February 26, 2013 – Federal Register Recent Federal Regulation Documents

The EPA is finding that seven states have not made complete state implementation plan (SIP) submissions to address certain SIP elements, as required by the Clean Air Act (CAA). Specifically, the EPA is determining that these seven states have not submitted complete SIPs that provide the basic CAA program elements necessary to implement the 2008 lead national ambient air quality standards (NAAQS). The EPA refers to these SIP submissions as ``infrastructure'' SIPs. Of the seven states, three are incomplete only due to prevention of significant deterioration (PSD)-related elements, for which a federal implementation plan (FIP) is in place. The remaining 43 states have made complete submissions. Each finding of failure to submit establishes a 24-month deadline for the EPA to promulgate FIPs to address the outstanding SIP elements unless prior to the EPA promulgating a FIP an affected state submits, and the EPA approves, a SIP that corrects the deficiency.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 1, 2013. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on selected genetic tests for cancer diagnosis (for cancers of unknown primary site and for cervical cytology findings of uncertain clinical significance). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The draft guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice replaces the draft guidance entitled, ``Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,'' dated June 2003. In addition, the draft guidance, when finalized, is intended to supersede the FDA memorandum to registered blood establishments dated December 12, 1991, entitled, ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''

The Commodity Futures Trading Commission (``Commission'') is amending its Rules of Practice, Rules Relating to Reparation Proceedings, and its Rules Relating to Review of National Futures Association (``NFA'') Decisions in Disciplinary, Membership Denial, Registration and Membership Responsibility Actions, to simplify and clarify service, filing and formatting requirements, particularly those requirements applicable to electronic service and filing. The Commission is also amending its Rules Relating to Reparations Proceedings to clarify the authority of its Judgment Officers.

The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential water heaters. EPCA also requires the U.S. Department of Energy (DOE) to determine whether more stringent amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. Accordingly, DOE established amended energy conservation standards for several classes of residential water heaters in an April 2010 final rule. Subsequent to the publication of that final rule, a number of utility companies brought forth concerns regarding the amended energy conservation standard levels for electric storage water heaters and the impact of these standards on electric thermal storage programs that utility companies administer to manage peak load. In this document, DOE proposes to establish a waiver process that will mitigate the concerns of utility companies regarding the implementation of the April 2010 standard levels by allowing for the manufacture of certain large-volume electric storage water heaters provided that they meet a set of conditions discussed in this proposed rule. The document also announces a public meeting to receive comment on the proposed waiver process and criteria for obtaining a waiver.

This document announces the effective date of rules published in the Federal Register on January 3, 2005. The final rules revised the obligation of television broadcasters to protect and serve children in their audience.

This final rule eliminates the requirement that states a NAS is needed for non-emergency inpatient mental health care in order for a TRICARE Standard beneficiary's claim to be paid. Currently, NAS are required for non-emergency inpatient mental health care for TRICARE Standard beneficiaries who live within a military treatment facility catchment area. At this time, the number of NASs issued is negligible as most mental health admissions are emergency admissions. Requiring a NAS for a relatively few non-emergency inpatient mental health admissions is disproportionate to the cost of maintaining the systems necessary to process and coordinate the NAS.