Determination of Regulatory Review Period for Purposes of Patent Extension; BRINEURA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINEURA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Guard Youth ChalleNGe Job ChalleNGe Evaluation; Office of the Secretary
The Department of Labor (DOL) is submitting the information collection request (ICR) proposal titled, ``National Guard Youth ChalleNGe Job ChalleNGe Evaluation,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection Requests
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0069
The Coast Guard published a document in the Federal Register on September 6, 2018, concerning a sixty-day notice requesting comments on an Information Collection Request to the Office of Management and Budget, Office of Information and Regulatory Affairs, requesting an extension of its approval for the following collection of information: 1625-0069, Ballast Water Management Reporting and Recordkeeping; without change. The document contained an error in the document title in the header.
Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0035
The Coast Guard published a document in the Federal Register on September 6, 2018, concerning a sixty-day notice requesting comments on an Information Collection Request to the Office of Management and Budget, Office of Information and Regulatory Affairs, requesting an extension of its approval for the following collection of information: 1625-0035, Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159); without change. The document contained an error in the information collection request section.
Proposed Agency Information Collection Activities; Comment Request
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Disclosure Requirements of Subpart H of Regulation H (Consumer Protections in Sales of Insurance) (Reg H-7; OMB No. 7100- 0298).
Environmental Dosimetry-Performance Specifications, Testing, and Data Analysis
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-4019, ``Environmental Dosimetry-Performance Specifications, Testing, and Data Analysis.'' This proposed revision (Revision 2) to Regulatory Guide (RG) 4.13 provides updated guidance that the NRC staff considers acceptable for performing surveys and evaluations of public dose in the unrestricted area and the controlled area of a licensed facility from direct radiation using environmental dosimetry. The DG endorses the American National Standards Institute/Health Physics Society (ANSI/HPS) N13.37- 2014, ``Environmental DosimetryCriteria for System Design and Implementation.''
Telecommunications Service Priority System
DHS NPPD CS&C will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995.
Nationwide Cyber Security Review Assessment
DHS NPPD CS&C will submit the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. DHS previously published this information collection request (ICR) in the Federal Register on Thursday, July 5, 2018 at 83 FR 31412 for a 60- day public comment period. 0 comments were received by DHS. The purpose of this notice is to allow an additional 30 days for public comments.
Meeting of Bureau of Economic Analysis Advisory Committee
Pursuant to the Federal Advisory Committee Act, we are announcing a meeting of the Bureau of Economic Analysis Advisory Committee. The meeting will address proposed improvements to BEA's economic accounts and provide an update on recent statistical developments.
Medicare and Medicaid Program; Application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for Approval of its Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Texas A&M AgriLife Research; Determination of Nonregulated Status of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed
We are advising the public of our determination that cotton designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Texas A&M AgriLife Research in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notices announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
Meeting of Humanities Panel
The National Endowment for the Humanities will hold nineteen meetings of the Humanities Panel, a federal advisory committee, during November 2018. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
Competitive Price Adjustment
The Commission is recognizing a recently filed Postal Service document with the Commission concerning changes in rates of general applicability for competitive products. The changes are scheduled to take effect January 27, 2019. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2019
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2019. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2019, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2019 are $264.90 for aged enrollees and $315.40 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2019 is $135.50, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus the $3.00 repayment amount required under current law. (The 2018 standard premium rate was $134.00, which also included the $3.00 repayment amount.) The Part B deductible for 2019 is $185.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20, respectively.
Medicare Program; CY 2019 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2019. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2019 for these individuals will be $437. The premium for certain other individuals as described in this notice will be $240.
Response to Comments on National Transit Database Reporting Changes and Clarifications
This notice responds to comments received on proposed changes and clarifications to the National Transit Database (NTD) reporting requirements published in the Federal Register on October 27, 2017 (ID: FTA-2017-0010).
Information Collection Being Reviewed by the Federal Communications Commission
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Medicare Program; CY 2019 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2019 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2019, the inpatient hospital deductible will be $1,364. The daily coinsurance amounts for CY 2019 will be: $341 for the 61st through 90th day of hospitalization in a benefit period; $682 for lifetime reserve days; and $170.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
National Register of Historic Places; Notification of Pending Nominations and Related Actions
The National Park Service is soliciting comments on the significance of properties nominated before September, 22, 2018, for listing or related actions in the National Register of Historic Places.
National Register of Historic Places; Notification of Pending Nominations and Related Actions
The National Park Service is soliciting comments on the significance of properties nominated before September 29, 2018, for listing or related actions in the National Register of Historic Places.
Mail Classification Schedule
The Commission is recognizing a recent Postal Service filing concerning minor classification changes to correct the names of foreign countries that appear in various portions of the Mail Classification Schedule. This document informs the public of the filing, invites public comment, and takes other administrative steps.
Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements: Definition of Emergency Response Employee
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding a definition of the term ``emergency response employees'' to the definitions section of the document entitled ``Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements,'' which contains a list of potentially life-threatening infectious diseases to which emergency response employees may be exposed and companion guidelines published by the National Institute for Occupational Safety and Health (NIOSH), pursuant to the Ryan White HIV/ AIDS Treatment Extension Act of 2009.
Safety Zone; Blue Angels Air Show; St. Johns River, Jacksonville, FL
The Coast Guard is establishing a temporary safety zone on the waters of the St. Johns River in the vicinity of Naval Air Station (NAS) Jacksonville, Florida during the Blue Angels Air Show. This rulemaking prohibits persons and vessels from entering, transiting through, remaining within, or anchoring in the safety zone unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.
Special Local Regulations; Marine Events in the Coast Guard Sector Detroit Captain of the Port Zone
This proposed rule is intended to amend the rules that regulate vessel traffic and control navigation of portions of waterways during events that pose a hazard to public safety. This rule, if adopted, would add six new reoccurring special local regulations, remove six special local regulations, and amend the event, dates, and/ or regulated areas for the 15 recurring special local regulations that will be listed in a table. The permanent special local regulations established by this proposed rule are necessary to protect spectators, participants, and vessels from the hazards associated with the varying types of marine events. This proposed rulemaking would restrict vessel traffic in the designated areas during the events unless authorized by the Captain of the Port Detroit or a designated representative. We invite your comments on this proposed rulemaking.
Great Lakes Pilotage Rates-2019 Annual Review and Revisions to Methodology
In accordance with the Great Lakes Pilotage Act of 1960, the Coast Guard is proposing new base pilotage rates and surcharges for the 2019 shipping season. This rule would adjust the pilotage rates to account for anticipated traffic, an increase in the number of pilots, anticipated inflation, and surcharges for applicant pilots. The result is an increase in pilotage rates, due to adjustment for inflation and the addition of two pilots.
Agency Information Collection Activities: Application for Extension of Bond for Temporary Importation
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Termination of Dormant Proceedings
In this document, the Consumer and Governmental Affairs Bureau (the Bureau) announces the availability of the FCC Public Notice seeking comment on whether certain docketed Commission proceedings should be terminated as dormant.
Privacy Act of 1974; System of Records
The Office of the Secretary of Defense (OSD) proposes to establish a new system of records, ``Personnel Vetting Records System,'' DUSDI 02-DoD. The system supports the Department of Defense (DoD) in conducting end-to-end personnel security, fitness, suitability, and credentialing processes, including application and questionnaire submission, investigations, adjudications, and continuous vetting activities. The Personnel Vetting Records System integrates DoD information technology capabilities developed to support the execution of federal background investigation activities, including: Investigations and determinations of eligibility for access to classified national security information, eligibility to occupy a sensitive position, and for access to special access programs; suitability for federal employment; fitness of contractor personnel to perform work for or on behalf of the U.S. Government, and Homeland Security Presidential Directive (HSPD)-12 determinations for Personal Identity Verification (PIV) credentials to gain logical or physical access to government facilities and systems. The Personnel Vetting Records System also supports: submissions of adverse personnel information; verification of investigation and adjudicative history and status; support of continuous evaluation (CE); and insider threat detection, prevention, and mitigation activities. The system may also be used as a management tool for statistical analyses; tracking, reporting, and evaluating program effectiveness; and conducting research related to personnel vetting.
Privacy Act of 1974; Implementation
In accordance with the Privacy Act of 1974, the Office of the Secretary of Defense is exempting records maintained in a new system of records, ``Personnel Vetting Records System,'' DUSDI 02-DoD, from certain requirements of the Act.
Request for Comments on the Cross-Agency Priority Goal: Leveraging Data as a Strategic Asset: Phase 2
In March 2018, President Trump launched the President's Management Agenda (PMA). It lays out a long-term vision for modernizing the Federal Government in key areas that will improve the ability of agencies to deliver mission outcomes, provide excellent service, and effectively steward taxpayer dollars on behalf of the American people. The PMA established a Cross-Agency Priority (CAP) goal of Leveraging Data as a Strategic Asset with an intended purpose of guiding development of a comprehensive long-term Federal Data Strategy to grow the economy, increase the effectiveness of the Federal Government, facilitate oversight, and promote transparency (https:// www.performance.gov/CAP/CAP_goal_2.html). This notice seeks comment on practices for Federal agencies to adopt in order to achieve this CAP goal. A subsequent Request for Comments to be published in January 2019 will seek input on a year-one action plan for implementing the Federal Data Strategy.
The U.S. Copyright Office is building a new registration system to meet the demands of the digital age. As the Office develops a new technological infrastructure for this system, it is considering several legal and policy changes to improve user experience, increase Office efficiency, and decrease processing times. The Office is seeking public comment to inform its decisions on how to improve the regulations and practices related to the registration of copyright claims.
New Mailing Standards for Domestic Mailing Services Products
On October 10, 2018, the Postal Service filed a notice of mailing services price adjustments with the Postal Regulatory Commission (PRC), effective January 27, 2019. This proposed rule contains the revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) that we would adopt to implement related regulatory changes coincident with the price adjustments.
Domestic Competitive Products Pricing and Mailing Standards Changes
The Postal Service is amending Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]), to reflect changes to prices and mailing standards for competitive products.
International Mailing Services: Product and Price Changes-CPI
The Postal Service proposes to revise Mailing Standards of the United States Postal Service, International Mail Manual (IMM[supreg]), to reflect changes in the prices, product features, and classification changes to Mailing Services. These changes would also implement a lower maximum weight limit on First-Class Mail International[supreg] (FCMI) large envelopes (flats), to bring them closer to compliance with Universal Postal Union (UPU) standards.
International Competitive Services Product and Price Changes
The Postal Service is revising Mailing Standards of the United States Postal Service, International Mail Manual (IMM[supreg]), to reflect the prices, product features, and classification changes to Competitive Services, as established by the Governors of the Postal Service.