December 5, 2007 – Federal Register Recent Federal Regulation Documents

We are advising the public that we are making available for review and comment a revised version of the National Animal Identification System (NAIS) Program Standards and Technical Reference document. A previous Program Standards document was originally made available in May 2005. The revised Program Standards and Technical Reference document reflects the continuing evolution of the NAIS, particularly with regard to identification devices available for official use within the system, and provides further guidance to NAIS participants and other interested stakeholders.

The National Labor Relations Board (NLRB) is amending regulations concerning the procedures for filing an appeal to adverse FOIA determinations. The revisions require that appeals be filed within 28 calendar days of the service of the notification of the adverse determination.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on September 12, 2007, page 52155, and allowed 60 days for public comment. One comment was received. 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, any information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Cardiovascular Health Study. Type of Information Request: Reinstatement (OMB No. 0925-0334). Need and Use of Information Collection: This study quantifies associations between conventional and hypothetical risk factors and coronary heart disease (CHD) and stroke in people age 65 years and older. The primary objectives include quantifying associations of risk factors with subclinical disease; characterizing the natural history of CHD and stroke; and identifying factors associated with clinical course. The findings provide important information on cardiovascular disease in an older U.S. population and lead to early treatment of risk factors associated with disease and identification of factors that may be important in disease prevention. OBM clearance is being sought for data collection activities at only one of the four CHS field centers (the Pittsburgh field center), which are expected to end on May 31, 2008. Other data collection efforts in the CHS cohort are supported by various non-contract funding sources. Frequency of response: Twice a year (participants) or once per cardiovascular disease event (proxies); Affected public: Individuals. Types of Respondents: Individuals recruited for CHS and their selected proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 467; Estimated Number of Responses per Respondent: 1.2; and Estimated Total Annual Burden Hours Requested: 281. The annualized cost to respondents is estimated at: $5,225. There are no capital, operating, or maintenance costs to report.

Due to the receipt of an adverse comment, the EPA is withdrawing the October 16, 2007 (72 FR 58546), direct final rule approving the State of Ohio's September 26, 2007, request to revise the Ohio State Implementation Plan (SIP) by incorporating provisions related to the implementation of EPA's Clean Air Interstate Rule (CAIR). In the direct final rule, EPA stated that if adverse comments were submitted by November 15, 2007, the rule would be withdrawn and not take effect. On November 9, 2007, EPA received a comment. EPA believes this comment is adverse and, therefore, EPA is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 16, 2007 (72 FR 58571). EPA will not institute a second comment period on this action.

EPA is proposing to approve State Implementation Plan (SIP) revisions to the sulfur dioxide (SO2) requirements for Northern States Power Company, doing business as Xcel Energy, Inver Hills Generating Plant (Inver Hills), located in Inver Grove Heights, Dakota County, Minnesota. The revisions make the limits of the sulfur content in its fuel and its sulfur dioxide emissions more stringent, and prohibit the burning of residual fuel oil. The revisions allow the facility to use simpler methods to analyze the sulfur content of its fuel. Because the sulfur dioxide emission limits are being reduced, the air quality of Dakota County will be protected.

EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia. This revision consists of amendments to extend the geographic applicability of four consumer and commercial product regulationsPortable Fuel Container Spillage, Mobile Equipment Repair and Refinishing Operations, Architectural and Industrial Maintenance Coatings, and Consumer Productsto the Fredericksburg VOC Emissions Control Area. These amendments are necessary to implement VOC contingency measures within the Fredericksburg Area. The revision also incorporates by reference two additional test methods and procedures needed for Virginia's Architectural and Industrial Maintenance Coatings Rule. EPA is approving this revision to the Virginia SIP in accordance with the requirements of the Clean Air Act (CAA).

This regulation extends the temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Vip3Aa20 protein in corn when applied or used as a plant-incorporated protectant. Syngenta Seeds, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting that the temporary tolerance exemption be extended. This regulation eliminates the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa20 protein in corn when applied or used as a plant- incorporated protectant on field corn, sweet corn, and popcorn. The temporary tolerance exemption expires on October 31, 2009.

This notice announces EPA's order for the cancellations, voluntarily requested by the registrants and accepted by the Agency, of products containing the pesticide chlorpyrifos-methyl, pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows the July 7, 2004 Federal Register Notice of Receipt of Requests from the chlorpyrifos-methyl registrants to voluntarily cancel their Gustafson Reldan 4E Insecticide and Reldan 4E product registrations. These are not the last chlorpyrifos-methyl products registered for use in the United States. In the July 7, 2004 notice, EPA indicated that it would issue an order implementing the cancellations, unless the Agency received substantive comments within the 30 day comment period that would merit its further review of these requests, or unless the registrants withdrew their requests within this period. The Agency received comments on the notice that merited its further review of the requests. The Agency granted an extension of the existing registration of Gustafson Reldan 4E Insecticide and Reldan 4E until the availability of an equally effective stored grain product was registered. Storicide II, for broad-spectrum control of stored grain insects, was conditionally registered on October 27, 2004. EPA hereby issues in this notice a cancellation order granting the requested cancellations. Any distribution, sale, or use of the chlorpyrifos-methyl products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.

This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement.

U.S. Agency for International Development (USAID) has submitted the following information collections to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Comments should be sent via e-mail to David Rostker@omb.eop.gov or fax to 202-395-7285. Copies of submission may be obtained by calling (202) 712-1365.

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of additional persons whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1901-1908, 8 U.S.C. 1182). In addition, OFAC is publishing a change to the listing of one individual previously designated pursuant to the Foreign Narcotics Kingpin Designation Act.