August 13, 2009 – Federal Register Recent Federal Regulation Documents

This proposed rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates; the national standardized 60-day episode rates, the national per-visit rates, the non-routine medical supply (NRS) conversion factor, and the low utilization payment amount (LUPA) add-on payment amount, under the Medicare prospective payment system for home health agencies effective January 1, 2010. In addition, this rule proposes a change to the HH PPS outlier policy and proposes to require the submission of OASIS data as a condition for payment under the HH PPS. Also, this rule proposes payment safeguards that would improve our enrollment process, improve the quality of care that Medicare beneficiaries receive from HHAs, and reduce the Medicare program's vulnerability to fraud. This rule also proposes clarifying language to the ``skilled services'' section and Condition of Participation (CoP) section of our regulations. This proposed rule also clarifies the coverage of routine medical supplies under the HH PPS. We are also soliciting comments on: Physician/patient interaction associated with the home health plan of care (POC); a Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey; the Outcome and Assessment Information Set (OASIS), Version C, effective January 1, 2010; proposed pay for reporting measures for use in CY 2011; and a number of minor payment-related issues. We are also responding to comments received as a result of our solicitation in the CY 2008 HH PPS final rule with comment period.

The Consumer Product Safety Commission (``CPSC'' or ``Commission'') is proposing to issue regulations establishing requirements for the periodic audit of third party conformity assessment bodies as a condition for their continuing accreditation. The proposed rule would implement section 14(d) of the Consumer Product Safety Act (``CPSA''), as amended by section 102(b) of the Consumer Product Safety Improvement Act of 2008 (``CPSIA'').

The Coast Guard is establishing a temporary safety zone in the vicinity of the Hood Canal Bridge due to the ongoing Hood Canal Bridge Construction Project. The safety zone is necessary to help protect construction personnel and the maritime public from the numerous dangers associated with the Hood Canal Bridge Construction Project. All persons and vessel are prohibited from entering the zone unless authorized by the Captain of the Port, Puget Sound or her Designated Representative.

The Coast Guard is establishing special local regulations during the Mattaponi Madness Drag Boat Races, a series of power boat races to be held on the waters of the Mattaponi River, near Wakema, Virginia. These special local regulations are necessary to provide for the safety of life on navigable waters during the events. This action is intended to restrict vessel traffic during the power boat races in a segment of the Mattaponi River that flows along the border of King William County and King and Queen County near Wakema, Virginia.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Bombardier Model DHC-8-100 and DHC-8-200 series airplanes, and DHC-8-301, -311, and -315 airplanes. This proposed AD would require implementing a corrosion prevention and control program (CPCP) either by accomplishing specific tasks or by revising the maintenance inspection program to include a CPCP. This proposed AD results from the determination that, as airplanes age, they are more likely to exhibit indications of corrosion. We are proposing this AD to prevent structural failure of the airplane due to corrosion.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. The supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects FDA's effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.

This final rule revises the Forest Service's downpayment and periodic payment regulations to reflect changes in contracting procedures and authorities since these regulations were adopted in 1991. The changes remove obsolete references and procedures; make downpayments and periodic payments optional for stewardship contracts; allow downpayment and periodic payment amounts to be recalculated when contracts receive rate redeterminations; revise procedures for releasing downpayments; and allow downpayments to be temporarily reduced for certain delays, interruptions, or extensions. This final rule protects the Government's financial security, reduces speculative bidding, and encourages purchasers to harvest timber in a timely manner. In addition, the rule provides financial relief to timber purchasers when forest product prices drastically decline or purchasers receive additional contract time and are not expected to operate.

EPA is proposing to approve a request submitted by the Ohio Environmental Protection Agency (Ohio EPA) on October 5, 2007, to revise the Ohio State Implementation Plan (SIP) under the Clean Air Act. The State has submitted new volatile organic compounds (VOCs) control rules for approval under Chapter 3745-112 of the Ohio Administrative Code (OAC). The rules include OAC 3745-112-01 to OAC 3745-112-08 and are intended to assist the State in achieving and/or maintaining the national 8-hour ground level ozone standard through the regulation of VOCs in consumer products.

This final rule extends the proprietary term of certain reprocessed geophysical information submitted to MMS under a permit. The rule gives up to 5 years of additional protection to reprocessed vintage geophysical information that MMS retains and, without an extension, is subject to release by MMS 25 years after issuing the permit. The extension provides incentives to permittees and third parties to reprocess, market, or in other ways use geophysical information that may not otherwise be reprocessed without the term extension. The extension does not apply to geological data or information.

The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.

EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania for the purpose of amending the 8-hour ozone maintenance plan for the York-Adams 8-Hour Ozone Maintenance Area. This revision amends the maintenance plan's 2009 and 2018 motor vehicle emissions budgets (MVEBs) by unequally dividing the overall MVEBs into two sub-regional MVEBs for each county comprising the area. In the Final Rules section of this Federal Register, EPA is approving the Commonwealth's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments

The Commodity Futures Trading Commission (the ``Commission'') proposes amending its regulations (the ``Regulations'') to create a sixth and separate ``account class,'' applicable only to the bankruptcy of a commodity broker that is a futures commission merchant (``FCM''), for positions in cleared over-the-counter (``OTC'') derivatives (and money, securities, and/or other property margining, guaranteeing, and securing such positions). In general, the concept of ``account class'' governs the manner in which the trustee calculates the net equity (i.e., claims against the estate) and the allowed net equity (i.e., pro rata share of the estate) for each customer of a commodity broker in bankruptcy. The Commission further proposes amending the Regulations to codify the appropriate allocation, in a bankruptcy of any commodity broker, of positions in commodity contracts of one account class (and the money, securities, and/or other property margining, guaranteeing, or securing such positions) that are commingled with positions in commodity contracts of the futures account class (and the money, securities, and/or other property margining, guaranteeing, or securing such positions), pursuant to an order issued by the Commission.

This establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.