August 27, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The U.S. Environmental Protection Agency (EPA) is announcing a public meeting of the National Drinking Water Advisory Council (NDWAC) Lead and Copper Rule Working Group (LCRWG). The meeting is scheduled for September 18 and 19, 2014, in Arlington, VA. During this meeting, the LCRWG and the EPA will focus discussions on the Lead and Copper Rule revision issues associated with lead sampling protocols and public education requirements for lead and copper.

This document proposes a change to the definition of an eligible organization that can avail itself of an accommodation with respect to coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health insurance coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These rules propose and seek comments on potential changes to the definition of ``eligible organization'' in the Departments' regulations in light of the Supreme Court's decision in Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), to ensure that participants and beneficiaries in group health plans (and enrollees and dependents in student health insurance coverage arranged by institutions of higher education) obtain, without additional cost, coverage of the full range of Food and Drug Administration (FDA) approved contraceptive services, as prescribed by a health care provider, while respecting certain closely held for-profit entities' religion-based objections to contraceptive coverage. These proposed rules also seek comments on any additional steps the government should take to help ensure coverage of the full range of FDA-approved contraceptives, as prescribed by a health care provider, without cost sharing, for participants and beneficiaries in group health plans of such entities (and enrollees and dependents in student health insurance coverage arranged by such entities that are institutions of higher education).

This document contains interim final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These interim final regulations augment current regulations in light of the Supreme Court's interim order in connection with an application for an injunction in Wheaton College v. Burwell, 134 S. Ct. 2806 (2014) (Wheaton order). These interim final regulations provide an alternative process that an eligible organization may use to provide notice of its religious objections to providing contraceptive coverage, while preserving participants' and beneficiaries' (and enrollees' and dependents') access to coverage for the full range of Food and Drug Administration (FDA)-approved contraceptives, as prescribed by a health care provider, without cost sharing.

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This AD was prompted by reports that elevator power control unit (PCU) shear pins may fail prematurely. This AD requires repetitive replacement of the elevator PCU shear pins. We are issuing this AD to prevent premature elevator PCU shear pin failure. If all pins fail on one elevator, the elevator surface would become inoperative, which could reduce the controllability of the airplane and could result in a loss of redundancy for flutter prevention.

On October 1, 2012, the Coast Guard published a Notice of Availability and Request for Public Comment regarding a petition for a rulemaking action. The petition requested that the Coast Guard establish a load line-exempted route in the Gulf of Mexico, along the western coast of Florida. Upon review of the comments as well as analysis of safety considerations and other factors described in the discussion section, the Coast Guard has decided not to proceed with the requested rulemaking. The public comments, and the Coast Guard's reasoning for its decision, are discussed in this notice.

We are adopting a new airworthiness directive (AD) for all Airbus Model A300 series airplanes. This AD was prompted by our determination of the need to incorporate new life limits for the main landing gear (MLG) barrel assembly, retraction actuator assembly linkage, and flange duct. This AD requires revising the maintenance or inspection program, as applicable, to include the new life limits. We are issuing this AD to prevent reduced structural integrity of the airplane and possible loss of controllability of the airplane.

We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 900EX airplanes. This AD was prompted by our determination to introduce a corrosion prevention control program, among other changes, to the maintenance requirements and airworthiness limitations. This AD requires revising the maintenance or inspection program, as applicable, to include the maintenance tasks and airworthiness limitations specified in the Airworthiness Limitations section of the airplane maintenance manual. We are issuing this AD to prevent reduced structural integrity and reduced controllability of the airplane.