2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), to establish the fiscal year (FY) 2008 fees that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. The Federal Food, Drug, and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to collect user fees for certain direct-to-consumer (DTC) television advertisements submitted to FDA for advisory review.

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.

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.

As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-0020 at https:// www.regulations.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.- flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388.

In accordance with 15 U.S.C. Section 1512 and Executive Order 11625, the Minority Business Development Agency (MBDA) is soliciting competitive applications from organizations to operate a Minority Business Opportunity Center (MBOC) in the locations and geographical service areas specified in this notice. The MBOC operates through the use of business consultants and provides business assistance and brokering services directly to eligible minority-owned businesses. The MBOC Program's primary evaluation criterion is the dollar value of contracts and financial transactions awarded to eligible minority business enterprises (MBEs). Responsibility for ensuring that applications in response to this competitive solicitation are complete and received by MBDA on time is the sole responsibility of the applicant. Applications submitted must be to operate an MBOC and to provide business assistance and brokering services to eligible clients. Applications that do not meet these requirements will be rejected. This is not a grant program to help start or to further an individual business.

On March 7, 2007, notice was published on page 10289 of the Federal Register (volume 72, number 44) of determinations made by the Department of State pertaining to the Exhibit, ``The World of 1607.'' The referenced notice is corrected as to additional objects to be included in the exhibition. Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects to be included in the exhibition ``The World of 1607'', imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Jamestown Settlement, Williamsburg, Virginia, from on or about January 1, 2008, until on or about April 25, 2008, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2007.

The Food and Drug Administration (FDA) is reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005 (70 FR 60751), (herein after referred to as the 2005 proposed rule). In that document, FDA proposed to amend its regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA received a number of comments that were opposed to the proposed requirement to declare fluid UF milk, when used, as ``ultrafiltered milk'' or ``ultrafiltered nonfat milk,'' as appropriate, in the ingredient statement of the finished cheese. FDA is reopening the comment period on the 2005 proposed rule to seek further comment only on two specific issues raised by the comments concerning the proposed ingredient declaration.

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.

The Assistant Secretary for Special Education and Rehabilitative Services, the Assistant Secretary for Vocational and Adult Education, and the Assistant Secretary for Postsecondary Education jointly propose a priority and definitions for a center on postsecondary education for students with intellectual disabilities under the DRRP program administered by NIDRR. The Assistant Secretary for Special Education and Rehabilitative Services may use this priority for competitions in fiscal year (FY) 2008 and later years. We take this action to focus attention on an area of national need. We intend this priority to improve postsecondary education and other outcomes for individuals with intellectual disabilities.

On August 7, 2007, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on purified carboxymethylcellulose (CMC) from Mexico. See Purified Carboxymethylcellulose From Mexico: Notice of Preliminary Results of Antidumping Duty Administrative Review, 72 FR 44095 (August 7, 2007) (Preliminary Results). The review covers exports of the subject merchandise to the United States produced and exported by Quimica Amtex S.A. de C.V. (Amtex). We invited interested parties to comment on the preliminary results. Based upon our analysis of the comments received from parties, we have made changes in the margin calculation for the final results of this review. The final weighted- average margin is listed below in the ``Final Results of Review'' section of this notice.

On October 4, 2007, the Department of Commerce (``Department'') published in the Federal Register the final results and partial rescission of the 19th administrative review of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished, from the People's Republic of China (``PRC''). See Tapered Roller Bearings and Parts Thereof, Finished or Unfinished, from the People's Republic of China: Final Results of 2005-2006 Administrative Review and Partial Rescission of Review, 72 FR 56724 (October 4, 2007) (``Final Results''), and accompanying Issues and Decision Memorandum (September 24, 2007). The period of review (``POR'') covered June 1, 2005, through May 31, 2006. We are amending our Final Results to correct a ministerial error made in the ``Scope of Order'' section therein, pursuant to section 751(h) of the Tariff Act of 1930, as amended (``Act'').

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 information collection requirements for reports of corrections and removal.

Notice is hereby given that a request for a scientific research permit [File No. 1039-1916] submitted by Ann Zoidis, Cetos Research Organization, 11 Des Isle Avenue, Bar Harbor, Maine has been denied.

The following permits were issued.

The Securities and Exchange Commission is publishing this adopting release to codify the meaning of Rule 14a-8(i)(8) under the Securities Exchange Act of 1934. Rule 14a-8 provides shareholders with an opportunity to place certain proposals in a company's proxy materials for a vote at an annual or special meeting of shareholders. Subsection (i)(8) of the Rule permits exclusion of certain shareholder proposals related to the election of directors. The Commission is adopting an amendment to Rule 14a-8(i)(8) to provide certainty regarding the meaning of this provision in response to a recent court decision.

EPA is proposing to make a determination under the Clean Air Act (CAA) that the nonattainment area of Kewaunee County has attained the 8-hour ozone National Ambient Air Quality Standard (NAAQS). This determination is based on quality-assured ambient air quality monitoring data for the 2004-2006 ozone seasons that demonstrate that the 8-hour ozone NAAQS has been attained in the area. Preliminary monitoring data for 2007 continue to show monitored attainment of the NAAQS. EPA is proposing to approve a request from the State of Wisconsin to redesignate the Kewaunee County area to attainment of the 8-hour ozone NAAQS. The Wisconsin Department of Natural Resources (WDNR) submitted this request on June 12, 2007. In proposing to approve this request EPA is also proposing to approve, as a revision to the Wisconsin State Implementation Plan (SIP), the State's plan for maintaining the 8-hour ozone NAAQS through 2018 in the area. EPA also finds adequate and is proposing to approve the State's 2012 and 2018 Motor Vehicle Emission Budgets (MVEBs) for the Kewaunee County area.

The State of Rhode Island has applied to EPA for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this immediate final action.

We are correcting an error in the cold treatment regulations that resulted from the publication of an interim rule on July 2, 2007, that was effective on August 31, 2007, and the publication of a separate final rule on July 18, 2007, that was effective on August 17, 2007. Because the July 18 final rule reorganized the cold treatment regulations, changes we made in the July 2 interim rule inadvertently removed provisions relating to places for cold treatment and ports of entry from the regulations when the interim rule became effective on August 31, 2007. This correction amends the regulations by reinstating those provisions.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps ensure that requested data is provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

Pursuant to National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of a Final Environmental Impact Statement for the Elk and Vegetation Management Plan, Rocky Mountain National Park, Colorado. This Final Plan analyzes five alternatives, including a no action alternative, to manage elk and vegetation within the Park. Alternative 3, the preferred alternative, would use a variety of conservation tools including fencing, redistribution of elk, vegetation restoration and lethal reduction of elk (culling). The number of elk removed would vary each year based on annual population surveys and hunter success outside the park.