October 17, 2018 – Federal Register Recent Federal Regulation Documents

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.

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.

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).

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.

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.

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.

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.

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).

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.

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.

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.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

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.

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.

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.

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.

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.

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.