February 2015 – Federal Register Recent Federal Regulation Documents

On March 18, 2013, NOAA proposed to prohibit the introduction of introduced species into the state waters of Gulf of the Farallones and Monterey Bay national marine sanctuaries (GFNMS and MBNMS, respectively). The proposed prohibition included exceptions for the catch and release of striped bass and for introduced species of shellfish as part of commercial aquaculture activities in the Tomales Bay region of GFNMS (the only geographic area within sanctuaries offshore of California where aquaculture occurs). On March 27, 2014, NOAA amended the proposal to allow GFNMS and MBNMS to consider authorizing the introduction of certain introduced species of shellfish, those considered to be non-invasive, from commercial aquaculture culture projects in all state waters of the sanctuaries. NOAA's final action allows MBNMS to authorize state of California permits or leases for commercial aquaculture projects in state waters involving introduced species of shellfish that a) the state management agencies and NOAA have determined to be non-invasive, and b) will not have significant adverse impacts to sanctuary resources or qualities. For GFNMS, NOAA will not adopt authorization authority for similar projects in state waters at this time and will revert to the proposal from March 2013, which prohibits introduction of introduced species, exempts state permitted commercial shellfish aquaculture activities within Tomales Bay only, and provides an exception for the catch and release of striped bass.

The Albuquerque-Bernalillo County Air Quality Control Board (ABCAQCB) submitted updated regulations for receiving delegation of the Environmental Protection Agency (EPA) authority for implementation and enforcement of New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources). The delegation of authority under this action applies only to sources located in Bernalillo County, New Mexico, and does not extend to sources located in Indian Country. EPA is providing notice that it is updating the delegation of certain NSPS to ABCAQCB, and is taking direct final action to approve the delegation of certain NESHAPs to ABCAQCB.

United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants United States Pharmacopeial Convention registration as an importer of those controlled substances.

Notice is hereby given that the Commonwealth of Puerto Rico is revising its approved Public Water System Supervision Program to adopt the Environmental Protection Agency's (EPA)'s National Primary Drinking Water Regulations for one major rule. The EPA has determined that this revision is no less stringent than the corresponding Federal regulations. Therefore, the EPA intends to approve this program revision. All interested parties may request a public hearing.

An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

FMCSA extends the comment period for its January 23, 2015, notice. This notice shares information on the ``Crash Weighting Analysis'' which informs decision-making about the feasibility of using a motor carrier's role in crashes as an indicator of future crash risk. The January notice advised the public of the availability of the study report for review and comment, and requested feedback on what steps the Agency should take regarding crash and Police Accident Report (PAR) data quality. The Agency extends the deadline for comment from February 23 to March 25, 2015.

The Forest Service intends to prepare an Environmental Impact Statement to analyze the impacts of the proposal to continue to authorize term livestock grazing permit(s) on all or portions of the Weminuche Landscape in a manner that moves resource conditions toward desired on-the-ground conditions and is consistent with Forest Plan standards and guidelines. The Environmental Impact Statement will be prepared pursuant to the National Environmental Policy Act and agency policy. The analysis area encompasses approximately 167,000 acres on six active allotments and seven vacant allotments. The project area is located northeast of Durango, Colorado; from northern Missionary Ridge east through the Weminuche Wilderness to the Pine River; in Townships 36-40 North, Ranges 4-9 West, N.M.P.M., and is within the Columbine Ranger District, San Juan National Forest, Colorado. The proposed action is designed to increase the flexibility of livestock grazing systems through adaptive management, which will allow quicker and more effective response to problem areas when they are revealed. Problems will be revealed through the use of short and long term monitoring. Application of adaptive management practices should result in improved soil, watershed, and vegetative conditions, and healthier wildlife populations.

The Lewis and Clark National Forest (LCNF) is going to prepare an environmental impact statement for vegetation management actions in the Castle Mountains located in Central Montana. The project is designed to meet the desired condition of restoring forest and grasslands ecosystems to promote landscape resiliency over time for multiple resource values while minimizing the threat of high intensity wildfire within the Willow Creek municipal watershed and areas of other valued resources and infrastructure in the 69,610 acre Castle Mountains landscape.

FMCSA announces its decision to exempt 34 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers.

The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each revision collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed for Veterans, Veteran Representatives and health care providers to request reimbursement from the federal government for emergency services at a private institution.

NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2015 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.

The Board is instituting a proceeding to determine the railroad industry's cost of capital for 2014. The decision solicits comments on the following issues: (1) The railroads' 2014 current cost of debt capital; (2) the railroads' 2014 current cost of preferred equity capital (if any); (3) the railroads' 2014 cost of common equity capital; and (4) the 2014 capital structure mix of the railroad industry on a market value basis. Comments should focus on the various cost of capital components listed above using the same methodology followed in Railroad Cost of Capital2013, EP 558 (Sub-No. 17) (STB served July 31, 2014).

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Board of Veterans' Appeals (BVA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506 (c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs (OWCP) is soliciting comments concerning the proposed collection: Request for Earnings Information (LS-426). A copy of the proposed information collection request can be obtained by contacting the office listed below in the address section of this Notice.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' This guidance describes the conditions under which FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility repackages human drug products. When this guidance becomes final, the Agency may also consider withdrawing or revising other guidance documents that address human drug repackaging, including section 446.100 of the Compliance Program Guidance (CPG) Manual, entitled ``Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations,'' which was issued in January 1991, and section 460.100 of the CPG Manual, entitled ``Hospital Pharmacies Status as Drug Manufacturer,'' which was issued in October 1980.