2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA)

The Department is publishing this proposed rule to implement section 703 of the National Defense Authorization Act (NDAA) for Fiscal Year 2007 (FY07), Public Law 109-364. Specifically, that legislation authorizes breast cancer screening and cervical cancer screening for female beneficiaries of the Military Health System, instead of constraining such testing to mammograms and Papanicolaou smears. The rule allows coverage for ``breast cancer screening'' and ``cervical cancer screening'' for female beneficiaries of the Military Health System, instead of constraining such testing to mammograms and Papanicolaou tests. This rule ensures new breast and cervical cancer screening procedures can be added to the TRICARE benefit as such procedures are proven to be a safe, effective, and nationally accepted medical practice. This amends the cancer specific recommendations for breast and cervical cancer screenings to be brought in line with the processes for updating other cancer screening recommendations.

On March 17, 2009, FMCSA published a notice in the Federal Register (74 FR 11318) extending the effective date of its January 16, 2009 final rule entitled ``Elimination of Route Designation Requirement for Motor Carriers Transporting Passengers Over Regular Routes'' until June 15, 2009. This allowed for the solicitation of additional public comments on the final rule and gave the incoming Administration sufficient time to consider and respond to comments. After reviewing the one comment that was received, FMCSA decided to allow the January

This rule would increase the assessment rate established for the Washington-Oregon Fresh Prune Marketing Committee (Committee) for the 2009-10 and subsequent fiscal periods from $1.00 to $2.00 per ton for fresh prunes. The Committee is responsible for local administration of the marketing order regulating the handling of fresh prunes grown in designated counties in Washington and in Umatilla County, Oregon. Assessments upon handlers of fresh prunes are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period for the marketing order begins April 1 and ends March 31. The assessment rate would remain in effect indefinitely unless modified, suspended or terminated.

NMFS announces the availability of the draft Amendment 3 to the Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP). Amendment 3 examines different management alternatives available to rebuild blacknose sharks consistent with the 2007 small coastal shark (SCS) stock assessment, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and other applicable law. Amendment 3 also examines management alternatives to end overfishing of blacknose sharks and shortfin mako sharks, consistent with the Magnuson-Stevens Act, and also proposes adding smooth dogfish under NMFS management. The proposed rule to implement Amendment 3 would, among other things, establish a quota for blacknose sharks and non-blacknose SCS, prohibit the use of gillnet gear to catch sharks from South Carolina south, prohibit the retention of blacknose sharks in recreational fisheries, take action at the international level to end overfishing of shortfin mako through participation in appropriate international fisheries organizations, such as International Commission for the Conservation of Atlantic Tunas (ICCAT), promote the live release of shortfin mako sharks, add smooth dogfish under NMFS management, establish a commercial quota for smooth dogfish, require smooth dogfish fishermen to obtain the appropriate Federal permit, and establish a mechanism for specifying Annual Catch Limits (ACLs) and Accountability Measures (AMs) for Atlantic sharks. These changes could affect all fishermen, commercial and recreational, who fish for sharks in the Atlantic Ocean, the Gulf of Mexico, and the Caribbean Sea.

The Federal Energy Regulatory Commission (Commission) is proposing to amend its regulations prescribing standards for interstate natural gas pipeline business practices and electronic communications (found at 18 CFR 284.12) to incorporate by reference standards adopted by the Wholesale Gas Quadrant of the North American Energy Standards Board (NAESB) for Index-Based Capacity Release and Flexible Delivery and Receipt Points. These standards can be obtained from NAESB at 1301 Fannin, Suite 2350, Houston, TX 77002, 713-356-0060, https:// www.naesb.org, and are available for viewing in the Commission's Public Reference Room.

This document contains a correction to the regulation of the Department of Veterans Affairs (VA) that governs recoupment of lump-sum readjustment pay from disability compensation. This correction is required in order to amend an authority citation in the regulation. No substantive change to the content of the regulation is being made by this correcting amendment.

The Federal Communications Commission Wireline Competition Bureau (Bureau) released a public notice establishing a pleading cycle for comments on how the Federal Communications Commission should interpret and implement sections 106(h)(1) and 106(h)(2) of the Broadband Data Improvement Act of 2008 (BDIA). (Broadband Data Improvement Act of 2008, Public Law 110-385, 122 Stat. 4097 (codified at 47 U.S.C. 1301-04)).

The Coast Guard is establishing a safety zone on the navigable waters of the Lower Colorado River, Laughlin, NV, in support of a fireworks display near the AVI Resort and Casino. This 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 U.S. Army Corps of Engineers (Corps) is amending its restricted area regulations to enlarge an existing restricted area in the Banana River and to establish a new restricted area in the Atlantic Ocean for the Cape Canaveral Air Force Station (CCAFS), located on Patrick Air Force Base (AFB), Florida. We are also removing an existing restricted area in the Banana River at CCAFS. CCAFS Command, located at Patrick AFB, Florida, is responding to Department of Defense (DoD) security assessments which have identified a need for CCAFS to have the capability to secure their shoreline. The enhancement of these capabilities is necessary to counter postulated threats to CCAFS.

The EPA is proposing to extend for an additional nine months the existing administrative stay of the ``grandfathering'' provision for particulate matter less than 2.5 micrometers (PM2.5) requirements in the Federal Prevention of Significant Deterioration (PSD) program published in the Federal Register on May 16, 2008 as part of the final rule entitled, ``Implementation of the New Source Review (NSR) Program for Particulate Matter Less Than 2.5 Micrometers (PM2.5).'' The grandfathering provision under the Federal PSD program allows the permitting authority to review PSD permit applications received before July 15, 2008 according to EPA's 1997 policy of satisfying the requirements for particulate matter less than 10 micrometers (PM10) as a surrogate for meeting the new requirements for PM2.5.

We are proposing to establish a new category of regulated articles in the regulations governing the importation of nursery stock, also known as plants for planting. This category would list taxa of plants for planting whose importation is not authorized pending pest risk analysis. If scientific evidence indicated that the taxon of plants for planting is a potential quarantine pest or a potential host of a quarantine pest, we would publish a notice that would announce our determination that the taxon is a potential quarantine pest or a potential host of a quarantine pest, cite the scientific evidence we considered in making this determination, and give the public an opportunity to comment on our determination. If we received no comments that changed our determination, the taxon would subsequently be added to the new category. We would allow any person to petition for a pest risk analysis to be conducted for a taxon that has been added to the new category. After the pest risk analysis was completed, we would remove the taxon from the category and allow its importation subject to general requirements, allow its importation subject to specific restrictions, or prohibit its importation. We would consider applications for permits to import small quantities of germplasm from taxa whose importation is not authorized pending pest risk analysis, for experimental or scientific purposes under controlled conditions. This new category would allow us to take prompt action on evidence that the importation of a taxon of plants for planting may pose a risk while continuing to allow for public participation in the process.

The FAA proposes to adopt a new airworthiness directive (AD) for certain CFM International Model CFM56-3B1 and -3B2 turbofan engines. This proposed AD would require initial and repetitive inspections for damage to the fan blades. This proposed AD results from a report of a failed fan blade with severe out-of-limit wear on the underside of the blade platform where it contacts the damper. We are proposing this AD to prevent failure of multiple fan blades, which could result in an uncontained failure of the engine and damage to the airplane.

The FAA proposes to supersede an existing airworthiness directive (AD) that applies to all Boeing Model 747-200F, 747-200C, 747-400, 747-400D, and 747-400F series airplanes. The existing AD currently requires repetitive inspections for cracking of certain fuselage internal structure (i.e., Sections 42 and 46 fuselage frames, upper deck floor beams, electronic bay access door cutout, nose wheel well, and main entry doors and door cutouts), and repair if necessary. This proposed AD would require additional repetitive inspections for cracking of certain fuselage structure (i.e., Section 41 fuselage frames where they connect to upper deck floor beams, and section 41 fuselage frames between stringer (S-8 and S-12), and related investigative/corrective actions if necessary. This proposed AD would also reduce the inspection threshold and repetitive inspection intervals for certain airplanes. This proposed AD results from fatigue tests and analysis by Boeing that identified additional areas of the fuselage where fatigue cracks can occur. We are proposing this AD to prevent the loss of structural integrity of the fuselage, which could result in rapid depressurization of the airplane.

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the white-sided jackrabbit (Lepus callotis) as an endangered species and designate critical habitat under the Endangered Species Act of 1973, as amended. Following a review of the petition, we find the petition provides substantial scientific or commercial information indicating that listing this species may be warranted. Therefore, with the publication of this notice, we are initiating a status review to determine if listing this species is warranted. To ensure that the status review is comprehensive, we are requesting the public to submit scientific and commercial data and other information regarding the white-sided jackrabbit. We will make a determination on critical habitat if and when we initiate a listing action for this species.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

This interim rule implements section 222 in Division I of the Omnibus Appropriations Act, 2009, Public Law 111-8 (2009 Appropriations Act). Section 222 authorizes HUD, to the extent of Fiscal Year (FY) 2009 loan guarantee authority, to provide community development loan guarantees, under section 108 of the Housing and Community Development Act of 1974 (HCD Act), to states borrowing on behalf of local governments in nonentitlement areas (governments that do not receive annual Community Development Block Grants (CDBG) from HUD). Section 108 authorizes HUD to guarantee notes issued by such nonentitlement local governments or their designated public agencies supported by the respective state's pledge of its CDBG funds. Prior to the enactment of section 222, HUD lacked authority to guarantee notes issued by states on their behalf. State officials interested in applying for a loan guarantee commitment pursuant to this new authority should take note that HUD's authority to issue such commitments will expire on September 30, 2010 (and could be fully utilized by other borrowers before that date), unless the provision continues to be included in future appropriations acts. The interim rule, however, contains language that will make the provisions implementing this new authority continue to apply, in the event that provisions equivalent to section 222 are included in future appropriations acts. Because the provisions of section 222 expand, rather than replace, existing Section 108 authority, HUD will also continue to accept nonentitlement local government issuers' state-supported applications for loan guarantee commitments.

The Commission is proposing to revise a rounding convention used in the statutory price cap calculation for purposes of establishing rates for certain postal products. This document invites public comment on the proposal.

PHMSA is proposing to incorporate by reference (IBR) into the pipeline safety regulations all or parts of new editions of voluntary consensus standards to allow pipeline operators to use current technology, new materials, and other industry and management practices. In this document, PHMSA also proposes to make nonsubstantive edits and clarify regulatory language in certain provisions. These proposed amendments to the pipeline safety regulations would not require pipeline operators to undertake any significant new pipeline safety initiatives.

As authorized the Immigration and Nationality Act this rule amends the definition of ``immediate family'' for the Foreign Government Official nonimmigrant visa category.

The Federal Labor Relations Authority (Authority) seeks public comment on a proposed revision to its regulations implementing the Freedom of Information Act, as amended. The proposed regulations contain new provisions to comply with the OPEN Government Act of 2007, as well as changes to satisfy the Electronic Freedom of Information Act Amendments of 1996. The regulations have also been revised to reflect changes required by Executive Order 12600 and Executive Order 13392. In addition, the proposed regulations have been updated to reflect changes in the Authority's policies and procedures. As a result of these proposed amendments, the public will have a clearer understanding of the Authority's policies and procedures implementing the FOIA.

The Postal Service is revising its standards for postage refunds for Express Mail[supreg] shipments of live animals in an effort to maintain the economic viability of shipping animals via Express Mail service.

We, the U.S. Fish and Wildlife Service, published a final rule in the Federal Register on October 8, 2008, to revise our regulations governing falconry in the United States. With this action, we propose to make several changes to those regulations to correct inconsistencies and oversights and make the regulations clearer. Because a few of our changes are technically substantive, we are opening a comment period for this action.

The U.S. Department of Energy (DOE) is adopting amended energy conservation standards for commercial packaged boilers and adopting a new energy conservation standard for water-cooled and evaporatively- cooled commercial package air conditioners and heat pumps with a cooling capacity at or above 240,000 Btu/h and less than 760,000 Btu/h at the efficiency levels specified in the American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. (ASHRAE)/ Illuminating Engineering Society of North America (IESNA) Standard 90.1-2007. DOE has determined that the ASHRAE Standard 90.1-2007 efficiency levels for commercial packaged boilers are more stringent than the existing Federal energy conservation standards and will result in economic and energy savings compared to existing energy conservation standards. Furthermore, DOE has concluded that clear and convincing evidence does not exist, as would justify more-stringent standard levels than the efficiency levels in ASHRAE Standard 90.1-2007. In addition, DOE is adopting related amendments to its test procedures for commercial packaged boilers.