September 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (215) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended to reduce the time to protocol concurrence.

The U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs (OES), Office of Marine Conservation announces that the Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission will meet on October 6, 2011. Dates: The meeting will take place via teleconference on October 6th, 2011, from 2 p.m. to 4 p.m. Eastern time. Meeting Details: The teleconference call-in number is toll-free 1- 888-989-7597, passcode 21898, and will have a limited number of lines for members of the public to access from anywhere in the United States. Callers will hear instructions for using the passcode and joining the call after dialing the toll-free number noted. Members of the public wishing to participate in the teleconference must contact the OES officer in charge as noted in the FOR FURTHER INFORMATION CONTACT section below no later than close of business on Tuesday, October 4th, 2011. For Further Information Contact: John Field, Office of Marine Conservation, OES, Room 2758, U.S. Department of State, 2201 C Street, NW., Washington, DC 20520. Telephone (202) 647-3263, fax (202) 736- 7350, e-mail fieldjd@state.gov. Supplementary Information: In accordance with the requirements of the Federal Advisory Committee Act, notice is given that the Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission (NPAFC) will meet on the date and time noted above. The panel consists of members from the states of Alaska and Washington who represent the broad range fishing and conservation interests in anadromous and ecologically related species in the North Pacific. Certain members also represent relevant state and regional authorities. The panel was established in 1992 to advise the U.S. Section of the NPAFC on research needs and priorities for anadromous species, such as salmon, and ecologically related species occurring in the high seas of the North Pacific Ocean. The upcoming Panel meeting will focus on two major topics: (1) Review of the agenda for the 2011 annual meeting of the NPAFC (October 24-28; Nanaimo, British Columbia, Canada); and (2) logistics for the U.S. Section at the NPAFC meeting. Background material is available from the point of contact noted above and by visiting https://www.npafc.org. This announcement will appear in the Federal Register less than 15 days prior to the meeting. The Department of State finds that there is an exceptional circumstance in that this advisory committee meeting must be held on October 6th in order to adequately prepare for the NPAFC to be convened in Canada beginning October 24th, including the logistics involved in attending the meeting.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), 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 collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on June 24, 2011 [76 FR 37189].

The Railroad Retirement Board (Board) amends its regulations to allow alternative signature methods in addition to the traditional pen-and-ink or ``wet'' signature in order to implement an electronic application process which will eventually eliminate the need to retain paper applications and make the application process more convenient for the individuals filing applications.

The National Institute of Justice (NIJ) and the International Association of Chiefs of Police (IACP) are hosting two workshops in conjunction with the 118th Annual IACP Conference in Chicago, Ill. The focus of the workshops is the development of NIJ performance standards for Interview Room Recording Systems and License Plate Readers used by law enforcement agencies. Sessions are intended to inform manufacturers, test laboratories, certification bodies and other interested parties of these standards development efforts. Attendees in each workshop will be provided with an overview of the NIJ standards development process, work to date on the effort and a projected timeline for completion. Please access the following webpage to register for the Interview Room Video Systems workshop: https://www.surveymonkey.com/s/ interviewroomworkshopreg. Please access the following webpage to register for the License Plate Reader workshop: https://www.surveymonkey.com/s/ALPRworkshop reg.

In a final rule that was published in the Federal Register on January 26, 2010, and effective on February 25, 2010, we amended the phytosanitary treatment regulations by removing the lists of approved treatments and treatment schedules from the regulations, while retaining the general requirements for performing treatments and certifying or approving treatment facilities. The final rule also removed treatment schedules from other places where they had been found in APHIS regulations and provided that approved treatment schedules will instead be found in the Plant Protection and Quarantine Treatment Manual, which is available on the Internet. In the final rule, we neglected to provide for the Administrator of the Animal and Plant Health Inspection Service to approve treatments that are not found in the Treatment Manual, and we did not retain text explaining that irradiation can be used as a substitute for other treatments. In this amendment, we are amending the regulation to provide for such approval of treatments and to restore the text we removed.

We are adopting as a final rule, without change, an interim rule that amended the regulations to add areas in Indiana, Maine, Ohio, Virginia, West Virginia, and Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those areas. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States.

We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the importation into the continental United States of fresh tejocote fruit from Mexico. Based on this analysis, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh tejocote fruit from Mexico. We are making the pest risk analysis available to the public for review and comment.

We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the importation into the continental United States of fresh pomegranate fruit from India. Based on that analysis, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh pomegranate fruit from India. We are making the pest risk analysis available to the public for review and comment.

In accordance with the requirements of Section 122(i)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (CERCLA), 42 U.S.C. 9622(i)(1), notice is hereby given of two Settlement Agreements under Section 122 (h)(1) of CERCLA, 42 U.S.C. 9622 (h)(1), between the United States Environmental Protection Agency (EPA) and Margery Metesh (Settling Party) and Mark Metesh (Settling Party), regarding the Granite Timber Site (Site), located 5 miles south of Philipsburg and 0.5 miles west of Montana Highway 10A in Granite County, Montana. The Settlement Agreements propose to compromise a claim the United States has at this Site for Past Response Costs, as those terms are defined in the Settlement Agreements. Under the terms of the Settlement Agreements, the EPA and the Settling Parties agree that the Settling Parties have no ability to pay and the Settling Parties agree not to assert any claims or causes of action against the United States or its contractors or employees with respect to the Site. Additionally, Margery Metesh (Settling Party) agrees to file a deed record notice concerning a building on a small portion of the Site property. In exchange, the Settling Parties will be granted a covenant not to sue under section 107(a) of CERCLA, 42 U.S.C. 9607(a), with regard to reimbursement of Past Response Costs. Opportunity for Comment: For thirty (30) days following the publication of this notice, the EPA will consider all comments received and may modify or withdraw its consent to that portion of the Settlement Agreement, if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The EPA's response to any comments received will be available for public inspection at the Superfund Record Center, EPA Region 8, 1595 Wynkoop Street, 3rd Floor, in Denver, Colorado.

In this notice, EPA is notifying the public that we have made insignificance findings through the transportation conformity adequacy process, under the Clean Air Act, for directly emitted fine particulate matter (PM2.5) and oxides of nitrogen (NOX) in the Ohio portion of the Huntington/Ashland WV-KY-OH area. Ohio submitted the insignificance findings with the redesignation and maintenance plan submittal on May 4, 2011. As a result of our findings, the Ohio portion of the Huntington/Ashland area is no longer required to perform a regional emissions analysis for either directly emitted PM2.5 or NOX as part of future PM2.5 conformity determinations for the 1997 annual PM2.5 air quality standard.

The Agricultural Marketing Service (AMS) is proposing to update the procedures for cotton futures quality classification services by using Smith-Doxey classification data in the cotton futures classification process. In addition, references to a separate and optional review of cotton futures certification would be eliminated to reflect current industry practices. These proposed changes in procedures for cotton futures quality classification services, as well as proposed conforming changes, reflect advances in cotton fiber quality measurement and data processing made since the regulations were last updated in 1992.

The U.S. Department of Energy (DOE) announces its decision to continue to provide financial support to the Texas Clean Energy Project (TCEP). DOE prepared an Environmental Impact Statement (EIS) (DOE/EIS- 0444) to assess the environmental impacts associated with the TCEP, a project that Summit Texas Clean Energy, LLC (Summit) would design, construct, and operate. The project will demonstrate advanced power systems using integrated gasification combined-cycle (IGCC) technology to generate 400 megawatts (gross) of electric power from coal and will put 130 to 213 megawatts on the power grid while capturing approximately 90 percent of its carbon dioxide (CO2) emissions. The project will sequester approximately 2.5 to 3.0 million tons (2.3 to 2.7 million metric tonnes) of CO2 per year. The CO2 will be delivered through a regional pipeline network to existing oil fields in the Permian Basin of West Texas for use in enhanced oil recovery (EOR) by third-parties. The plant will also produce urea, argon, and sulfuric acid for sale in commercial markets. Because of its multiple products, the facility is referred to as a polygeneration (polygen) plant. The plant will be built on a 600-acre (243-hectare) oil field site in Ector County, Texas, north of the community of Penwell, and will continue in commercial operation for 30 to 50 years. DOE's proposed action, as described in the EIS, is to provide cost- shared financial assistance under DOE's Clean Coal Power Initiative (CCPI) using a combination of American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) funds and other CCPI program funds. After careful consideration of the potential environmental impacts and other factors such as program goals and objectives, DOE has decided to provide, through a cooperative agreement with Summit, $450 million in cost-shared funding, which is approximately 26 percent of the project's total capital cost of $1.73 billion (2009 dollars). The balance of project funding is expected to come from private sector investors and lenders.

We, the Fish and Wildlife Service (Service, USFWS), announce the availability of our revised comprehensive conservation plan (CCP) and finding of no significant impact (FONSI) for the Selawik National Wildlife Refuge (Refuge). In this revised CCP, we describe how we will manage the Refuge for the next 15 years.

This document informs the public that an appeal of the closing of the Clarksville, New York post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.