January 7, 2013 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Paul J. Muchowski, Ph.D., The J. David Gladstone Institutes: Based on the report of an investigation conducted by The J. David Gladstone Institutes (Gladstone) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Paul J. Muchowski, former Senior Investigator, Gladstone Institute of Neurological Disease, Gladstone, engaged in research misconduct in research supported by National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS054753-06A1. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating data that was included in one (1) funded NIH grant R01 NS054753-06A1 and two (2) submitted NIH grant applications R01 NS054753-06 and R01 NS047237-06. Specifically, ORI finds that the Respondent knowingly and intentionally: Falsely reported research experiments when the results did not exist at the time the grant applications were submitted. Specifically: [rtrif] in Figures 19-21 and related text of grant application R01 NS047237-06, the Respondent claimed he had successfully transduced human neuroblastoma SH-SY5Y cells expressing [alpha]-synuclein ([alpha]Syn) with lentiviruses containing small hairpin RNAs (shRNAs) that targeted Cog6, Stx7, Vps52, or Vps33a. The Respondent reported lentiviral expressed Cog6 significantly exacerbated [alpha]-Syn toxicity in SH-SY5Y cells, when only plasmid shRNAs were generated and utilized at the time the grant application was submitted. [rtrif] in Figure 5 and the accompanying text of grant R01 NS054753-06A1, the Respondent described the insertion of toxic and inert mutant huntingtin (htt) fragments into maltose binding protein- Htt-Cerulean constructs with a nonpathogenic (25Q) or pathogenic (46Q) polyQ repeat, with and without Cerulean. The modified proteins were claimed to have been purified, when the constructs had not been made at the time the grant was submitted. [rtrif] in Figures 5 and 6 and the accompanying text of grant R01 NS054753-06A1, the Respondent claimed to have cloned toxic and inert mutant htt fragments into lentiviral constructs and generated lentiviruses, when the constructs were not made. [rtrif] in Figure 6 and related text in grant R01 NS054753-06A1, the Respondent claimed to have tested immunoblots of lysates from primary neurons with an antibody against mutant htt, which demonstrated that levels of htt expression in transduced cells were roughly equivalent to levels in normal neurons, when the experiment was not conducted. Falsified Figure 3 of grant application R01 NS054753-06 by labeling the Western blot images for the expression of mutant htt in lentiviral-transduced primary neurons as `Cortex' (left panel) and `Striatum' (right panel), when the results were actually from the microglial cell lines N9 and BV2, respectively. Dr. Muchowski has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on December 10, 2012: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for PHS support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and (2) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Commission is noticing a recent Postal Service filing concerning the addition of Global Expedited Package ServicesNon- Published Rates 4 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

We (National Park Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on June 30, 2013. We may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

Applicant seeks an order declaring that it has ceased to be an investment company. The applicant transferred its assets to a series of Managers AMG Funds, and on June 29, 2012, made a final distribution to its shareholders based on net asset value. Expenses of $2,889,552 incurred in connection with the reorganization were paid by Yacktman Asset Management Co., applicant's investment adviser, and Managers Investment Group LLC, the surviving fund's investment adviser. Filing Dates: The application was filed on October 4, 2012 and amended on December 11, 2012. Applicant's Address: 6300 Bridgepoint Pkwy., Building One, Suite 320, Austin, TX 78730.

This document contains proposed regulations that create a new taxpayer identifying number known as an IRS truncated taxpayer identification number, a TTIN. As an alternative to using a social security number (SSN), IRS individual taxpayer identification number (ITIN), or IRS adoption taxpayer identification number (ATIN), the filer of certain information returns may use a TTIN on the corresponding payee statements to identify the individual being furnished a statement. The TTIN displays only the last four digits of an individual's identifying number and is shown in the format XXX-XX- 1234 or ***-**-1234. These proposed regulations affect filers of certain information returns who will be permitted to identify an individual payee by use of a TTIN on the payee statement furnished to the individual, and those individuals who receive payee statements containing a TTIN.

On July 12, 2012, the Commodity Futures Trading Commission (``Commission'' or ``CFTC'') published for public comment, pursuant to section 4(c) of the Commodity Exchange Act (``CEA''), a proposed order (``Proposed Order'') that would grant market participants temporary conditional relief from certain provisions of the CEA, as amended by Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank Act'' or ``Dodd-Frank''), and the Commission also published its proposed interpretive guidance and policy statement (``Proposed Guidance'') regarding the cross-border application of the swap provisions of the CEA as added by Title VII of the Dodd-Frank Act. The Commission is proposing further guidance on certain specific aspects of the Proposed Guidance (``Further Proposed Guidance''). The Commission has separately determined to finalize the Proposed Order.

EPA is proposing to approve revisions to the Imperial County Air Pollution Control District (ICAPCD) portion of the California Implementation Plan (SIP). These revisions concern local rules that regulate inhalable particulate matter (PM10) emissions from sources of fugitive dust such as unpaved roads and disturbed soils in open and agricultural areas in Imperial County. We are proposing to approve local rules that regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

EPA is taking final action to determine that the Nogales nonattainment area in Arizona has attained the 2006 24-hour fine particle (PM2.5) National Ambient Air Quality Standard (NAAQS). This determination is based upon complete, quality-assured, and certified ambient air monitoring data showing that this area has monitored attainment of the 2006 24-hour PM2.5 NAAQS based on the 2009-2011 monitoring period. Based on the above determination, the requirements for this area to submit an attainment demonstration, together with reasonably available control measures (RACM), a reasonable further progress (RFP) plan, and contingency measures for failure to meet RFP and attainment deadlines are suspended for so long as the area continues to attain the 2006 24-hour PM2.5 NAAQS.

EPA is proposing to approve revisions to the San Diego Air Pollution Control District (SDAPCD), Northern Sierra Air Quality Management District (NSAQMD), and Sacramento Metropolitan Air Quality Management District (SMAQMD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from transfer of gasoline at gasoline dispensing facilities. We are proposing to approve four local rules to regulate these emission sources under the Clean Air Act (CAA or the Act).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Using Health Information Technology in Practice Redesign: Impact of Health Information Technology on Workflow.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on October 31st, 2012 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

EPA is making a determination of attainment regarding the Philadelphia-Wilmington, PA-NJ-DE fine particulate matter (PM2.5) nonattainment area (hereafter referred to as ``the Philadelphia Area'' or ``the Area''). EPA has determined that the Philadelphia Area has attained the 2006 24-hour PM2.5 National Ambient Air Quality Standard (NAAQS), based upon quality- assured, quality-controlled and certified ambient air monitoring data for the 2008-2010 and 2009-2011 periods. Preliminary data available for 2012 are consistent with continued attainment of the Philadelphia Area. This determination of attainment suspends the requirements for the respective state portions of the Philadelphia Area to submit an attainment demonstration and associated reasonably available control measures (RACM), a reasonable further progress (RFP) plan, contingency measures, and other planning State Implementation Plan (SIP) revisions related to the attainment of the standard for so long as the Area continues to attain the 2006 24-hour PM2.5 NAAQS. This action is being taken under the Clean Air Act (CAA). This action does not constitute a redesignation to attainment, and the Philadelphia Area will remain designated nonattainment for the 2006 24-hour PM2.5 NAAQS until such time as EPA determines that the Philadelphia Area, or portion thereof, meets the CAA requirements for redesignation to attainment for the standard, including an approved maintenance plan.

In December 2011, the ODNI accepted responsibility from the Information Security Oversight Office for the maintenance of Standard Form 312: Classified Information Nondisclosure Agreement; Standard Form 713: Consent For Access to Records; and Standard Form 714: Financial Disclosure Report, which are directly related to responsibilities assigned to the Director of National Intelligence (DNI) as Security Executive Agent. Accordingly, ODNI is giving public notice regarding its acceptance of responsibility of the aforementioned forms. Also, section 10 of the Standard Form 312 is being updated as described in the Supplementary Information.

EPA is taking direct final action to approve the Limited Maintenance Plan (LMP) submitted by the State of Alaska on September 29, 2010 for the Eagle River nonattainment area (Eagle River NAA) and the State's request to redesignate the area to attainment for the National Ambient Air Quality Standards (NAAQS) for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM10).

PHMSA is amending the Hazardous Materials Regulations to maintain alignment with international standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the Hazardous Materials Regulations (HMR) with recent changes made to the International Maritime Dangerous Goods (IMDG) Code, the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the United Nations Recommendations on the Transport of Dangerous GoodsModel Regulations (UN Model Regulations) and address a petition for rulemaking.

As authorized by 46 U.S.C. 12121, 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.