December 13, 2010 – Federal Register Recent Federal Regulation Documents

The Department of Commerce is seeking nominations for membership on the Marine Protected Areas Federal Advisory Committee (Advisory Committee). The Advisory Committee was established to advise the Secretary of Commerce and the Secretary of the Interior in implementing Section 4 of Executive Order 13158, specifically on strategies and priorities for developing the national system of marine protected areas (MPAs) and on practical approaches to further enhance and expand protection of new and existing MPAs. Nominations are sought for highly qualified non-Federal scientists, resource managers, and people representing other interests or organizations involved with or affected by marine conservation including in the Great Lakes. Six members of the Committee have terms that expire October 31, 2011, and nominations are sought to fill these vacancies. Individuals seeking membership on the Advisory Committee should possess demonstrable expertise in a related field or represent a stakeholder interest affected by MPAs. Nominees also will be evaluated based on the following factors: marine policy experience, leadership and organization skills, region of country represented, and diversity characteristics. The membership reflects the Department's commitment to attaining balance and diversity. The full text of the Advisory Committee Charter and its current membership can be viewed at the Agency's Web page at https://mpa.gov.

This action proposes to revise Class E airspace at Platinum AK. The creation of a new Standard Instrument Approach Procedure (SIAP) at the Platinum Airport has made this action necessary to enhance safety and management of Instrument Flight Rules (IFR) operations.

The ONMS is seeking applications for the following vacant seats on the Hawaiian Islands Humpback Whale National Marine Sanctuary Advisory Council: Honolulu County (primary only), Research (alternate only), Commercial Shipping, Whale Watching, Ocean Recreation, Business/ Commerce, Citizen-at-Large, Conservation, Tourism, Lanai Island Representative, and Molokai Island Representative. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members should expect to serve two-year terms, pursuant to the council's charter.

This action proposes special conditions for the Gulfstream GVI airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include an electronic flight control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Department of the Army announces that, unless there is an objection, after 15 days it contemplates granting an exclusive license to Polymer Processing Institute, a not-for-profit corporation having a place of business in the New Jersey Institute of Technology Campus in Newark, New Jersey, to produce the following inventions: ARDEC Reference 2006-043, and U.S. patent application 12/ 483420``Foamed Celluloid Mortar Propellant Increment Containers'' Inventors Ming-Wan Young, Costas G. Gogos; Niloufar Faridi; Linjie Zhu; Peter Bonnett; Howard Shimm; Elbert Caravaca; Joseph Palk. ARDEC Reference 2006-043 continuation (disclosure) ``Foamed Celluloid and Applications Therefor''. ARDEC Reference 2009-014 (disclosure)``Prepare Foamed Energetic Material at a High Production Rate''Inventors Linjie Zhu; Fei Shen; Ming-wan Young; Costas G. Gogos; Chong Peng; Mohamed Elalem; Joseph Palk; Howard (Howie) Shimm, Dale Conti; Elbert Caravaca; Peter Bonnett. ARDEC Reference 2009-015 (disclosure)``Prepare Foamed Energetic Material by Expandable Bead Methodology''Inventors Niloufar Faridi; Linjie Zhu; Ming-wan Young; Costas G. Gogos; Kuanyin Lin; Mohamed Elalem; Joseph Palk; Elbert Caravaca; Dale Conti. Any license granted shall comply with 35 U.S.C. 209 and 37 CFR part 404.

The FAA proposes to supersede an existing airworthiness directive (AD) for General Electric (GE) CF6-45/-50 series and CF6-80A series turbofan engines with certain part number (P/N) side links of the five-link forward mount assembly installed. That AD currently requires an initial and repetitive visual inspection of the side links for cracks, and stripping and reapplying the Sermetel W coating on the side link at every exposure of the side link. That AD also requires replacing the side links and pylon attachment bolts, and inspecting the fail-safe bolt and platform lug if the side links are cracked. This proposed AD would continue to require those same inspections and stripping and reapplying the Sermetel W coating, and would add two part numbers to the applicability. This proposed AD results from a review of the inspection program, which revealed that GE had omitted two affected part numbers from the applicability. We are proposing this AD to prevent failure of the side links and possible engine separation from the airplane.

The Gogebic Resource Advisory Committee will meet in Ironwood, Michigan. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose is to review and make recommendations on Title II Projects submitted by the Public.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Sagar S. Mungekar, PhD, New York University School of Medicine: Based on the Respondent's written admission and set forth below, the New York University School of Medicine (NYUSOM) and the Office of Research Integrity (ORI) found that Sagar S. Mungekar, PhD, former MD/ PhD student in the Sackler Institute of Graduate Biomedical Sciences at NYUSOM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM35769, R01 GM55624, and T32 GM07308, and National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant T32 AI007180. Dr. Mungekar admitted that in his PhD thesis he ``increased statistical significance of the calculated means and standards of deviation [sic] of the UV spectrophometic [sic] data presented by discarding certain experimental data and thus presented data that was falsified. In addition, as the repression ratios calculated and conclusions reached based on these data that included falsified data, those values and conclusions are fabricated. Approximately, 60-75 of the [Respondent's] PhD research data was changed or falsified.'' Dr. Mungekar also admitted ``while doing these experiments, I did not sequence all of the constructs that I constructed, thus, I could not be certain of the exact identity of the plasmids in question.'' ORI found that Dr. Mungekar engaged in research misconduct (42 CFR 93.103) by fabricating and falsifying data. Specifically, ORI found that Dr. Mungekar falsified five tables and five figures (Tables 2-1, 2-2, 3-1, 4-1, 4-2 and Figures 2-3, 3-1, 3-2, 4-3, and 4-4) in his Ph.D. thesis entitled ``Autoregulation of Ribonuclease E,'' by discarding certain spectrophotometric data, to increase statistical significance, used to calculate repression ratios and RNA decay rates. Dr. Mungekar also claimed to have constructed 53 different reporter plasmids with RNase E mutants, when sequencing data did not exist to support this claim. Dr. Mungekar has entered into a Voluntary Settlement Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on November 22, 2010: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution; Respondent agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (2) that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-funded research in which he is involved, a certification to ORI that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report; and (3) to exclude himself voluntarily from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for designated officers, medical facilities, and State and community public health officers regarding exposure of emergency response employees (EREs) to potentially life-threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. CDC is seeking comment on the list of diseases and guidelines contained in this notice.

Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, the Council on Environmental Quality Final Regulations (40 CFR Parts 1500 through 1508), and the United States Section`s Operational Procedures for Implementing Section 102 of NEPA, published in the Federal Register September 2, 1981, (46 FR 44083); the USIBWC hereby gives notice of availability of the Final Environmental Assessment and FONSI for Arroyo Colorado South Levee Rehabilitation Project located in Cameron and Hidalgo Counties, Texas are available. An environmental impact statement will not be prepared.

In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on a new information collection for the National Pipeline Registry. PHMSA is preparing to request Office of Management and Budget (OMB) approval for a new information collection.

Notice is hereby given that the U.S. International Trade Commission has determined to extend the deadline for filing submissions on remedy, the public interest, and bonding in the above-captioned investigation.