July 2017 – Federal Register Recent Federal Regulation Documents

This proposed rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 3rd- year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. This rule proposes case-mix methodology refinements, as well as a change in the unit of payment from 60-day episodes of care to 30-day periods of care, to be implemented for home health services beginning on or after January 1, 2019; and finally, this rule proposes changes to the Home Health Value- Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP).

The Department of Veterans Affairs proposes to amend the portion of the Schedule for Rating Disabilities that addresses the genitourinary system. The purpose of this change is to update current medical terminology, incorporate medical advances that have occurred since the last review, and provide well-defined criteria in accordance with actual, standard medical clinical practice. The proposed rule reflects the most up-to-date medical knowledge and clinical practice of nephrology and urology specialties, as well as comments from subject matter experts and the public garnered during a public forum held January 27-28, 2011.

This regulation establishes tolerances for residues of fenamidone in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

On August 29, 2012, the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), submitted changes to the Kentucky State Implementation Plan (SIP) on behalf of the Louisville Metro Air Pollution Control District (District). The Environmental Protection Agency (EPA) is taking direct final action to approve a portion of the submission that modifies the District's air quality regulations as incorporated into the SIP. Specifically, the revision pertains to definitional changes, including the modification of the definition of ``volatile organic compounds'' (VOCs). EPA is taking direct final action to approve this portion of the SIP revision because the Commonwealth has demonstrated that these changes are consistent with the Clean Air Act (CAA or Act). EPA will act on the other portion of KDAQ's August 29, 2012, submittal in a separate action.

On August 29, 2012, the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), submitted changes to the Kentucky State Implementation Plan (SIP) on behalf of the Louisville Metro Air Pollution Control District (District). The Environmental Protection Agency (EPA) is proposing to approve a portion of the submission that modifies the District's air quality regulations as incorporated into the SIP. Specifically, the revisions pertain to definitional changes, including the modification of the definition of ``volatile organic compounds''. EPA is proposing to approve this portion of the SIP revision because the Commonwealth has demonstrated that these changes are consistent with the Clean Air Act. EPA will act on the other portion of KDAQ's August 29, 2012, submittal in a separate action.

The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the State of Maryland. This revision pertains to removing a discontinued Technical Memorandum 90-01 (TM 90-01) from Maryland's SIP, which is now superseded by a new continuous emission monitoring (CEM) regulation. EPA is approving this revision to remove TM 90-01 from Maryland's SIP in accordance with the requirements of the Clean Air Act (CAA).

This final rule makes non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations. This rule will have no substantive effect on the regulated public.

The Coast Guard will enforce the Fleet Week Maritime Festival's Pier 66 Safety Zone in Elliott Bay, WA 30 minutes prior to the beginning, during, and 30 minutes following the conclusion of the parade of ships. This action is necessary to promote safety on navigable waters. During the enforcement period, entry into, transit through, mooring, or anchoring within this zone is prohibited unless authorized by the Captain of the Port, Puget Sound or his designated representative

The Coast Guard will enforce the annual Seafair Air Show Performance safety zone on Lake Washington, Seattle, WA daily, from 8 a.m. until 4 p.m., from August 3, 2017, through August 6, 2017. This action is necessary to ensure the safety of the public from inherent dangers associated with these annual aerial displays. During the enforcement period, no person or vessel may enter or transit this safety zone unless authorized by the Captain of the Port or his designated representative.

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

In this document, a Second Further Notice of Proposed Rulemaking (Second FNPRM) seeks comment on new proposed rural call completion requirements for covered providers and on proposals to either modify or eliminate the Commission's existing data recording, retention, and reporting requirements. The Second FNPRM also seeks comment on any additional measures the Commission should take to address rural call completion problems.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Interstate 5 (I-5) Bridges across the Columbia River, mile 106.5, between Portland, Oregon, and Vancouver, Washington. The deviation is necessary to facilitate the presence of participants in the Hands Across the Bridge Project. This deviation allows the bridges to remain in the closed-to-navigation position during the event.

This regulation amends a tolerance for residues of ametoctradin in or on hops. BASF Corporation requested this tolerance amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This regulation increases existing tolerances for residues of fenpyroximate in or on dried citrus pulp, citrus oil, and the citrus fruit group 10-10. Nichino America, Inc. requested these tolerance increases under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The U.S. Coast Guard is issuing a new task to the Great Lakes Pilotage Advisory Committee (GLPAC). The U.S. Coast Guard is asking GLPAC to help the agency identify existing regulations, guidance, and collections of information (that fall within the scope of the Committee's charter) for possible repeal, replacement, or modification. This tasking is in response to the issuance of Executive Orders 13771, ``Reducing Regulation and Controlling Regulatory Costs; 13777, ``Enforcing the Regulatory Reform Agenda;'' and 13783, ``Promoting Energy Independence and Economic Growth.'' The full Committee is scheduled to meet by teleconference on August 23, 2017, to discuss this tasking. This teleconference will be open to the public. The U.S. Coast Guard will consider GLPAC recommendations as part of the process of identifying regulations, guidance, and collections of information to be repealed, replaced, or modified pursuant to the three Executive Orders discussed above.

The Privacy and Civil Liberties Oversight Board is updating its Freedom of Information Act regulation to conform to the FOIA Amendments Act of 2016 and updating its Sunshine Act regulation to clarify how public meetings will be announced and how changes to the meeting may occur after public announcement.

We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A300 B4-600R series airplanes; Model A300 B4-603, B4-620, and B4-622 airplanes; Model A300 C4-605R Variant F airplanes; and Model A300 F4-605R airplanes. This proposed AD was prompted by a determination that the top stringer joints at rib 18 are an area of uniform stress distribution, which indicates that cracks may develop in adjacent stringers at the same time. This proposed AD would require an inspection of the upper wing skin and top stringer joints, and modification of the stringer joint couplings if necessary. We are proposing this AD to address the unsafe condition on these products.

We propose to supersede Airworthiness Directive (AD) AD 2016- 20-11, for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. AD 2016-20-11 requires repetitive inspections of the external area of the aft cargo door sill beam for cracking, repetitive inspections for fatigue cracking of the cargo door sill beam, lock fitting, and torsion box plate, and repair if necessary. Since we issued AD 2016-20-11, we have determined that reinforcement of the aft cargo door sill beam area is necessary to address the unsafe condition, which constitutes terminating action for the repetitive inspections. This proposed AD would retain the inspections for cracking, and repair if necessary; and require reinforcement of the aft cargo door sill beam area. We are proposing this AD to address the unsafe condition on these products.

This action announces the U.S. Environmental Protection Agency's (EPA's) approval of alternative testing methods for use in measuring the levels of contaminants in drinking water and determining compliance with national primary drinking water regulations. The Safe Drinking Water Act authorizes EPA to approve the use of alternative testing methods through publication in the Federal Register. EPA is using this streamlined authority to make 17 additional methods available for analyzing drinking water samples. This expedited approach provides public water systems, laboratories, and primacy agencies with more timely access to new measurement techniques and greater flexibility in the selection of analytical methods, thereby reducing monitoring costs while maintaining public health protection.

We are adopting a new airworthiness directive (AD) for Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters. This AD requires an inspection and reduces the retirement lives of certain landing gear components. This AD is prompted by a revised analysis of the fatigue life of the landing gear. The actions of this AD are intended to prevent an unsafe condition on these products.

The Environmental Protection Agency (EPA) is taking direct final action to amend the national emission standards for hazardous air pollutants for flame attenuation (FA) lines in the wool fiberglass manufacturing industry. This direct final rule provides affected sources a 1-year extension to comply with the emission limits for FA lines. The EPA can provide sources up to 3 years to comply with emission limits in the Clean Air Act (CAA) standards. FA lines initially were given 2 years to comply with the emission limits. This action will extend the compliance date to the maximum of 3 years while we conduct our review. This compliance date extension will enable the EPA to conduct a review of the emission limits for FA lines in light of recently submitted corrected source emissions data.

The Environmental Protection Agency and the Department of the Army (``the agencies'') are publishing this proposed rule to initiate the first step in a comprehensive, two-step process intended to review and revise the definition of ``waters of the United States'' consistent with the Executive Order signed on February 28, 2017, ``Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the `Waters of the United States' Rule.'' This first step proposes to rescind the definition of ``waters of the United States'' in the Code of Federal Regulations to re-codify the definition of ``waters of the United States,'' which currently governs administration of the Clean Water Act, pursuant to a decision issued by the U.S. Court of Appeals for the Sixth Circuit staying a definition of ``waters of the United States'' promulgated by the agencies in 2015. The agencies would apply the definition of ``waters of the United States'' as it is currently being implemented, that is informed by applicable agency guidance documents and consistent with Supreme Court decisions and longstanding practice. Proposing to re-codify the regulations that existed before the 2015 Clean Water Rule will provide continuity and certainty for regulated entities, the States, agency staff, and the public. In a second step, the agencies will pursue notice-and-comment rulemaking in which the agencies will conduct a substantive re-evaluation of the definition of ``waters of the United States.''

The Coast Guard is establishing a temporary safety zone on the navigable waters of Newtown Creek, NY within 2,000 feet of the existing Kosciuszko Bridge at mile 2.1. This action is necessary to provide for the safety of life on these navigable waters during the explosives demolition of the approach spans on each adjacent shoreline. This rulemaking prohibits persons and vessels from being in the safety zones unless authorized by the Captain of the Port New York or a designated representative.

This document contains final regulations that define the term controlled group for purposes of the branded prescription drug fee. The final regulations supersede and adopt the text of temporary regulations that define the term controlled group. The final regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs.