October 1, 2012 – 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information related to emergency use authorizations by the Agency.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a scientific public workshop to solicit information on a variety of issues related to the clinical development of disease-modifying agents for the treatment of peripheral neuropathy. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. FDA intends to take this information into account in developing FDA guidance on clinical development programs for disease-modifying products for the management of peripheral neuropathy. Date and Time: The public workshop will be held on February 11, 2013, from 8:30 a.m. to 5 p.m. and February 12, 2013, from 8:30 a.m. to 2 p.m. Location: The public workshop will be held at FDA White Oak Campus, Building 31, The Great Room (Rm. 1503),White Oak Conference Center, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Entrance for the consultation meeting's participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm Contacts:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.

This notice is being amended to provide for a one hundred thirty (130) day comment period. The original ninety (90) day public comment period provided for in the initial notice is amended in order to allow the election community additional time to comment after the November 2012 Presidential election. As required by Section 222(d) of HAVA, the U.S. Election Assistance Commission (EAC) is publishing for public comment a set of proposed requirements, the Voluntary Voting System Guidelines, Version 1.1. The VVSG provides specifications and standards against which voting systems can be tested to determine if they provide basic functionality, accessibility, and security capabilities.

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm.

The National Urban and Community Forestry Advisory Council will meet on November 15, 2012, at 9:45 a.m. to 2:05 p.m. The meeting will be held in Sacramento California at the Sacramento Convention Center Complex. The purpose of this meeting is to convene for its first meeting of the 2013 fiscal year. The Council will discuss the 2013 grant cycle and process, preparation for the 10 year action plan revisions; work plan action items; communications; and accomplishment/ recommendations report.

This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR Part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.

The Internal Revenue Service (IRS) is requesting applications for membership to serve on the Advisory Committee on Tax Exempt and Government Entities (ACT). Applications will be accepted for the following vacancies, which will occur in June 2013: Two (2) employee plans and two (2) exempt organizations. To ensure appropriate balance of membership, final selection from qualified candidates will be determined based on experience, qualifications, and other expertise. Members of the ACT may not be federally registered lobbyists.

New or modified Base (1% annual-chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or the regulatory floodway (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.

This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR Part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.

The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Coos County, Oregon, and Incorporated Areas.

Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

EPA is taking final action to approve the State Implementation Plan (SIP) submission, submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), as demonstrating that the State meets certain state implementation plan (SIP) requirements of sections 110(a)(1) and (2) of the Clean Air Act (CAA or the Act) for the 1997 annual and 2006 24-hour fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). Section 110(a) of the CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. Alabama certified that the Alabama SIP contains provisions that ensure the 1997 annual and 2006 24-hour PM2 NAAQS are implemented, enforced, and maintained in Alabama (hereafter referred to as ``infrastructure submission''). Alabama's infrastructure submissions, provided to EPA on July 25, 2008, and September 23, 2009, addressed all the required infrastructure elements for the 1997 annual and 2006 24-hour PM2.5 NAAQS with the exception of sections 110(a)(2)(D)(i) and (E)(ii), which will be addressed in separate actions.

EPA is proposing to approve six Permit-by-Rule provisions, a Permit to Install and Operate program, two permanent exemptions from the Permit to Install requirement and a general permit program as additions to Ohio's State Implementation Plan under the Clean Air Act. The Ohio Environmental Protection Agency has requested these rule revisions to make its air pollution permit program more efficient. Approving these additions will make the Permits by Rule, Permits to Install and Operate and general permits federally enforceable. Because these rule revisions will make Ohio's air permit program more efficient while continuing to protect human health and the environment, EPA is taking direct final action to approve the revisions.

The Executive Director of the Joint Board for the Enrollment of Actuaries gives notice of a closed meeting of the Advisory Committee on Actuarial Examinations.