July 14, 2011 – Federal Register Recent Federal Regulation Documents

The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans, that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project along Interstate 805, San Diego, CA, PM: 4.4-15.8 in the County of San Diego, State of California. Those actions grant licenses, permits, and approvals for the project.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on June 8, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Freescale Semiconductor, Inc. of Austin, Texas. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain integrated circuits, chipsets, and products containing same including televisions by reason of infringement of certain claims of U.S. Patent No 5,467,455 (``the `455 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.

Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 8) granting a joint motion to terminate the investigation.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe and effective use or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products. This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight of companion diagnostic devices; clarifies that, in most circumstances, if use of a companion diagnostic device is essential for the safe and effective use of a therapeutic product, the diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling; provides guidance for industry and FDA staff on possible premarket regulatory pathways and FDA's regulatory enforcement policy; and describes certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulate concomitant use of a companion diagnostic device to ensure safety and effectiveness of the therapeutic product. This draft guidance is not final, nor is it in effect at this time.

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following 7 grantees: Colorado, Iowa, Kansas, Louisiana, Minnesota, South Carolina, and Vermont to develop and implement their Tracking Networks. These activities are proposed by the above-mentioned grantees in their FY 2011 applications submitted under funding opportunity EH09-907, ``National Environmental Public Health Tracking ProgramNetwork Implementation (EPHT),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $4,920,000 in ACA funding will be awarded to the grantees for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH09-907:

We, the Fish and Wildlife Service, as lead agency advise the public that we intend to prepare an environmental impact statement (EIS) on a proposed application, including a Habitat Conservation Plan (HCP), for an Incidental Take Permit (ITP) under the Endangered Species Act of 1973, as amended. The potential ITP would include federally listed and candidate species within portions of nine states (North Dakota, South Dakota, Montana, Colorado, Nebraska, Kansas, New Mexico, Oklahoma, and Texas). The activities covered by a potential ITP would include regional- level construction, operation, and maintenance associated with multiple commercial wind energy facilities. The planning partners are currently considering, for inclusion in the HCP, certain species listed as federally threatened or endangered, or having the potential to become listed during the life of the HCP, and having some likelihood of being taken by the applicant's activities within the proposed permit area. The intended effect of this notice is to gather information from the public to develop and analyze the effects of the potential issuance of an ITP that would facilitate wind energy development within the planning area, while minimizing incidental take and mitigating the effects of any incidental take to the maximum extent practicable. We provide this notice to (1) Describe the proposed action; (2) advise other Federal and state agencies, potentially affected tribal interests, and the public of our intent to prepare an EIS; (3) announce the initiation of a 90-day public scoping period; and (4) obtain suggestions and information on the scope of issues and possible alternatives to be included in the EIS.

The Commodity Futures Trading Commission (``CFTC'' or ``Commission'') is adopting final rules pursuant to section 753 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank Act''), to implement amended subsections (c)(1) and (c)(3) of section 6 of the Commodity Exchange Act (``CEA''). These rules broadly prohibit fraud and manipulation in connection with any swap, or contract of sale of any commodity in interstate commerce, or contract for future delivery on or subject to the rules of any registered entity.

The Postal Service is amending 39 CFR part 241 to improve the administration of the Post Office closing and consolidation process. In addition, certain procedures employed for the discontinuance of Post Offices are applied to the discontinuance of other types of retail facilities operated by Postal Service employees.

This proposed rule updates HUD's regulations to conform to the statutory requirement that appraisers must be certified, rather than licensed, by a state appraisal licensing board in order to appear on the FHA Appraiser Roster. This requirement was established by the Housing and Economic Recovery Act of 2008. Although current HUD practice is in compliance with the statutory mandate, the regulations reflect outdated prior policy of permitting state-licensed appraisers to be listed on the FHA Appraiser Roster. In addition, HUD has taken this opportunity to update the FHA Appraiser Roster by replacing the obsolete references to the Credit Alert Interactive Voice Response System with references to its successor, the online-based Credit Alert Verification Reporting System.

On June 29, 2011, OSM published an interim rule approving a program amendment submitted by the West Virginia Department of Environmental Protection (WVDEP). The interim rule provided an opportunity for public comment and gave the comment due date and tentative hearing date. The summary and preamble to the interim rule specified that it was effective upon publication; however, the DATES section of the rule failed to list an effective date. This final rule corrects that omission by providing an effective date.

Pursuant to the Environmental Protection Agency's (EPA) authority in the Clean Air Act (CAA or Act), section 110(k)(5), to call for plan revisions, EPA is making a finding that the Iowa State Implementation Plan (SIP) is substantially inadequate to maintain the 2006 24-hour National Ambient Air Quality Standard (NAAQS) for Fine Particulate Matter (PM2.5) in Muscatine County, Iowa. The specific SIP deficiencies needing revision are described below. EPA is also finalizing a timeline for Iowa to revise its SIP to correct these deficiencies by a date which is no later than 18 months after the effective date of this rule.

The Regional Administrator of EPA Region 10 is hereby granting a waiver from the Buy American requirements of ARRA Section 1605(a) under the authority of Section 1605(b)(2) [manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality] to the City for the purchase of Greensand Plus pressure filter media, manufactured in Brazil. This is a project specific waiver and only applies to the use of the specified products for the ARRA project being proposed. Any other ARRA recipient that wishes to use the same product must apply for a separate waiver based on project specific circumstances. The waiver applicant states that the project requires the Greensand Plus filter media for use in their new shallow aquifer treatment plant. The design specifications of the project require a combination treatment process comprised of greensand filtration and MIEX [supreg] treatment. The greensand filtration process will primarily target the removal of iron and manganese, whereas the proprietary MIEX [supreg] process targets removal of dissolved organic carbon and other anionic species. Greensand Plus is currently used in the City's existing water treatment plant 1. In 2005, the City utilized Greensand Plus for their greensand filter media during pilot testing, and identified that product as the desired filter media for the proposed water treatment plant. The Regional Administrator is making this determination based on the review and recommendations of the Drinking Water Unit. The City has provided sufficient documentation to support their request.