May 5, 2010 – Federal Register Recent Federal Regulation Documents

Under the Clean Air Act (CAA or ``Act''), EPA is granting requests by the State of California to reclassify the following four areas designated as nonattainment for the 1997 8-hour ozone national ambient air quality standard (NAAQS): The San Joaquin Valley area from ``serious'' to ``extreme,'' the South Coast Air Basin area from ``severe-17'' to ``extreme,'' and the Coachella Valley and Sacramento Metro areas from ``serious'' to ``severe-15.'' In connection with the reclassifications, EPA is setting a deadline of no later than 12 months from the effective date of reclassification for submittal of revisions to the Sacramento Metro area portion of the California State Implementation Plan (SIP) to meet the additional new source review (NSR) requirements for ``severe-15'' 8-hour ozone nonattainment areas. EPA is deferring the setting of a submittal deadline for certain fee rules under section 185 of the CAA. A number of Indian tribes have Indian country located within the boundaries of the affected areas. The State of California is not approved to administer any CAA programs in Indian country, and the relevant Indian tribes have not applied for eligibility to administer programs under the CAA for their areas. In these circumstances, EPA implements relevant reclassification provisions of the CAA in these Indian country areas and is reclassifying these areas, except Indian country pertaining to the Morongo Band of Mission Indians (``Morongo Tribe'') and the Pechanga Band of Luise[ntilde]o Mission Indians (``Pechanga Tribe''), in keeping with the classifications of nonattainment areas within which they are located. EPA is deferring the reclassification of Indian country pertaining to the Morongo and Pechanga Tribes pending EPA's final decisions on their previously-submitted boundary change requests. In connection with this final action, EPA notified the affected tribal leaders and consulted with interested tribes.

This interim final rule with comment period (IFC) implements the Early Retiree Reinsurance Program, which was established by section 1102 of the Patient Protection and Affordable Care Act (the Affordable Care Act). The Congress appropriated funding of $5 billion for the temporary program. Section 1102(a)(1) requires the Secretary to establish this temporary program not later than 90 days after enactment of the statute, which is June 21, 2010. The program ends no later than January 1, 2014. The program provides reimbursement to participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses and dependents. The Secretary will reimburse plans for certain claims between $15,000 and $90,000 (with those amounts being indexed for plan years starting on or after October 1, 2011). The purpose of the reimbursement is to make health benefits more affordable for plan participants and sponsors so that health benefits are accessible to more Americans than they would otherwise be without this program.

In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations of certain products containing the pesticide carbaryl. The requests would not terminate the last carbaryl products registered for use in the United States. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registration has been canceled only if such sale, distribution, or use is consistent with the terms as described in the final order.

The Department of Veterans Affairs (VA) proposes to amend its regulations regarding access to VA facilities to control the promotion of drugs and drug-related supplies at VA facilities and the business relationships between VA staff and sales representatives promoting drugs and drug-related supplies. The purposes of the proposed rule are to reduce or eliminate any potential for disruption in the patient care environment, manage activities and promotions at VA facilities, and provide sales representatives with a consistent standard of permissible business practice at VA facilities. It would also facilitate mutually beneficial relationships between VA and such sales representatives.

This Notice announces that the Secretary of Homeland Security (Secretary) has extended the designation of Honduras for temporary protected status (TPS) for 18 months from its current expiration date of July 5, 2010, through January 5, 2012. This Notice also sets forth procedures necessary for nationals of Honduras (or aliens having no nationality who last habitually resided in Honduras) with TPS to re- register and to apply for an extension of their employment authorization documents (EADs) with U.S. Citizenship and Immigration Services (USCIS). Re-registration is limited to persons who previously registered for TPS under the designation of Honduras and whose applications have been granted or remain pending. Certain nationals of Honduras (or aliens having no nationality who last habitually resided in Honduras) who have not previously applied for TPS may be eligible to apply under the late initial registration provisions.

Notice is hereby given that on March 18, 2010, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of the Office of Research Integrity (ORI) in the following case:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover SheetForm FDA 3601'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

On October 9, 2009, the Commodity Futures Trading Commission (``CFTC'' or ``Commission'') published for comment in the Federal Register \1\ a notice of its intent to undertake a determination whether the Zone 6-NY Financial Basis (``TZS'') contract traded on the IntercontinentalExchange, Inc. (``ICE''), an exempt commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act''), performs a significant price discovery function pursuant to section 2(h)(7) of the CEA. The Commission undertook this review based upon an initial evaluation of information and data provided by ICE as well as other available information. The Commission has reviewed the entire record in this matter, including all comments received, and has determined to issue an order finding that the TZS contract does not perform a significant price discovery function. Authority for this action is found in section 2(h)(7) of the CEA and Commission rule 36.3(c) promulgated thereunder.

By this final rule, NMFS establishes fishery management measures for the 2010 ocean salmon fisheries off Washington, Oregon, and California and the 2011 salmon seasons opening earlier than May 1, 2011. Specific fishery management measures vary by fishery and by area. The measures establish fishing areas, seasons, quotas, legal gear, recreational fishing days and catch limits, possession and landing restrictions, and minimum lengths for salmon taken in the U.S. exclusive economic zone (EEZ) (3-200 NM) off Washington, Oregon, and California. The management measures are intended to prevent overfishing and to apportion the ocean harvest equitably among treaty Indian, non- treaty commercial, and recreational fisheries. The measures are also intended to allow a portion of the salmon runs to escape the ocean fisheries in order to provide for spawning escapement and to provide for inside fisheries (fisheries occurring in state internal waters).

This is a notice to inform the public of three upcoming meetings in Kansas City, MO, Riverdale, MD, and Denver, CO, to provide an opportunity for stakeholders to offer their input on the new framework being developed for animal disease traceability. Additional meetings are currently being planned and will be announced in a future notice. The meetings are being organized by the Animal and Plant Health Inspection Service.

The Food and Drug Administration (FDA) has determined that BREVIBLOC (esmolol hydrochloride (HCl)) Injection, 250 milligrams (mg)/ milliliter (mL), 10-mL ampule, was withdrawn from sale for reasons of safety or effectiveness. This determination means the agency will not accept or approve abbreviated new drug applications (ANDAs) for esmolol HCl injection, 250 mg/mL, 10-mL ampule.