November 2008 – Federal Register Recent Federal Regulation Documents

Following the two recent Buy America rulemakings pursuant to the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), the Federal Transit Administration (FTA) received a petition for reconsideration of the treatment of bi-metallic composite conducting rail as a steel product that must be manufactured in the United States. At present, FTA's Buy America regulation treats both running rail and contact rail as a steel or iron product which must be manufactured entirely in the United States. During the recent rulemakings, several commenters proposed that bi-metallic rail be instead categorized as ``traction power equipment.'' If adopted, the proposal would have changed the regulatory treatment of contact rail based on the rail's composition. As traction power equipment, bi-metallic rail would have been subject to a lower 60 percent domestic content requirement, in contrast to running rail made of steel and iron, which must contain 100 percent domestic content. In addition, as traction power equipment, bi- metallic rail would be subject only to ``final assembly'' in the United States, which may be a less rigorous process than the manufacturing process required for other forms of power rail, including steel and iron. Because FTA believed adopting the proposal in the Final Rule would have altered the regulatory environment for affected parties who may have been unaware of the proposal, including manufacturers of steel and iron contact rail, without subjecting the issue to full notice-and- comment from all affected parties, FTA declined to adopt the proposal, instead deferring action to this separate rulemaking. Through this Notice of Proposed Rulemaking (NRPM), FTA proposes to amend its Buy America regulations to re-categorize bi-metallic composite conducting rail as ``traction power equipment'' which need only consist of 60 percent domestic content, with final assembly taking place in the United States.

This interim final rule with comment period makes technical changes to the existing methodology and process used to compute and issue each State's preliminary and final allotments available to pay the Medicare Part B premiums for qualifying individuals (QIs). The technical revisions conform the existing regulations to reflect continued funding of this program. Additionally, this rule contains charts providing the States' final QI allotments for the Federal fiscal year (FY) 2008 and preliminary QI allotments for FY 2009, determined in accordance with the methodology set forth in the October 2006 final rule, and reflecting funding for the QI program made available under recent legislation.

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The collection of the requested information requires that the sites for HUD insured structures must be free of termite hazards. Builders certify and guarantee that all required treatment for termites are performed and there is no infestation of treated areas for a year. Also, pest control companies are required to provide a record of any soil treatment methods used to prevent subterranean termite infestation. The respondents for this collection are builders, pest control companies, mortgage lenders and home buyers.

The Secretary of the Interior proposes to withdraw 40 acres of public land from surface entry and mining on behalf of the Bureau of Land Management to protect the Parting of the Ways Historic Site in Sweetwater County. This notice segregates the land for up to 2 years from surface entry and mining while various studies and analyses are made to support a final decision on the withdrawal application. The land will remain open to the mineral leasing laws.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. George Kindness from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Kindness was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kindness failed to request a hearing. Mr. Kindness's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on September 8, 2008, pages 52052-52053 and allowed 60 days for public comment. The National Institutes of Health received one comment that was determined to be not relevant to the specific questions stated in the notice. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, the collection of information that has been extended, revised, or implemented unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Diabetes Educations Program Comprehensive Evaluation Plan. Type of Information Collection Request: Extension of a currently approved collection (0925- 0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to improve the treatment and health outcomes of people with diabetes, to promote early diagnosis, and, ultimately, to prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families and the public. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759, Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital Costs, Operating or Maintenance Costs to report.

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has initiated a strategic planning process that will culminate in the ODS Strategic Plan for 2010-2014. To assist with this process, the ODS requests input from research communities academic, government, and industryand from other interested parties. The overall purpose of the strategic planning effort is to identify both new opportunities and emerging needs for incorporation in the programmatic efforts of the Office. A background paper has been prepared, A Report to the Public, that summarizes progress in four key areas of ODS activity. The background paper and related information are available on the ODS Web site at https://ods.od.nih.gov/strategicplan. Public comment can be sent directly to ODS or through the public Webinars ODS will hold on January 29, 2009, February 3, 2009, February 11, 2009, and February 19, 2009. The section on Public Participation (below) gives details for the Webinars.

DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to update references and the list of Army contracting activities.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through February 28, 2009. DoD proposes that OMB extend its approval for use for three additional years.

DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update the list of ``least developed'' countries that are designated as eligible countries under the Trade Agreements Act, in accordance with direction from the United States Trade Representative.

DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update requirements for reporting of Government property in the possession of DoD contractors. The rule replaces DD Form 1662 reporting requirements with requirements for DoD contractors to electronically submit, to the Item Unique Identification (IUID) Registry, the IUID data applicable to the Government property in the contractor's possession.

The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

EPA is taking direct final action to approve the State Implementation Plan (SIP) revision submitted by the State of Tennessee on October 12, 2007. The revision pertains to the Knox County portion of the Tennessee SIP and includes changes to Knox County Air Quality Management Regulation (Knox County Regulation) Section 25.10Permit by Rule. Specifically, Section 25.10 was changed so that it clearly states that turbines and other internal combustion engines are excluded from the ``Permit by Rule'' provision. This revision is considered by the Tennessee Department of Environment and Conservation (TDEC), to be as or more stringent than the State of Tennessee's SIP requirements. This action is being taken pursuant to section 110 of the Clean Air Act (CAA).