April 2013 – Federal Register Recent Federal Regulation Documents

This final rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act, governing the National Practitioner Data Bank, to incorporate statutory requirements under the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act). The Department of Health and Human Services (HHS) also is removing regulations which implemented the Healthcare Integrity and Protection Data Bank. Section 6403 of the Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (HIPDB) (established under section 1128E of the Social Security Act) and the National Practitioner Data Bank (NPDB). It requires the Secretary to establish a transition period to transfer all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank, and, once completed, to cease operations of the Healthcare Integrity and Protection Data Bank. Information previously collected and disclosed to eligible parties through the HIPDB will then be collected and disclosed to eligible parties through the NPDB. This regulatory action consolidates the collection and disclosure of information from both data banks into one part of the CFR.

NMFS issues this advance notice of proposed rulemaking (ANPR) to provide background information and request public comment on potential issues related to the implementation of the Billfish Conservation Act of 2012.

NMFS has determined that the Atlantic bluefin tuna (BFT) daily retention limit that applies to vessels permitted in the Highly Migratory Species (HMS) Charter/Headboat category (when fishing recreationally for BFT) should be adjusted for the remainder of 2013, based on consideration of the regulatory determination criteria regarding inseason adjustments and based on preliminary 2013 landings data. The adjusted limit for HMS Charter/Headboat vessels is one school BFT and one large school/small medium BFT per vessel per day/trip when fishing recreationally for BFT (i.e., one BFT measuring 27 to less than 47 inches, and one BFT measuring 47 to less than 73 inches). This retention limit is effective in all areas, except for the Gulf of Mexico, where NMFS prohibits targeted fishing for BFT. NMFS also closes the southern area Angling category fishery for large medium and giant (``trophy'') BFT. These actions are being taken consistent with the BFT fishery management objectives of the 2006 Consolidated HMS Fishery Management Plan (Consolidated HMS FMP) and to prevent overharvest of the 2013 Angling category quota.

NMFS proposes to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) prepared by the Gulf of Mexico Fishery Management Council (Council). If implemented, this rule would increase the commercial and recreational quotas for red snapper in the Gulf of Mexico (Gulf) reef fish fishery for the 2013 fishing year. This proposed rule is intended to help achieve optimum yield (OY) for the Gulf red snapper resource without increasing the risk of red snapper experiencing overfishing.

The Coast Guard proposes to add, delete, and modify safety zones and special local regulations and add language to clarify time frames and notification requirements for annual marine events in the Sector Long Island Sound Captain of the Port (COTP) Zone. When these regulated areas are activated and subject to enforcement, this rule would restrict vessels from portions of water areas during these recurring events. The safety zones and special local regulations will facilitate public notification of events and provide protective measures for the maritime public and event participants from the hazards associated with these recurring events.

The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; and transilluminator for breast evaluation. FDA is also announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. In addition, FDA is proposing to reclassify sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls) based on new information respecting the device. This action implements certain statutory requirements.

On April 14, 2010, EPA published a direct final rule approving delegations of authority for Louisiana. There was an error in the amendatory language which resulted in errors in the codification of the delegated Federal authorities for Kentucky and Louisiana. This action corrects the errors.

We are superseding an existing airworthiness directive (AD) for all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. That AD currently requires repetitive inspections of the aft attach lugs of the elevator tab control mechanisms, and replacement of any discrepant elevator tab control mechanism. This new AD requires replacing the left and right elevator tab control mechanisms with elevator tab control mechanisms that have the modified attach lugs, which would terminate the existing requirements. This AD was prompted by reports of failure of the aft attach lugs on the elevator tab control mechanisms, which resulted in severe elevator vibration; and reports of gaps in elevator tab control mechanisms and analysis indicating that additional elevator tab control mechanisms might have bearings that will come loose. We are issuing this AD to prevent discrepancies in the aft attach lugs of the elevator tab control mechanism, which could result in severe elevator and tab vibration. Consequent structural failure of the elevator or horizontal stabilizer could result in loss of structural integrity and aircraft control.

The Federal Communications Commission (FCC) is making a technical amendment to correct a final rule that appeared in the Federal Register of February 28, 2008. The document revised rules concerning Leased Commercial Access. Some of the revised rules contained information collections that required approval by OMB. Some other revised rules were held in abeyance pending OMB approval. Finally, some rule revisions were effective without OMB approval. The entire order, FCC 07-208, was judicially stayed pending judicial review, which is being held in abeyance, and no rule revisions have become effective. Therefore, the previously published rules are still in effect. This document makes a technical amendment so that the rules that are published in the Federal Register reflect the Leased Commercial Access rules that have remained in effect continuously and are currently still in effect.

We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our October 11, 2012 (77 FR 61938), proposal to list Taylor's checkerspot butterfly as endangered and streaked horned lark as threatened and to designate critical habitat, and on our December 11, 2012 (77 FR 73770), proposal to list four subspecies of Mazama pocket gopher (Olympia, Tenino, Yelm, and Roy Prairie) and to designate critical habitat, under the Endangered Species Act of 1973, as amended (Act). We also announce the availability of a draft economic analysis (DEA) of the proposed critical habitat designations and an amended required determinations section of the proposed designations. The draft economic analysis addresses the potential economic impacts of critical habitat designation for all six subspecies (collectively, the ``prairie species'') under consideration in these rulemakings. In addition, we are providing information that we inadvertently omitted from the preamble to the October 11, 2012, proposed rule (77 FR 61938) to list Taylor's checkerspot butterfly as endangered and streaked horned lark as threatened and to designate critical habitat. We are reopening the comment periods to allow all interested parties an opportunity to comment simultaneously on the proposed rules, the associated DEA, and our amended required determinations. Comments previously submitted on these proposed rulemakings do not need to be resubmitted, as they will be fully considered in preparation of the final rules. We also announce a public hearing and three public information workshops on our proposed rules and associated documents.

EPA Region 10 proposes to approve a modification to the State of Oregon's approved Municipal Solid Waste Landfill Program. On March 22, 2004, EPA issued final regulations allowing research, development, and demonstration (RD&D) permits to be issued to certain municipal solid waste landfills by approved states. On June 14, 2012, Oregon submitted an application to EPA Region 10 seeking Federal approval of its RD&D requirements.

EPA is adjusting the allowance system controlling U.S. consumption and production of hydrochlorofluorocarbons (HCFCs) as a result of a 2010 Court decision vacating a portion of the 2009 final rule titled ``Protection of Stratospheric Ozone: Adjustments to the Allowance System for Controlling HCFC Production, Import, and Export.'' EPA interprets the Court's vacatur as applying to the part of the rule that establishes the company-by-company baselines and calendar year allowances for HCFC-22 and HCFC-142b. On August 5, 2011, EPA published an interim final rule allocating allowances for 2011. Today's action relieves the regulatory ban on production and consumption of these two chemicals following the Court's vacatur by establishing company-by- company HCFC-22 and HCFC-142b baselines and allocating production and consumption allowances for 2012-2014.

The Coast Guard is establishing a temporary safety zone within the Lake Moovalya region of the navigable waters of the Colorado River in Parker, Arizona for the Blue Water Resort and Casino Spring Classic. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.

The Coast Guard proposes to establish special local regulations during the swim segment of the ``TriRock Triathlon Series'', a marine event to be held on the waters of Spa Creek and Annapolis Harbor on July 20, 2013. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to temporarily restrict vessel traffic in a portion of Spa Creek and Annapolis Harbor during the event.

We are issuing these special conditions for the Turbomeca Ardiden 3K model engines. This engine model will have a novel or unusual design feature that is a 30-minute all engines operating (AEO) power rating for hovering at increased power (HIP). This rating is primarily intended for high-power hovering operations that are normal mission functions. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the FAA considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

EPA is taking final action to approve changes to the South Carolina State Implementation Plan (SIP), submitted by the South Carolina Department of Health and Environmental Control (SC DHEC) to EPA in five separate SIP submittals dated May 1, 2012, July 18, 2011, February 16, 2011, December 23, 2009, and December 4, 2008. The SIP revisions make changes to South Carolina's New Source Review (NSR) Prevention of Significant Deterioration (PSD) program to adopt federal PSD requirements regarding fine particulate matter (PM2.5) and changes to the State's provisions related to the national ambient air quality standards (NAAQS) and volatile organic compounds (VOC). EPA is approving portions of the submittals as revisions to South Carolina's SIP because the Agency has determined that they are consistent with the Clean Air Act (CAA or Act) and EPA regulations regarding NSR permitting.

This document corrects an error in the codification in an October 26, 2010, final rule under the Clean Air Act. This rule approved revisions to Ohio regulations that consolidated air quality standards in a new chapter of rules and adjusted the rule references accordingly in various related rules. Of particular note is a revision that adjusted the provision for measurements for comparison with the particulate matter air quality standards. EPA erroneously codified approval of the entirety of the rule, which may be misread as having inadvertently approved several other provisions which were not addressed in the October 26, 2010 final rule, and which EPA in separate rulemaking had proposed to disapprove. Therefore, EPA is correcting its action to clarify the codification to show that only one paragraph of this rule was approved. This action simply makes the codification consistent with the approval.

This regulation establishes an exemption from the requirement of a tolerance for residues of castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid (CAS Reg. No. 1357486-09- 9) when used as an inert ingredient in a pesticide formulation. Advance Polymer Technology submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricinoleic acid on food or feed commodities.

The Federal Open Market Committee is amending its Rules of Procedure to require that at least one of the seven members constituting a quorum of the Committee represent a Federal Reserve Bank.

EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania (Pennsylvania). The revision consists of an update to the SIP-approved Motor Vehicle Emissions Budgets (MVEBs) for the Pennsylvania counties in the Philadelphia-Wilmington, PA-NJ-DE 1997 fine particulate matter (PM2.5) nonattainment area (hereafter referred to as the Philadelphia Area) to reflect the use of the most recent version of the Motor Vehicle Emission Simulator model (MOVES). The Pennsylvania counties impacted by this revision are: Philadelphia, Montgomery, Delaware, Chester, and Bucks Counties. EPA is approving this revision to the MVEBs and thereby making them available for transportation conformity purposes in accordance with the requirements of the Clean Air Act (CAA).

This action amends VHF Omnidirectional Range (VOR) Federal airways V-68, V-76, V-194, and V-548 in the vicinity of Houston, TX. The FAA is taking this action to correct the airway descriptions contained in Part 71 to ensure they match the information contained in the FAA's aeronautical database and depicted on the associated aeronautical charts.

The Department of Veterans Affairs (VA) amends its regulations to establish a new program to provide grants to eligible entities to assist veterans in highly rural areas through innovative transportation services to travel to VA medical centers, and to otherwise assist in providing transportation services in connection with the provision of VA medical care to these veterans, in compliance with section 307 of title III of the Caregivers and Veterans Omnibus Health Services Act of 2010. This final rule establishes procedures for evaluating grant applications under the new grant program, and otherwise administering the new grant program.

The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Third Street Drawbridge across the China Basin, mile 0.0, at San Francisco, CA. The deviation is necessary to allow the public to cross the bridge to participate in the scheduled CycleSF, a community event. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.