December 30, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling requirements for blood and blood components, including Source Plasma. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a system for labeling blood and blood components, and the use of new labeling systems that may be developed in the future. Additionally, these requirements are issued to help ensure the continued safety of the blood supply and facilitate consistency in labeling.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing for public comment draft regulatory guide (DG), DG-1274, ``Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Postaccident Engineered-Safety-Feature Atmosphere Cleanup Systems in Light-Water-Cooled Nuclear Power Plants.'' This guide applies to the design, inspection, and testing of air filtration and iodine adsorption units of engineered-safety-feature (ESF) atmosphere cleanup systems in light-water-cooled nuclear power plants.

The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities and deletes a service previously provided by such agency. Comments Must Be Received On or Before: 1/30/2012.

In July 2011, NOAA and the Department of the Interior (DOI) invited federal, state, commonwealth, and territorial marine protected area (MPA) programs with potentially eligible existing MPAs to nominate their sites to the National System of MPAs (national system). The national system and the nomination process are described in the Framework for the National System of Marine Protected Areas of the United States (Framework), developed in response to Executive Order 13158 on Marine Protected Areas. The final Framework was published on November 19, 2008, (73 FR 69608) and provides guidance for collaborative efforts among federal, state, commonwealth, territorial, tribal and local governments and stakeholders to develop an effective and well coordinated national system of MPAs that includes existing MPAs meeting national system criteria as well as new sites that may be established by managing agencies to fill key conservation gaps in important ocean areas.

The Department of the Interior, through the Bureau of Reclamation and the National Park Service, is extending the public scoping period for the Draft Environmental Impact Statement (EIS) for Adoption of a Long-term Experimental and Management Plan (LTEMP) for the Operation of Glen Canyon Dam to January 31, 2012. The Notice to Solicit Comments and Hold Public Scoping Meetings was published in the Federal Register on October 17, 2011 (76 FR 64104). The public scoping period was originally scheduled to end on Friday, December 30, 2011.

We propose to supersede an existing airworthiness directive (AD), for all International Aero Engines AG (IAE) V2500-A1, V2525-D5 and V2528-D5 turbofan engines, and certain serial numbers (S/Ns) of IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines. The existing AD currently requires initial and repetitive on-wing ultrasonic inspections (USIs) of certain high- pressure compressor (HPC) stage 3 to 8 drums, and replacement of drum attachment nuts. This proposed AD would expand the affected population for initial and repetitive on-wing inspections of the HPC stage 3 to 8 drum, introduce an eddy current inspection (ECI) procedure, and require additional cleaning and repetitive on-wing USI or ECI of some HPC stage 3 to 8 drums. We are proposing this AD to prevent failure of the HPC stage 3 to 8 drum, uncontained engine failure, and damage to the airplane.

As required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3519 (PRA), the Surface Transportation Board (STB or Board) gives notice that it has submitted a request to the Office of Management and Budget (OMB) for an extension of approval with revision of a currently approved collection: Application to Open a Billing Account. The revision consists of a reduction in burden hours due to the agency's revised estimate of the number of annual respondents. The Board previously published a notice about this collection in the Federal Register on September 30, 2011, at 76 FR 60,964. That notice allowed for a 60-day public review and comment period. No comments were received. The application to open a billing account is described in detail below. Comments may now be submitted to OMB concerning: (1) The accuracy of the Board's burden estimates; (2) ways to enhance the quality, utility, and clarity of the information collected; (3) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate; and (4) whether this collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility.

The Department of Labor (we or the Department), as a result of Congressional appropriations language, recently delayed the effective date of the Wage Methodology for Temporary Non-agricultural Employment H-2B Program Final Rule (the Wage Rule) to January 1, 2012. This Notice provides additional guidance to those employers who have received from the Department either a supplemental or dual prevailing wage determinations based on a previous effective date of the new prevailing wage methodology. This guidance provides additional clarification regarding the wage payment requirements for employers participating in the H-2B Temporary Non-agricultural program.

The Department of Labor (Department) is delaying the effective date of the Wage Methodology for the Temporary Non-agricultural Employment H-2B Program (the Wage Rule) to October 1, 2012 in response to recently enacted legislation that prohibits any funds from being used to implement the Wage Rule for the remainder of fiscal year (FY) 2012. The Wage Rule revised the methodology by which we calculate 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.

NMFS issues this final rule to implement Amendment 6 to the Fishery Management Plan (FMP) for the Reef Fish Fishery of Puerto Rico and the U.S. Virgin Islands (Reef Fish FMP), Amendment 5 to the FMP for the Spiny Lobster Fishery of Puerto Rico and the U.S. Virgin Islands (Spiny Lobster FMP), Amendment 3 to the FMP for the Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands (Queen Conch FMP), and Amendment 3 to the FMP for Corals and Reef Associated Plants and Invertebrates of Puerto Rico and the U.S. Virgin Islands (Corals and Reef Associated Plants and Invertebrates FMP). In combination, the amendments represent the 2011 Caribbean ACL Amendment prepared by the Caribbean Fishery Management Council (Council). This final rule will: Establish annual catch limits (ACLs) and accountability measures (AMs) for reef fish, spiny lobster, and aquarium trade species which are not determined to be undergoing overfishing; allocate ACLs among island management areas; establish recreational bag limits for reef fish and spiny lobster; remove eight conch species from the Queen Conch FMP; and establish framework procedures for the Spiny Lobster and Corals and Reef Associated Plants and Invertebrates FMPs. The 2011 Caribbean ACL Amendment will also revise management reference points and status determination criteria for selected reef fish, spiny lobster, and aquarium trade species. The intended effect of the rule is to prevent overfishing of reef fish, spiny lobster, and aquarium trade species while maintaining catch levels consistent with achieving optimum yield (OY).

NMFS issues this final rule to implement Amendment 2 to the Fishery Management Plan for Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands, and Amendment 5 to the Fishery Management Plan for the Reef Fish Fishery of Puerto Rico and the U.S. Virgin Islands (Amendments 2 and 5), prepared by the Caribbean Fishery Management Council (Council). This final rule: Establishes annual catch limits (ACLs) and accountability measures (AMs) for queen conch and for all reef fish units or sub-units that are classified as undergoing overfishing (i.e., snapper, grouper and parrotfish); allocates ACLs among island management areas; revises the composition of the snapper and grouper complexes; prohibits fishing for and possession of three parrotfish species; establishes recreational bag limits for snappers, groupers, and parrotfishes; and establishes framework procedures for the queen conch and reef fish fishery management plans. Amendments 2 and 5 also revise management reference points and status determination criteria. The intended effect of the rule is to prevent overfishing of queen conch and reef fish species while maintaining catch levels consistent with achieving optimum yield (OY).

This regulation establishes tolerances for residues of difenoconazole in or on oat and rye commodities, and wheat, hay. Syngenta Crop Protection, Incorporated requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This regulation establishes tolerances for residues of tepraloxydim in or on the imported commodities ``Pea and bean, dried shelled, except soybean, subgroup 6C'' and ``Sunflower subgroup 20B''. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also removes established tolerances for residues of tepraloxydim on ``Lentil, seed'' and ``Pea, dry, seed,'' as residues on these commodities will be covered by the new tolerance on the pea and bean subgroup (6C).

This action amends two VHF Omnidirectional Range (VOR) Federal airways in Alaska, V-320 and V-440, due to the relocation of the Anchorage VOR navigation aid. The FAA is taking this action to ensure the continued safe and efficient management of Instrument Flight Rules (IFR) operations within the National Airspace System.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

The Department of Veterans Affairs (VA) proposes to amend its regulations in part 17 to establish a new program to provide grants to eligible entities to assist veterans in highly rural areas through innovative transportation services to travel to VA medical centers, and to otherwise assist in providing transportation services in connection with the provision of VA medical care to these veterans. This rulemaking is necessary to implement new statutory authority by establishing procedures for evaluating grant applications under the new grant program, and otherwise administering the new grant program. This proposed rule would implement section 307 of title III of the Caregivers and Veterans Omnibus Health Services Act of 2010 (the 2010 Act).

This interim final rule implements a possession limit and increases the minimum fish size for haddock caught in the Gulf of Maine by recreational anglers aboard private or charter/party vessels. This action is intended to address an overage of the fishing year 2010 GOM haddock sub-annual catch limit by the recreational fishery, and prevent a similar overage from occurring in the future. NMFS implements this interim final rule pursuant to its authority under the Magnuson-Stevens Fishery Conservation and Management Act and the Northeast Multispecies Fishery Management Plan and its implementing regulations.

NMFS issues this final rule to implement the Comprehensive Ecosystem-Based Amendment 2 (CE-BA 2) to implement the following South Atlantic fishery management plan (FMP) amendments: Amendment 1 to the FMP for Pelagic Sargassum Habitat of the South Atlantic Region (Sargassum FMP); Amendment 7 to the FMP for Coral, Coral reefs, and Live/Hard Bottom Habitats of the South Atlantic Region (Coral FMP); and Amendment 25 to the FMP for the Snapper-Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council); as well as Amendment 21 to the FMP for Coastal Migratory Pelagic (CMP) Resources (CMP FMP) as prepared and submitted by the South Atlantic and Gulf of Mexico Fishery Management Councils. This rule modifies the fishery management unit (FMU) for octocorals in the South Atlantic exclusive economic zone (EEZ), establishes an annual catch limit (ACL) for octocorals, modifies management in special management zones (SMZs) off South Carolina, and modifies sea turtle and smalltooth sawfish release gear specifications in the South Atlantic region. CE-BA 2 also designates new Essential Fish Habitat (EFH) for Sargassum, and EFH- Habitat Areas of Particular Concern (EFH-HAPCs) for the Snapper- Grouper, Coral FMPs. This rule specifies ACLs for species not undergoing overfishing (octocorals), implements management measures to ensure overfishing does not occur for these species but optimum yield may be achieved, and conserves and protects habitat in the South Atlantic region.