October 2, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is notifying generic drug facilities, and certain sites and organizations identified in a generic drug submission, that they must provide identification information to FDA. This information is required to be submitted to the FDA annually under the Generic Drug User Fee Act Amendments of 2012 (GDUFA) included in the Food and Drug Administration Safety and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to self-identify with the FDA, determine what information they are required to submit, and familiarize themselves with the means and format for submitting the required information.

On January 22, 2008, the Department of Commerce (the Department) signed the current suspension agreement on fresh tomatoes with growers/exporters of Mexican tomatoes accounting for substantially all (i.e., not less than 85 percent) of Mexico's tomato exports to the United States. The agreement covers all fresh or chilled tomatoes of Mexican origin, except tomatoes that are for processing. On June 22, 2012, the U.S. petitioners in the suspended antidumping duty investigation filed a request for withdrawal of the petition and termination of the investigation and the suspension agreement. On August 21, 2012, the Department published a notice of initiation of changed circumstances review to examine the petitioners' request to terminate the suspended investigation. See Fresh Tomatoes from Mexico: Notice of Initiation of Changed Circumstances Review, 77 FR 50554 (August 21, 2012) and Correction: Fresh Tomatoes From Mexico: Notice of Initiation of Changed Circumstances Review and Consideration of Termination of Suspended Investigation, 77 FR 50556 (August 21, 2012) (collectively, Initiation Notice). In the Initiation Notice we invited interested parties to submit comments for the Department's consideration by September 4, 2012. We have considered the comments received by September 4, 2012, and, for the reasons stated in this notice and in the accompanying decision memorandum, the Department is notifying the public of our preliminary intent to terminate the suspended investigation. If the suspended investigation is terminated in the final results of this review, the suspension agreement will also terminate, effective on the date of publication of the notice of final results of the changed circumstances review in the Federal Register. Interested parties are invited to comment on these preliminary results.

The OCC, Board, FDIC, FCA, and FHFA (collectively, the Agencies) are reopening the comment period for the proposed rule published in the Federal Register on May 11, 2011 (76 FR 27564) to establish minimum margin and capital requirements for uncleared swaps and security-based swaps entered into by swap dealers, major swap participants, security-based swap dealers, and major security-based swap participants for which one of the Agencies is the prudential regulator (Proposed Margin Rule). Reopening the comment period that expired on July 11, 2011 will allow interested persons additional time to analyze and comment on the Proposed Margin Rule in light of the consultative document on margin requirements for non-centrally-cleared derivatives recently published for comment by the Basel Committee on Banking Supervision (BCBS) and the International Organization of Securities Commissions (IOSCO).

The Federal Aviation Administration (FAA) is considering a proposal to authorize the release of 138.33 acres of airport property at the former Willmar Municipal Airport, Willmar, MN. The land will be used for an industrial park. The FAA issued a Categorical Exclusion on August 8, 2012. The City of Willmar built a new airport in 2006, therefore the acreage being released is not needed for aeronautical use. The 138.33 acres are on the east side of the former Willmar Municipal Airport, more specifically west of County Road 5 and north of Willmar Avenue SW. The acreage was originally acquired with City of Willmar funds. There are no impacts to the airport by allowing the airport to dispose of the property. The fair market value of this land is $729,100 and will be applied to the new Willmar Municipal Airport for operating and maintaining the airport. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. In accordance with section 47107(h) of title 49, United States Code, this notice is required to be published in the Federal Register 30 days before modifying the land-use assurance that requires the property to be used for an aeronautical purpose.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. 14 CFR part 21 prescribes certification standards for aircraft, aircraft engines, propellers appliances and parts. The information collected is used to determine compliance and applicant eligibility. The respondents are aircraft parts designers, manufacturers, and aircraft owners.

FRA is issuing Safety Advisory 2012-04 to remind track owners, railroads, and their track inspectors of the importance of complying with the applicable rail management programs and engineering procedures that address rail with severe rail head wear and rolling contact fatigue (RCF) conditions. FRA is issuing this notice in response to a July 11, 2012, derailment in Ohio that a preliminary investigation indicates was likely caused by the failure of multiple defects involving detail fractures in rail exhibiting significant vertical head loss (rail head wear) and gage-side-oriented RCF. This notice contains recommendations to track owners to ensure that their employees and other entities performing track inspections comply with the requirements of the applicable engineering procedures that address critical rail head wear, particularly if the track under inspection exhibits significant RCF or a sudden increase in localized rail failure.

The Department of Labor (Department) is delaying the effective date of the Wage Methodology for the Temporary Non-agricultural Employment H-2B Program final rule, in response to recently enacted legislation that prohibits any funds from being used to implement the Wage Rule for the first 6 months of fiscal year (FY) 2013. The Wage Rule revised the methodology by which the Department calculates the prevailing wages to be paid to H-2B workers and United States (U.S.) workers recruited in connection with a temporary labor certification for use in petitioning the Department of Homeland Security to employ a nonimmigrant worker in H-2B status.

The Bureau of Indian Affairs (BIA) is confirming the interim final rule published and effective on May 24, 2012, addressing heating, cooling, and lighting standards for Bureau-funded dormitory facilities. This rule was developed through negotiated rulemaking, as required by the No Child Left Behind Act of 2001. The May 24, 2012, publication stated that the BIA would review comments on the interim final rule and either confirm the rule or initiate a proposed rulemaking. BIA did not receive any adverse comments, and therefore confirms the rule without change.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Crew Member's Declaration (Form 5129). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This information collection was previously published in the Federal Register (77 FR 40892) on June 11, 2012, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Application for Identification Card (CBP Form 3078). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This information collection was previously published in the Federal Register (77 FR 42753) on June 20, 2012, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

EPA is proposing to approve the fine particulate matter (PM2.5) 2002 base year emissions inventory portion of the West Virginia State Implementation Plan (SIP) revision submitted by the State of West Virginia, through the West Virginia Department of Environmental Protection (WVDEP), on May 28, 2009 for the Huntington- Ashland, WV-KY-OH nonattainment area (hereafter referred to as the Huntington Area). The emissions inventory is part of the West Virginia May 28, 2009 SIP revision that was submitted to meet nonattainment requirements related to West Virginia's portion of the Huntington Area for the 1997 PM2.5 National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM2.5 emissions inventory for the Huntington Area in accordance with the requirements of the Clean Air Act (CAA).

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Exportation of Used Self-Propelled Vehicles. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register (76 FR 44258) on June 27, 2012, allowing for a 60-day comment period. One comment was received. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning Deferral of Duty on Large Yachts Imported for Sale. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

In accordance with 5 U.S.C. 4314(c)(4), NOAA announces the appointment of members who will serve on the NOAA Performance Review Board (PRB). The NOAA PRB is responsible for reviewing performance appraisals and ratings of Senior Executive Service Professional members and making written recommendations to the appointing authority on retention and compensation matters, including performance-based pay adjustments, awarding of bonuses, and reviewing recommendations for potential Presidential Rank Award nominees. The appointment of new members to the NOAA PRB will be for a period of two (2) years.

Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR 151.13, Amspec Services LLC, 4370 Oakes Road Unit 732, Davie, FL 33314, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to cbp.labhq@dhs.gov. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories.

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is publishing the final regulatory basis for rulemaking to streamline non-power reactor license renewal. This final regulatory basis incorporates input from the public, licensees, certificate holders, and other stakeholders provided during the public comment period that ended July 31, 2012. This regulatory basis provides the technical basis to support proceeding with rulemaking to streamline and enhance the Research and Test Reactor (RTR) License Renewal Process. This contemplated rulemaking also recommends conforming changes to address technical issues in existing non-power reactor regulations. The NRC has developed a final technical basis for this proposed rulemaking that describes the agency's overall objectives, conceptual approaches, potential solutions, integration with agency strategic goals, and related technical and regulatory clarity issues.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Otitis Media: Developing Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of the same name issued on January 18, 2008.

The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on November 1, 2012.

Notice is hereby given that Mystic Aquarium, Mystic, Connecticut 06355 [Responsible Party: Stephen Coan], has applied in due form for a permit to collect, import, export, and receive marine mammal parts for scientific research.