March 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for metronidazole vaginal gel.

The Coast Guard is establishing a special local regulation on the waters of Charleston Harbor in Charleston, South Carolina during Charleston Race Week, a series of sailboat races. From Thursday, April 18, 2013, until Sunday, April 21, 2013, approximately 300 sailboats are anticipated to participate in these races, and approximately 15 spectator vessels are expected to watch the event. A special local regulation is necessary to provide for the safety of life on the navigable waters of the United States during the races. This special local regulation consists of three race areas. Except for those persons and vessels participating in the sailboat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless authorized by the Captain of the Port Charleston or a designated representative.

The Coast Guard published a notice of meeting for the National Maritime Security Advisory Committee (NMSAC) in the Federal Register on March 18, 2013. Based on budgetary constraints, NMSAC will no longer meet as previously reported. NMSAC will now meet on April 2, 2013 via web and teleconference to discuss various issues relating to national maritime security. This meeting will be open to the public.

The Coast Guard is establishing a temporary moving safety zone on the waters of Bahia de San Juan during the transit of the Spanish Navy School Ship San Sebastian El Cano, a public vessel, and during their 21 gun salute in accordance with the military tradition of vessel proving that it is unarmed upon entrance into a foreign country. The safety zone is necessary to protect the public from the hazards associated with the 21 gun salute near the Bar Channel entrance, and to protect the high ranking officials on board the Spanish Navy School Ship San Sebastian El Cano. The inbound escort is scheduled to take place on Saturday, April 6, 2013, and will entail an escort of the Spanish Navy School Ship San Sebastian El Cano and 21 gun salute. The outbound escort is scheduled to take place on Wednesday, April 10, 2013. The safety zone is necessary to ensure the safety of high ranking officials, commercial traffic, spectators, and the general public on the navigable waters of the United States during the transit and salute. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port San Juan or a designated representative.

The Coast Guard proposes to establish a safety zone within Milwaukee Harbor, Milwaukee, Wisconsin. This Zone is intended to restrict vessels from a portion of Milwaukee Harbor due to the 2013 and 2014 Olympic and Sprint Distance National Championships. This proposed safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the 2013 and 2014 Olympic and Sprint Distance National Championships.

Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The United States Copyright Office will host a public hearing to discuss issues relating to the consideration of a federal resale royalty right in the United States. The meeting will provide a forum for interested parties to address the legal and factual questions raised in the comments received by this Office in response to its September 2012 Notice of Inquiry.\1\

The Federal Transit Administration (FTA) announces the allocation of $2,000,000,000 under the Public Transportation Emergency Relief Program (Emergency Relief Program, Catalogue of Federal Domestic Assistance 20.527) for FTA recipients affected by Hurricane Sandy, which impacted the northeastern seaboard in October 2012 and had a particularly devastating impact on transit systems in New York and New Jersey. FTA is allocating funds as outlined in a Notice of Availability of Emergency Relief Funds published in the Federal Register on February 6, 2013 (78 FR 8691), and consistent with the requirements of the Disaster Relief Appropriations Act of 2013 (Appropriations Act, Pub. L. 113-2). Concurrently with this notice of allocations, FTA is publishing in today's Federal Register an interim final rule (IFR) for the Emergency Relief Program (49 CFR Part 602). This rule outlines general program requirements that will apply to all funds allocated in this notice and to subsequent grant awards under this program. The rule takes effect immediately. FTA's Emergency Relief Program was authorized by Congress in the Moving Ahead for Progress in the 21st Century Act (MAP-21, Pub. L. 112- 141) and provides FTA with primary responsibility for reimbursing emergency response and recovery costs after an emergency or major disaster that affects public transportation systems. The Appropriations Act provides $10.9 billion for FTA's Emergency Relief Program for recovery, relief and resiliency efforts for public transportation in areas affected by Hurricane Sandy. As a result of the Budget Control Act of 2011 (Pub. L. 112-25), five percent of the $10.9 billion made available under the Appropriations Act ($545,000,000) is subject to the significant spending cuts known as sequestration and is unavailable for Hurricane Sandy disaster relief. The Appropriations Act requires that not more than $2 billion shall be made available no later than March 30, 2013. With this notice, FTA is allocating the initial $2 billion, excluding funds to be used for program implementation and oversight, to recipients affected by Hurricane Sandy (affected recipients) for eligible emergency response and recovery costs. In the February 6, 2013, Federal Register notice, FTA instructed affected recipients to submit requests for reimbursement of eligible expenses incurred in advance of January 29, 2013, and for the costs of contract work advertised and force account work budgeted prior to January 29, 2013. FTA announced individual allocations on a rolling basis beginning March 6, 2013. Table 1 shows a summary of the allocations made in this notice. Table 2 shows the allocation for each affected recipient. In addition to funds allocated for the reimbursement of costs meeting the above criteria, FTA is allocating the remainder of the initial $2 billion, based on the anticipated cost of recovery for each affected recipient. These funds are available for eligible emergency operations, emergency protective measures, and emergency and permanent repairs to and replacement of assets that suffered serious damage as a result of the storm. Recipients should develop a list of eligible projects, consistent with the Emergency Relief Program rule, at 49 CFR Sec. 602.17, and review the list of projects with the applicable FTA Regional Office prior to submitting a grant application in FTA's Transportation Electronic Award Management (TEAM) system. FTA granted affected recipients pre-award authority for projects eligible for the initial $2 billion allocation in the February 6, 2013 Federal Register notice. Prior to exercising pre-award authority, recipients are encouraged to work with the appropriate Regional Office to ensure that the applicable Federal requirements are followed. All allocations, including these pro-rated allocations, are included in Table 2. Guidance regarding project eligibility and determinations regarding applicability of certain FTA requirements issued in the February 6, 2013 notice will only apply to costs incurred prior to January 29, 2013, and to other expenses that meet the requirements specified in that notice for inclusion under Category One, Two or Three. Recipients may request waivers of FTA administrative requirements by submitting a request to FTA docket number FTA-2013-0001, as described in the February 6, 2013 Federal Register notice, and in the Emergency Relief Program rule at 49 CFR Sec. 602.15, however, recipients should not proceed with a project under the expectation that waivers will be provided. Additional program requirements, considerations and grant application procedures specific to these funds are included in this notice.

The EPA proposes to amend the compliance certification requirements for state and federal operating permits programs that were published in the Federal Register on June 27, 2003. In that action, one sentence was removed from the rules in error. This action proposes to restore the sentence to its original location in the rules.

The Federal Communications Commission is correcting the comment and reply comment dates for a proposed rule that appeared in the Federal Register of March 8, 2013. The document proposed rules for Earth Stations Aboard Aircraft.

EPA is taking direct final action to convert a conditional approval of specified provisions of the Ohio state implementation plan (SIP) to a full approval. Ohio submitted a request to approve revised particulate matter (PM) rules on February 23, 2012. The PM rule revisions being approved establish work practices for coating operations, add a section clarifying that sources can be subject to both stationary source and fugitive source PM restrictions, and add a PM emission limitation exemption for jet engine testing. Pursuant to a state commitment underlying a previous conditional approval of this rule, the revised rule provides that any exemption from the work practice requirements that the state grants to large coating sources must be submitted to EPA for approval.

EPA is partially approving and partially disapproving State Implementation Plan (SIP) revisions submitted by the State of Colorado on June 20, 2003. The intended effect of this final rule is to approve and make federally enforceable those portions of the revisions to Colorado's Common Provisions that are consistent with the Clean Air Act (CAA). Primarily, the revisions involved changes designed to fix ambiguous language, to make the definitions more readable or to delete obsolete definitions. In addition, a number of definitions were revised to reflect developments in federal law or were deleted to eliminate duplicative provisions that appear in other Colorado regulations. EPA is approving portions of the revision that delete duplicative or obsolete definitions, or that clarify existing definitions in a manner consistent with the CAA. In addition, EPA is disapproving those portions of the rule revisions that EPA determined are inconsistent with the CAA. This action is being taken under section 110 of the CAA.

The Bureau of Indian Affairs (BIA) published a rule in the Federal Register of December 5, 2012, announcing the revisions to regulations addressing non-agricultural surface leasing of Indian land. This notice makes some minor corrections to include the proper indefinite article for the term ``agricultural lease'' and clarifies two provisions for wind energy evaluation leases (WEELs).

In accordance with the National Environmental Policy Act (NEPA) of 1969, as amended, and the Federal Land Policy and Management Act (FLPMA) of 1976, as amended, the Bureau of Land Management (BLM) has prepared a combined Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for Billings and Pompeys Pillar National Monument within the Billings Field Office of the BLM Montana/ Dakotas State Office and by this notice is announcing the opening of the comment period.

This regulation establishes a tolerance for residues of clothianidin in or on tea, dried and increases the tolerance level for pepper to support a shorter pre-harvest interval (PHI). These tolerances were requested by Interregional Research Project Number 4 (IR-4) and Valent U.S.A. Corporation, respectively, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This action establishes Class E airspace at Round Mountain, TX. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at West Ranch Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.

This is Supplement No. 6 to the Treasury Department Circular 570, 2012 Revision, published July 2, 2012, at 77 FR 39322.

We are adopting a new airworthiness directive (AD) for REIMS AVIATION S.A. Model F406 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as fretting (wear and/or chafing) found between the elevator pushrod assembly and the horizontal tail structure, which could cause the elevator pushrod to jam and could result in loss of control. We are issuing this AD to require actions to address the unsafe condition on these products.