Proposed Gold Rock Mine Project, White Pine County, NV

Plats of Surveys:

Alaska

Millennium Challenge Corporation

Rules

Freedom of Information Act

National Archives and Records Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

National Institute of Food and Agriculture

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

National Institutes of Health

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Collection of Customer Service, Demographic, and Smoking/Tobacco use Information from the National Cancer Institute's Contact Center Clients
Intramural Continuing Umbrella of Research Experiences Application

Commission of a Surgeon General's Report on Oral Health

Meetings:

National Cancer Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Neurological Disorders and Stroke

Prospective Grants of Exclusive Patent Licenses:

Development and Commercialization of Cancer Immunotherapy
Radiotherapeutics Against Somatostatin-receptor Expressing Neuroendocrine Tumors
Radiotherapy for Metastatic Castration-resistant Prostate Cancer

Requests for Nominations:

National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee

National Oceanic and Atmospheric Administration

Rules

Taking and Importing Marine Mammals:

Taking Marine Mammals Incidental to Northwest Fisheries Science Center Fisheries Research

Proposed Rules

Atlantic Highly Migratory Species:

Shortfin Mako Shark Management Measures; Proposed Amendment 11

Fisheries of the Northeastern United States:

Amendment 20 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan

Notices

Permit Applications:

Marine Mammals; File No. 21678

Navy Department

Notices

Government-Owned Inventions; Available for Licensing

Rural Utilities Service

Notices

Requests for Comments:

Broadband e-Connectivity Pilot Program

Securities and Exchange Commission

Notices

Self-Regulatory Organizations; Proposed Rule Changes:

Amended Plan for the Allocation of Regulatory Responsibilities Among the Financial Industry Regulatory Authority, Inc., Miami International Securities Exchange, LLC, and MIAX PEARL, LLC
NYSE National, Inc.

Substance Abuse and Mental Health Services Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Transportation Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Transportation Security Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Law Enforcement Officers Flying Armed

U.S. Customs and Border Protection

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Visa Waiver Program Carrier Agreement