May 7, 2018 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.

The Coast Guard will enforce the safety zone for the Marinette Logging and Heritage Festival Fireworks on the Menomonee River in Marinette, WI from 9 p.m. through 11 p.m. on July 14, 2018. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the fireworks display. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.

The Environmental Protection Agency (EPA) is issuing a supplement to its March 1, 2018 proposed approval of the Commonwealth of Virginia's (the Commonwealth or Virginia) request to change reliance on the Clean Air Interstate Rule (CAIR) to reliance on the Cross-State Air Pollution Rule (CSAPR) to address certain regional haze requirements and to convert the Agency's limited approval/limited disapproval of Virginia's regional haze SIP to a full approval. EPA's March 1, 2018 notice of proposed rulemaking (NPR) also proposed to approve the ``visibility element'' of Virginia's infrastructure SIP submittals for the 2010 sulfur dioxide (SO2) and 2012 fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). This supplemental proposal clarifies the infrastructure elements the Agency is proposing to approve for the 2010 SO2 National Ambient Air Quality Standards (NAAQS) and proposes to remove EPA's June 7, 2012 federal implementation plan (FIP) for Virginia which replaced reliance on CAIR with reliance on CSAPR to address certain deficient regional haze requirements identified in the Commonwealth's regional haze state implementation plan (SIP). EPA is seeking comment only on the issues raised in this supplemental proposal and is not reopening for comment other issues raised in its prior proposal. This action is being taken under the Clean Air Act (CAA).

EPA issued a notice in the Federal Register of September 15, 2017, announcing the initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

This rule finalizes the interim final rule (IFR) that was published on May 25, 2016, to implement the debt refinancing program reauthorized by Section 521 of Division E of the Consolidated Appropriations Act, 2016. In response to comments received on the IFR, this final rule makes some additional revisions to the program's regulations with respect to the definition of Qualified debt, the requirements related to Eligible Business Expenses, the refinancing of Projects involving single or limited use properties, and the disbursement period.

On October 16, 2017, the U.S. Small Business Administration (SBA) published a document announcing the Express Bridge Loan Pilot Program (Express Bridge Pilot). In that document, SBA provided an overview of the Express Bridge Pilot and modified an Agency regulation relating to loan underwriting for loans made under the Express Bridge Pilot. SBA continues to refine and improve the design of the Express Bridge Pilot and is issuing this document to revise the program requirements, including the modification of an Agency regulation relating to fees that can be collected from the Applicant or Borrower in connection with a loan made under the Express Bridge Pilot.

Based on recommendations from the Pacific Fishery Mangement Council (Council), NMFS is issuing regulations under the Magnuson- Stevens Fishery Conservation and Management Act (MSA) to implement Amendment 4 to the Fishery Management Plan for U.S. West Coast Highly Migratory Species (HMS FMP). The intent of Amendment 4 is to bring descriptions of the management context for HMS fisheries up to date, to better describe the Council's role in the process of making stock status determinations for highly migratory species (HMS), including the Council's evaluations of the best scientific information available (BSIA), and to change the schedule of the Council's three-meeting biennial management cycle for HMS stocks. This rule updates and amends the descriptions of biennial management cycle activities in the regulations for the HMS FMP to allow the Council to shift the schedule of Council meetings for the consideration of HMS stock status updates and management recommendations in response to instances in which a stock or stocks is determined to be subject to overfishing, overfished, or both. The changes to the Council's biennial management cycle activities and the schedule are intended to better streamline international and domestic management processes for HMS. This rule is administrative in nature and is not expected to affect activities authorized under the FMP or harvest levels of HMS.

This action modifies Class E airspace extending upward from 700 feet above the surface at Batten International Airport, Racine, WI, contained within the Milwaukee, WI, airspace description. This action is required due to the decommissioning of the Horlick VHF omnidirectional range (VOR) which provided navigation guidance for the standard instrument approach procedures to this airport. The Horlick VOR is being decommissioned as part of the VOR Minimum Operational Network (MON) Program. This action enhances the safety and management of instrument flight rules (IFR) operations at the airport.

The Rural Utilities Service (RUS) is amending its regulations regarding its Policy on Audits to incorporate 2011 revisions to the Generally Accepted Government Auditing Standards (GAGAS) issued by the Government Accountability Office (GAO), the clarified audit standards issued by the American Institute of Certified Public Accountants (AICPA) in 2011, and Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, Subpart F, Audit Requirements, issued by the Office of Management and Budget on December 26, 2013, and adopted by USDA on December 26, 2014. RUS is also expanding and clarifying its regulations to: include grant recipients, amend its peer review requirements, amend its reporting requirements, expand the options for the electronic filing of audits, and clarify a number of existing audit requirements, and is amending the title to reflect this change.

The Information Security Oversight Office (ISOO) of the National Archives and Records Administration (NARA), is revising the National Industrial Security Program (NISP) Directive. The NISP safeguards classified information the Federal Government or foreign governments release to contractors, licensees, grantees, and certificate holders. This revision adds provisions incorporating executive branch insider threat policy and minimum standards, identifies the Office of the Director of National Intelligence (ODNI) and the Department of Homeland Security (DHS) as new cognizant security agencies (CSAs), and adds responsibilities for all CSAs and non-CSA departments and agencies (to reflect oversight functions that are already detailed for private sector entities in the National Industrial Security Program Operating Manual (NISPOM)). This revision also makes other administrative changes to be consistent with recent revisions to the NISPOM and with updated regulatory language and style.

This action modifies Class E airspace designated as a surface area and Class E airspace extending upward from 700 feet above the surface at Muscatine Municipal Airport, Muscatine, IA. This action is required due to the decommissioning of the Port City VHF omnidirectional range (VOR) facility, which provided navigation guidance for the instrument procedures to this airport. The VOR has been decommissioned as part of the VOR Minimum Operational Network (MON) Program.

On January 9, 2017, the Occupational Safety and Health Administration (OSHA) issued a final rule adopting a comprehensive general industry standard for exposure to beryllium and beryllium compounds. In this proposed rule, OSHA is proposing to adopt a number of clarifying amendments to address the application of the standard to materials containing trace amounts of beryllium. OSHA believes this proposal will maintain safety and health protections for workers while reducing the burden to employers of complying with the current rule.

We are adopting a new airworthiness directive (AD) for certain Airbus Model A318 series airplanes and Model A319 series airplanes; all Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and all Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the holes of the upper cleat to upper stringer attachments at certain areas of the left- and right-hand wings are subject to widespread fatigue damage (WFD). This AD requires modifying the holes of the upper cleat to upper stringer attachments at certain areas of the left- and right-hand wings. We are issuing this AD to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for certain Gulfstream Aerospace Corporation Models G-IV and GIV-X airplanes. This AD was prompted by the potential for fatigue cracks developing in the main landing gear actuator attachment fitting that had a certain repair incorporated. This AD requires incorporating new revisions into the Instructions for Continued Airworthiness of the Limitations section of the FAA-approved maintenance program (e.g., maintenance manual) that establish an inspection cycle for the repaired MLG side brace actuator fittings. We are issuing this AD to address the unsafe condition on these products.

We propose to revise the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving musculoskeletal disorders in adults and children under titles II and XVI of the Social Security Act (Act). These proposed revisions reflect our adjudicative experience, advances in medical knowledge and treatment of musculoskeletal disorders, and recommendations from medical experts.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these proposed changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are proposing to provide the market basket update that would apply to the rate[dash]of[dash]increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2019. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS[dash]exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are proposing changes to the requirements that apply to States operating Medicaid Promoting Interoperability Prrograms. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to make changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.