February 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the opening of a public docket to make available to the public a report of the pediatric studies of meropenem that were conducted in accordance with section 409I of the Public Health Service Act (PHS Act) and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs.

The Food and Drug Administration (FDA) is announcing the availability of the final decision withdrawing approval of the breast cancer indication for AVASTIN (Bevacizumab). The Commissioner of Food and Drugs (the Commissioner) issued the decision following a June 2011 public hearing on a proposal to withdraw the approval.

In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-587, Land Description (Public Land States/Non-Public Land States [Rectangular or Non- Rectangular Survey System Lands in Public Land States]).

The Coast Guard proposes to establish a temporary safety zone upon certain waters of the Patapsco River, Northwest Harbor and Inner Harbor during the movement of the historic sloop-of-war USS CONSTELLATION on May 25, 2012. This action is necessary to provide for the safety of life on navigable waters during the tow of the vessel from its berth at the Inner Harbor in Baltimore, Maryland, to a point on the Patapsco River near the Fort McHenry National Monument and Historic Shrine in Baltimore, Maryland, and its return. This action will restrict vessel traffic in portions of the Patapsco River, Northwest Harbor, and Inner Harbor during the event.

This final rule sets forth a procedural framework for submission and review of initial applications for a Waiver for State Innovation described in section 1332 of the Patient Protection and the Affordable Care Act including processes to ensure opportunities for public input in the development of such applications by States and in the Federal review of the applications.

The Department of the Interior is requesting comments on its draft policy on consultation with Alaska Native Claims Settlement Act corporations.

The Coast Guard proposes amend its regulations requiring safety zones in the Captain of the Port Lake Michigan zone. This proposed rule is intended to amend the rules that restrict vessels from portions of water areas during events that pose a hazard to public safety. The safety zones amended or established by this proposed rule are necessary to protect spectators, participants, and vessels from the hazards associated with various maritime events.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to approve the following information collection: Transit Safety Survey.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Under the terms of the existing concession contract, the National Park Service intends to request an extension of visitor services in Mount Rainier National Park for a period not to exceed one year from the expiration date of the current contract.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance 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 to ensure that requested data can be 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 Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of ``General Inquiries to State Agency Contacts.'' A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Michael W. Miller, Ph.D., State University of New York, Upstate Medical University: Based on the report of an investigation conducted by the State University of New York, Upstate Medical University (SUNY UMU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Michael W. Miller, former Professor and Chair, Department of Neuroscience and Physiology, SUNY UMU, engaged in research misconduct in research supported by National Institute of Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), grants R01 AA07568-18A1, R01 AA06916, and P50 AA017823-01. ORI finds that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in grant applications R01 AA07568-18, R01 AA07568-18A1, R01 AA006916-25, and P50 AA017823-01 and in the following: Miller, M.W., Hu, H. ``Lability of neuronal lineage decisions is revealed by acute exposures to ethanol.'' Dev. Neurosci. 31(1-2):50-7, 2009 (``Dev. Neurosci. 2009'') Bruns, M.B., Miller, M.W. ``Functional nerve growth factor and trkA autocrine/paracrine circuits in adult rat cortex are revealed by episodic ethanol exposure and withdrawal.'' J. Neurochem. 100(5):1115-68, 2007 (``J. Neurochem. 2007'') A prepared manuscript submitted to PNAS for publication. As a result of its investigation, SUNY UMU recommended that Dev. Neurosci. 2009 and J. Neurochem. 2007 be retracted. Both publications have now been retracted: Dev. Neurosci. 2009 was retracted online on January 19, 2012, at: https://content.karger.com/ProdukteDB/ produkte.asp?Aktion=ShowPDF&ArtikelNr=323471&Ausgabe=0&Produk tNr=224107& filename=323471.pdf. J. Neurochem. 2007 was retracted online on January 23, 2012, at: https://onlinelibrary.wiley.com/doi/10.1111/j.1471- 4159.2012.07662.x/full. Specifically, ORI finds that the Respondent: Falsified Figure 5 in NIH grant application R01 AA07568- 18A1 by altering the bar graphs to make the experimental results appear valid and consistent with his hypothesis that ethanol exposure in-utero alters the transition of cells from Pax 6 expression to Tbr2 expression, which is critical to normal brain development. Specifically: a. In the VZ/SZ panel (upper row, right), Dr. Miller decreased the values by 50% for the bar graphs representing control and treated mice for ``Tbr2,'' ``both,'' and ``both/Ki-67,'' to falsely report an equivalent frequency of Tbr2 expressing cells in the right and left panels; this result was required for the experiment to appear valid; b. In the MGE panel (lower row, right), Dr. Miller altered the bar graphs representing control and treated mice for ``Ki-67,'' ``Pax6,'' and ``both'' to falsely report that ethanol increased the frequency of K-67+ cells and to report an equivalent frequency of Pax expressing cells in the right and left panels. Fabricated bar graphs in Supplemental Figure 2 in a manuscript submitted to PNAS and text in the manuscript also appearing in the grant application AA00616-25 to support the hypothesis that ethanol exposure during postnatal weeks 1 and 2 causes specific neuronal cell death in layers II/III and V of the cortex. Specifically, Dr. Miller: a. Fabricated bar graphs in Supplemental Figure 2 and related text in the PNAS manuscript to show that in select layers of the cortex, ethanol induced neuronal death occurred in post-natal day 10 (P10) mice; b. Included fabricated text in the PNAS manuscript and the grant application citing results of experiments using 15-25-day-old mice treated with ethanol during the second postnatal week, when these mice were never generated. Falsified Figure 6 in a manuscript submitted to PNAS by altering data points for the labeling index of caspase3 and TUNEL in cortex layers II/III and V after exposure to ethanol in postnatal day 7 (P7) mice, such that the two assays confirmed each other. The same data were also included as Figure 4 in NIH grant application R01 AA06916 and as Figure 7 in a poster presentation at the 2009 Research Society on Alcoholism. Falsified the figure legends and/or text in a published paper and multiple grant applications to support the primary hypothesis of the published paper that gestational alcohol exposure had an effect on brain development by affecting the way neurons differentiate and migrate into the cortex, rather than by changes to cell growth or death. Specifically, Dr. Miller falsely reported the number of animals (n) that were used in figure legends and/or text in the following: [cir] Figures 2 and 5, Dev. Neurosci. 2009, also included as Figures 3 and 4, respectively, in R01 AA07568-18; [cir] Figure 4 and Table 2 in P50 AA017823-01. Falsified Figures 4 and 6 in J. Neurochem. 2007 by altering bar graphs to increase the significance of the effect of ethanol exposure and/or withdrawal on NGF or trkA protein expression, thereby conforming with the paper's hypothesis that ethanol exposure and withdrawal affect the normal NGF/trkA circuits in cortical layer V. Specifically, Dr. Miller: a. Increased the value of the ethanol treated NGF expression in Figure 4 and decreased the value of withdrawal NFG to alter the difference between the two from approximately 2.2% to 11.6%, thereby falsely reporting significance where there was none; b. In Figure 6: (a) Increased the value of withdrawal trkA data by approximately 70% to falsely report significance with relation to the ethanol treated value and increase significance with relation to the control; (b) Increased the value of the ethanol treated phospho-trkA data by approximately 100% to increase the significance with relation to the control; (c) Falsely reported the results for Figure 6 as showing a nearly doubled ratio of p-trkA to total trkA after ethanol exposure when there was no increase at all. Dr. Miller has entered into a Voluntary Exclusion Agreement (Agreement). Dr. Miller neither admits nor denies committing research misconduct but accepts ORI has found evidence of research misconduct as set forth above. Dr. Miller has voluntarily agreed: (1) To exclude himself voluntarily from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations'') for a period of one (1) year, beginning on February 6, 2012; (2) To have his research supervised for a period of two (2) years immediately following the one (1) year period of exclusion; Respondent agrees that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to the Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution as outlined below; Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; the requirements for Respondent's supervision plan are as follows: i. A committee of 2-3 senior faculty members at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for two (2) years immediately following the period of exclusion; the committee will review primary data from Respondent's laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates, Respondent's compliance with appropriate research standards, and confirming the integrity of Respondent's research; and ii. The committee will conduct an advance review of any PHS grant applications (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts; the review will include a discussion with Respondent of the primary data represented in those documents and include a certification to ORI that the data presented in the proposed application/publication is supported by the research record; (3) That any institution employing him during the two (2) years during which the supervisory plan is in effect shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (4) To exclude himself 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 for a period of three (3) years, beginning on February 6, 2012.