2010 – Federal Register Recent Federal Regulation Documents

We are amending the black stem rust quarantine and regulations by adding four varieties to the list of rust-resistant Berberis species or cultivars in the regulations. This action will allow for the interstate movement of these newly developed varieties without unnecessary restrictions.

Due to an adverse comment, EPA is withdrawing the direct final rule to extend the attainment date from June 15, 2010 to June 15, 2011 for the Baltimore nonattainment area, which is classified as moderate for the 1997 8-hour ozone national ambient air quality standard (NAAQS). In the direct final rule published on July 23, 2010, we stated that if we received any adverse comments by August 23, 2010, the rule would be withdrawn and would not take effect. EPA received an adverse comment within the comment period. EPA will address the comment received in a subsequent final action based upon the proposed action also published on July 23, 2010 (75 FR 43114). EPA will not institute a second comment period on this action.

The EPA is designating the Guam Deep Ocean Disposal Site (G- DODS) as a permanent ocean dredged material disposal site (ODMDS) located offshore of Guam. Dredging is essential for maintaining safe navigation at port and naval facilities in Apra Harbor and other locations around Guam. Beneficial re-use of dredged material (e.g., for habitat creation, construction material, or landfill cover) is preferred over ocean disposal. However, not all dredged materials are suitable for beneficial re-use, and not all suitable materials can be re-used or stockpiled for future use given costs, logistical constraints, and capacity of existing land disposal or re-handling sites. Therefore, there is a need to designate a permanent ODMDS offshore of Guam. Disposal operations at the site will be limited to a maximum of 1 million cubic yards (764,555 cubic meters) per calendar year and must be conducted in accordance with the Site Management and Monitoring Plan and any project-specific permit conditions. The designated ODMDS will be monitored periodically to ensure that the site operates as expected.

The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device type.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for use of an increased strength of tiamulin concentrate solution in the drinking water of swine for the treatment of certain bacterial respiratory and enteric diseases.

We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated 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:

In this document the Commission seeks comment on revisions to the Commission's wireless hearing aid compatibility rules. The Commission initiates this proceeding to ensure that consumers with hearing loss are able to access wireless communications services through a wide selection of devices without experiencing disabling interference or other technical obstacles.

The Department of Veterans Affairs (VA) published a final rule in the Federal Register on May 13, 1996 (61 FR 21964), amending its medical regulations in 38 CFR part 17 by making a number of nonsubstantive changes. Specifically, section numbers were redesignated, redundant and obsolete material was removed, certain position and organizational titles were changed, and material previously deleted was restored. The document contained an error in an amendatory instruction. We removed portions of Sec. 17.31 and inadvertently redesignated Sec. 17.31(b)(5) as the new Sec. 17.31, creating two sections for Sec. 17.31. This document will correct that error by removing the second, obsolete Sec. 17.31.

We, the U.S. Fish and Wildlife Service (Service), propose endangered status under the Endangered Species Act of 1973, as amended (Act), for the Ozark hellbender (Cryptobranchus alleganiensis bishopi) throughout its entire range. The species is found in southern Missouri and northern Arkansas. If we finalize this proposed rule, it would extend the Act's protection to the Ozark hellbender. However, we find that designation of critical habitat is not prudent for the Ozark hellbender at this time, because the increased threat to the species from illegal collection and trade outweighs the benefits of designating critical habitat. We seek data and comments from the public on this proposed listing rule and prudency determination.

This rule proposes to establish the requirements regarding the allocation of administrative funds for the Food Distribution Program on Indian Reservations and the Food Distribution Program for Indian Households in Oklahoma, both of which are referred to as ``FDPIR'' in this rulemaking. The rulemaking would propose amendments to FDPIR regulations to ensure that administrative funding is allocated in a fair and equitable manner. The proposed rule would also revise FDPIR regulations to clarify current program requirements relative to the distribution of administrative funds to Indian Tribal Organizations (ITOs) and State agencies.

This document withdraws proposed regulations published in the Federal Register on September 10, 2003 (68 FR 53448), related to the treatment of controlled services transactions under section 482 and the allocation of income from intangibles, in particular with respect to contributions by a controlled party to the value of an intangible that is owned by another controlled party. The IRS and Treasury Department are withdrawing those proposed regulations because they have been superseded.

DoD is adopting as final, without change, an interim rule that amended the Defense Federal Acquisition Regulation Supplement to implement section 825 of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009 and the Vessel Hull Design Protection Amendments of 2008. Section 825 clarifies the Government's rights in technical data in the designs of a DoD vessel, boat, craft, or components thereof.

DoD is adopting as final, without change, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the National Defense Authorization Act for Fiscal Year 2010 to amend the definition of ``contract action'' to include task orders and delivery orders.

The Forest Service, U.S. Department of Agriculture (USDA), is proposing to make administrative corrections affecting Big Creek Fringe, French Creek, Placer Creek, Secesh, and Smith Creek Idaho Roadless Areas on the Payette National Forest. These corrections will remedy two errors regarding regulatory classification and mapping that concern Forest Plan Special Areas (Big Creek and French Creek). Notice is given pursuant to 36 CFR 294.27(a), that the Chief proposes to issue an administrative correction after a 30-day public notice and opportunity to comment.

We, the U.S. Fish and Wildlife Service (Service/USFWS), announce a revised 12-month finding on a petition to list the upper Missouri River Distinct Population Segment (Missouri River DPS) of Arctic grayling (Thymallus arcticus) as endangered or threatened under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that listing the upper Missouri River DPS of Arctic grayling as endangered or threatened is warranted. However, listing the upper Missouri River DPS of Arctic grayling is currently precluded by higher priority actions to amend the Lists of Endangered and Threatened Wildlife and Plants. Upon publication of this 12-month finding, we will add the upper Missouri River DPS of Arctic grayling to our candidate species list. We will develop a proposed rule to list this DPS as our priorities allow. We will make any determination on critical habitat during development of the proposed listing rule. In the interim, we will address the status of this DPS through our annual Candidate Notice of Review (CNOR).

In this document, EPA is making a correction to the Action to Ensure Authority To Issue Permits Under the Prevention of Significant Deterioration Program to Sources of Greenhouse Gas Emissions: Federal Implementation Plan; Public Hearing to be held on September 14, 2010 (published in the Federal Register on August 30, 2010, 75 FR 52916). We inadvertently within the summary section of the document stated that the hearing will be held in Arlington, VA. This document corrects the location to Washington, DC.

NMFS is prohibiting directed fishing for species that comprise the shallow-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the fourth seasonal apportionment of the Pacific halibut bycatch allowance specified for the shallow-water species fishery in the GOA has been reached.

We are revising our regulations to incorporate improvements to the Supplemental Security Income (SSI) program made by the HEART Act. The HEART Act changes the way we treat certain cash payments to members of the uniformed services and veterans and the way we treat cash and in-kind payments to AmeriCorps volunteers. In addition, we are making a technical change to our rules to reflect the correct section of the Internal Revenue Code.

The Bureau of Industry and Security (BIS) maintains the Commerce Control List (CCL), which identifies items subject to Department of Commerce export controls. This final rule revises the Export Administration Regulations (EAR) to implement changes made to the Wassenaar Arrangement's List of Dual Use Goods and Technologies (Wassenaar List) maintained and agreed to by governments participating in the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual Use Goods and Technologies (Wassenaar Arrangement, or WA) at the December 2009 WA Plenary Meeting (the Plenary). The Wassenaar Arrangement advocates implementation of effective export controls on strategic items with the objective of improving regional and international security and stability. To harmonize with the changes made to the Wassenaar List at the Plenary, this rule revises the EAR by amending certain entries that are controlled for national security reasons in Categories 1, 2, 3, 4, 5 Part I (telecommunications), 6, 7, and 9, revising reporting requirements, and adding, removing and amending EAR Definitions. The changes agreed to at the Plenary that pertain to Export Control Classification Numbers (ECCNs) 5A002, 5D002, 6A002, 6A003, 8A002 and all related ECCNs will be implemented in a separate rule because of the sensitivity of the items and complexity of procedures and controls for these items. The changes agreed to at the Plenary that pertain to raising the Adjusted Peak Performance (APP) for digital computers in ECCN 4A003 will be implemented in a separate rule when the President's report for High Performance Computers has been sent to Congress that sets forth the new APP in accordance with the National Defense Authorization Act for FY1998.

In this document, the Commission extends for an additional year current waivers of certain Telecommunications Relay Services (TRS) mandatory minimum standards for Video Relay Service (VRS) and Internet Protocol Relay (IP Relay). The waived TRS mandatory minimum standards are: One-line voice carry over (VCO); VCO-to-teletypewriter (TTY); VCO- to-VCO; one-line hearing carry over (HCO); HCO-to-TTY; HCO-to-HCO; call release; speech-to-speech (STS); pay-per-call (900) calls; types of calls; and equal access to interexchange carriers requirements. The Commission also extends for one year a requirement for default Internet-based TRS providers that are unable to meet such standards for newly-registered Internet-based TRS users who port their customer premises equipment (CPE) from a former default provider. The Commission extends the waivers for one year because the record demonstrates that it is technologically infeasible for VRS and IP Relay providers to offer these services at this time. All of these waivers are conditioned on the filing of a report, due April 16, 2011, addressing whether it is necessary for the waivers to remain in effect.

In this rule, we are proposing to withdraw two provisions from the ``Medicaid Program; Prescription Drugs'' final rule (referred to hereafter as ``AMP final rule'') published in the July 17, 2007 Federal Register. The provisions we are proposing to withdraw are as follows: The determination of average manufacturer price (AMP), and the Federal upper limits (FULs) for multiple source drugs. We are also proposing to withdraw the definition of ``multiple source drug'' as it was revised in the ``Medicaid Program; Multiple Source Drug Definition'' final rule published in the October 7, 2008 Federal Register. The provisions of the AMP final rule and the definition of multiple source drug that we are proposing to withdraw were challenged in a lawsuit that was filed in November 2007. The challenged regulations have been superseded in significant part by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, and the FAA Air Transportation Modernization and Safety Improvement Act. This document would withdraw the regulatory provisions challenged in the aforementioned litigation.

NMFS is proposing regulations under the Tuna Conventions Act of 1950 (Act), as amended, to increase the vessel capacity limit for the U.S. purse seine fishery operating in the eastern Pacific Ocean (EPO) and make U.S. regulations more consistent with the Inter-American Tropical Tuna Commission (IATTC) Resolution on the Capacity of the Tuna Fleet Operating in the Eastern Pacific Ocean. These revisions would ensure that the United States is satisfying its obligations under the Tuna Conventions Act while dismantling regulatory constraints preventing economic development of the U.S. industry.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADAs provide for administering a Type C medicated feed containing ractopamine hydrochloride as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter.

The U.S. Department of Energy (DOE) is initiating the rulemaking and data collection process to develop a test procedure for televisions. To inform interested parties and to facilitate this process, DOE has gathered data, identifying several issues associated with the currently available test procedures on which DOE is particularly interested in receiving comment. The issues outlined in this document mainly concern televisions in active mode (they do not, for example, include issues related to low power modes). DOE welcomes written comments from the public on any subject within the scope of this rulemaking (including topics not raised in this request for information).

This final rule amends the Department of Veterans Affairs (VA) medical regulations to make the language of several provisions conform to changes in law made by the Homeless Veterans Comprehensive Assistance Act of 2001; the Veterans Health Care, Capital Asset, and Business Improvement Act of 2003; and the Veterans' Mental Health and Other Care Improvements Act of 2008.