September 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of its report of scientific and medical literature and information concerning the use of non-standardized allergenic extracts in the diagnosis and treatment of allergic disease. The report is provided in a data file entitled ``Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease.'' FDA is making this report available to provide information and obtain comments from public and private stakeholders. FDA will also seek input on the report from the Allergenic Products Advisory Committee (APAC) at a meeting to be held on October 25, 2011. FDA has not made any regulatory decisions concerning the report or the products discussed in the scientific literature and information cited. FDA will review comments and other information it receives, as part of its continued oversight of regulated products.

The South Atlantic Fishery Management Council (Council) will hold a meeting of its Habitat and Environmental Protection Advisory Panel (AP) in Charleston, SC.

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing two offices and their substructures under the Office of Medical Policy: Office of Prescription Drug Promotion (OPDP) and Office of Medical Policy Initiatives (OMPI). OPDP will consist of the Division of Direct-to-Consumer Promotion and the Division of Professional Promotion. OMPI will consist of the Division of Medical Policy Development and Division of Medical Policy Programs.

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.

Notice is hereby given that the U.S. International Trade Commission (Athe Commission@) has determined to reconsider its decision not to review the final initial determination (AID@) issued by the presiding administrative law judge (AALJ@) on May 20, 2011, in the above-captioned investigation, and, on review, to find no violation of section 337 and terminate the investigation.

This is an amendment of the Presidential declaration of a major disaster for the State of Montana (FEMA-1996-DR), dated 07/26/ 2011. Incident: Severe Storms and Flooding. Incident Period: 04/03/2011 through 07/22/2011. Effective Date: 09/19/2011. Physical Loan Application Deadline Date: 10/11/2011. EIDL Loan Application Deadline Date: 04/26/2012.

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

This document informs the public that an appeal of the closing of the Ellisburg, 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, petitioner, and others to take appropriate action.

This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4029-DR), dated 09/09/2011. Incident: Wildfires. Incident Period: 08/30/2011 and continuing. Effective Date: 09/16/2011. Physical Loan Application Deadline Date: 11/08/2011. EIDL Loan Application Deadline Date: 06/06/2012.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Vermont (FEMA-4022-DR), dated 09/01/2011. Incident: Tropical Storm Irene. Incident Period: 08/27/2011 through 09/02/2011. Effective Date: 09/16/2011. Physical Loan Application Deadline Date: 10/31/2011. Economic Injury (EIDL) Loan Application Deadline Date: 06/01/2012.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Jersey (FEMA- 4033-DR), dated 09/15/2011. Incident: Severe Storms and Flooding. Incident Period: 08/13/2011 through 08/15/2011. Effective Date: 09/15/2011. Physical Loan Application Deadline Date: 11/14/2011. Economic Injury (EIDL) Loan Application Deadline Date: 06/15/2012.

EPA is taking direct final action to approve revisions to the Maryland State Implementation Plan (SIP). The revisions establish transportation conformity regulations for the State of Maryland. EPA is approving these revisions in accordance with the requirements of the Clean Air Act (CAA).

EPA is approving a State Implementation Plan (SIP) revision submitted by the State of North Carolina for the purpose of establishing system-wide emission limitations from the North Carolina Clean Smokestacks Act (CSA) into the North Carolina SIP. On August 21, 2009, the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), submitted an attainment demonstration for the Hickory-Morganton-Lenoir and Greensboro-Winston Salem-High Point 1997 fine particulate matter (PM2.5) nonattainment area. That submittal included a request that the system-wide emission limitations from the North Carolina CSA be incorporated into the State's federally approved SIP. EPA has determined that the CSA portion of this SIP revision is approvable pursuant to the Clean Air Act (CAA or Act).