May 20, 2011 – Federal Register Recent Federal Regulation Documents

EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania. This revision pertains to the control of nitrogen oxide (NOX) emissions from Portland cement kilns. This action is being taken under the Clean Air Act (CAA).

The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the ``Affordable Care Act''), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program.

The FMCSA extends until June 30, 2012, the compliance date of the requirement for drivers and motor carriers to prepare a driver- vehicle inspection report (DVIR) on an item of intermodal equipment (IME) when no damage, defects, or deficiencies are discovered by, or reported to, the driver (hereafter ``no-defect DVIR''). The previous compliance date was June 30, 2011, as a result of the Agency's August 20, 2010, amended final rule which extended the compliance date of the same provision of the December 17, 2008, final rule concerning maintenance responsibilities for IME. As a result of this action, drivers and carriers are not required to prepare no-defect DVIRs until June 30, 2012. This action is being taken to provide the Agency with sufficient time to address, through a notice-and-comment rulemaking proceeding, a petition to rescind the requirement for no-defect DVIRs. The Agency emphasizes that all requirements concerning drivers' preparation of DVIRs to report damage, defects, or deficiencies to intermodal equipment providers (IEPs) remain in effect, as well as the requirements for IEPs to take appropriate action in addressing the safety issues identified by such reports.

EPA is taking direct final action to approve revisions to the Mojave Desert Air Quality Management District (MDAQMD) portion of the California State Implementation Plan (SIP). These revisions concern negative declarations for volatile organic compound (VOC) source categories for the MDAQMD. We are approving these negative declarations under the Clean Air Act as amended in 1990 (CAA or the Act).

The Federal Housing Finance Agency (FHFA) is re-organizing and re-adopting existing investment regulations that apply to the Federal Home Loan Banks (Banks) and that were previously adopted by the Federal Housing Finance Board (Finance Board). The regulation is being adopted as a new part in FHFA's regulations. As part of this rulemaking, FHFA will incorporate limits on the Banks' investment in mortgage-backed securities (MBS) and certain asset-backed securities (ABS) that were previously set forth in the Finance Board's Financial Management Policy (FMP). The FMP will terminate as of the effective date of this rule.

EPA is finalizing the update of the Outer Continental Shelf (``OCS'') Air Regulations proposed in the Federal Register on January 10, 2011. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (``COA''), as mandated by section 328(a)(1) of the Clean Air Act, as amended in 1990 (``the Act''). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which the Santa Barbara County Air Pollution Control District (``Santa Barbara County APCD'' or ``District'') is the designated COA. The intended effect of approving the OCS requirements for the Santa Barbara County APCD is to regulate emissions from OCS sources in accordance with the requirements onshore.

The Bureau of Industry and Security (BIS) maintains, as part of the agency's Export Administration Regulations (EAR), the Commerce Control List (CCL), which identifies items subject to Department of Commerce export controls. This final rule revises the CCL to implement changes made to the Wassenaar Arrangement's List of Dual-Use Goods and Technologies (Wassenaar List) maintained and agreed to by governments participating in the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement, or WA) at the December 2010 WA Plenary Meeting (the Plenary). The Wassenaar Arrangement advocates implementation of effective export controls on strategic items with the objective of improving regional and international security and stability. To harmonize the CCL with the changes made to the Wassenaar List at the Plenary, this rule amends entries on the CCL that are controlled for national security reasons in Categories 1, 2, 3, 4, 5 Parts I & II, 6, 7, 8, and 9, revises reporting requirements, and adds and amends definitions in the EAR.