Office of the Secretary February 27, 2012 – Federal Register Recent Federal Regulation Documents

The Office of the Secretary published a document in the Federal Register of February 3, 2012, announcing the first meeting of the National Commission on Indian Trust Administration and Reform (the Commission). This notice corrects the times and address of the first meeting and extends the RSVP date to February 29, 2012.

Pursuant to 44 U.S.C. 3506(c)(2)(A) (the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.) the Office of the Under Secretary of Defense (Personnel and Readiness) announces the following proposed reinstatement of a public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) The accuracy of the agency's estimate of burden of the proposed information collection; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

Under the provisions of 10 U.S.C. 2166(e), the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.50(a), the Department of Defense gives notice that it is renewing the charter for the Board of Visitors for the Western Hemisphere Institute for Security Cooperation (hereafter referred to as ``the Board''). The Board shall provide the Secretary of Defense, through the Secretary of the Army, with independent advice and recommendations on matters pertaining to the operations and management of the Institute. The Board shall: (a) Inquire into the curriculum, instruction, physical equipment, fiscal affairs, and academic methods of the Institute; other matters relating to the Institute that the Board decides to consider; and any other matter that the Secretary of Defense determines appropriate; (b) Review the curriculum to determine whether it adheres to U.S. doctrine, complies with applicable U.S. laws and regulations, and is consistent with U.S. policy goals toward Latin America and the Caribbean; and (c) Determine whether the Institute emphasizes human rights, including the rule of law, due process, civilian control of the military, and the role of the military in a democratic society. The Board shall report to the Secretary of Defense through the Secretary of the Army. The Board shall be comprised of no more than fourteen members appointed by the Secretary of Defense. All Board member appointments must be renewed by the Secretary of Defense on an annual basis. The Board shall be comprised of: (a) Two Members of the Senate (the Chair and Ranking Member of the Armed Services Committee or their designees); (b) two Members of the House of Representatives (the Chair and Ranking Members of the Armed Services Committee or their designees); (c) one person designated by the Secretary of State; the senior military officer responsible for training and education in the U.S. Army (or designee); the commanders of the combatant commands with geographic responsibility for the Western Hemisphere (U.S. Northern Command and U.S. Southern Command (or designees); and (d) six persons designated by the Secretary of Defense, including, to the extent practicable, persons from academia, religious institutions, and human rights communities. Board members appointed by the Secretary of Defense, who are not full-time or permanent part-time federal employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109 and shall serve as special government employee members. With the exception of travel and per diem for official Board related travel, Board members shall serve without compensation. The Secretary of Defense may approve the appointment of Board members for one to four year terms of service; however, no member, unless authorized by the Secretary of Defense, may serve more than two consecutive terms of service. This same term of service limitation also applies to any DoD authorized subcommittees. Whenever possible, appointments shall be staggered to avoid complete turnover of the Board's membership at one time. In addition, the Board may be assisted by non-voting subject matter experts or consultants. These consultants are designated at the request of the Board by the Secretary of the Army with the concurrence of the Secretary of Defense. Each Board member is appointed to provide advice on behalf of the government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. The Department, when necessary, and consistent with the Board's mission and DoD policies and procedures may establish subcommittees deemed necessary to support the Board. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense or the advisory committee's sponsor. Such subcommittees shall not work independently of the chartered Board, and shall report all their recommendations and advice to the Board for full deliberation and discussion. Subcommittees have no authority to make decisions on behalf of the chartered Board; nor can any subcommittee or its members update or report directly to the Department of Defense or any Federal officers or employees. All subcommittee members shall be appointed in the same manner as the Board members; that is, the Secretary of Defense shall appoint subcommittee members even if the member in question is already a Board member. Subcommittee members, with the approval of the Secretary of Defense, may serve a term of service on the subcommittee of one to four years; however, no member shall serve more than two consecutive terms of service on the subcommittee. Subcommittee members, if not full-time or part-time government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109, and shall serve as special government employees, whose appointments must be renewed by the Secretary of Defense on an annual basis. With the exception of travel and per diem for official Board related travel, subcommittee members shall serve without compensation. All subcommittees operate under the provisions of FACA, the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), governing Federal statutes and regulations, and governing DoD policies/ procedures.

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.