November 21, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile. Bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations. Date and Time:The public hearing will be held on December 12 and 13, 2012, from 9 a.m. to 4 p.m. The meeting may be extended or may end early, depending on the level of public participation. Location: The public hearing will be held at the DoubleTree by Hilton Hotel Washington, DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD 20910. Contact Person: Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-3441, FAX: 301- 847-8753, email: AntisepticPreOpPublicMeeting@fda.hhs.gov. Registration: The public hearing is free, and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. If you need special accommodations due to disability, please contact Lee Lemley (see Contact Person) at least 7 days in advance. Requests for Oral Presentations: If you wish to make an oral presentation during the hearing, you must register by submitting a written or electronic request by close of business on November 27, 2012, to Lee Lemley (see Contact Person). Provide your name, title, business affiliation (if applicable), address, telephone and fax numbers, email address, and type of organization you represent (e.g., pharmaceutical company or consumer organization). You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation. We encourage individuals and organizations with common interests to consolidate or coordinate their presentations to allow adequate time for each request for presentation. Persons registered to make an oral presentation should check in before the hearing. Participants should submit a copy of each presentation to Lee Lemley (see Contact Person) no later than December 7, 2012. We will file the hearing schedule, indicating the order of presentation and the time allotted to each person, with the Division of Dockets Management (see Comments). We will mail, email, or telephone the schedule to each participant before the hearing. In anticipation of the hearing presentations moving ahead of schedule, participants are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called risk forfeiting their scheduled time. Comments: Interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to https:// www.regulations.gov. Comments will be accepted after the hearing until February 12, 2013. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management. You should annotate and organize your comments to identify the specific questions identified by the topic to which they refer. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

Pursuant to the Marine Mammal Protection Act (MMPA) as amended, NMFS provides notice that we have issued an Incidental Harassment Authorization (IHA) to the Washington State Department of Transportation Ferries Division (WDF) to incidentally harass, by Level B harassment only, 11 species of marine mammals during the transfer span replacement project at the Port Townsend ferry terminal in Port Townsend Bay, Washington.

Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the National Aeronautics and Space Administration is issuing public notice of its intention to revise a previously noticed system of records Earth Observing System Data and Information System (EOSDIS) User Information/GSFC 51EUI. This notice publishes updates of this system of records as set forth below under the caption SUPPLEMENTARY INFORMATION.

The state of Colorado has applied to the EPA for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). The EPA proposes to grant final authorization to the hazardous waste program changes submitted by the state of Colorado. In the ``Rules and Regulations'' section of this Federal Register, the EPA is authorizing the changes in a final rule. The EPA did not propose the rule prior to issuing the final rule because the Agency believes this action is not controversial and does not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the final rule. Unless we receive written comments that oppose this authorization during the comment period, the final rule will become effective on the date it establishes, and the EPA will not take further action on this proposal. If the Agency receives comments that oppose this action, the EPA will publish a document in the Federal Register withdrawing this rule before it takes effect. The EPA will then address public comments in a later, final rule, based on this proposal. Any parties interested in commenting on this action must do so at this time. The EPA may not provide further opportunity for comment.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

The Environmental Protection Agency (EPA) will begin to accept requests, from December 1, 2012 through January 31, 2013, for grants to supplement State and Tribal Response Programs. This notice provides guidance on eligibility for funding, use of funding, grant mechanisms and process for awarding funding, the allocation system for distribution of funding, and terms and reporting under these grants. EPA has consulted with state and tribal officials in developing this guidance. The primary goal of this funding is to ensure that state and tribal response programs include, or are taking reasonable steps to include, certain elements and a public record. Another goal is to provide funding for other activities that increase the number of response actions conducted or overseen by a state or tribal response program. This funding is not intended to supplant current state or tribal funding for their response programs. Instead, it is to supplement their funding to increase their response capacity. For fiscal year 2013, EPA will consider funding requests up to a maximum of $1.1 million per state or tribe. Subject to the availability of funds, EPA regional personnel will be available to provide technical assistance to states and tribes as they apply for and carry out these grants.

The Advisory Committee on Historical Diplomatic Documentation's meeting location on December 10-11, 2012 has changed from that provided in the previous Federal Register Notice at 77 FR 5292, February 2, 2012. The new location will be at the National Archives in College Park, MD on December 10, 2012; and in room 1205 of the Harry S. Truman building of Main State on December 11, 2012. The Committee's sessions in the morning and afternoon of Monday, December 10, 2012 will be closed in accordance with Section 10(d) of the Federal Advisory Committee Act (Pub. L. 92-463). The agenda calls for discussions of agency declassification decisions concerning the Foreign Relations series and other declassification issues. These are matters properly classified and not subject to public disclosure under 5 U.S.C. 552b(c)(1) and the public interest requires that such activities be withheld from disclosure. The Committee will meet in open session from 11:00 a.m. until 12:00 noon on Tuesday, December 11, 2012, in the Department of State, 2201 ``C'' Street NW., Washington, DC, in Conference Room 1205, to discuss declassification and transfer of Department of State records to the National Archives and Records Administration and the status of the Foreign Relations series. Prior notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or military ID) are required for entrance into the building. Members of the public planning to attend the meeting on December 11, 2012, RSVP to Colby Prevost, Office of the Historian (202-663-1147) no later than December 6, 2012. When responding, please provide date of birth, valid government-issued photo identification number and type (such as driver's license number/ state, passport number/country, or U.S. government ID number/agency or military ID number/branch), and relevant telephone numbers. If you cannot provide one of the specified forms of ID, please consult with Colby Prevost for acceptable alternative forms of picture identification. In addition, any requests for reasonable accommodation should be made no later than December 4 for the December 11th meeting. Requests for reasonable accommodation received after those dates will be considered, but might be impossible to fulfill. Personal data is requested pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and Executive Order 13356. The purpose of the collection is to validate the identity of individuals who enter Department facilities. The data will be entered into the Visitor Access Control System (VACS-D) database. Please see the Security Records System of Records Notice (State-36) at https://www.state.gov/documents/ organization/103419.pdf, for additional information. Questions concerning the meeting should be directed to Stephen P. Randolph, Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State, Office of the Historian, Washington, DC 20520, telephone (202) 663-1123, (email history@state.gov).

In accordance with the Paperwork Reduction of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

This notice sets forth the schedule and proposed agenda for the upcoming meeting of the National Assessment Governing Board (Board) and also describes the specific functions of the Board. Notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act. This notice is issued to provide members of the general public with an opportunity to attend and/or provide comments. Individuals who will need special accommodations in order to attend the meeting (e.g. interpreting services, assistive listening devices, materials in alternative format) should notify Munira Mwalimu at 202- 357-6938 or at Munira.Mwalimu@ed.gov no later than November 19, 2012. We will attempt to meet requests after this date but cannot guarantee availability of the requested accommodation. The meeting site is accessible to individuals with disabilities.

The President's Advisory Council on Financial Capability (``Council'') will convene for an open meeting on November 28, 2012, at the Department of Treasury, 1500 Pennsylvania Avenue NW., Washington DC, beginning at 8:00 a.m. Eastern Time. The meeting will be open to the public. The Council will: (1) Receive reports from the Council's subcommittees (Underserved and Community Empowerment, Research and Evaluation, Partnerships, and Youth) on their progress; (2) discuss recommendations made by the subcommittees and (3) receive a status report on the implementation of the previous recommendations of the Council.

On May 3, 2012, and consistent with the Paperwork Reduction Act of 1995 (PRA), HUD published for public comment, for a period of 60 days, a notice advising that HUD was updating and revising a set of production, underwriting, asset management, closing, and other documents used in connection with transactions involving healthcare facilities, excluding hospitals, that are insured pursuant to section 232 of the National Housing Act (Section 232). These documents are referred to collectively as the healthcare facility documents. The 60- day notice published on May 3, 2012, together with a companion proposed rule published on that same date, started the process of updating the healthcare facility documents and the Section 232 program regulations. This 30-day notice published today continues the process required by the PRA. With the issuance of this notice, HUD will submit the information collection for the closing documents to the Office of Management and Budget (OMB) for review and approval, and assignment of OMB control numbers. In accordance with the PRA, the closing documents will undergo the public comment process every three years to retain OMB approval.

In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval. On May 17, 2012, FMCSA published a Federal Register notice allowing for a 60-day comment period on the ICR. The agency received no comments in response to this notice.

On August 3, 2012, the Department of Commerce (``the Department'') published in the Federal Register its preliminary results of administrative review of the countervailing duty order on certain pasta from Turkey for the period January 1, 2010, through December 31, 2010. We received no comments on those preliminary results and we continue to determine that Marsan Gida Sanayi ve Ticaret A.[Scedil]. (``Marsan''), Birlik Pazarlama Sanayi ve Ticaret A.[Scedil]. (``Birlik''), and Bellini Gida Sanayi A.[Scedil]. (``Bellini'') received de minimis countervailable subsidies during the period of review.\1\

FRA is issuing this Notice to advise the public that a Draft Tier 1 Environmental Impact Statement (Tier 1 EIS) has been prepared for the Chicago to Omaha Regional Passenger Rail System Planning Study (Study). The Tier 1 EIS was prepared pursuant to the National Environmental Policy Act of 1969 (NEPA); FRA's Procedures for Considering Environmental Impacts (Environmental Procedures); and guidelines published by the Council on Environmental Quality (CEQ) on implementing NEPA. The Study includes both a Tier 1 EIS and a Service Development Plan. FRA is the lead federal agency and the Iowa Department of Transportation (Iowa DOT) is the joint-lead state agency for the environmental review process. For passenger rail projects, this Tier 1 EIS focuses on broad corridor and service level issues, while subsequent Tier 2 analyses will focus on the details of a specific project or action. Iowa DOT proposes to establish high-speed passenger rail service between Chicago, Illinois, through Iowa, to Omaha, Nebraska. The proposed project would provide an alternative to automobile, bus, and air travel by decreasing travel times, increasing frequency of service, improving reliability (particularly in inclement weather), providing an efficient transportation option, and providing amenities to improve passenger ride quality and comfort. The project would also promote environmental benefits, including reduced air pollutant emissions, improved land use options, and fewer adverse impacts to the surrounding habitat and water resources. The Tier 1 EIS presents the proposed project's purpose and need, identifies reasonable alternatives, describes the affected environment, and analyzes the potential environmental impacts of the alternatives considered, including the no-build alternative.