February 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

The United States Patent and Trademark Office (USPTO) is seeking public input and guidance to direct its continued efforts towards enhancing patent quality. These efforts focus on improving patent operations and procedures to provide the best possible work products, to enhance the customer experience, and to improve existing quality metrics. In pursuit of these goals, the USPTO is launching a comprehensive and enhanced quality initiative. This initiative begins with a request for public comments on the set of proposals outlined in this document and will continue with a two-day ``Quality Summit'' with the public to discuss the outlined proposals. The conversation with the public held at this Quality Summit, complemented by written comments to these proposals, is the first of many steps toward developing a new paradigm of patent quality at the USPTO. Through an active and long- term partnership with the public, the USPTO seeks to ensure the issuance of the best quality patents and provide the best customer service possible.

The Environmental Protection Agency (EPA) is announcing an extension of the public comment period for the proposed rule titled ``Greenhouse Gas Reporting Program: 2015 Revision and Confidentiality Determinations for Petroleum and Natural Gas Systems''. The public comment period for this proposal began on December 9, 2014. This document announces the extension of the deadline for public comment from February 9, 2015 to February 24, 2015.

The U.S. Environmental Protection Agency (EPA) Region 8 is publishing a direct final Notice of Deletion of the Midvale Slag Superfund Site (Site), located in Salt Lake County, Utah, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Utah, through the Utah Department of Environmental Quality (UDEQ), because EPA has determined that all appropriate response actions under CERCLA, other than operation, maintenance and five-year reviews of the Site, have been completed. However, this deletion does not preclude future actions under Superfund.

This document contains technical corrections to the USDA organic regulations (7 CFR part 205) which were published in the Federal Register on December 21, 2000. The correcting amendments are minor, mostly typographical amendments which do not change, or alter the interpretation, of any provision within the USDA organic regulations.

NMFS implements an accountability measure (AM) to close the hook-and-line component of the commercial sector for king mackerel in the Florida west coast southern subzone. This closure is necessary to protect the Gulf of Mexico (Gulf) king mackerel resource.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Cask System listing within the ``List of approved spent fuel storage casks'' to add Amendment No. 8, Revision No. 1, to the Certificate of Compliance (CoC) No. 1014. Amendment No. 8, Revision No. 1, changes burnup/cooling time limits for thimble plug devices; changes Metamic-HT material testing requirements; changes Metamic-HT material minimum guaranteed values; and updates fuel definitions to allow boiling water reactor fuel affected by certain corrosion mechanisms with specific guidelines to be classified as undamaged fuel.

The Environmental Protection Agency (EPA) is proposing to grant approval to four State Implementation Plan (SIP) revisions submitted by the West Virginia Department of Environmental Protection for the State of West Virginia on June 29, 2010, July 8, 2011, July 6, 2012, and July 1, 2014 with the exception of certain revisions related to ethanol production facilities on which EPA is taking no action at this time. These revisions proposed for approval pertain to West Virginia's nonattainment New Source Review (NSR) program, notably provisions for preconstruction permitting requirements for major sources of fine particulate matter (PM2.5) and NSR reform. This action is being taken under the Clean Air Act (CAA).

This proposed rule would amend HUD's Section 108 Loan Guarantee Program (Section 108 Program) regulations to permit HUD, in accordance with statutory authority, to collect fees from Section 108 borrowers to offset the costs of Section 108 loan guarantees. HUD is proposing this rule to ensure that it can begin to make Section 108 loan guarantee commitments without appropriated subsidy. The Department of Housing and Urban Development Appropriations Act, 2014, authorizes HUD to collect fees from borrowers for this program. In anticipation of further appropriations acts authorizing the collection of fees for Section 108 loan guarantees, HUD proposes to add a new section to its current regulations to reflect that when appropriations for credit subsidy costs as authorized by Congress are either not available or insufficient and HUD has statutory authority to collect fees, HUD will impose a fee on Section 108 Program borrowers and explain the basis for the fee imposed. The proposed new regulatory section would provide for HUD to set the fee by notice. Elsewhere in today's Federal Register, HUD is publishing the notice that would propose the fee to be established for the fiscal year 2015, subject to statutory authorization.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Signature Brands, LLC, proposing that the color additive regulations be amended to provide for the safe use of mica-based pearlescent pigments in egg decorating kits for coloring shell eggs.

The Environmental Protection Agency (EPA) is taking final action to approve State Implementation Plan (SIP) revisions submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR) on January 31, 2008, May 24, 2010, October 11, 2013, and February 11, 2014, pertaining to state rule changes to the North Carolina Inspection and Maintenance (I/M) program. Specifically, these SIP revisions update the North Carolina I/ M program as well as repeal one rule that is included in the federally- approved SIP. In this final rulemaking, EPA is also responding to comments received on the proposed approval.

The U.S. Small Business Administration (SBA or Agency) is proposing to amend its regulations to implement provisions of the Small Business Jobs Act of 2010 and the National Defense Authorization Act for Fiscal Year 2013. Based on authorities provided in these two statutes, the proposed rule would establish a Government-wide mentor- prot[eacute]g[eacute] program for all small business concerns, consistent with SBA's mentor-prot[eacute]g[eacute] program for Participants in SBA's 8(a) Business Development (BD) program. The proposed rule would also make minor changes to the mentor- prot[eacute]g[eacute] provisions for the 8(a) Business Development program in order to make the mentor-prot[eacute]g[eacute] rules for each of the programs as consistent as possible. The proposed rule would amend the current joint venture provisions to clarify the conditions for creating and operating joint venture partnerships, including the effect of such partnerships on any mentor-prot[eacute]g[eacute] relationships. Finally, the proposed rule would make several additional changes to current size, 8(a) Office of Hearings and Appeals or HUBZone regulations, concerning among other things, ownership and control, changes in primary industry, standards of review and interested party status for some appeals.

The Fulton Terminals Superfund site (Site), located in the City of Fulton, Oswego County, New York, consists of an ``On-Property'' portion, an approximately 1.5-acre parcel of land bounded on the west by First Street, on the south by Shaw Street, on the east by New York State Route 481, and on the north by a warehouse, and an ``Off- Property'' portion, defined by the area between the On-Property portion's western property boundary to the Oswego River (approximately 50 feet). The Environmental Protection Agency (EPA) Region 2, is publishing this direct final Notice of Partial Deletion (NOPD) of the On-Property portion of the Site from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final partial deletion is being published by EPA with the concurrence of the State of New York, through the New York State Department of Environmental Conservation (NYSDEC), because EPA has determined that all appropriate response actions under CERCLA have been completed at the On-Property portion of the Site and that the soil on the On-Property portion of the Site and the groundwater beneath the On-Property portion of the Site no longer pose a threat to public health or the environment. The NOPD pertains to the On-Property portion of the Site. The Off-Property portion of the Site will remain on the NPL. Because residual groundwater contamination remains in the Off-Property portion of the Site, groundwater monitoring and five-year reviews will still be required for this area. The partial deletion does not preclude future actions under Superfund.

The U.S. Department of Energy (DOE) proposes to amend the test procedure proposals presented in a notice of proposed rulemaking (NOPR), published on May 21, 2014. The proposed revisions include modifications to the whole-home dehumidifier test setup and conduct, and revisions to the measurement of energy use in fan-only operation first proposed in the May 2014 NOPR. DOE also introduces a methodology to determine whole-home dehumidifier case volume, clarifies the equations used to calculate corrected relative humidity and capacity for portable and whole-home dehumidifiers, and provides additional technical corrections and clarifications. The additional proposals are to be combined with the initial proposals from May 2014.

This regulation establishes, amends, and removes tolerances for residues of flutriafol in or on multiple commodities which are identified and discussed later in this document. Cheminova A/S c/o Cheminova, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

On October 21, 2014, the U.S. Department of Energy (DOE) published a notice of proposed determination (NOPD) regarding energy conservation standards for high-intensity discharge (HID) lamps in the Federal Register. This notice tentatively determined that potential standards for three subcategories of HID lamps are either not technologically feasible or not economically justified. On December 22, 2014, DOE received a joint comment from the Appliance Standards Awareness Project (ASAP), Northwest Energy Efficiency Alliance (NEEA), the American Council for an Energy-Efficient Economy (ACEEE), and the Natural Resources Defense Council (NRDC) (Joint Comment), opposing DOE's proposed determination. This document announces a reopening of the public comment period for submitting comments and data in response to the Joint Comment. The comment period is extended to March 6, 2015.

This rule updates the list of institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2014, and ending September 30, 2015.

NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 meters (m)) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2015 Pacific cod total allowable catch allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.

We propose to supersede airworthiness directive (AD) 2014-19- 05 that applies to all Turbomeca S.A. Arriel 1A1, 1A2, 1B, 1C, 1C1, 1C2, 1D, 1D1, 1E2, 1K1, 1S, 1S1, 2B, 2B1, 2C, 2C1, 2C2, 2S1, and 2S2 turboshaft engines. AD 2014-19-05 requires an initial one-time vibration check of the engine accessory gearbox (AGB) on certain higher risk Arriel 1 and Arriel 2 model engines and repetitive vibration checks for all Arriel 1 and Arriel 2 engines. Since we issued AD 2014- 19-05, we determined that a Technical Instruction (TI) number and a Test Bed Acceptance Test Specifications number in the Actions and Compliance and the Related Information sections are incorrect. This proposed AD would correct these numbers. We are proposing this AD to prevent failure of the engine AGB, which could lead to in-flight shutdown and damage to the engine, which may result in damage to the aircraft.

This regulation establishes an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3- carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10- C16) alkyl ethers, disodium salts when used as an inert ingredient (surfactant) in pesticide formulations applied to growing crops (seed treatment use only) under 40 CFR 180.920 at a concentration not to exceed 0.125% by weight. BASF submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1- oxosulfopropyl)-[omega]-hydroxy-, (C10-C16) alkyl ethers, disodium salts.

In this final rule the Coast Guard is updating our regulations to harmonize U.S. regulations with international conventions regarding oil pollution. We are amending the regulations covering Title 33: Navigation and Navigable Waters to align with recent amendments to Annex I of the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978, which were adopted by the International Maritime Organization's Marine Environment Protection Committee during its 52nd, 54th, 55th, and 59th sessions. This final rule also amends sections of the Vessel Response Plan regulations to include the Safety of Life at Sea Material Safety Data Sheets as an equivalent hazardous communications standard.

The Environmental Protection Agency (EPA) is taking direct final action to amend the National Emission Standards for Hazardous Air Pollutants for Polyvinyl Chloride and Copolymers Production Area Sources. This direct final rule withdraws the total non-vinyl chloride organic hazardous air pollutant (TOHAP) process wastewater emission standards for new and existing polyvinyl chloride and copolymers (PVC) area sources.

The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including commercial warm air furnaces (CWAF). EPCA also requires that every six years, the U.S. Department of Energy (DOE) must consider amending its standards for specified types of commercial heating, air-conditioning, and water-heating equipment in order to determine whether more- stringent, amended standards would be technologically feasible and economically justified, and would save a significant additional amount of energy. DOE has tentatively concluded that there is sufficient record evidence to support more-stringent standards, so DOE is proposing to amend the current energy conservation standards for CWAF. DOE also announces a public meeting to receive comment on these proposed standards and associated analyses and results.

We are adopting a new airworthiness directive (AD) for certain Rolls-Royce Corporation (RRC) AE 2100 series turboprop engines and AE 3007A and 3007C series turbofan engines. This AD was prompted by reports of pitting in the wheel bores and subsequent RRC analysis that concluded that lower life limits are needed for the affected turbine wheels. This AD requires a reduction for the approved life limits of the affected turbine wheels. This AD also requires an eddy current inspection (ECI) of certain RRC engines with affected turbine wheels. We are issuing this AD to prevent uncontained failure of the turbine wheels, damage to the engine, and damage to the airplane.